SNM Board of Directors 2008 Mid-Winter Meeting...2008/02/15 · 2008 Mid-Winter Meeting February...

SNM Board of Directors 2008 Mid-Winter Meeting

February 15, 2008 6:00 – 10:00pm Terrace Room

Friday, February 15, 2008 SNM Board of Directors Meeting

1. Opening Schedule A. Commencement: 6:00pm

B. Cocktail Reception: 7:30pm

C. Dinner: 7:45pm

2. Commencement A. Welcome and Call to Order, Alexander J. B. McEwan, MD, President

B. Establishment of a Quorum, Alexander J. B. McEwan, MD, President

C. Approval of Agenda and Standing Rules, Alexander J. B. McEwan, MD

1) ACTION: Approval of Agenda

2) ACTION: Approval of Standing Rules

D. Approval of Prior Meeting Minutes, Richard Noto, MD

1) ACTION: Approval of September 29, 2007 Minutes

2) Minutes of the September 29, 2007 Board of Directors Meeting

3) ACTION: Approval of September 30, 2007 Minutes

4) Minutes of the September 30, 2007 Board of Directors Meeting

5) ACTION: Approval of November 13, 2007 Minutes

6) Minutes of the November 13, 2007 Board of Directors Meeting

7) ACTION: Approval of January 17, 2008 Minutes

8) Minutes of the January 17, 2008 Board of Directors Meeting

2. SNM President’s Report, Alexander J. B. McEwan, MD 3. SNM President-Elect Report, Robert W. Atcher, PhD

A. Academy of Radiology Research

B. Committee Restructuring

1) Discussion: Committee Restructuring

2) Committee Chair Orientation at Annual Meeting

4. Agenda Topics

A. National Research Universal (NRU) Nuclear Reactor, Alexander J. B. McEwan, MD

1) Discussion of Recent Challenges

2) Plan for Moving Forward

B. Committee on Pharmacopeia, Josepha Hung, MD

C. Bylaws Committee Update/Report, Warren H. Moore, MD, FACNP

D. Board of Directors Composition, Robert W. Atcher, PhD

E. Education and Research Foundation (ERF), Peter Kirchner, MD

Page 1 of 3

F. SNM Awards Committee, Mathew L. Thakur, PhD

1) Update on New Awards

5. Cocktail Reception (7:30pm) 6. Dinner (7:45pm) 7. New Business 8. Recess until reconvened, Saturday, February 16, 6:00pm 9. Informational Reports

A. CEO Report

B. SNM Committees

1) ACNP/SNM Joint Government Relations

2) Annual Meeting (General Program Chair)

3) Awards

4) Chapters

5) Coding and Reimbursement

6) Continuing Education

7) Councils

8) Education

9) Finance

10) Health Care Policy and Practice

11) MIRD

12) Nominations

13) Pharmacopeia

14) Practice Standards

15) Procedure Guidelines

16) Publications

17) Quality Assurance

18) Radiopharmaceuticals

19) Scientific Program

20) Young Professionals

C. SNM Council Reports

1) Academic Council

2) Brain Imaging Council

3) Cardiovascular Council

4) Computer and Instrumentation Council

5) Correlative Imaging Council

Page 2 of 3

6) GI Council

7) Nuclear Oncology Council

8) Pediatric Council

9) Radiopharmaceutical Council

D. SNM Liaison Organizations

1) BIROW

Page 3 of 3

Commencement

Welcome and Call to Order

Establishment of Quorum

Approval of Agenda and Standing Rules

RESOLUTION FORM SNM Board of Directors

February 15, 2008 ACTION ITEM: Approval of Meeting Agenda SUBMITTED BY: Alexander J. B. McEwan, MD PROPOSED RESOLUTION: Resolved, that the meeting agenda for the February 15,

2008 Board of Director’s Meeting be adopted. FINANCIAL IMPACT: N/A BACKGROUND: Robert’s Rules of Order (current issue) provide that it is

customary to adapt an agenda for each session in organizations that meet less than quarterly. An Agenda requires a two-thirds vote (or unanimous consent) in order to be changed.

ACTION: ADOPTED ___ DEFEATED ___ OTHER ___

ACTION

DATE (year-mo-day)

AYES

NAYS

Unanimous

NOTES

Adopted

Defeated

Revised

Withdrawn

Other

RESOLUTION FORM SNM Board of Directors

February 15, 2008

ACTION ITEM: Approval of Board of Directors Standing Rules SUBMITTED BY: Alexander J. B. McEwan, MD PROPOSED RESOLUTION: Resolved, that the standing rules of the Board of

Directors stated below be adopted for this meeting:

Raise hand to be recognized Those that have not yet spoken will get priority Limit discussion on any one topic to thirty (30)

minutes unless voted on by the Board with majority vote approving to extend discussion.

FINANCIAL IMPACT: N/A BACKGROUND: N/A ACTION: ADOPTED ___ DEFEATED ___ OTHER ___

ACTION

DATE (year-mo-day)

AYES

NAYS

Unanimous

NOTES

Adopted

Defeated

Revised

Withdrawn

Other

Approval of Meeting Minutes

RESOLUTION FORM

SNM Board of Directors February 15, 2008

ACTION ITEM: Approval of September 29, 2007 Board of Director’s

Minutes SUBMITTED BY: Richard B. Noto, MD Secretary/Treasurer PROPOSED RESOLUTION: Resolved, that the minutes from the Board of Director’s

September 29, 2007 Meeting be adopted. FINANCIAL IMPACT: N/A BACKGROUND: N/A SUPPORT MATERIAL: September 29, 2007, Board of Director’s Meeting

Minutes. ACTION: ADOPTED ___ DEFEATED ___ OTHER ___

ACTION

DATE (year-mo-day)

AYES

NAYS

Unanimous

NOTES

Adopted

Defeated

Revised

Withdrawn

Other

SNM Board of Directors Fall Meeting

Hyatt Regency, Reston, VA September 29,2007

SNM Members in Attendance: Alexander JB McEwan, MD; Robert W. Atcher, PhD, MBA; Peter S. Conti, MD, PhD; Michael M. Graham, MD, PhD; David Gilmore, CNMT, RT(R), RT(N); Mark Wallenmeyer, CNMT, RT(R), RT(N); Author J. Hall, CNMT, FSNMTS, Frances K. Keech, MBA, RT(N), FSNMTS; Warren R. Janowitz, MD, JD; Mathew L. Thakur, PhD; Leonie L. Gordon, MD; Paul H. Murphy, PhD; Gary L. Dillehay, MD; Warren R. Janowitz, MD, JD; Peter Herscovitch, MD; Bennett S. Greenspan, MD; Peter T. Kirchner, MD; Heinrich R. Schelbert, MD, PhD; Richard B. Noto, MD, Virginia Pappas, CAE; SNM Staff in Attendance: Michael Nelson, CAE; Rebecca Maxey; Naomi Lynn Barnes; Hugh Cannon; Marybeth Howlett; Joanna Spahr; Jane Day; Cecilia Noblett; Teri Pinkham; Vince Pistilli; Nikki Wenzel; Nicole Kern, Ivone Wells A. Welcome and Call to Order: The SNM President, Alexander J.B. McEwan, MD, called the meeting to order at 1:13pm and welcomed all SNM Board meeting attendees.

1. Establishment of Quorum: Dr. Richard B. Noto, SNM Secretary/Treasurer, established that there was a quorum.

2. Approval of the Agenda and Standing Rules:

a. A motion was made to approve the Standing Rules of the Board of Directors.

• Raise hand to be recognized. • Those that have not yet spoken will get priority. • Limit discussion on any one topic to thirty (30) minutes unless voted on

by the Board with majority vote approving to extend discussion.

It was moved, seconded and voted to approve the Standing Rules of the Board of Directors.

b. The agenda was reviewed.

It was moved, seconded and voted to approve the meeting agenda for the SNM Board of Directors meeting on Saturday, September 29, 2007.

3. Approval of Meeting Minutes:

The minutes from the SNM Board of Directors Annual Meeting, and July and August conference calls were reviewed. Dr. Janowitz requested that his name be added to the attendees present for the July 13 conference call.

It was moved, seconded and voted to approve the SNM Board of Directors meeting minutes from the Annual Meeting (May 31 and June 1), July 13 conference call and August 21 conference call with edits.

4. Conflict of Interest Statement:

The conflict of interest statement will be presented during the next Board of Directors conference call.

B. SNM President, Alexander J. B. McEwan, MD The Board of Directors monthly conference calls have been successful and will continue to be held on a monthly basis. The next conference call will be the beginning on November. Currently, there is no formal new member orientation in place for new board members The SNM staff develop a formal orientation program to be in place next fall.

The Board of Directors meeting on Sunday will be dedicated to strategic planning and working together with other organizations; Biomarkers Consortium, NCCR, ASTRO, ASNC and others to collaborate on meetings, advocacy and educational opportunities.

It is important to decrease the fragmentation between sister societies. There will a meeting at RSNA of a task force with 2 representatives from SNM and AMI. The goal of the task force is to determine the best way the two societies to work together and to build a strong strategic relationship. Over the summer, ERF and SNM had a SNM/ERF Oversight meeting that brought in an outside consultant to discuss the current state of ERF. The next stage of the discussions will include; joint strategic direction, cohesive strategic approach, management of monies and refining the structural relationship. The SNM Board would like to thank ERF for significantly increasing the funding to SNM that will introduce a new slate of awards for the 2007-2008 year. SNM was recognized in the top 25 most influential in a NAS report. This is a unique opportunity for SNM and shows the continued growth of the public relations opportunities. A Committee Restructuring Task Force was recreated during the appointments process to re-evaluate the usefulness of the SNM Committees. The task force will report to the board by the end of the year. SNM continues to welcome international opportunities. In attending the Chinese Society of Nuclear Medicine’s Annual Meeting, Dr. McEwan discussed various the possibilities of joint educational programs. Moving forward, SNM will work with the CSNM to provide the JNM in Chinese. In addition, SNM supported IAEA with a grant of $5,000 and the Canadian Society has contributed monies to help South Africa for the WFNMB. The next international meeting will be EANM mid-October. C. SNMTS President’s Report Mr. David Gilmore, MS, CNMT, NCT, RT(R)(N), highlighted the achievements of the SNMTS over the past several months. The SNMTS went through a period of restructuring in which the number of committees were cut by half; a new Strategic Plan was developed and the SNMTS is currently working to implement it; the SNMTS Scope of Practice was finalized and published. The Advanced Practitioner is moving forward and the outline of the curriculum was approved during the Annual Meeting. Although ACR is still not in support of the new title, SNMTS continues to move forward and recently asked that an ACR representative join the Task Force, Jay Harolds, MD.

The SNMTS hosted the First Annual Leadership Academy, September 14-16 in Berkley, CA. Twelve young professionals from various chapters met for a two-day seminar on team-development, communication, decision-making and conflict resolution. A full report on the SNMTS Leadership Academy will be published in the SNMTS Uptake as well as on the SNMTS Website.

The SNMTS would also like to thank ERF for the generous monies allocated to further developing the SNMTS awards programs. D. ERF Report Dr. Peter Kirchner, ERF President-Elect, reported that since the launch of the Bench to Bedside campaign last June, the MI Campaign has received $112,270 in pledges and contributions from 109 members. The primary goal is to raise $500,000 over 5 years from individuals for this important initiative. As of September 27, 2007 the corporate and individual donations total is $3,950,020.

Contributions in support of the ERF year to date amounts total $147,354.60. This figure includes $34,580 in donations to the Molecular Imaging Campaign. With an additional $18,580 in outstanding pledge payments, the total designated to the Campaign (gifts received and pledges) in FY2007 amounts to $53,160. The ERF has budgeted $400,000 in support of the SNM and SNMTS Grants and Awards Program.

The ERF and SNM are also pleased to announce the successful recruitment of Theresa Pinkham as the new Development Office Director. On October 10th, the ERF leadership will have a strategy meeting with the Development Director to map out a fundraising plan and to determine next steps. E. Secretary/Treasurer’s Report Dr. Richard Noto, SNM Secretary/Treasurer reported on the status of SNM monies as reflected in the SNM Management Rreport dated June 30, 2007. F. Agenda Topics

1. Fiscal Year 2007-2008 Budget

The SNM Department Directors gave an overview of the proposed budget.

Dr. Conti requested that the monies be increased for PR and government affairs, the current funds distributed to these two sections are significantly under-funded. Board members voiced concern in moving forward without a more detailed proposal. It is requested that, before changing the budget to reflect these needs, a more detailed proposal be created that includes both a short and long term plan. The SNM Health Policy and Regulatory Affairs staff will present the plan and budget during the Board meeting the next day.

Dr. McEwan requested that the budget be reviewed as proposed and during the strategic discussion on Sunday, additional information be presented regarding the specifics of the monies needed to move forward. A motion was made to accept the FY 2007-2008 budget as proposed by the SNM Finance Committee.

It was move, seconded and voted to approve the FY 2007-2008 budget as proposed by the SNM Finance Committee.

The board recessed at 3:50pm. The board reconvened at 4:09pm.

2. NAS Report Study Showing Need to Restore Federal Nuclear Medicine Research Funding

Dr. McEwan requested that this information topic be held until Sunday in correspondence with the GR Retreat follow-up by Dr. Conti.

3. IMT Discussion, Peter Cempellin Mr. Cempellin is the representative for IMTIMT and is currently the CEO, General Manager, Nuclear Medicine, PET/CT, PET/MR for Philips. Current support for the IMTIMT comes from: Philips Medical Systems, GE Healthcare, Siemens Medical Systems, IBA, Cardinal Health, Alliance Imaging, US Oncology and almost 30 other services providers representing over 150 sites world wide. The IMT has proposed the following mission statement: “The Molecular Imaging Industry Council (IMT) will be formed to help education healthcare professionals, policy makers, the administration and the public on the value of advanced molecular, with a particular focus on PET, PET/CT and PET/MR.” The purpose of IMT is to sponsor and promote efforts to educate medical, biotechnology and pharmaceutical professionals, patients and the public, congress (House and Senate) and government agencies such as the FDA and CMS. The key activities the IMT would support are: reimbursement of FDG PET thru Regulatory and Political Action, education, training and promotion of FDG clinical PET, expanding coverage of FDG PET-Alzheimer, standardization of practice guidelines – NCCN, ASCO and others, and accelerate the new tracer approval process. By proposing that IMT is a part of SNM, IMT is requesting that there be sufficient autonomy for IMT to carry out their strategy and have control of the budget for the IMT; to have a seat on the SNM Board (proposed representative, Peter Cempellin), have a dedicated administrator that would report to the Chairman of IMT and to have own IMT publication for members.

The Board discussed the IMT proposal and its effects on the current SNM structure.

The board addressed the issues regarding the IMT requesting a seat on the SNM Board of Directors. Board members requested additional information regarding other similar organizations board make-up, specifically relating to whether or not industry is represented on the board.

A motion was made to approve the SNM leadership to enter into discussions with IMT regarding the proposal and possible relationship with the IMT and report back to the board by the first fortnight in November. It was moved, second and voted to approve the SNM leadership to enter into discussions with IMT regarding the proposal and possible relationship with the IMT and report back to the board by the first fortnight in November.

4. Approval of Authorized Signatories Staff recommends three individuals on SNM staff, be allowed to sign checks; Virginia Pappas, Vince Pistilli and Mike Nelson. Mr. Pistilli, SNM CFO and Ms. Pappas, SNM CEO will be the main signers of checks, Mr. Nelson, COO, will serve as an alternate if Ms. Pappas or Mr. Pistilli. There was discussion from the board regarding the current procedures for approving large checks. Any check over $25,000 requires two signatures. Dr. Noto suggested decreasing this amount to $10,000+/-. It was recommended that the motion be voted on as is, and then if the Board would like to alter the current policy, they can do so through another resolution. A motion was made to approve Vince Pistilli, CFO; and Mike Nelson, COO as additional signatories for the BB&T bank account.

It was moved, seconded and voted to approve; Vince Pistilli, CFO; and Mike Nelson, COO as additional signatories for the BB&T bank account.

5. MWM and AM Governance Schedule Ms. Pappas and Mr. Gilmore discussed the possibilities of having the SNMTS committee meetings during the Mid-Winter and Annual Meetings rather than before. Both Ms. Pappas and Mr. Gilmore have agreed on a schedule that will condense the MWM and AM schedule for the technologists. 6. Nuclear Medicine Residency Curriculum . The MI task force is requesting that the SNM BOD approve the proposed curriculum during the fall meeting to ensure that it will be forwarded to RRC by early November.

A motion was made for SNM to formally submit a request to the Residency Review Committee (RRC) and American Board of Nuclear Medicine (ABNM) to consider suggested revisions to the Nuclear Medicine Residency Curriculum to incorporate more molecular imaging topics.

It was moved, seconded and approved that the SNM BOD approves the proposed curriculum (attached as Appendix A) and for SNM to formally submit a request to the Residency Review Committee (RRC) and American Board of Nuclear Medicine (ABNM) to consider suggested revisions to the Nuclear Medicine Residency Curriculum to incorporate more molecular imaging topics.

7. American Medical Association Five-Year Review Every five-years the AMA reviews the representation to the AMA House of Delegates. SNM’s five-year review is this year, 2007. SNM has submitted a letter requesting that representation to the AMA House of Delegates be continued. The AMA requires at least 35% of SNM membership to also be AMA members. AMA also requires a motion by the SNM BOD requesting that SNM be represented in the AMA HOD. A motion was made to approve the five-year review process for representation in the American Medical Association House of Delegates.

It was moved, seconded and voted to approve the five-year review process for representation in the American Medical Association House of Delegates.

8. CME Mission Statement The CME Mission Statement has been edited to be in accordance with the updated ACCME Accreditation Criteria and sound educational practice. The SNM reviews its CME mission statement periodically to ensure that the mission includes the purpose, content areas, target audience, type of activities provided, and expected results of the program. To that end, the Continuing Education Committee has updated the mission statement. It was recommended that the language under “Target Audience and Specific Goals – Technologist” be amended to reflect the SNMTS Bylaws changes from June 2007. The new Technologist section will read:

“Technologists: Enrich technologists’ knowledge and provide quality updated skills related to nuclear medicine/molecular imaging and related fields.”

In addition it was recommended that the section entitled “Target Audience and Specific Goals – Pharmacists” be amended to reflect “molecular probes.” The new Pharmacists section will read:

“Pharmacists: Enhance the quality of practice by refining and updating knowledge related to nuclear pharmacy and molecular probes.”

Lynn Barnes, SNM Education Director and Frances Keech, Continuing Education Committee member, accepted the recommendations on behalf of the committee. A motion was made to approve the revised Continuing Education Mission Statement, as amended . It was moved and voted to approve the revised Continuing Education Mission Statement as amended. (attached as Appendix B).

9. Awards Task Force The MI Center, as one of its goals, developed several new awards. Dr. McEwan appointed an Awards task force that reviewed SNM’s current awards and the new MI awards. This task force presented a comprehensive list of awards for SNM that were presented to the SNM BOD for approval. ERF has increased its grant to $400,000 this year for the SNM and SNMTS Awards. The actual amount needed to cover both the SNM and SNMTS awards for fiscal year 2007-2008 is $450,000. SNM has requested that ERF grant the additional monies. ERF will discuss it during the ERF Board meeting in November. Dr. Atcher, chair of the Awards Task Force, proposed a motion to approve the SNM and SNMTS awards as listed.

It was moved and voted to approve the SNM and SNMTS awards as listed (see Appendix C).

10. Procedure Guidelines/Standards and Consensus Statements Published in JNM. A document entitled, “was submitted to JNM but was rejected for publication: the Publications committee rejected it due to space and page limitations

The board discussed the possible alternatives for publishing guidelines.

A motion was made to publish all guidelines in the JNMT and at the discretion of the JNMT editor, a short summary be published in the Newsline.

It was moved, seconded and voted to approve that all guidelines be published in the JNMT and at the discretion of the JNM editor, a short summary be published in Newsline.

11. Awards Committee

The candidate for the 2008 Abersold Award, Ronald G. Blasberg, MD was presented by the SNM Awards Committee to the BOD.

A motion was made to present the 2008 Abersold Award to Ronald G. Blasberg, MD. It was moved and voted to present the 2008 Abersold Award to Ronald G. Blasberg, MD.

12. Annual Meeting Site Selection The General Program Chair presented the pros and cons from the selected cities and recommended St. Louis over Denver for 2014 and Baltimore over Philadelphia for 2015. There was discussion regarding the expected attendance at the various cities.

A motion was made to approve the Annual Meeting site selection as proposed; St. Louis in 2014 and Baltimore in 2015.

It was moved, seconded and voted to approve the Annual Meeting site selection as proposed; St. Louis in 2014 and Baltimore in 2015.

13. New Business SNM leadership has entered into discussion with the Chinese Society of Nuclear Medicine regarding possible joint initiatives:

- helping developing manuscripts - developing young investigators meeting - work on developing bank of volunteers - development of CME combined Chinese program - developing residency training programs and CE for physicians.

A motion was made to approve the continued discussion between the SNM Leadership, Dr. Heinrich Schelbert and the CSNM to develop a proposed business plan.

It was moved, seconded and approved to continue the discussion between the SNM Leadership, Dr. Heinrich Schelbert and the CSNM to develop a proposed business plan.

D. New Business

Jane Day, Meetings Director is leaving SNM. Her last day will be October 31. Jane was presented with a gift and card from the SNM Board of Directors.

E. Adjournment

A motion was made to adjourn the September 29, 2007 SNM Board of Directors Meeting. It was moved, seconded and voted to adjourn the September 29, 2007 SNM Board of Directors Meeting at 6:21pm.

RESOLUTION FORM


ACTION ITEM: Approval of September 30, 2007 Board of Director’s

Minutes SUBMITTED BY: Richard B. Noto, MD Secretary/Treasurer PROPOSED RESOLUTION: Resolved, that the minutes from the Board of Director’s

September 30, 2007 Meeting be adopted. FINANCIAL IMPACT: N/A BACKGROUND: N/A SUPPORT MATERIAL: September 30, 2007, Board of Director’s Meeting


ACTION

DATE (year-mo-day)

AYES

NAYS

Unanimous

NOTES

Adopted

Defeated

Revised

Withdrawn

Other

SNM Board of Directors Fall Meeting

Hyatt Regency, Reston, VA September 30, 2007

SNM Members in Attendance: Alexander JB McEwan, MD; Robert W. Atcher, PhD, MBA; Peter S. Conti, MD, PhD; Michael M. Graham, MD, PhD; David Gilmore, CNMT, RT(R), RT(N); Author J. Hall, CNMT, FSNMTS, Frances K. Keech, MBA, RT(N), FSNMTS; Warren R. Janowitz, MD, JD; Mathew L. Thakur, PhD; Leonie L. Gordon, MD; Paul H. Murphy, PhD; Gary L. Dillehay, MD; Warren R. Janowitz, MD, JD; Peter Herscovitch, MD; Bennett S. Greenspan, MD; Peter T. Kirchner, MD; Heinrich R. Schelbert, MD, PhD; Richard B. Noto, MD, Virginia Pappas, CAE SNM Staff in Attendance: Michael Nelson, CAE; Rebecca Maxey; Naomi Lynn Barnes; Hugh Cannon; Marybeth Howlett; Joanna Spahr; Jane Day; Cecilia Noblett; Teri Pinkham; Vince Pistilli; Nikki Wenzel; Nicole Kern, Ivone Wells A. Welcome and Call to Order: The SNM President, Alexander J.B. McEwan, MD, called the meeting to order at 8:17am and welcomed all SNM Board meeting attendees.

1. Establishment of Quorum: Dr. Richard B. Noto, SNM Secretary/Treasurer, established that there was a quorum.

2. Approval of the Robert Standing Rules: It was requested that the standing rules be amended to remove limiting discussion to 30 minutes.

• Raise hand to be recognized. • Those that have not yet spoken will get priority.

A motion was made to approve the Standing Rules of the Board of Directors as listed above. It was moved, seconded and voted to approve the Standing Rules of the Board of Directors as listed above.

Approval of the Agenda: The agenda was reviewed, Dr. Kirchner requested that an

additional topic be added to the agenda, “Awards.”

It was moved, seconded and voted to approve the meeting agenda for the SNM Board of Directors meeting on Saturday, September 29, 2007.

B. Strategic Issues Facing SNM The MI Strategic Plan and SNM Strategic Plan goals and progress were reviewed. Action items moving forward and possible challenges were identified and are listed below:

Actions Moving Forward 1. Purchase Survey data to secure data analysis of professional issues. 2. Establish a series of Task Forces in government relations/advocacy(agency specific)

– have specific liaisons to each a. DOE b. FDA c. NRC

3. Secure PR Counsel to develop the following: a. Marketable strategies for the Hill b. ??Counter press releases c. Patient release

4. CMS data analysis program/reimbursement 5. Expand Outreach - Increase grassroots engagement 6. Engage/Build-up ACNP 7. Engage the future MIIC organelle to work on Advocacy Issues

Possible Challenges Moving Forward

1. Need more volunteers 2. Declining Membership 3. Loss of Industry Support

C. GR Retreat Overview and NAS Report The ACNP/SNM Government Relations Committee met in Chicago for a day and a half strategic planning session. The committee reviewed the issues currently facing SNM and discussed how to deal with the issues and what issues need to be addressed. Attached is a a brief outline of the issues and actions proposed. Listed below are additional actions discussed during the meeting:

1. Reimbursement/HOPPS Possible actions include continuing to analyze and educate the community about HOPPS; reach out to patient advocacy groups about the lack of reimbursement; analyze data from the SNM Radiopharmaceutical Cost Survey and approach CMS; explore legislative angle with SNM Consultants; hire a statistical consultant to analyze the CMS data; and/or change CME Cost calculation methodologies.

2. Reimbursement/Access to Medicare Imaging Act of 2007

At this time it is not advisable to go after this issue because at best, we would be trying to revise legislation. To get involved now would not be the best thing to do.

3. Reimbursement/CHAMP Act of 2007 The Board discussed different possibilities including patient advocacy coupled with lobbying and continue press and public campaigning to inform the community of the dangers of further imaging reductions.

4. CARE Legislation

SNM will continue to monitor the progress of the CARE bill. If the bill passes SNM will re-engage legislative efforts to begin working with individual states.

5. Regulations/NRC/NARM Rule

The NRC hosted a CE session during the 2007 Annual Meeting and will host an other CE session during the 2008 Annual Meeting in New Orleans.

6. Regulations/NRC Part 35 T&E Requirements SNM will continue to monitor the NRC’s ongoing re-evaluation of T&E requirements and push for the SNM supported changes.

The board discussed the various opportunities. The MI Campaign is a great example of gathering funding to educate the population about these subjects. The PR firm SNM contracts with will help facilitate this. It is also important to have a strong college; SNM should re-engage the ACNP to ensure its success.

The board recessed at 10:22am.

The board reconvened at 10:35am. D. Drug Development Discussion was opened regarding the societies involvement in the drug development process. SNM leadership is visiting various pharma companies to determine what they want and how SNM can help them achieve their goals. Dr. Conti has several meetings scheduled over the next couple of weeks.

Currently, within the Society there is not a specific group dedicated to Drug Development or Drug Discovery. The structure needs to allow for the ability to do an early phase clinical trial with an imaging agent in house. SNM needs to create something that is marketable to pharma. The visits to pharma companies will help in soliciting key players from other companies to form a Task Force in order to map our exactly what Pharma is looking for and needs. Dr. Conti will send a report via e-community to the board prior to the next BOD conference call regarding his discussions and proposal concerning pharma. E. Institute of Molecular Technologies (IMT) The SNM submitted a proposal for agreement between the SNM and the Institute of Molecular Technologies (IMT). The goal of the agreement is to enhance and expand the current clinical roles of PET and PET/CT, and also to develop the future clinical use of Molecular Imaging (MI). SNM is proposing the formation of an IMT structure within the SNM that shall support SNM in the achievement of scientific, public policy, outreach and other objectives that will enhance research and patient care through the use of PET and PET/CT imaging modalities.

IMT would still be required to submit a business plan and budget to the SNM BOD for final approval. There are currently 30 members of IMT, all have agreed to the proposal, except two, GE and Siemens. These two would like to take a much slower approach to implementing the plan. The current structure at AMI, gives them a seat on the board; they are requesting the same from SNM.

There was additional discussion regarding the pros and cons of allowing IMT to have a seat on the SNM Board of Directors. A possible consideration of structuring IMT should be the “Committee on Commercial Affairs.”

A motion was approved during the Saturday BOD meeting, stating the SNM leadership enter into discussions with IMT regarding the proposal and possible relationship with the IMT and report back to the board by the first fortnight in November

F. Committee Restructuring A task force is working on a recommendation to restructure the SNM committees. The task force will come up with a draft for the restructuring and present it to the board prior to the end of November. It is essential that the board approve the new structure during the Mid-Winter Meeting to ensure that it will be in place in time for the 2008-2008 Committee Appointments. G. Strategic Priorities

1. SNM Healthy Policy and Regulatory Affairs staff will work to develop a business plan from the items discussed during the GR Retreat. Dr. Conti and Dr. Janowitz will work with the SNM staff to ensure that a proper budget is established for the business plan. The business plan and budget will be presented on the next Board of Directors conference call the first week of November. 2. The MI Industry Summit Overview agenda was reviewed. It is important to begin inviting speakers. The focus of the summit is to discuss where we are, what we’ve done and outline what has to be done in the future. If the agenda does not change again, Dr. Conti will work with MI Staff to begin inviting speakers. If speakers have not been invited over the next month, the Summit will be cancelled.

E. Proposed 2007-2008 Awards The approved 2007-2008 awards list was reviewed by the board again, with special attention to the Travel Awards to trainees. It was recommended that the amount be decreased to allow for additional awardees. The original award was recommended for 25 @ $1,500; the new proposal recommended 30@ $1,000.

A motion was made to change the “SNM Travel Awards” proposed for the 2007-2008 year from 25@ $1,500 to 30@ $1,000. It was moved, seconded and voted to approve changing the SNM Travel Awards proposed for 2007-2008 year from 25@ $1,500 to 30@ $1,000.

F. Adjournment

A motion was made to adjourn the September 30, 2007 SNM Board of Directors Meeting. It was moved, seconded and voted to adjourn the September 30, 2007 SNM Board of Directors Meeting at 12:04pm.

RESOLUTION FORM


ACTION ITEM: Approval of November 13, 2007 Board of Director’s

conference call Minutes SUBMITTED BY: Richard B. Noto, MD Secretary/Treasurer PROPOSED RESOLUTION: Resolved, that the minutes from the Board of Director’s

conference call of November 13, 2007 be adopted. FINANCIAL IMPACT: N/A BACKGROUND: N/A SUPPORT MATERIAL: November 13, 2007, Board of Director’s Meeting


ACTION

DATE (year-mo-day)

AYES

NAYS

Unanimous

NOTES

Adopted

Defeated

Revised

Withdrawn

Other

SNM Board of Directors Conference Call

November 13, 2007

SNM Members in Attendance: Alexander J.B. McEwan, MD; Michael M. Graham, MD, PhD; Peter Herscovitch, MD; Richard B. Noto, MD; Bennett S. Greenspan, MD; Leonie L. Gordon, MD; Author J. Hall, CNMT, FSNMTS; David Gilmore, CNMT, RT(R), RT(N); Mark Wallenmeyer, MBA, CNMT, RT(R), RT(N); Warren R. Janowitz, MD, JD; Conrad E. Nagle, MD SNM Staff in Attendance: Virginia M. Pappas, CAE; Mike Nelson, CAE; Hugh Cannon; Nikki Wenzel I. Welcome and Call to Order: The conference call was called to order at 9:05am by Dr. Alexander McEwan. II. HOPPS Rule The SNM leadership had a conference call with Denise Merlino and Kenneth McKusick to discuss the HOPPS Rule. Hugh Cannon was invited to attend the CORAR meeting today, November 13. The SNM leadership is also working to link up with ACR and ASTRO to discuss the HOPPS rule and will be meeting with IMT at RSNA. Hugh will debrief the SNM leadership following the CORAR meeting and report back to the BOD on the December conference call. III. Proposed Budget for the Government Relations Plan At the September BOD meeting Dr. Peter Conti requested additional funding from SNM to support supplemental government relations activities. A budget and plan was developed following the September BOD meeting. The BOD reviewed the plan. A motion was made to endorse the government relations plan with the stipulation that the leadership would discuss possible funding options and make recommendations for budget amounts to the board for approval on the December conference call.

It was moved, seconded and voted to endorse the government relations plan with the stipulation that the leadership would discuss possible funding options and make recommendations to the board for approval on the December conference call.

IV. IMT Update The IMT proposal was reviewed by the SNM lawyer and several minor changes were made to include additional language that was necessary. The SNM BOD has not addressed the request of IMT to have a member represented on the BOD. SNM Leadership will be meeting with IMT Leadership at RSNA. Once the proposal has been finalized, the leadership will report back to the board. V. NAS Update The NAS Ad was placed in Roll Call and distributed on Capital Hill. The next step is to try and submit the ad to the Wall Street Journal. There have been numerous hits on the ad and it continues to gain momentum. This will continue to be an item on the BOD agenda as an update next month. VI. PET Utilization Task Force The PET Utilization Task Force was created by the PET Center of Excellence. The Task Force had the first conference call last week and developed a list of background material needed to move forward. Dr. George Segall is acting chair since Dr. Homer Macapinlac was out of the

country. The Task Force will be having a one-day meeting in Chicago at the beginning of December to begin working on action items moving forward. Virginia has asked Susan Wallace and Joanne Lockwood to help gather data and facilitate the meeting. Dr. Leonie Gordon suggested the task force name be changed to the PET/CT Utilization Task Force. This suggestion will be submitted to the Task Force for consideration. VII. ERF Board Meeting Ms. Pappas gave a brief update on the ERF BOD meeting held the first weekend of November. Teri Pinkham held a training session for all board members. The ERF BOD discussed the campaign and how they could fulfill their commitment of $500,000. There has been a lot of progress since the retreat. There will be an ERF Oversight Meeting at RSNA. The leadership will be discussing the board composition. It was suggested that Teri host a fundraising training session for all board members to review the principals of fundraising and how to ask for a gift. VIII. MI Summit Update The MI Summit agenda was reviewed. Earlier this week Marybeth Howlett, MICoE Director confirmed all moderators and is currently working to confirm the speakers for each session. Summit invitations will be going out in the next week or two. IX. ASNC Clinical Imaging The Cardiovascular Council enthusiastically supported the ASNC Clinical Imaging Part I and requested that they be involved in the development of Part 2. Although several members of the Part I committee are SNM members, SNM will request that the SNM Cardiovascular Council be represented on the committee as well. A motion was made to endorse the ASNC “Clinical Imaging Prevention: Directed Strategies for Improved Detection of Pre-Symptomatic Patients with Undetected Atherosclerosis,” and request that athe SNM Cardiovascular Council be represented on the Part 2 committee.

It was moved, seconded and voted to endorse the ASNC “Clinical Imaging Prevention: Directed Strategies for Improved Detection of Pre-Symptomatic Patients with Undetected Atherosclerosis,” and request that an SNM Cardiovascular Council be represented on the Part 2 committee.

X. Siemens Business Award During a meeting with Dr. Atcher, Siemens proposed a SNM Siemens Business Award. There are two parts to the request from Siemens: 1. an award that is focused on the SNM membership and encourages them to start thinking about economic values issues; and 2. have an organized PR campaign. SNM has already begun interviewing PR firms and will look to Siemens for possible support opportunities once a PR firm has been chosen. Siemens has committed to a restricted fund for this Business Award initiative of $10.000 that would be used as follows: $5000 for the winner and 4 x $1,250 for the following 4 papers received as travel awards as well as complimentary registration to the upcoming SNM conference in New Orleans. It was recommended that the award be linked to the new Healthcare Policy Abstract Tract. A motion was made to accept the Siemens Business Awards restricted fund and move forward immediately with advertising and marketing for the awards.

It was moved, seconded and voted to accept the Siemens Business Awards restricted fund and move forward immediately with advertising and marketing for the awards.

XI. CEO Report Ms. Pappas announced that Dr. Henry Wagner has agreed to chair the Direct Mail Campaign for 2007-2008. The first solicitation will be mailed in November with an end-of-year giving message. Dr. Wagner will sign four (4) solicitations that will go out this and next year in November, February, May and September. The SNM Mid-Winter Meeting Official Notification with draft governance schedule will be sent out later this week. Jane Day’s last day was November 5. Judy Brazel is now the new SNM Director of Meetings. XII. New Business There was no new business to discuss. XIII. Adjournment A motion was made to adjourn the conference call. It was moved, seconded and voted to adjourn the SNM Board of Directors Conference Call at 9:54am (ET).

RESOLUTION FORM


ACTION ITEM: Approval of January 17, 2008 Board of Director’s

conference call Minutes SUBMITTED BY: Richard B. Noto, MD Secretary/Treasurer PROPOSED RESOLUTION: Resolved, that the minutes from the Board of Director’s

conference call of January 17, 2008 be adopted. FINANCIAL IMPACT: N/A BACKGROUND: N/A SUPPORT MATERIAL: Janaury 17, 2008, Board of Director’s Meeting Minutes. ACTION: ADOPTED ___ DEFEATED ___ OTHER ___

ACTION

DATE (year-mo-day)

AYES

NAYS

Unanimous

NOTES

Adopted

Defeated

Revised

Withdrawn

Other

SNM Board of Directors Conference Call January 17, 2008

SNM Members in Attendance: Alexander J.B. McEwan, MD; Robert W. Atcher, PhD; Michael M. Graham, MD, PhD; Peter Herscovitch, MD; Bennett S. Greenspan, MD; David Gilmore, CNMT, RT(R), RT(N); Mark Wallenmeyer, MBA, CNMT, RT(R), RT(N); Warren R. Janowitz, MD, JD; Martin P. Sandler, MD; Frances K. Keech, MBA, RT(N), FSNMTS; Mathew L. Thakur, PhD; Peter S. Conti, MD, PhD; Paul H. Murphy, PhD SNM Staff in Attendance: Virginia M. Pappas, CAE; Mike Nelson, CAE; Nikki Wenzel I. Welcome and Call to Order: The conference call was called to order at 9:34am by Dr. Alexander McEwan. II. Advanced Practice David Gilmore gave a brief overview of the discussion to date regarding advanced practice. During the RSNA meeting, the SNM and SNMTS leadership met with Dr. Jay Harolds from ACR and decided on a title that was welcomed by all, “Nuclear Medicine Advanced Associate.” A motion was made to approve the title of Nuclear Medicine Advanced Associate as the professional title for the technologist advanced practice position.

It was moved, seconded and voted unanimously to approve the title of Nuclear Medicine Advanced Associate as the professional title for the technologist advanced practice position.

III. World Molecular Imaging Conference Meeting (WMIC) The Society of Molecular Imaging (SMI), the coordinator for the WMIC, requested SNM’s involvement with the WMIC meeting some time ago requesting $30-$50 for participation. After further discussion, the WMIC and SNM came to the following agreement:

1. SNM will co-organize a clinical PET session at WMIC. 2. Representing the SNM on the WMIC Program Committee will be Homer Macapinlac and

Henry Van Brocklin (likely). 3. Homer and Henry will work with the appropriate representatives of the WMIC steering

and program committees in developing the session. 4. The SNM will reimburse all travel-related costs for co-organized session.* 5. The SNM will cover the cost of room rental and AV for the co-organized session** 6. The SNM will be recognized as the session co-organizer in primary meeting materials 7. The SNM will be recognized on the WMIC website with logo (and perhaps other

marketing literature) and brief verbiage regarding the session (as it develops) * The WMIC Steering Committee has authorized the following reimbursement guidelines:

1. Up to $500 for European travel plus three nights hotel 2. Up to $1,500 for Asian and American travel plus three nights hotel 3. No honorarium

** SNM would pay actual costs for room rental and audio-visual (av) estimated at $1,000 room rental and $1,000 AV.

A motion was made to approve SNM’s participation in the WMIC as outlined above.

It was moved, second and voted unanimously to approve SNM’s participation in the WMIC as outlined above.

IV. Discussion Public Relations and Government Relations Strategic Planning Meeting The SNM and MICoE leadership met in Reston on January 6, 2008 to begin developing a strategic plan for public relations and government relations. Bob Waters and staff from the FDA, CMSS, etc met with leadership on Monday as well as the staff from the new PR Firm, Porter Novelli. Three plans came out of this meeting, a GR plan, which will be delivered by the end of the week, a Siemens Business plan, which has been finalized and a PR plan, which Porter Novelli will have completed by mid-month. All of these strategic plans will be sent out prior to the Mid-Winter Meeting for review and will be discussed during the MWM board meeting. This information should be confidential until finalized. V. Review Mid-Winter Meeting Board Schedule and Agenda The Mid-Winter Meeting board agenda is filled with strategic topics that will encourage discussion. In the same spirit, the House of Delegates agenda has been filled with strategic topics, including HOPPS, Pet Utilization, etc. Moving forward, the HOD meeting will be schedule prior to the SNM Board of Directors to ensure that any resolutions brought forth from the House of Delegates will be presented to the BOD during the same meeting time. Dr. Graham and Dr. Atcher will be attending the Committee on Chapters and Committee on Councils meeting during the Mid-Winter to discuss how chapters and councils can become more engaged. VI. 2nd Industry/Expert Molecular Imaging Summit The agenda has been finalized for the summit and summit leaders held a conference call with all moderators to discuss expectations and speaker topics. The funding received for the summit was enough to offset costs. Marybeth will send the summary of the 2006-2007 activities within the next week. VII. CEO Report (Hot Topics) Ms. Pappas highlighted the launch of Smart Briefs; a recent gift to the Bench to Bedside campaign from Bracco ($250,000), Mediso ($50,000) and two individual gifts totaling $30,000; and SNM website hits increased by over 2 million from 2006 to 2007. VIII. New Business Dr. McEwan gave a brief update on the NIU reactor and encouraged anyone that was interested to read the Globe for more information. IX. Adjournment A motion was made to adjourn the conference call. It was moved, seconded and voted to adjourn the SNM Board of Directors Conference Call at 10:23am (ET).

SNM President’s Report Alexander J. B. McEwan, MD

SNM President-Elect’s Report Robert Atcher, PhD

Officers: R. Nick Bryan, MD, PhD President Steven E. Seltzer, MD Vice President James H. Thrall, MD Secretary/Treasurer Executive Committee Stephen R. Baker, MD Richard L. Ehman, MD Hedvig Hricak, MD, PhD Valerie P. Jackson, MD R. Gilbert Jost, MD Joseph K.T. Lee, MD N. Reed Dunnick, MD (ex officio) Board of Directors: Gary J. Becker, MD Wendie A. Berg, MD, PhD James A. Brink, MD Dorothy I. Bulas, MD Michael D. Devous, Sr., PhD Les. R. Folio, DO, MPH. Jonathan G. Goldin, MD, PhD Bennett S. Greenspan, MD David B. Hackney, MD Elizabeth A. Krupinski, PhD Jonathan S. Lewin, MD B.J. Manaster, MD, PhD Norbert J. Pelc, ScD Etta D. Pisano, MD Mitchell D. Schnall, MD, PhD Executive Director: Renée L. Cruea, M.P.A.

Academy of Radiology Research 1029 Vermont Avenue NW, Suite 505 Washington, DC 20005-3517 (202) 347-5872 Phone (202) 347-5876 Fax www.acadrad.org

December 10, 2007 TO: Board of Directors FROM: Renee Cruea RE: Board of Directors Annual Meeting The Academy of Radiology Research Board of Directors met on November 26th, 2007 at 9:30am at McCormick Place South Building Room 103D in Chicago, IL. The following individuals were in attendance: Officers N. Reed Dunnick, M.D. R. Nick Bryan, M.D., Ph.D. Steven E. Seltzer, M.D. Executive Committee Stephen R. Baker, M. D. Richard L. Ehman, M.D. Hedvig Hricak, M.D., Ph.D. Valerie Jackson, M.D. R. Gilbert Jost, M.D. Joseph K. T. Lee, M.D. Ronald L. Arenson, M.D. (ex officio) Board of Directors Kimberly E. Applegate, M.D., M.S. Gary J. Becker, M.D. Wendie Berg, M.D., Ph.D. James A. Brink, M.D. Dorothy I. Bulas, M.D. Bennett S. Greenspan, M.D. Krishna Kandarpa, M.D., Ph.D. Elizabeth A. Krupinski, Ph.D. Jonathan S. Lewin, M.D. B.J. Manaster, M.D., Ph.D. James H. Thrall, M.D.

ARR November 2007 Board Meeting Minutes December 10, 2007 Page 2 Other Attendees Robert W. Atcher, Ph.D. President-elect, SNM Stanley Baum, M.D. (Chair, Blueprint for Imaging and Biomedical Research) Ted Burnes, RADPAC, American College of Radiology Hugh Cannon, Director Health Policy and Regulatory Affairs, SNM Michael M. Graham, Ph.D., M.D., Vice President-elect, SNM Virginia Pappas, CEO, SNM Dan Sullivan, M.D. Academy Staff Renee Cruea, Executive Director Sarah Oliphant, Government Relations Associate Opening Remarks: Dr. Dunnick opened the meeting by stressing the importance of the mission of the Academy to increase federal funding to the various institutes at NIH for imaging research through advocacy and education. The approach to accomplishing this goal, through new partnerships with diverse constituencies, requires a strong working foundation. In order to ensure financial stability of the ARR, Dr. Dunnick explained the financial restructuring and increase in dues for fiscal year 2008. This increase allows for a reserve that the Academy has never had. Overall, the Academy has seen an increase in funding to the NIH but continues to face obstacles in the current Congress getting funds appropriated at levels most beneficial to the NIH and the radiology community. Dr. Dunnick explained that the Coalition of Imaging and Bioengineering Research (CIBR) now have twenty patient advocacy groups and one new addition to the list of industry members (Gammex rmi). CIBR continues to grow and in doing so gives imaging and bioengineering issues a higher profile and voice on Capitol Hill. Employment Changes: Sarah Oliphant was introduced as the new Government Relations Associate for the Academy of Radiology Research and the Coalition for Imaging and Bioengineering Research. Executive Directors Report: Renee Cruea gave the legislative report, explaining that it is likely that the LHHS appropriations bill will be included in an omnibus. Membership with the Academy remains stable. CIBR membership has increased with four new members added to the patient advocacy group list, and Gammex rmi, Inc. was added to the list of industry members.

ARR November 2007 Board Meeting Minutes December 10, 2007 Page 3 Renee discussed the two imaging briefings that the Academy and CIBR will sponsor in 2008 on Capitol Hill, along with an increase of tours to different radiology facilities and tours of NIH institutes, clinical centers, and labs for Hill staff and potential and current patient advocacy group members of CIBR. Nuclear Medicine Funding: Dr. Dunnick and Renee Cruea addressed the issue of research funding related to nuclear medicine and how the Academy could best advocate on this issue. The Society of Nuclear Medicine had several representatives present who gave a brief presentation/explanation for advocating funding to the Department of Energy, as their research capabilities are much better suited to this type of research than the NIH. As a founding and continuous supporter of the Academy, the SNM’s interests and goals are ones we should continue to advocate for and support. Renee Cruea will continue to work with Hugh Cannon, Director Health Policy and Regulatory Affairs, to ensure effective communication on this issue. CIBR: Sarah Oliphant gave a brief summary of what her goals are specific to CIBR. Sarah’s primary focus with CIBR has been to raise the profile of the coalition as an entity on Capitol Hill and within the health research community. Sarah will continue to recruit patient advocacy groups to join CIBR, while also planning the imaging briefings on Capitol Hill with other patient advocacy members and radiology facility tours for members and their corresponding constituency. Industry membership is also extremely important to the mission of the coalition and progress is being made in reaching out to potential industry members. RADPAC: The American College of Radiology RADPAC Director Ted Burnes has been instrumental to the efforts of the Academy and CIBR in reaching out to Members of Congress and articulating our goals for 2008. Representation and face-to-face interaction on Capitol Hill is crucial and RADPAC has included us in more than 30 events where we have had the opportunity to communicate our goals, most importantly to members of the appropriations committee. Legislative Update: Renee Cruea gave an update of the legislative environment in Washington. The appropriations struggle between President Bush and the Democratic Congress is evident in the President’s insistence to increase funding for the war while vowing to veto any appropriations proposal over his budget. At the present time, it is likely that we will see some sort of compromised omnibus appropriations package where several appropriations bills will be lumped together and signed into law. Renee will update the Academy board on the process as it plays out through the end of the calendar year.

ARR November 2007 Board Meeting Minutes December 10, 2007 Page 4 Nominating Committee Vote: The full board unanimously voted to elect Steven E. Seltzer, Vice President and James H. Thrall, Secretary Treasurer. The Academy also welcomed new board members Etta Pisano and Norbert Pelc, while N. Reed Dunnick joined the Executive Committee as ex officio member. Spring Meeting: A poll will be taken of Academy board members to determine the best meeting location for the Academy spring meeting. The choices are AUR or ARRS. (*as of Dec. 10th the vote favors the AUR meeting). Summary: With consistent support from our member societies, the Academy has been extremely successful. NIBIB now has an annual budget approaching over $300 million. Moreover, the total amount of NIH research grants to radiology departments has more than quadrupled since the Academy was created.

The Academy’s success in increasing the federal investment in imaging research will continue to benefit our discipline and all of our subspecialties in the coming years. Our efforts also ensure that radiology will have a central role in federally-supported imaging research and thus be a leader in the clinical application of innovative new technologies.

We have come a long way, but there is still much to do. We hope to make the NIBIB a billion-dollar Institute and to expand and strengthen imaging research programs in the other Institutes and federal agencies. Additionally, we plan to significantly raise the profile of imaging by utilizing the 20 patient advocacy groups who are now members of our coalition. Reaching those goals will require a sustained advocacy effort supported by all segments of our specialty. It is important that the Academy represent ALL of radiology and imaging science.

The Academy Record For an average annual investment in the Academy of less than $500,000, the radiology community has realized an exceptional return that includes:

• Creation of the National Institute of Biomedical Imaging and Bioengineering (NIBIB), which now has an annual budget of $300 million

• Increase in the total amount of NIH grants to radiology departments from $75 to 306 million

(1995-2006)

• Increase in the NCI Cancer Imaging Program from $48 to $179 million (1996-2006)

ARR November 2007 Board Meeting Minutes December 10, 2007 Page 5

• Creation of a Blueprint for Imaging in Biomedical Research (BIBR), a white paper that will position radiology for leadership in the broad field of biomedical research as well as in clinical medicine, published in July 07

• Hosted tours of the National Institute of Biomedical Imaging and Bioengineering and the Clinical

Center at the National Institutes of Health for congressional staff, patient advocacy group representatives and our own membership

Current Academy initiatives and efforts include:

• Continuous development and maintenance of advocacy and education initiatives for increased federal investments in imaging research

• Sponsor of the Bioengineering & Imaging Research Opportunities Workshop (BIROWV)

http://www.birow.org/

• Foster relationships between radiology and NIH Institutes and other federal agencies that support imaging research

• Maintain partnership with the ACR’s political action committee, which enables the Academy to

have direct access to members of Congress. To date, the Academy has attended more than thirty events through RADPAC

• Host additional NIBIB and NIH tours in 2008

• Co-host three imaging briefings on Capitol Hill in 2008, the first one in collaboration with the

patient advocacy group National Alliance for Eye and Vision Research in February. Each of these briefings will highlight the benefits imaging has or will have on current and future patients

• Continued development of The Coalition for Imaging and Bioengineering Research (CIBR), a

permanent alliance of radiology and imaging science societies, bioengineering societies, imaging companies, medical device manufacturers, and patient groups. CIBR strengthens advocacy activities in support of imaging research (All Academy member societies are members of CIBR at no additional cost) CIBR believes that a strong, unified voice conveying the message of all the stakeholders – NIBIB, imaging and bioengineering research organizations, technology creators, .and patient advocacy organizations – will have far greater success persuading Congress that more, not less, federal funding for advanced medical research must be part of every budget cycle. In addition to advocating for government funding, CIBR also is committed to facilitating better awareness of advances in diagnostics and treatment imaging and bioengineering research among industry, patient interests, and the public.

ARR November 2007 Board Meeting Minutes December 10, 2007 Page 6

ACADEMY OF RADIOLOGY RESEARCH and COALITION FOR IMAGING AND BIOENGINEERING RESEARCH

MEMBERSHIP Alliance for Aging Research Alpha-1 Foundation American Association for Women Radiologists American Association of Physicists in Medicine American Brain Tumor Association American College of Radiology American Diabetes Association American Institute for Medical and Biological Engineering American Osteopathic College of Radiology American Roentgen Ray Society American Society of Emergency Radiology American Society of Neuroradiology Association for Research in Vision and Ophthalmology Association of Community Cancer Centers Association of University Radiologists/Association of Program Directors in Radiology Brain Injury Association of America Brain Tumor Society Cooley’s Anemia Foundation Gammex rmi GE Healthcare Hydrocephalus Association International Society for Magnetic Resonance in Medicine Intracranial Hypertension Research Foundation Juvenile Diabetes Research Foundation Kidney Cancer Association National Alliance for Eye and Vision Research National Prostate Cancer Coalition Philips Prostate Health Education Network Pulmonary Fibrosis Foundation Radiological Society of North America Radiological Society of North America Research and Education Foundation Siemens Society of Interventional Radiology Society for Molecular Imaging Society for Pediatric Radiology Society for Women's Health Research Society of Breast Imaging Society of Computed Body Tomography and Magnetic Resonance Society of Gastrointestinal Radiologists Society of Nuclear Medicine Society of Skeletal Radiology Society of Thoracic Radiology Society of Uroradiology Taking Care of Your Diabetes Von Hippel-Lindau Disease Family Forum

Proposed Committee Structure 2008-2009

Committee on Radiopharmaceuticals

Committee on Education

Committee on Health Care Practice

1. Radar 2. Pharmacopeia 3. MIRD

Finance Committee

SNM Board of Directors

1. Comm. on Continuing Ed. 2. Publications Committee 3. Scientific Program Comm.

1. Practice Standards Committee 2. Procedure Guidelines Committee 3. Coding and Reimbursement Comm. 4. Quality Assurance Committee 5. Ethics Committee 6. ACNP/SNM Joint Govt. Relations

1. Audit Subcommittee 2. Investments Subcommittee

Membership

Board of Directors - 18 Members (13 Voting/5 Non-Voting)

Voting BOD: Non-Voting BOD: * President (4 yrs.) * Chairperson, Committee on Finance * President-Elect * Chairperson, Committee on Government Relations* Vice-President-Elect * General Program Chairperson * Past President * Chairperson, Committee on Publications * Secretary/Treasurer (3 yrs.) * SNM Chief Executive Officer * 4 HOD Delegates-at-Large (3 yrs.) * TS President (2 yrs.) * TS President-Elect * 2 TS HOD Delegates-at-Large (3 yrs.)

House of Delegates – 65 Members (53 Voting/12 Non-Voting) Voting HOD: Non-Voting HOD: * 2 Delegates from each Chapter (24) * Officers of the SNM and SNMTS * 2 Delegates from each Council (18) President (5) * 2 Delegates from each Center (4) * Past Presidents (5) * TS Delegates (8) * Speaker of the House (1) * Historian (1) *Vice Speaker of the House (1)

Chapters (12) 1. Pacific NW 2. Prairie Province 3. No. California 4. So. California 5. Missouri Valley 6. Central 7. Pittsburgh 8. Eastern Great Lakes9. South Eastern 10. Mid Eastern 11. Greater NY 12. New England

Councils (9) 1. Academic 2. Brain Imaging 3. Cardiovascular 4. Computer & Instrument 5. Correlative Imaging 6. Nuclear Oncology 7. Pediatric Imaging 8. Radiopharmaceutical Science 9. GI

Standing Committees (5) 1. Committee on Chapters 2. Committee on Councils 3. Committee on Ethics 4. Committee on Nominations5. Committee on Bylaws

National Council

Technologists Section

Centers of Excellence (2) 1. PET Center 2. Molecular Imaging

Committees 1. Committee on Awards 2. Committee on Finance

Audit Subcommittee Investments Subcommittee

3. Committee on Membership 4. Committee on Education Committee on Continuing Education Publications Committee Scientific Program Committee 5. Committee on Health Care Policy and Practice Practice Standards Committee Procedure Guidelines Committee Coding and Reimbursement Committee Quality Assurance Committee Ethics Committee ACNP/SNM Joint Govt. Relations 6. Committee on Radiopharmaceuticals RADAR Committee on Pharmacopeia MIRD

Special/Ad Hoc Committees (0)

SNM, Inc. Organizational Chart

Last updated: June 18, 2007

Agenda Topics

National Research Universal (NRU) Nuclear Reactor

SNM Board of Directors

February 15, 2008 Molybdenum-99 Shortage

AECL—the operator of the NRU reactor and MDS Nordion's primary supplier of Mo-99—had originally scheduled a maintenance shutdown for the week of November 19 to make the modifications necessary to comply with their CNSC license requirements. AECL was unsuccessful in the time allotted and thus, under pressure from the CNSC, decided to keep the NRU reactor in an extended shutdown until the work could be completed. On November 30, 2007, MDS Nordion released a public statement announcing an imminent shortage of molybdenum-99 used in the manufacturing of technetium-99m generators and iodine-131 because of an extended shutdown of the National Research Universal (NRU) reactor in Chalk River, Ontario. MDS Nordion later announced that the NRU reactor shutdown was expected to extend into January 2008. Atomic Energy of Canada Limited (AECL), which runs the NRU reactor, originally scheduled a regular maintenance shutdown the week of November 19. In a December 6 Canadian Nuclear Safety Commission (CNSC) staff report to the Commission Tribunal, CNSC staff reported “the AECL management decided to maintain the NRU Reactor in an extended shutdown to work on emergency power supply availability to the main heavy water pumps.” AECL stated that “safety was never compromised, and NRU operated safely up to the point of the current outage.” CNSC is reportedly receiving daily updates on the progress of the modifications from AECL. On December 12, the Parliament of Canada passed emergency legislation to bypass the Canadian Nuclear Safety Commission (CNSC) and allow the Atomic Energy of Canada Limited (AECL) to restart the National Research Universal (NRU) reactor. AECL initiated procedures to restart the NRU reactor on December 13 and it was safely returned to service on December 16. Full production of Mo-99 resumed the week of December 24.

SNM’s Role SNM worked directly with relevant federal agencies and industry leaders in the United States and Canada to keep the medical-scientific community as informed as possible on the status of the molybdenum-99 shortage and surrounding issues. SNM developed an “Online Resource Center,” where updates were given daily to keep SNM members and industry leaders informed on the current status of the NRU reactor in Chalk River.

Committee on Pharmacopeia Joseph Hung, MD

AMMONIA (13N) INJECTION Ammoniae (13N) solutio iniectabilis

DEFINITION Ammonia (13N) injection is a sterile solution of [13N]ammonia for diagnostic use. The injection contains not less than 90.0 per cent and not more than 110.0 per cent of the declared nitrogen-13 radioactivity at the date and time stated on the label. Not less than 99 per cent of the total radioactivity corresponds to nitrogen-13 in the form of [13N]ammonia. Not less than 99.0 per cent of the total radioactivity corresponds to nitrogen-13. PRODUCTION RADIONUCLIDE PRODUCTION Nitrogen-13 is a radioactive isotope of nitrogen which may be produced by various nuclear reactions, such as proton irradiation of carbon-13 or oxygen-16, or deuteron irradiation of carbon-12. RADIOCHEMICAL SYNTHESIS [13N]Ammonia may be prepared by proton irradiation of water followed by the reduction of the resulting [13N]nitrates/nitrites mixture with a reducing agent. The [13N]ammonia formed is distilled from the reaction mixture and trapped in a slightly acidic solution. Other methods may produce [13N]ammonia “in-target” by proton irradiation of water containing a small amount of ethanol or acetic acid, or by proton irradiation of a slurry of [13C]carbon powder in water. The resulting solution can be purified, to remove radionuclidic and radiochemical impurities, using anion and cation exchange columns. CHARACTERS A clear, colourless solution. Nitrogen-13 has a half-life of 9.96 min and emits positrons with a maximum energy of 1.198 MeV, followed by annihilation gamma radiation of 0.511 MeV. IDENTIFICATION

A. Record the gamma-ray spectrum using a suitable instrument. The only gamma photons have an energy of 0.511 MeV and, depending on the measurement geometry, a sum peak of 1.022 MeV may be observed.

B. It complies with test (a) for radionuclidic purity (see Tests). C. Examine the chromatograms obtained in the test for radiochemical purity. The

principal peak in the radiochromatogram obtained with the test solution has approximately the same retention time as the principal peak in the radiochromatogram obtained with the reference solution. TESTS pH (2.2.3). The pH of the injection is 5.5 to 8.5. Sterility. It complies with the test for sterility prescribed in the monograph on Radiopharmaceutical preparations (0125). The injection may be released for use before completion of the test. Bacterial endotoxins (2.6.14): less than 175/V IU/ml, V being the maximum recommended dose in millilitres. The injection may be released for use before completion of the test. CHEMICAL PURITY

Aluminium. In a test-tube about 12 mm in internal diameter, mix 1 ml of acetate buffer solution pH 4.6 R and 2 ml of a 1 in 20 dilution of the preparation to be examined in water R. Add 0.05 ml of a 10 g/l solution of chromazurol S R. After 3 min, the colour of the solution is not more intense than that of a standard prepared at the same time and in the same manner using 2 ml of a 1 in 20 dilution of aluminium standard solution (2 ppm Al) R (2 ppm). The injection may be released for use before completion of the test. RADIONUCLIDIC PURITY (a) Half-life. The half-life is between 9 min and 11 min. (b) Gamma emitting impurities. Retain a sample of the preparation to be examined for 2 h. Examine the gamma-ray spectrum of the decayed material for the presence of radionuclidic impurities, which should, where possible, be identified and quantified. The total gamma radioactivity due to these impurities does not exceed 1.0 per cent of the total radioactivity. The injection may be released for use before completion of tests (a) and (b). RADIOCHEMICAL PURITY Examine by liquid chromatography (2.2.29). Test solution. The preparation to be examined. Reference solution. Dilute 1.0 ml of dilute ammonia R2 to 10.0 ml with water R. The chromatographic procedure may be carried out using:

— a column 0.04 m long and 4.0 mm in internal diameter packed with cation exchange resin R (10 µm),

— as mobile phase at a flow rate of 2 ml/min 0.002 M nitric acid, — a suitable radioactivity detector, — a conductivity detector, — a loop injector,

maintaining the column at a constant temperature between 20 °C and 30 °C. Inject separately the test solution and the reference solution. The chromatogram obtained with the radioactivity detector and the test solution shows a principal peak with approximately the same retention time as the peak in the chromatogram obtained with the reference solution and the conductivity detector. Not less than 99 per cent of the total radioactivity corresponds to nitrogen-13 in the form of ammonia. The injection may be released for use before completion of the test. RADIOACTIVITY Measure the radioactivity using suitable equipment by comparison with a standardised fluorine-18 solution or by using an instrument calibrated with the aid of such a solution. Standardised fluorine-18 solutions are available from laboratories recognised by the competent authority. IMPURITIES

A. [13N]O2−,

B. [13N]O3−,

C. [18F−], D. H2[15O].

Ammonia N 13 Injection

» Ammonia N 13 Injection is a sterile solution of 13NH3 in Sodium

Chloride Injection, suitable for intravenous administration, in which a

portion of the molecules are labeled with radioactive 13N (see

Radiopharmaceuticals for Positron Emission Tomography—

Compounding 823 ). It contains not less than 90.0 percent and not

more than 110.0 percent of the labeled amount of 13N expressed in MBq

(or mCi) per mL at the time indicated in the labeling. Specific activity: no carrier added.

Packaging and storage—Preserve in single-dose or multiple-dose containers

that are adequately shielded.

Labeling—Label it to include the following, in addition to the information

specified for Labeling under Injections 1 : the time and date of calibration; the

amount of 13N as ammonia expressed as total MBq (mCi) per mL, at time of

calibration; the expiration time and date; and the statement “Caution—

Radioactive Material.” The labeling indicates that in making dosage calculations

correction is to be made for radioactive decay and also indicates that the

radioactive half-life of 13N is 9.96 minutes. The label also includes the statement

“Do not use if cloudy or if it contains particulate matter.”

USP Reference standards 11 —

USP Ammonium Chloride RS.

USP Endotoxin RS.

Identification—

A: Radionuclidic identity—Its half-life, determined using a suitable detector

system (see Radioactivity 821 is between 9.5 and 10.5 minutes.

B: Radiochemical identity—The retention time of the major peak in the

chromatogram of the Test solution corresponds to that in the chromatogram of

the Standard solution, as obtained in the Radiochemical purity test.

http://www.uspnf.com/uspnf/pub/data/v30252/usp30nf25s2_c823.xml#usp30nf25s2_c823




http://www.uspnf.com/uspnf/pub/data/v30252/usp30nf25s2_alpha-18-34.xml#usp30nf25s2_c11rs1662



Bacterial endotoxins 85 (see Sterilization and Sterility Assurance under

Radiopharmaceuticals for Positron Emission Tomography—Compounding

823 )—It contains not more than 175/V USP Endotoxin Unit per mL of the

Injection, in which V is the maximum administered total dose, in mL, at the

expiration time.

pH 791 : between 4.5 and 7.5.

Radiochemical purity—

Mobile phase—Add 0.25 mL of concentrated nitric acid to 1000 mL of a mixture

of water and methanol (7:3), filter, and degas.

Standard solution—Dissolve an accurately weighed quantity of USP Ammonium

Chloride RS in water, and dilute quantitatively, and stepwise if necessary, with

water to obtain a solution having a known concentration of about 0.1 mg per mL.

Test solution—Use the Injection.

Chromatographic system (see Chromatography 621 )—The liquid

chromatograph is equipped with a 4.1-mm × 25-cm column that contains 10-µm

packing L17. It is equipped with a gamma ray detector and a conductivity

detector. The flow rate is about 2.0 mL per minute. Chromatograph the Test

solution, and record the peak responses as directed for Procedure: the relative

standard deviation for replicate injections is not more than 5%.

Procedure—Prepare a mixture of the Standard solution and the Test solution

(1:1), and inject about 20 µL of the mixture into the chromatograph, record the

chromatograms, and measure the peak areas. The areas of both the main

radioactive and nonradioactive peaks are equal. [NOTE—The volume of Injection

may be adjusted to obtain suitable detection system sensitivity.] The radioactivity

of the major peak is not less than 95% of the total radioactivity measured. The

retention time of the Test solution corresponds to the retention time of the

Standard solution.

Radionuclidic purity—Using a suitable gamma-ray spectrometer (see Selection

of a Counting Assembly under Radioactivity 821 ), count an appropriate

aliquot of the Injection for a period of time sufficient to obtain a gamma spectrum.









The resultant gamma spectrum should be analyzed for the presence of

identifiable photopeaks which are not characteristic of 13N emissions. Not less

than 99.5% of the observed gamma emissions should correspond to the 0.511

MeV, 1.022 MeV, or Compton scatter peaks of 13N.

Chemical purity—This article may be synthesized by different methods and

processes and, therefore, contains different impurities. The presence of

unlabeled ingredients, reagents, and by-products specific to the process must be

controlled, and their potential for physiological or pharmacological effects must

be considered.

ALUMINUM (to be determined if Devarda's alloy is used to reduce 13N

nitrate/nitrite)—

Aluminum standard solution—Transfer 35.17 mg of aluminum potassium sulfate

dodecahydrate, accurately weighed, to a 1000-mL volumetric flask, and dilute

with water to volume to obtain a solution having a known concentration of 2 µg of

aluminum per mL.

Procedure—Pipet 10 mL of Aluminum standard solution into each of two 50-mL

volumetric flasks. To each flask add 3 drops of methyl orange TS and 2 drops of

6 N ammonium hydroxide, then add 0.5 N hydrochloric acid, dropwise, until the

solution turns red. To one flask add 25 mL of sodium thioglycolate TS, and to the

other flask add 1 mL of edetate disodium TS. To each flask add 5 mL of

eriochrome cyanine TS and 5 mL of acetate buffer TS, and add water to volume.

Immediately determine the absorbance of the solution containing sodium

thioglycolate TS at the wavelength of maximum absorbance at about 535 nm,

with a suitable spectrophotometer, using the solution containing the edetate

disodium TS as a blank. Repeat the procedure using two 1.0-mL aliquots of

Injection. Calculate the quantity, in µg per mL, of aluminum in the Injection taken

by the formula:

20(TU / TS)

in which TU and TS are the absorbances of the solutions from the Injection and the

Aluminum standard solution, respectively. The concentration of aluminum ion in

the Injection is not greater than 10 µg per mL.

http://www.uspnf.com/uspnf/pub/data/v30252/usp30nf25s2_ris1s126.xml#usp30nf25s2_ris1s284





Other requirements—It meets the requirements under Injections 1 , except

that the Injection may be distributed or dispensed prior to completion of the test

for Sterility 71 , the latter test being started within 24 hours of final

manufacture, and except that it is not subject to the recommendation in Volume

in Container.

Assay for radioactivity—Using a suitable calibrated system as directed under

Radioactivity 821 , determine the radioactivity, in MBq (or mCi) per mL, of the

Injection.

Auxiliary Information—Staff Liaison : Andrzej Wilk, Ph.D., Senior Scientific

Associate

Expert Committee : (RMI05) Radiopharmaceuticals and Medical Imaging Agents

05

USP30–NF25 Page 2763

Pharmacopeial Forum : Volume No. 29(3) Page 641

Phone Number : 1-301-816-8305

Chromatographic Reagent—

AMMONIA N 13 INJECTION

Chromatographic reagents text is not derived from, and not part of, USP 30 or

NF 25.




mailto:[email protected]


http://www.uspnf.com/uspnf/pub/data/v30252/usp30nf25s2_crm56930.xml#usp30nf25s2_crm56930

1

Proposed Revisions for USP Monograph on Ammonia N 13 Injection

Proposed by

Committee on Pharmacopeia

Radiopharmaceutical Sciences Council

Society of Nuclear Medicine

Revision 8.0

2

Note:

• Proposed revisions are shown with strike-through text proposed for deletion.

• Text appear in blue is new addition or revision to the current monograph on Ammonia N

13 Injection.

• Each proposed change is identified with a superscripted number in the main text of the

revised monograph, and a corresponded explanation is listed in the section titled

“Reasoning for the Suggested Changes.”

3

Ammonia N 13 Injection

Ammonia N 13 Injection is a sterile solution of 13NH3 1in Sodium Chloride Injection,

suitable for intravenous administration, in which a portion of the molecules are labeled with

radioactive 13N (see Radiopharmaceuticals for Positron Emission Tomography — Compounding

<823>). It contains not less than 90.0 percent and not more than 110.0 percent of the labeled

amount of 13N expressed in MBq (or mCi) per mL at the time indicated in the labeling.

Reason for the Suggested Change

1. Ammonia N 13 Injection may be prepared with the use of 0.9% sodium chloride or

sterile water.

4

Appearance

1The solution must be clear, colorless, and free from particulate matter. To reduce

radiation exposure, direct visual inspection containing high radioactivity should be conducted in

accordance with as low as reasonably achievable (e.g., observing a representative sample rather

than the whole batch).


1. The USP should include “Appearance” testing in the official monograph for

Ammonia N 13 Injection since the USP section titled “Labeling” implicitly requires

that a visual inspection be performed prior to product release.

5

Specific activity

No changes.

6

Packaging and Storage

No changes.

7

Labeling

Label it to include the following, in addition to the information specified for Labeling

under Injections <1 >: the time and date of calibration; the amount of 13N as ammonia expressed

as total MBq (mCi) per mL, at time of calibration; the expiration time and date; and the

statement “Caution — Radioactive Material.” The labeling indicates that in making dosage

calculations correction is to be made for radioactive decay and also indicates that the radioactive

half-life of 13N is 9.96 minutes. The label also includes the statement “Do not use if cloudy or if

it contains particulate matter.”

1Prior to the preparation of Ammonia N 13 Injection, pre-label the immediate radioactive dose

container with “Ammonia N 13 Injection, the assigned batch or lot number, and date”. The full

labeling information (see list below) should be placed on the outer shielded container upon

completion of quality control test. Alternatively, a string label with the full labeling information

may be used to label the immediate container provided that there is a way to associate the label

with the vial if the label were to come off.

• Name of the PET drug product (i.e., Ammonia N 13 Injection)

• Time and date of calibration

• Total radioactivity in MBq (mCi may be included) and radioactive concentration

MBq/mL (mCi/mL may be included) at time of calibration

• Expiration time and date

• Assigned batch or lot number

• Added substances (e.g., stabilizer and preservatives)

• Require warning (e.g., radioactive) statement(s) (e.g., “Caution-Radioactive Material”) or

symbol(s)

8

• Applicable warning statements (e.g., “Do not use if cloudy or if it contains particulate

matter”)

• Other pertinent information (if required), such as storage conditions, radioactive half-life

of 13N (9.96 minutes), and name and place of business of the manufacturer, packer, or

distributor.

Reasons for the Suggested Changes

1. In addition to the information as specified in the monograph and the “Labeling”

section of Injections <1>, the labeling should also include the added substances as per

Radiopharmaceuticals for Positron Emission Tomography — Compounding <823>.

Rather than simply mentioning the names of three USP documents (i.e., Injections

<1>, Radiopharmaceuticals for Positron Emission Tomography — Compounding

<823>, and USP monograph for Ammonia N 13 Injection), it may be more

convenient to the end user by specifically listing each of the required labeling

information on the monograph. In order to reduce radiation exposure, it may be

sensible to pre-label the empty drug product vial (i.e., immediate dose container) with

partial but essential labeling information (e.g., Ammonia N 13 Injection, the assigned

batch or lot number, and date) prior to initiating the preparation procedure.

9

USP Reference Standards

No changes.

10

Identification

A: Radionuclidic identity — 1Its The radioactive half-life of 13N is 9.96 minutes,

determined using a suitable detector system (see Radioactivity <821>) over an appropriate time

(e.g., 10 minutes). The half-life must be between 9.5 and 10.5 minutes.

B: Radiochemical identity — 2The retention time of the major peak in the chromatogram

of the Test solution corresponds (± 10%) to that in the chromatogram of the Standard solution, as

obtained in the Radiochemical purity test. 3Alternative testing method(s) may be used providing

the system suitability conditions are validated (see Validation of Compendial Methods <1225>).

Reasons for the Suggested Changes

1. We suggest an addition stating the accurate half-life for 13N, as well as the time

period for measuring the half-life of 13N. The half-life measurement should be

conducted for a count time up to 3 or 4 half-lives of the radioisotope of interest. This

is to ensure that one can properly calculate any deviation in the measured half-life and

to better estimate other potential radioisotope contaminants. As such, it will take 30-

40 minutes to properly determine the half-life of 13N. However, our experience has

shown that a count time of at least 10 minutes provides a relatively accurate value for

13N half-life. The draft Chemistry, Manufacturing, and Controls Section issued by

the FDA for Ammonia N 13 injection indicates that the determination of 13N half life

should be carried out by measuring the radioactivity for decay of a sample over 10-

minute period.

2. A ± 10% range is necessary in order to account for the time shift for a given flow-rate

between the radioactivity and mass HPLC detectors, as well as the measurement

variance.

11

3. We think that the performance of identification can be carried out by other means as

long as the methodology is validated.

12

Bacterial Endotoxins

(See Sterilization and Sterility Assurance under Radiopharmaceuticals for Positron

Emission Tomography – Compounding <823>) — 1It contains not more than 175/V USP

Endotoxin Units per mL of in the total batch volume of Ammonia N 13 Injection, in which V is

the maximum administered total dose, in mL, at the expiration time.

Reason for the Suggested Changes

1. Because the maximum administered total volume of Ammonia N 13 Injection may be

equal to the total volume of the entire batch of ammonia 13N Injection production, it

would seem to be appropriate to calculate the bacterial endotoxin limit (i.e., 175/V USP

EU), using the total Ammonia N 13 Injection volume in the batch vial for the V value.

Although this approach is simple in that it does not take into consideration the maximum

administered dose, decay factor, or expiration time, the result is a bacterial endotoxin

limit with the lowest value because the total volume of the entire batch of ammonia N 13

injection, rather than a partial volume, is used as the denominator for calculation of the

acceptable bacterial endotoxin limit.

13

pH

1Between 4.5 and 87.5.


1. The European Pharmacopeia has a higher pH limit (i.e., 8.5).

14

Radiochemical Purity

Mobile phase — Add 0.25 mL of concentrated nitric acid to 1000 mL of a mixture of

water and methanol (7:3), filter, and degas.

Standard solution — Dissolve an accurately weighed quantity of USP Ammonium Chloride RS

in water, and dilute quantitatively, and stepwise if necessary, with water to obtain a solution

having a known concentration of about 0.1 mg per mL.

Test solution — Use the Injection.

Chromatographic system (see Chromatography <621>) —The liquid chromatograph is

equipped with a 4.1-mm × 25-cm column that contains 10-µm packing L17. It is equipped with

a gamma ray detector and a conductivity detector. The flow rate is about 2.0 mL per minute.

Chromatograph the Test solution, and record the peak responses as directed for Procedure: the

relative standard deviation for replicate injections is not more than 5%.

Procedure — Prepare a mixture of the Standard solution and the Test solution (1:1), and

inject about 20 µL of the mixture into the chromatograph, record the chromatograms, and

measure the peak areas. The areas of both the main radioactive and non-radioactive peaks are

equal. [NOTE — The volume of Injection may be adjusted to obtain suitable detection system

sensitivity.] The radioactivity of the major peak is not less than 95% of the total radioactivity

measured. 1The retention time of the Test solution corresponds (± 10%) to the retention time of

the Standard solution.

15




variance.

16

Radionuclidic Purity

Using a suitable gamma-ray spectrometer (see Selection of a Counting Assembly under

Radioactivity <821>), count an appropriate aliquot of the Injection for a period of time sufficient

to obtain a gamma spectrum. The resultant gamma spectrum should be analyzed for the presence

of identifiable photopeaks which are not characteristic of 13N emissions. 1Not less than 99.5% of

the observed gamma emissions should correspond (± 10%) to the 0.511 MeV, 1.022 MeV, or

Compton scatter peaks of 13N.




variance.

17

Chemical Purity

This article may be synthesized by different methods and processes and, therefore,

contains different impurities. The presence of unlabeled ingredients, reagents, and by-products

specific to the process must be controlled, and their potential for physiological or

pharmacological effects must be considered. 1Appropriate limits should be set for the chemical

impurities and suitable methods should be used to measure the presence of the above impurities.

1Alternative testing method(s) for measuring aluminum may be used providing the proposed

method is validated (see Validation of Compendial Methods <1225>). 2However, if the

method/process used to synthesis ammonia N 13 injection does not generate aluminum impurity,

the testing for aluminum content is not required.

ALUMINUM (to be determined if Devarda’s alloy is used to reduce 13N nitrate/nitrite) -

Aluminum standard solution — Transfer 35.17 mg of aluminum potassium sulfate

dodecahydrate, accurately weighed, to a 1000-mL volumetric flask, and dilute with water to

volume to obtain a solution having a known concentration of 2 µg of aluminum per mL.

Procedure — Pipet 10 mL of Aluminum standard solution into each of two 50-mL

volumetric flasks. To each flask add 3 drops of methyl orange TS and 2 drops of 6 N ammonium

hydroxide, then add 0.5 N hydrochloric acid, dropwise, until the solution turns red. To one flask

add 25 mL of sodium thioglycolate TS, and to the other flask add 1 mL of edetate disodium TS.

To each flask add 5 mL of eriochrome cyanine TS and 5 mL of acetate buffer TS, and add water

to volume. Immediately determine the absorbance of the solution containing sodium

thioglycolate TS at the wavelength of maximum absorbance at about 535 nm, with a suitable

spectrophotometer, using the solution containing the edetate disodium TS as a blank. Repeat the

18

procedure using two 1.0-mL aliquots of Injection. Calculate the quantity, in µg per mL, of

aluminum in the Injection taken by the formula:

20(TU / TS),

in which TU and TS are the absorbances of the solutions from the Injection and the Aluminum

standard solution, respectively. The concentration of aluminum ion in the Injection is not greater

than 10 µg per mL.


1. Self explanatory.

2. We would like to propose that the aluminum analysis is not required if the production

method/process does not generate aluminum impurity.

19

Other Requirements

1It meets the requirements under Injections <1>, except that the Injection may be

distributed or dispensed prior to completion of the test for Sterility <7>, the latter test being

started within 24 30 hours of final manufacture the completion of quality control sub-batch, and

except that it is not subject to the recommendation in Volume in Container. 1If the sample for

sterility testing is held longer than indicated (e.g., over the weekend or long holiday), one should

demonstrate that the longer period does not adversely affect the sample and the test results

obtained will be equivalent.

2Bubble point measurement should be used for the testing of the membrane filter

integrity, and the limit of the filter being used should be specified in accordance with

manufacturer’s specification(s).

Reasoning for the Suggested Changes

1. We would like to suggest that the initiation time for sterility test should be within 30

hours after the completion of quality control sub-batch of Ammonia N 13 Injection. This

requirement would be in consistent with the recent revision of proposed rule and draft

guidance of current good manufacturing practice on PET drug products issued by the

Food and Drug Administration. If the sample for sterility testing is held longer than

indicated (e.g., over the weekend or long holiday), one should demonstrate that the longer

period does not adversely affect the sample and the test results obtained will be

equivalent.

2. Since the sterility test is completed retrospectively, the membrane filter integrity test may

be considered to be an indicator of the microbiological integrity of the product. Thus, it

is important that this test be included in the quality control testing procedures for

20

Ammonia N 13 Injection. Bubble point measurement is a common method for the testing

of the membrane filter integrity.

21

Assay for Radioactivity

No change.

Bylaws Committee Update/Report

Committee Report SNM Board of Directors

February 15, 2008 Committee on Bylaws

Committee Charges for 2007-2008:

1. Maintain the Bylaws and Procedures of the Society of Nuclear Medicine.

2. Review all proposed amendments to the Bylaws and report them to the Board of Directors, as well as the House of Delegates.

Current Working Objectives/Goals:

1. Update the SNM Board of Directors on status of current proposed bylaw changes. 2. Announce proposed bylaw changes to the SNM House of Delegates.

3. Update SNM Procedure Manual to be consistent with current SNM Bylaws.

Progress of Charge/Objectives/Goals to Date:

1. The SNM Board of Directors approved the following proposed changes to the Bylaws during the SNM Board of Directors Meeting on May 31, 2007.

• Deletion of Committees: Commercial Affairs and Annual Meeting outlined in section “Committees

of the Board of Directors” under 2:Number of Committees; remove “Policy and” in the committee name of HCPP (Health Care Policy and Practice).

These changes have been reviewed by the SNM Bylaws committee and will be announced to the SNM House of Delegates during the Mid-Winter Meeting.

2. The SNM Board of Directors approved the following proposed changes to the Procedures during the SNM Board of Directors Meeting on May 31, 2007.

• Add the following: the chairperson of the Committee on Awards shall be the immediate Past

President under “Committee of the Board of Directors” under 3: Membership Composition of the committees of the Board of Directors.

• Change the following: The Immediate Past President shall not be eligible to be nominated for a position for a period of 3 years.

These changes have been reviewed by the SNM Bylaws committee and will be announced to the SNM House of Delegates during the Mid-Winter Meeting.

3. The SNM Bylaws Committee has developed an ad to be included in the JNM to announce the proposed

Bylaws Changes. The ad will run in the April JNM, with a mail distribution date of April 1.

Additional Goals/Objectives Added for 2007-2008:

1. The Bylaws Committee is currently working to ensure that all voting members of SNM are notified of the proposed changes, accordingly to the SNM Bylaws, 60 days in advance of the next HOD meeting. (Proposed date: April 1)

2. The SNM Bylaws Committee Chair is currently working with SNM staff to ensure that all proposed bylaw changes are included on the HOD agenda for vote the June 2008 meeting.

3. The Bylaws committee will review Article XV Amendments Section 2 and Section 3 to see if a shorter time period for notification of proposed changes and announcement of changes to membership is an option.

Bylaws Proposed Changes

ARTICLE XII COMMITTEES Section 1: DESCRIPTION A. The House of Delegates shall have the following standing committees, as well as such

additional committees or subcommittees as may be required by the House: 1. Committee on Chapters 2. Committee on Councils 3. Committee on Ethics 4. Committee on Nominations 5. Committee on Bylaws

B. The Board of Directors shall have the following standing committees, as well as such

additional committees or subcommittees as may be required by the Board: 1. Committee on Awards 2. Committee on Audit 3. Committee on Commercial Affairs 4. Committee on Finance 5. Committee on the Annual Meeting 6. Committee on Government Relations 7. Committee on Membership 8. Committee on Publications 9. Committee on Education 10. Committee on Health Care Policy and Practice 11. Committee on Radiopharmaceuticals

Section 2: APPOINTMENTS Appointments to all committees shall be recommended by the Vice President and approved by the House of Delegates at the Annual Meeting. Appointments to all standing committees of the Board of Directors shall be nominated by the Vice President and approved by the Board of Directors.

Section 3: COMPOSITION, QUALIFICATIONS, TERMS OF OFFICE RESPONSIBILITIES, AND MEETINGS The composition, qualifications, terms of office, responsibilities, and meetings shall be specified in Procedures.

Section 4: EX-OFFICIO MEMBERS

A. The President, or a liaison from the Board of Directors appointed by the President, shall serve as a non-voting ex-officio member of all committees, except the Committee on Nominations.

B. The Executive Director shall serve as a non-voting member of all committees, except the Committee on Nominations.

Section 5: REMOVAL FROM OFFICE Committee members may be removed from office as stated in Article IX.

Procedures Proposed Changes

SNM, Advancing Molecular Imaging and Therapy

PROCEDURES

Revised January 24, 2008

2

TABLE OF CONTENTS

COMMITTEES OF THE HOUSE OF DELEGATES ..................................………………….. 3

COMMITTEES OF THE BOARD OF DIRECTORS ..............................….……………………6

TASK FORCES…………………………………………………………………………………………………..10

ELECTION BY THE HOUSE OF DELEGATES OF FOUR (4) DIRECTORS-AT-LARGE TO THE BOARD OF DIRECTORS…………………………………………………………………………………….11

3

TYPES OF COMMITTEES There are four types of Committees: A. Standing Committees – Committees required by the SNM Bylaws.

B. Special Committees – Committees created by the Board of Directors or the House of Delegates.

C. Task Forces – Created to accomplish a specific task

D. Subcommittees – Created by the parent Committee, the President, the House of Delegates or the Board of Directors with responsibility to report to the parent Committee.

COMMITTEES OF THE HOUSE OF DELEGATES

1. Role and Function of Committees

A. The primary function of each Committee of the House of Delegates is to coordinate in a comprehensive and cohesive manner the professional, scientific, research, education and practice issues, policies and programs of the Society under its respective category.

B. The goals and objectives of each Committee are determined by the Board of Directors. Oversight of Committee actions will be provided by the House of Delegates.

2. Number of Committees:

A. The House of Delegates shall have the Standing Committees as specified in the Bylaws (BYLAWS, Article XII, Section l.).

B. In addition, the House of Delegates may establish other Committees, as circumstances warrant.

C. The House of Delegates currently has the following Standing Committees

identified in the Bylaws: 1. Committee on Chapters; 2. Committee on Councils; 3. Committee on Ethics; 4. Committee on Nominations; 5. Committee on Bylaws.

4

3. Membership Composition of the Committees of the House of Delegates:

A. The Chairperson of each Committee will be nominated by the Vice President [President-Elect] and approved by the House of Delegates at the Annual Meeting, for a term of one (1) year.

B. Whenever appropriate and feasible, members of the Committees of the House of Delegates serve for a term of three (3) years. The Members of each Committee to be appointed will be nominated by the Vice President (President-elect) and approved by the House of Delegates at the Annual Meeting. The Vice President (President-Elect) shall consult with Committee Chairpersons for advice on Committee appointments. If a proposed appointment shall result in a member serving on a Committee for more than six (6) years, the nominations letter to the House of Delegates shall make note of the proposed extended service and indicate the reason for the extended service.

C. In the case of the Committee on Councils, the Council Presidents will serve as its voting members. The Vice President-Elect will appoint the Chairperson of the Committee on Councils.

D. Vice Chairpersons for an individual Committee may be appointed, as circumstances warrant. Vice Chairpersons do not necessarily succeed to the Committee Chairperson.

E. The President or a liaison from the Board of Directors, appointed by the President, the Vice President [President-Elect] and the Vice President-Elect will serve as Ex-Officio non-voting Members of each Committee [BYLAWS, Article XII, Section 4], as well as the Executive Director, except for the Committee on Nominations.

3. Meetings of the Committees:

A. Committees will meet at least one time a year in person or by electronic means. Attendees and outcomes of the meeting shall be documented. Minutes of the Committee meetings must indicate if a quorum was present.

B. To the extent possible, each Committee will process its charges in between meetings of the House of Delegates by telephone, correspondence, email, web meetings and in person meetings, as circumstances warrant.

C. A quorum is 50% or more of the voting members. If a quorum is not

5

established, the Committee may take no formal action. Establishment of a quorum will be documented in the minutes of any Committee proceedings. Agenda topics being presented to the House of Delegates must indicate that a quorum was present at the Committee meeting when action was taken.

D. Each Committee Chairperson shall inform Committee members of current issues quarterly or more frequently, and discuss current issues and proposed actions with Committee members at these times by electronic means or in person, as circumstances warrant.

E. The Committee Chairpersons will report after each electronic or in person meeting to the Speaker of the House of Delegates and to the Board of Directors. The Committee Chairperson shall report Committee activity at least quarterly or more frequently, as circumstances warrant.

4. Establishment and Dissolution of Committees:

A. The Society will always have those Committees identified in the Bylaws, unless circumstances require any change, which must be processed in accord with the Bylaws regarding Amendments.

B. In addition, the House of Delegates may establish or dissolve other Committees, as circumstances warrant.

6

COMMITTEES OF THE BOARD OF DIRECTORS

1. Role and function of the Committees:

A. The primary function of each Committee of the Board of Directors is to coordinate in a comprehensive and cohesive manner the professional, scientific, research, education and practice issues, policies and programs of the Society

B. The goals and objectives of each Committee are determined by the Board of Directors with input, as appropriate, from Committee members. Oversight of Committee actions will be provided by the Board of Directors

2. Number of Committees:

A. The Board of Directors shall have the Standing Committee as specified in the Bylaws.

B. The Board of Directors currently has the following Standing Committees identified in the Bylaws:

1) Awards 2) Commercial Affairs 3) Finance 4) Annual Meeting 5) Government Relations 6) Publications 7) Committee on Education 8) Committee on Health Care Policy and Practice 9) Committee on Radiophramaceuticals

C. In addition, the Board of Directors may establish other Committees, as circumstances warrant.

3. Membership Composition of the Committees of the Board of Directors:

A. The Chairperson of each Committee will be nominated by the Vice President [President-Elect] and approved by the Board of Directors at the Annual Meeting, for a term of one (1) year, except where noted in the remainder of this section:

B. The Chairperson of the Committee on Education shall serve a three (3) year term, with a maximum of two (2) full terms.

C. The Chairperson of the MIRD Committee shall serve a three (3) year

term.

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D. The Chairperson of the Committee on Awards shall be the SNM immediate

past president. E. Whenever appropriate and feasible, members of the Committees of the

Board of Directors should be appointed for terms of three (3) years. The Members of each Committee to be appointed will be nominated by the Vice President (President-Elect) and approved by the Board of Directors at the Annual Meeting. The Vice President (President-Elect) shall consult with Committee Chairpersons for advice on Committee appointments. If the proposed appointment shall result in a member serving on a Committee for more than six (6) years, the nomination letter to the Board of Directors shall make note of the proposed extended service and indicate the reason for the extended service.

EF. Vice Chairpersons for an individual Committee may be appointed, as circumstances warrant. Vice Chairpersons do not necessarily succeed to the Committee Chairpersonship.

FG. The President or a liaison from the Board of Directors, appointed by the President, the Vice President [President-Elect] and the Vice President-Elect will serve as Ex-Officio non-voting Members of each Committee [BYLAWS, Article XII, Section 4], as well as the Executive Director.

4. Meetings of the Committees:

A. Committees will meet at least one time a year in person or by electronic means. Attendees and outcomes of the meeting shall be documented. Minutes of the Committee meetings must indicate if a quorum was present.

B. To the extent possible, each Committee will process its charges in between meetings of the Board of Directors by telephone, correspondence and meetings, as circumstances warrant.

C. A quorum is 50% or more of the voting members. If a quorum is not established, the Committee may take no formal action. Establishment of a quorum will be documented in the minutes of any Committee proceedings. Agenda topics being presented to the Board of Directors must indicate that a quorum was present at the Committee meeting when action was taken.

D. Each Committee Chairperson shall inform Committee members of current issues quarterly or more frequently, and discuss current issues and proposed actions with Committee members at these times by electronic means or in person, as circumstances warrant.

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E. The Committees will report after each electronic or in person meeting to the President and Board of Directors. The Committee shall report at least quarterly or more frequently, as circumstances warrant.

5. Establishment and Dissolution of Committees:

A. The Society will always have those Committees identified in the Bylaws, unless circumstances require any change, which must be processed in accordance with the Bylaws regarding Amendments.

B. In addition, Board of Directors may establish or dissolve other Committees, as circumstances warrant.

6. Specific Board of Director Committee Membership Requirements

A. General Program Chairperson and Annual Meeting Committee

a. The General Program Chairperson serves as the Chairperson of the Committee on Annual Meetings and is responsible for the oversight and coordination of the Mid-Winter Meeting, the Annual Scientific Meeting and other scientific and educational meetings.

b. The General Program Chairperson is nominated by the Executive Committee and approved by the Board of Directors for a three (3)-year term, serving as General Program Chairperson-elect one (1) year in advance of the commencement of his term as General Program Chairperson.

c. The following serve as ex-officio members of the Annual Meeting Committee without the right to vote:

i. Scientific Program Chairperson; ii. Associate Chairperson for Continuing Education; iii. Associate Chairperson for Scientific Exhibits; iv. Chairperson of the Scientific and Teaching Committee; v. The General Program Chairperson-elect; vi. Scientific Program Chairperson-elect.

B. The Scientific Program Committee will consist of the following:

a. Scientific Program Chairperson with a term of two (2) years, to be approved by the Board of Directors on nomination by the Executive Committee;

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b. Immediate Past Scientific Program Chairperson; c. Chairperson of the SNMTS Scientific and Teaching Committee; d. Associate Chairperson for Continuing Education; e. Associate Chairperson for Categorical Seminars; f. Five (5) Vice Chairpersons for Cardiovascular Procedures,

Instrumentation & Data Analysis, Radiopharmaceutical Sciences, and two (2) additional Vice Chairpersons for all additional remaining clinical categories;

g. Subchairpersons will be appointed by the Scientific Program Chairperson on recommendation of each of the Vice Chairpersons with responsibility for each of the topical areas;

h. Scientific Program Chairperson-elect and General Program Chairperson-elect are to be appointed by the Board of Directors on nomination by the Executive Committee at least one (1) year in advance of their respective terms;

i. General Program Chairperson. C. Editor of the JNM and JNMT

The Editor of the Journal of Nuclear Medicine (JNM) and the Editor of the Journal of Nuclear Medicine Technology (JNMT) will be additional ex-officio members without the right to vote on the Committee on Publications; neither editor may serve as Committee Chairperson.

D. Committee on Finance

1. The Committee on Finance will consist of the SNM and SNMTS President, the Vice President [President-Elect], Vice President-Elect, Secretary/Treasurer, the Immediate Past SNM and the SNMTS Treasurer, 2. Chair, Subcommittee on Investments, the Chairperson of the Technologist Section Finance Committee and five (5) members, including two (2) Technologist Section Members, each member including the Chairperson, serving a term of four (4) years. 3. The Subcommittee on Audit will consist of the Secretary/Treasurer, Immediate Past Secretary/Treasurer, the Chair and Vice-Chair of the Committee on Finance, the Chairperson and four (4) elected members, with one (1) member elected for a four (4)-year term each year.

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TASK FORCES

A task force may be created to address one or more specific issues of the House of Delegates, The Board of Directors, the Executive Committee, the Speaker of the House or the President. Task Forces created by the House of Delegates shall report to the House of Delegates and provide an informational report to the Board of Directors. All other Task Forces shall report to the Board of Directors and provide an informational report to the Speaker of the House. A task force may be disbanded at any time by the entity that created it, and a Task Force shall automatically cease to exist after two years, unless the entity that created the Task Force extends its life. The life of a Task Force may be extended by time increments of one year.

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ELECTION BY THE HOUSE OF DELEGATES OF FOUR (4) DIRECTORS-AT-LARGE TO THE BOARD OF DIRECTORS

1. Election of Directors at Large

Directors-at-Large will serve a three year term of office. There will be one or two vacancies to be filled each year as terms expire. Delegates-at-Large will be elected by voting members of the House of Delegates, nominated from the voting members of the House of Delegates.

Voting Members of House of Delegates:

Chapter Representatives 28 Council Representatives 18

Technologists Representatives 8 Historian 1

Total 55

2. Composition of Nominating Committee

The Nominating Committee will consist of six (6) voting members of the HOD. The non-voting chairperson will be the SNM Past President once removed. The Historian will solicit nominees for the committee members. Selection of members will be by the drawing of names. The Nominating Committee will consist of the following: three (3) members from the Chapter delegates, two (2) from the Council delegates and one (1) from the Technologist Section Delegates. Term of office for chairperson and members will be one year. The Chairperson of the Nominating Committee may vote in order to break a tie vote.

3. Duties of Nominating Committee

The Nominating Committee would nominate the following individuals as needed:

a) The Vice-President-Elect (one-year term, with automatic ascendancy to one-year terms as VP/President-Elect and President)

b) The Secretary/Treasurer (two-year term) c) The Speaker of the House (two-year term) d) The Historian (three-year term) e) The non-technologist at-large members of the BOD elected from the HOD

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4. Nominations and Election Process Nominations may be received from any voting member of the House of Delegates. The immediate past president shall not be eligible for nomination to a position for a period of three years after termination of their term of office. The Committee will select candidates by serial votes, similar to the way the current Nominating Committee selects candidates for House of Delegates. For one vacancy at least two candidates will be nominated. For two vacancies, at least three candidates will be nominated. Vacancies for incomplete terms would be filled by the next highest vote getter for the remainder of the incomplete term. Election will be by written ballot at the Annual meeting of the House of Delegates by all voting members of the House of Delegates. Those elected would assume office following the Annual Meeting. 5. Technologist Section Representatives The Technologist Section representatives are elected in accord with Procedures developed by the Section.

Board of Directors Composition

Education and Research Foundation Robert Carretta, MD

The Education and Research Foundation for the Society of Nuclear Medicine Report to Board of Directors Date: February 15, 2008 Bench to Bedside Molecular Imaging Campaign Since the launch of the Campaign last June, we have received $136,241 in pledges and contributions from 141 members. Our primary goal is to raise $500,000 from individuals for this important initiative. As of December 31, 2007 the combined corporate and individual gift and pledge total is $4,276,241. FY 2008 Contributions in Support of Education and Research Quarter 1 of Fiscal Year 2008 (October 1, 2007- December 31, 2007) contributions to the ERF total $49,819. This figure includes $14,301 in donations to the Molecular Imaging Campaign and also a gracious $25,000 contribution from Covidien to support the 2008 SNM/Covidien Seed Grant in Nuclear Medicine and Molecular Imaging. ERF Annual Fund $5,677.00 No. of Donations: 88 Paul Cole Scholarship Fund $2,566.00 No. of Donations: 105 Robert J. Lull Fund $1,525.00 No. of Donations: 2 Howard Kay Fund $7,700.00 No. of Donations: 14 Restricted ERF Fund $25,000.00 No. of Donations: 1 MI Campaign Gifts $14,301.00 No. of Donations: 55 Total Gifts $56,749.00 264 Total Gifts

We are posting a 9% increase over the $52,139 raised during this period last year. MI Campaign gifts and pledges for this period are up 85% from the same period

last FY ($7,715.00).

FY 2008 ERF Budgeted Support for the SNM and SNMTS Grants and Awards Program

$430,000: In support to existing SNM and SNMTS grants and awards as well as new MI grants and awards.

New Business

The Development office is pleased to report that Robin Cousins has been hired as the new Development Assistant. Robin will be assisting with conference calls, reporting, gift entry, tracking and invoicing pledges and general office support.

ERF has begun making major gift requests of top prospects. In January two requests were made for gifts totaling $35,000. Three major donor appointments are scheduled during the MWM. Another meeting is in the process of being scheduled for March as well.

Committee on Awards Matthew Thakur, PhD

Grants and AwardsGrants and Awards

2008 Grants and Awards Highlights2008 Grants and Awards Highlights

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SNM Grants and Awards Program Highlights

• In September the ERF agreed to fund $430,000 in Grants and Awards for 2008.

• We set about establishing new applications, guidelines, and reviewer criteria for an ambitious slate of new programs for SNM and SNMTS.

• SNM awards went online on January 18, 2008.• The awards were posted in the SmartBrief to 3,601

live email addresses in January and February (ongoing).


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SNM Grants and Awards Program Highlights

• Posted in targeted email blasts to 11,829 live addresses in January (ongoing).

• Posted in SNM’s weekly email blast to 12,097 live addresses with “hit rate” of 5 to 7% (ongoing).

• Applications are due Friday, April 4, 2008.• Awardees will be announced at the Annual

Meeting.

Molecular Imaging Research Grants for Junior Medical Faculty Molecular Imaging Research Grants for Junior Medical Faculty

SNM Molecular Imaging Research Grants for Junior Medical Faculty

– Will support board-certified nuclear medicine physicians or radiologists engaging in molecular imaging research.

– Up to two years of salary support at $50,000 per year is available for a junior faculty member in nuclear medicine or radiology whose research relates to diagnostic or therapeutic applications.

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Postdoctoral Molecular Imaging Scholar Program Postdoctoral Molecular Imaging Scholar Program

Postdoctoral Molecular Imaging Scholar Program

– Will support a two-year research endeavor by MD or PhD holders to promote the integration of molecular imaging into their career.

– $30,000 per year for two years is available for two researchers.

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Predoctoral Molecular Imaging Scholar Program Predoctoral Molecular Imaging Scholar Program

Predoctoral Molecular Imaging Scholar Program

– Will support PhD candidates in an established molecular imaging research facility.

– Scholars will apply molecular imaging approaches (including tool development) to investigate biological pathways in disease models.

– Up to $40,000 over two years may be awarded to institutions to support two “SNM Scholars.”

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SNMTS Grants and Awards Program Highlights

• SNMTS awards went online on January 24, 2008.• Will be posted in the SmartBrief to 3,601 live

email addressed in February (ongoing).• Posted in targeted email blasts to 11,829 live

addresses February 1, 2008 (ongoing).• Posted in SNM’s weekly email blast to 12,097 live

addresses with “hit rate” of 5 to 7% (ongoing).


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SNMTS Grants and Awards Program Highlights

• Ads will run in March issue of JNMT to 309 recipients

• Applications are due Friday,May 30, 2008.• Awardees will be approved and then

notified by August 1, 2008.

SNMTS Bachelor’s Degree Completion Scholarship SNMTS Bachelor’s Degree Completion Scholarship

SNMTS Bachelor’s Degree Completion Scholarship

– Serves to support a student who is pursuing a Bachelor’s degree completion program related to his/her nuclear medicine career.

– Five (5) $5,000 scholarships, which may be renewed for one academic year, will be awarded.

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SNMTS Advanced Practitioner Program Scholarship SNMTS Advanced Practitioner Program Scholarship

SNMTS Advanced Practitioner Scholarships

– Serve to support students who are pursuing an advanced practitioner program to advance their careers in nuclear medicine.

– Two (2) $5,000 scholarships will be awarded.

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SNMTS Clinical Advancement Scholarship SNMTS Clinical Advancement Scholarship

SNMTS Clinical Advancement Scholarships

– Serve to support technologists who are pursuing clinical advancement through didactic educational programs.

– Fifty (50) $500 scholarships will be awarded.

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New Travel AwardsNew Travel Awards

• SNM Travel Awards: – Thirty (30) $1,000 awards offered

• SNMTS Travel Awards: – Twenty-five (25) $1,500 awards offered

• SNMTS Student Travel Awards:– Twenty-five (25) $1,500 awards offered

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Travel awards are provided to aid supporting the attendance of physicians/researchers/trainees, technologists, and NMT students to present their molecular imaging abstracts at SNM’s Annual Meeting in New Orleans.

SNM/Covidien Seed GrantSNM/Covidien Seed Grant

- This grant will support basic and clinical scientists in the early stages of their careers, employed by academic and research-oriented organizations worldwide.

- $25,000 is available for one scientist in 2008.

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The SNM/Covidien Seed Grant in Nuclear Medicine Research for 2008 is designed to assist researchers in conducting new and innovative pilot projects that have potential for future support from foundations, corporations, or government agencies.

NM-Siemens Award for Excellence in Practice-Based Research NM-Siemens Award for Excellence in Practice-Based Research

- This award recognizes an investigator for originality, scientific methodology, and practical applications. Abstracts must contain scientific examination on the economic value of practice- or evidence-based research in the field of nuclear medicine and molecular imaging and therapy.

- Seven prizes will be awarded:

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The purpose of the SNM-Siemens Award for Excellence in Practice-Based Research is to encourage interested authors to submit abstracts that demonstrate the economic value of molecular imaging including nuclear medicine in the daily patient management process and, ultimately, improved patient outcomes.

-One first place award of $5,000.00 and a certificate-One second place award of $4,000.00 and a certificate-One third place award of $2,000.00 and a certificate-Four honorable mentions awarded $1,000.00 and complimentary registration for the 2009 SNM Annual Meeting in Toronto.

New Business

Recess Until Reconvened Saturday, February 16 – 6:00pm

Informational Reports

2008 SNM Mid-Winter Meeting

Virginia Pappas, CAE SNM Chief Executive Officer (CEO) Report

As we have entered into a new fiscal year our focus and determination on the objectives and mission has not changed. The Society leadership and staff have strived to stay abreast of issues and monitor and respond to the changes in the industry. In this report I will provide the Society’s progress on these efforts and its accomplishments to date. SNM continues to be at the forefront of new and innovative educational opportunities for our members. Over the past six months, the Education Committee has been working to develop a Strategic Plan that will take SNM into 2010 with cutting edge education. In addition, the Education Committee is planning to develop the “Practice Performance Assessment Program” (PPAP), maintenance of certification Part IV activity. While the MOC will continue to be an evolving program, SNM is at the forefront of meeting the requirements for Part IV and many other organizations are looking to us for direction and guidance. SNM has released the following LLSAP Modules/Cases, 28 LLSAP modules (with 112 cases within the LLSAP modules), 50 CT interactive online cases, and 100 PET/CT interactive online cases. New titles this year include; Cardiovascular SPECT and PET – Part I, Partial-Volume Effect in PET Tumor Imaging, Diagnostic CT Cases 51-100, Radiopharmaceutical Therapy for Bone Pain, Sentinel Node Imaging: Melanoma, Breast Cancer and Others, Immunoscintigraphy and Radioimmunotherapy of Lymphoma, and PET/CT Cases 101-150 (final set). For the first time, the SNM Communications Department and the SNM Publications Committee is working to develop an “English/Spanish Guide to Nuclear Medicine Procedures” for patients. The book will go to press later this month. Additionally, with the closing of the Atomic Energy of Canada Limited (AECL), which runs the NRU reactor, Dr. McEwan , SNM President gained the society and the issue of radioisotope production in Canada extensive media exposure throughout December and into January. Dr. McEwan participated in interviews with major newspapers, television and radio outlets in Canada and the United States. He actively responded to reporter requests and fielded calls and interviews for days. Dr. McEwan was also quoted in the New York Times and in stories distributed to the Associated Press. Starting Monday, Jan. 14, a new publication from SNM called "SNM SmartBrief" was launched bringing a summary of the most important and timely news stories affecting nuclear medicine and molecular-imaging professionals directly to subscribers' e-mail boxes. Currently, more than 3,600 individuals have subscribed. The total launch rate was 11,830 individuals. From the original lists submitted, of the 3,778 physician/scientists the

e-mail was sent to, 947 subscribed. Additionally, 8,052 technologists individuals were sent the first e-mail, and of that, 1,561 subscribed. The overall conversion rate of subscribers is 25%. Another 538 individual signed-up to receive the SmartBrief’s that were not on either original list. This is a combination of individuals using different e-mail address, suspended members who are now subscribing and individuals who receive the brief through the “forward to a friend” function. With the addition of Teri Pinkham, Director of Development in September 2007, and the generous gift from the ERF in respect to the Hal Anger estate, the Development Office has soared to new levels of donors, individual’s gifts and awards. To date, SNM has 13 corporate donors whose combined pledges total $4,140,000 to the Bench to Bedside Molecular Imaging Campaign. When added the contributions received through individual donors totaled $136,241, the Campaign has raised a total of $4,276,241 of the $5,000,000 goal. Fifteen (15) Student Fellowship applications and thirty (30) Pilot Research Grant applications were submitted and will be considered by the SNM Awards Committee. This is in comparison to 2007, when only seven (7) Student Fellowship applications and seventeen (17) Pilot Research Grant applications were submitted. SNM introduced three new molecular imaging awards “Molecular Imaging Research Grants for Junior Medical Faculty,” “Postdoctoral Molecular Imaging Scholar Program,” and the “Predoctoral Molecular Imaging Scholar Program.” In addition, three new scholarships were introduced for the Nuclear Medicine Technologists including; “SNMTS Bachelor’s Degree Completion Scholarship,” “SNMTS Clinical Advancement Scholarship,” and “SNMTS Advanced Practitioner Program Scholarship.” SNM has received a gracious donation from Covidien for $25,000 per year for the next three years to support the SNM/Covidien Seed Grant in Molecular Imaging/Nuclear Medicine Research. In addition, Siemens has provided a $15,000 grant to create The SNM-Siemens Award for Excellence in Practice-Based Research. Abstracts for the 2009 SNM Annual Meeting that demonstrate the economic value of molecular imaging including nuclear medicine in the daily patient management process and, ultimately, improved patient outcomes will be considered The SNM Journal of Nuclear Medicine continues to be the premier journal in the field of Nuclear Medicine. In response to the continued high-level research in the journal, journal subscription revenue received as of 02/08/08 was $638,369, in comparison to subscriptions at this time last year; $610,914; a net increase of $27,455. JNM commercial advertising has also increased from $33,525 in February 2007 to $35,895 in February 2008; a net increase of $2,370. Online commercial advertising has also showed an increase of $5,000 over February 2007. Annual Meeting Program Book and Abstract Book advertising are over halfway to FY2008 budget with $34,650 in program book and $21,150 in abstract book advertising to date. While SNM continues to grow, so does its membership. The Membership Department launched a “Member-get-a-Member drive in December and has received 34 new members to date. In comparison to February 2007, SNM has increased membership by 491 full members and 1,162 technologists over last year this time, for a total of 15,025

members compared to 13,539 members at this time last year. Of the 491 full members, 34 of those are new members were received from the Member-get-a-Member drive. In addition, there are 257 free trial residents; 20 more than at this time last year. We currently have 916 free trial technologists, or 254 more compared to this time last year. These students represent 26 schools participating in the program. Overall, the membership retention rate for SNM is at 82.9%, compared to FY2007 (78.3%), an increase of 4.6% over last year. In order to keep pace with the ever-growing membership, SNM launched a new online application and renewal process at the beginning of the new fiscal year (October 1, 2008). To date, a total of $323,838.58, or 2,868 member transactions have occurred via the online renewal system. From October 1 to December 1, the online /join & renew page received 33,483 hits for renew and 6,624 hits for new members wishing to join. The 2008 budget estimate for both full and technologists is $2,223,736. Currently we are within $257,870 of that goal. In the results from the 2007 member needs survey, the cost of membership was the number one reason individuals did not renew their membership, beating other options by over 30%. When asked whether SNM provide the member with the educational opportunities needed to assist in advancing their career, 45.28% agreed. Additional results showed that 50.94% of members felt that SNM provides them with up-to-date information about the field of nuclear medicine and molecular imaging. The 2008 Mid-Winter Meeting in Newport Beach, CA is showing record pre-registration, almost doubling physician/scientist numbers from last year; 105 in 2007 compared to 218 in 2008. Additionally, overall meeting attendance is up 30 registrants from 236 in 2007 to 266 in 2008. Current exhibit sales are at 29 booths, and sponsorship for the Mid-Winter Meeting is at $7,500. The 55th SNM Annual Meeting to be held June 14-18 in New Orleans, LA is shaping up to be an exciting meeting with educational programs from the councils, centers and technologist section, including a joint-session with the SNMTS and the European Society of Nuclear Medicine technologists. Registration and housing opened January 15 and both are on target with proposed numbers to date. Exhibit sales for the Annual Meeting are also increasing with 139 exhibiting companies, representing $1,251,750 in revenue and 560 booths. The exhibit hall is currently at 81% sold, which is on track to meet projected budget for FY2008. Sponsorship for the Annual Meeting is at $261,000, already exceeding FY2008 budget ($217,000) by $44,000. SNM will be introducing a new virtual exhibit hall, which will make the exhibit hall easier to view for exhibitors and attendees. The launch of the new SNM website has contributed to the increasing number of hits September – December 2007. Compared to December 2006 with 432,290 hits, December 2007 showed a 377,655 increase, with a total of 809,945 hits, showing a 44% increase over last year. Overall, the top pages of the website being viewed were the new LLSAP Modules with 1,160 average hits per day, the 2007 Annual Meeting Education program

online meeting planner with 79 average hits per day, online teaching files, with 770 average hits per day and the SNM Web Seminars with 710 average hits per day. SNM developed a task force to monitor and respond to issues related to practice standards, including pay for performance, and continues to work with the American Medical Association to influence a gradual pay-for-performance strategy that will improve health care. In January, the SNM sent comments to the Centers for Medicare & Medicaid Services (CMS) regarding the Hospital Outpatient Prospective Payment System (HOPPS) and the Medicare Physician Fee Schedule (MPFS) final rules for calendar year 2008. Between January 21 and February 1, the Alliance for Quality Medical Imaging and Radiation Therapy (co-founded by SNMTS) asked their various constituencies to urge both the Senate and the House to pass the CARE bill in the forthcoming mark-ups. During the two weeks, the “virtual march” produced roughly 300 letters to legislators throughout Congress, which will hopefully help this legislation move through committee. As SNM was named one of the “25 Most Influential” in recognizing radiology’s movers and shakers, in September 2007, SNM continues to collaborate with those in related professional and patient associations leading the molecular imaging revolution into the new year. We are looking forward to another successful year with new initiatives, programs and members.

SNM Committees

ACNP/SNM Joint Government Relations

Committee Report


SNM-ACNP Joint Government Relations Committee (GRC) Committee Charges for 2007-2008: - Monitor and respond to U.S. government policy and issues related to the nuclear medicine community. - Work to strengthen relations between the nuclear medicine community and Capitol Hill, FDA, NRC, DOE,

DOD, DHS, DOT, NIH-NIBIB, NIH-NCI, NAS, and other government organizations/agencies. - Manage issues and provide technical expertise to SNM staff regarding government-related items of

concern. Current Working Objectives/Goals (SNM Strategic Plan Long-Term Goals B, D, and E): - Provide the lead on legislative and regulatory issues. - Continue to support basic and translational research at DOE Office of Science. Conduct follow-up in the

wake of the FY 2008 appropriations victory, and work on the probable need for FY 2009 appropriations increases. Continue to advocate for the initiatives in the NAS “Advancing Nuclear Medicine Through Innovation” study.

- Support the CARE legislative efforts of the SNMTS. - Continue to work toward cooperative working partnerships with the NRC, FDA, and other regulatory

agencies. Monitor and appropriately respond to the emerging and continuing issues at NRC and FDA. Assist the MI Center of Excellence in advocating for change in the FDA imaging agents review/approval processes.

- Work with the SNM RPSC Committee on Radiopharmaceuticals on government relations issues surrounding isotope production, domestic supply of Mo-99, etc.

- Work with Coding & Reimbursement Committee leaders to appropriately address policy/GR needs in the area of CMS and related Medicare legislation.

- Work together with the SNMTS Advocacy Committee and other relevant committees to enhance the grassroots advocacy programs and initiatives of SNM.

- Continue to build bridges with HHS and the CDC on issues including travel security and radiation alarms, as well as radiological incident / emergency preparedness and education.

Progress of Charge/Objectives/Goals to Date: LEGISLATIVE - SNM achieved the long-awaited victory of restoring funding for basic nuclear medicine research in the

DOE Office of Science / Office of Biological and Environmental Research / Medical Applications and Measurement Science Program. This was included in the end-of-the-year FY 2008 omnibus appropriations package.

- The CARE legislation is on pace to pass again this year, but Congress must move quickly. - Congress passed the 6-month temporary reimbursement freeze to keep RIT reimbursement at the 2007

Medicare levels. REGULATORY - NRC implemented the first phase of their regulatory authority over naturally occurring and accelerator

produced radioactive materials (NARM) on November 30. NRC agreed to educate the regulated community about NARM implementation and transition at their continuing education session at the 2008 SNM Annual Meeting in New Orleans.

- SNM is monitoring the NRC security reevaluation and “increased controls” concepts, meetings, and issues in the wake of last year’s GAO “sting” on the NRC materials licensing program. These issues are expected to be “hot topics” in 2008 and 2009.

- SNM submitted testimony to NRC and the Advisory Committee on Medical Uses of Isotopes (ACMUI) in June 2007 about desired changes regarding the implementation of the Part 35 Training & Experience (T&E) requirements. NRC plans regarding SNM Part 35 requests will be addressed at the April 2008 ACMUI meeting.

- SNM leaders met with the FDA Commissioner and FDA staff to (1) support the MI Center of Excellence “Emerging Technologies White Paper,” (2) advocate for personnel with molecular imaging backgrounds at the Division of Medical Imaging and Hematology Products (DMIHP), and (3) reinstate the Medical Imaging Drugs Advisory Committee (MIDAC) or an approximation thereof.

MISCELLANEOUS - The NAS “Advancing Nuclear Medicine Through Innovation” report was published in Summer 2007 and

was favorable to SNM’s positions on research, training programs, and isotope production. - The CDC published their report on patient radiation alarms in the December 2007 JNM Newsline. This is

the first step toward working cooperatively with HHS and CDC on issues related to the report, as well as other topics, including radiological incident / emergency response and preparedness.

Additional Goals/Objectives Added for 2007-2008: LEGISLATIVE - Continue working on the issues listed in the previous section of this report. - The President’s FY 2009 Budget Request will roll out in early February 2008. Based on past meetings

with DOE and OMB, SNM anticipates a significant drop in funding levels for basic nuclear medicine research from what was appropriated in FY 2008. More legislative work will need to be done to secure increased funding in the legislative process.

- The passage of the CARE legislation is a top priority for 2007 - 2008. - The reimbursement freeze for RIT is only temporary, so work will need to be done to permanently fix the

cost calculation methodologies for therapeutics like Bexxar and Zevalin. - Legislative work should be done to fix other Medicare reimbursement problems, including the

classification of diagnostic radiopharmaceuticals by CMS as “supplies” rather than “drugs.” This issue led to the bundling problem in the 2008 HOPPS rule.

REGULATORY - Continue working on the issues listed in the previous section of this report. - Continue working cooperatively with, and building relationships with, the NRC staff and Commissioners. - FDA PET Drug CGMP is currently scheduled for Spring (possible April) 2008. This projected date is

subject to change. MISCELLANEOUS - Continue monitoring upcoming NAS studies and reports, including the report on “isotope production

without highly enriched uranium (HEU).” - Explore developing educational programs and grant proposals to work with HHS / CDC and ORISE on

emergency preparedness and response issues / education. - Work with the SNM RPSC Committee on Radiopharmaceuticals and other SNM groups to address

domestic isotope supply issues in the wake of the Mo-99 supply crisis of December 2007.

General Program Chair

Committee Report


General Program Chair Report (as of February 2, 2008)

Current Working Objectives/Goals: • Successful SNM Mid-Winter Meeting • Quality Annual Meeting in New Orleans • Increased exhibit sales and sponsorship revenue for both MWM and AM Progress of Charges/Objectives/Goals to Date: Mid-Winter Meeting • Registration figures for MWM are currently 266 versus 236 as at the end of pre-registration (January 11) • Current exhibit sales for MWM is 29 booths meeting the budgeted goal of 29 booths • Sponsorship for MWM is currently $7500 aiming for budgeted goal of $19,500 Annual Meeting • Registration and housing opened January 15th and both are progressing along well on target at this early date • Exhibit sales for the AM are tracking along on pace with 139 exhibiting companies representing $1,251,750 in revenue and 560 booths. The Exhibit Hall is 81% sold which is on target to meet budget. • Sponsorship for AM is currently $261,000 already breaking a budgeted goal of $217,000. • Implemented new virtual Exhibit Hall allowing more ease for exhibitors and attendees use Additional Goals/Objectives Added for 2007-2008: • Registration figures for the 2008 AM will be tracked against 2007 AM figures Misc. • The 2009 MWM will be held February 5-8 at the Hilton in Clearwater, FL • The 2009 Annual Meeting will be held June 13-17 in Toronto, Canada

2008 Mid-Winter Meeting Pre-Registration Budget/Actual

(as of 1/14/08) Category 2008

Budgeted # 2008 Actual #

2007 Actual # 2006 Actual #

Physician M 94 202 94 98 Physician NM 13 4 11 10 Res./Intern --- 12 --- --- Tech M 70 48 67 132 Tech NM 66 0 64 43 Tech Student --- 0 --- --- TOTAL 243 266 236 283 ACNP Dinner --- 33 58 N/A no joint

mtg. w/ACNP

Awards Committee


February 15, 2008 SNM Awards Committee

Chair: Mathew Thakur, PhD Liaison: Nicole Kern


• Conduct an annual review of the current ERF-funded grants and awards that are non-donor designated to determine their usefulness in: meeting the needs of the molecular imaging/nuclear medicine community, and advancing the Society’s strategic goals.

• Choose the Aebersold Award Recipient. • Evaluate competitive applications and select recipients of ERF-funded grants and awards for physicians,

scientists and students. Put forth to the Board of Directors a resolution to accept the proposed recipients. • Develop criteria, award processes, and related materials for new SNM grants and awards. • Recommend to the SNM Executive Committee grant and award fundraising priorities. • Report on the grants and awards program to the SNM Board of Directors and House of Delegates.

Current Working Objectives/Goals: The SNM Awards Committee work relates most closely to the Goal A of the Strategic Plan, which states: “SNM will be members’ indispensable resource for education, knowledge exchange, training and networking.” The Committee established two objectives in our annual review of current ERF-funded grants and awards. The first was to set about developing the criteria, application guidelines, and selection process for the new grants and awards that were recommended by the Molecular Imaging Awards Task Force. Each of the new grants and awards correspond to Goal A2, which is to: “Create and award grants and fellowships for individuals interested in Molecular Imaging.” Secondly, the committee restructured the grants and awards program with a $430,000 allocation (a $227,000 increase over last year) from ERF for FY 08.

Progress of Charge/Objectives/Goals to Date: In the summer of 2007, the Molecular Imaging Awards Task Force has recommended to the SNM Awards Committee the following new molecular imaging focused awards for 2008:

• SNM Molecular Imaging Research Grants for Junior Medical Faculty o The objective of this program is to provide salary support for junior faculty members in Nuclear

Medicine or Radiology to enable them to engage in Molecular Imaging research. o One award will be offered at $50,000 per year for 2 years. o Applicants must have an MD degree (or equivalent) and have completed a nuclear medicine or

radiology residency and be ABNM/ABR BC/BE. Applicants must be practicing in an academic/research setting as a faculty member in a department of radiology, or nuclear medicine (or equivalent) in the U.S. Applicants must be within 5 years of their initial faculty appointment with an academic rank of instructor or assistant professor (or equivalent). Applicants must provide a detailed proposal of the research activity. Applicants must not have received grant/contract amounts totaling $50,000 or more in a single calendar year as the principal investigator.

• Postdoctoral Molecular Imaging Scholar Program o The postdoctoral program would support a 2-year research endeavor that promotes integration of

molecular imaging into the career of the trainee. o Two awards will be offered at $30,000 per year for 2 years. o Applicants holding the following degrees are eligible: MD, MD/PhD, and PhD.

• Predoctoral Molecular Imaging Scholar Program o The predoctoral program would support a 1-year research scholar in an established molecular

imaging lab that will apply a molecular imaging approach to investigate biological pathways in disease models. The objective is to encourage the integration of imaging approaches in the research of molecular pathways of disease.

o Two awards will be offered at $20,000 up to 2 years. o Applicants must have advanced to candidacy as a PhD.

• Grant Development Award o The purpose of this award is to support registration, travel, and accommodations for young faculty

(within 2 years of graduation) to attend intensive workshops on grant writing. The purpose is to assist participants in preparing quality grant applications to NIH or other equivalent institutions specifically related to molecular imaging research.

o Two $2,500 stipends will be awarded. o Applicants must either be residents of nuclear medicine fellows to be eligible.

• SNM Travel Awards o The purpose of these awards is to support the attendance of students and postdoctoral or clinical

trainees to present molecular imaging abstracts at the SNM Annual Meeting. Selection of recipients will be based upon the abstract grade, ranking as well as the contents of the travel award application.

o Thirty $1,000 awards will be offered. o Applicants must currently be students or trainees in a field relative to nuclear medicine and/or

molecular imaging. These awards were presented and passed at the SNM Board of Directors meeting in Reston, VA in September 2007. Currently the SNM Awards Committee is working to develop the applications and review criteria of the newly approved awards. Members of the Molecular Imaging Awards Task Force were solicited to comment on the drafts of the applications in December 2007 and will be asked to help the SNM Awards Committee finalize the applications by February 2008. It is anticipated that the applications will be finalized and available online by February 2008, to be reviewed in May 2008, and then awarded after approval by the Board of Directors in June 2008. The only exception to these anticipated dates is the SNM Travel Award, which will be awarded prior to the Annual Meeting. The 2008 Paul C. Aebersold Award recipient is Dr. Ronald G. Blasberg, MD of the Memorial Sloan-Kettering Cancer Center in New York. Dr. Blasberg was notified of his award in October 2007 and will be recognized and awarded at the 2008 Annual Meeting in New Orleans in June 2008. The 2007/2008 Student Fellowship Award application deadline has been extended to January 25, 2008 in order to give an opportunity to more students to apply for the Fellowship. The Committee will review the applications in February 2008. Both the Covidien Seed Grant and the Pilot Research Grant have February 15, 2008 application deadlines. The applications will be reviewed by the Committee and then awarded upon the SNM Board of Directors approval in June 2008. Additional Goals/Objectives Added for 2007-2008: There are currently no additional goals or objectives for 2007-2008.

Committee on Chapters

Committee Report


Committee on Chapters Committee Charges for 2007-2008:

1. To provide a regional geographic perspective to the Board of Directors and House of Delegates on Chapter Activities.

2. To identify issues of direct concern to Chapters and develop proposals for solution. 3. Share information about successful SNM activities with Chapters. 4. Make available and disseminate to Chapters teaching materials (as they are produced), traveling SNM

roadshows, and SNM demonstration booths. 5. Provide a forum for SNM educational materials. 6. To identify the major issues influencing the field that is not already being addressed by the SNM.

Current Working Objectives/Goals (please reference Strategic Plan):

- To work with SNM and ERF leadership to provide SNM National Office Updates to the Chapters during Chapter annual meetings.

- Work to improve National office and chapter communication regarding membership challenges, administrative materials, officer updates, delegate reporting.

- Identify major issues/challenges that have been identified within the chapter as issues affecting the field.

Progress of Charge/Objectives/Goals to Date: New chapter officers (physicians and technologists) received an orientation manual with administrative information regarding the National Office and “how to’s.” SNM and ERF leadership have been attending Chapter meetings in an effort to keep the chapters abreast of on-going issues within the profession. SNM and ERF leadership will continue visiting chapters throughout the coming year. The Chapters supplied the National office with their chapter reports prior to Mid-Winter meeting to ensure that all chapter issues may be discussed. The Committee on Chapters meeting has been scheduled prior the House of Delegates and Board meetings to ensure that any issues that are proposed to the board/house will be discussed during the same meeting. The chapter executive directors have been holding quarterly conference calls to update the National office on on-going activities. These calls serve as a time to answer any questions and address concerns of the chapters. All chapter executive directors (or presidents) were contacted one month prior to the Mid-Winter Meeting to ensure missing officer information would be updated prior to the Mid-Winter Meeting. Additional Goals/Objectives Added for 2007-2008:

1. SNM will work to reinvigorated HOD to increase Chapter awareness 2. SNM President-Elect will solicit chapter leadership for suggestions during the committee appointment

process.

Coding and Reimbursement

Committee Report


Coding and Reimbursement Committee Charges for 2007-2008:

1. To monitor, analyze, influence and disseminate information about coding and reimbursement policies and procedures that affect nuclear medicine; to actively participate in the development of coding and the use of coding that supports the utilization of nuclear medicine procedures in medical practice, such as CPT, ICD-9 and ICD-10, HCPCS codes and APCs; to establish a working dialogue with regulators, particularly HCFA, and payers to effect change.

2. Conduct coding and reimbursement seminars

3. Participate in AMA CPT, RUC and PEAC process to obtain appropriate codes, procedure

descriptions and reimbursement rates for new and existing nuclear medicine procedures.

4. Work with NMAPC Task Force and others to obtain appropriate reimbursement for all nuclear medicine resources, including radiopharmaceuticals, under the APC system.

5. Work with CMS, Congress and local carriers and other medical intermediaries to ensure that

appropriate nuclear medicine procedures are available to and attainable by the public. Current Working Objectives/Goals (please reference Strategic Plan):

1. Taking a proactive role in lobbying for reimbursement and research funding.


• 2008 Reimbursement Roadshows are scheduled: (St. Louis- January 18, Savannah- January 22, Los Angeles- February 4)

• Produced online educational materials for the nuclear medicine community

• Worked with CMS and other associations in maintaining the National Oncologic PET Registry (NOPR)

• Managed the NM APC Task Force Committee

• Developed a proposed method for radiopharmaceutical reimbursement and shared it with CMS and other

organizations

• Attended CPT, PERC and RUC meetings and discussed appropriate coding for the nuclear medicine community

• Monitored the 2005 Deficit Reduction Act Imaging Cuts, Pay-for Performance Issue and other issues,

such as the sustainable growth rate (SGR)

• Presented at the September 2007 APC Panel Meeting

• Commented on the Hospital Outpatient Perspective Payment System (HOPPS) and Medicare Physician Fee Schedule (MPFS) Proposed Rules for 2008

• Created and conducted successful nationwide Radiopharmaceutical Survey

• Worked with CMS HCPCS workgroup regarding radiopharmaceutical coding


Committee on Continuing Education

Committee Report


Continuing Education Committee Committee Charges for 2007-2008: The Continuing Education Committee is responsible for reviewing and monitoring all continuing education activities of all types that are sponsored, jointly-sponsored or co-sponsored by the SNM for continuing education credit for physicians, pharmacists and scientists. This includes live courses, enduring materials, distance education and journal articles. The committee ensures the activities satisfy the educational mission of the SNM and meet accreditation criterion for ACCME, ACPE, and CAMPEP. The Committee’s responsibilities meet the following SNM goals:

• Goal A. SNM will be members’ indispensable resource for education, knowledge exchange, training and networking.

• Goal C. SNM will be the leader in educating and promoting collaboration with referring physician and patient groups.

• Goal E. SNM will be recognized as the society, which positions molecular medicine as an essential tool in providing the highest standards of patient care around the world.

Current Working Objectives/Goals (SNM Goals A, C and E):

• Review and monitor activities sponsored by SNM ensuring they are in compliance with the Essentials and Standards of the Accreditation Council for Continuing Medical Education (ACCME), the Criteria for Quality and Interpretive Guidelines of the Accreditation Council on Pharmacy Education (ACPE), and the Guidelines of the Commission on the Accreditation of Medical Physics Education Program.

• Provide guidance to chapter administrators and CME/CPE liaisons regarding SNM policies and procedures for joint and co-sponsorship of continuing education activities.

• Recommend program, policy or procedural changes, as needed, to ensure activities remain in compliance with the accreditation criterion as updates and changes occur.

• Conduct periodic evaluation of educational activities (focus groups, interviews, questionnaires, etc.) to gather needs assessment and evaluation data.

• Provide progress or interim reports as required by the ACCME and ACPE. • Participate in strategic planning for the overall educational plan of the organization.


• Submitted a progress report to the ACCME as part of SNM’s 2006 Accreditation decision. SNM will receive notification of the ACCME’s decision in March 2008. This report provides the ACCME with specific information on how SNM is making necessary improvements to “Partial” and “Noncompliance” findings that were identified in SNM’s 2006 accreditation decision.

• Addressed working objectives and goals with the Committee on Education at a strategic planning meeting

held November 16-17, 2007.

• Developed action plans to implement ACCME 2006 updated criteria for accreditation.

• Revised the Continuing Education Mission Statement.

• Identified topics for JNM CE articles.

• Integrate ACCME revised standards for accreditation into MOC Part IV.

• The following is a synopsis of directly sponsored and jointly sponsored activities that were reviewed and approved for credit September 2007 – December 2007:

– Reviewed 3 directly sponsored activities and 5 jointly sponsored activities for CME credit for physicians.

– Reviewed 6 JNM articles for CME credit.

– Reviewed 3 activities and 6 JNM articles for ACPE credit.

Additional Goals/Objectives Added for 2007-2008: No additional goals/objectives have been added to date.

Committee on Councils


February 15, 2008 Committee on Councils


To provide an active forum for discussion of issues involving the individual and collective interests of SNM Councils. To facilitate timely, quarterly reports to SNM leadership on individual and collective Council activities and issues of concern to Councils. To ensure individual councils meet the charge in the SNM bylaws to further the knowledge base in their respective subspecialty field. To work with SNM leadership to assure the input of SNM Councils as active participants in SNM governance process (Board of Directors and House of Delegates). Define minimal operating procedures for dissolution, suspension and approval of new councils. Recommend dissolution, suspension and approval of new councils.


1. The Committee will be discussing the Internship Program and how to implement the program into each council during the 2008 Mid-Winter Meeting. (Goal D)

2. Decide on 2009 Mid-Winter Meeting Council Educational track. (Goal A)

3. Approve new awards as developed, Radiopharmaceutical Council Award.

4. Encourage all councils to review Standard Operating Procedures once every two years and make any updates/changes, as needed.


1. The Committee on Councils has developed council educational tracks for the 2008 MWM.

2. The Internship Program approved during the June 2007 meeting is being circulated through the councils for review and suggested implementation processes.

3. The Committee on Councils has also been enforcing the awards process with each council. During the 2007 Mid-Winter Meeting, the Committee on Councils approved an Award Process, requiring each council to submit a detailed description of any named awards they currently distributed. If any council wishes to adopt a new award, the description must be completed and the Committee on Councils must approve the award. To date, the Committee has collected from three councils.


1. The committee would like to begin holding quarterly conference calls to ensure that all action items can be discussed in a timely manner.

2. The committee would also like to encourage engagement at the national level with chapters and SNM leadership.

Committee on Education

Committee Report


Committee on Education Committee Charges for 2007-2008: The Committee on Education is responsible for meeting the SNM’s goals as they relate to education. The Committee’s role is to develop high quality, professional instructional materials and activities that provide avenues for the exchange of information related to patient care, patient outcomes, research and socioeconomic issues. The Committee’s responsibilities meet the following SNM goals:

• Goal A. SNM will be members’ indispensable resource for education, knowledge exchange, training and networking.

• Goal C. SNM will be the leader in educating and promoting collaboration with referring physician and patient groups.

• Goal E. SNM will be recognized as the society, which positions molecular medicine as an essential tool in providing the highest standards of patient care around the world.

Current Working Objectives/Goals (SNM Goals A, C and E):

• Identify strategic issues for the overall education needs for SNM and recommend policies for approval by the Board of Directors.

• Identify yearly goals of the overall education program in a concise manner • Identify the scope of education efforts and the characteristics of the potential participants • Describe the general types of education activities and services to be provided by SNM • Develop a plan for implementation for optimum delivery of the SNM education program • Review compiled needs assessment results and offer organizational guidance to SNM education

committees. Progress of Charge/Objectives/Goals to Date: The Committee on Education addressed all of its current working objectives and goals at a strategic planning meeting held November 16-17, 2007. The new goals and objectives for FY20008 through FY2010 are outlined below. Additional Goals/Objectives Added for 2007-2008: New goals and objectives were developed at the November 2007 Strategic Planning Meeting, which included members of the Committee on Education, the Continuing Education Committee, and representatives of all SNM member types, including pharmacists, scientists, and technologists, as well as physicians. The new goals for the Committee on Education are: Goal 1 – Coordinate all group activities within SNM related to education, including committees, councils, centers and chapters Goal 2 – Meet SNM’s Strategic Goals Goal 3 – Meet Revised CE Mission/ACCME Revised Criteria for Accreditation Goal 4 – Meet Pharmacists’ Education Needs Goal 5 – Meet Scientists’s Education Needs

Goal 6 – Meet Physicians’ Education Needs Goal 7 – Meet ARRT Requirements and Education Needs of Entry-Level, Practicing and Advanced Practice Technologists New strategic objectives for the Committee are: Goal 1

• Provide services to SNM Chapters to help them meet their goals. • Utilize the expertise of Councils and Centers of Excellence.

Goal 2

• Extend outreach to other organizations and groups. • Recognize the importance of molecular imaging and continuously increase presence of

molecular imaging in education activities over next three years. • In-training professionals are recognized as a constituency of SNM and are included in the

overall education program. • Raise awareness of importance of nuclear medicine procedures and need to educate physicians

about benefits of nuclear medicine procedures. Goal 3

• Focus on quality improvement and measures throughout education program • MOC Part IV business plan must interlink CE with MOC.

Goal 4

• Follow ACPE’s new Accreditation Standards for Continuing Pharmacy Education. • Expand CE offerings for pharmacists

Goal 5

• Expand CE offerings for scientists Goal 6

• Continue to meet physicians’ need for activities that meet MOC Part II requirements as defined by the ABNM and ABR.

• Meet physicians’ need for activities that meet Part III requirements as defined by ABNM. • Meet physicians’ need for activities that meet Part IV requirements as defined by the ABNM and

ABR. • Continue Annual Meeting and Mid-Winter Education Symposia Continuing Education and

Scientific Sessions • Continue offering CE articles in JNM and JNMT • Transition Online Lectures into other education activities as they expire. • The need for CT education will continue to be met.

Goal 7

• Meet the needs of technologists preparing to take certification examinations. • Provide education activities based on practice guidelines. • Ensure education activities meet recommendations of the ARRT.

Finance Committee

Committee on Nominations

Committee Report


SNM COMMITTEE ON NOMINATIONS Committee Charges for 2007-2008: The Nominating Committee will conduct the annual election process for the SNM. The Nominating Committee will oversee the new online voting process for the current year election and will oversee a complete transition to online-only voting for future years. The Nominating Committee will review the Election Handbook and provide suggestions to the Policy and Procedures Task Force. Current Objectives/Goals (please reference Strategic Plan):

- Review candidates for Vice-President position – and develop successful slate of candidates. (Infrastructure Issues – Governance – Review and enhance it’s leadership development and succession plan.)

- Hold election for Vice-President position. (Infrastructure Issues – Governance – Review and enhance it’s leadership development and succession plan.)

Progress of Charge/Objectives/Goals to Date: There is only one elected position open this year, Vice-President. Staff spoke with Dr. Conti, Chair of the Nominating Committee in August and the slate was determined. The individuals nominated for Vice-President have been contacted and instructed to complete the Election Nomination Forms and return to the office no later than December 21. The Nominating Committee will meet via conference call in January to approve the slate. The slate will be distributed to the SNM BOD for approval during the Mid-Winter Meeting. New this year, SNM is developing an online candidate bio system that will allow the candidate to input information directly into a secured system managed by the Election Company. Each candidate will receive an e-mail from the Election Company with instructions on how to upload their CV, platform statement and picture. This information will undergo a stringent review process within the SNM National Office, and the SNM Nominating Committee. The final product will be shown to the specific candidates for final approval. Additional Goals/Objectives for 2007-2008:

1. Work with SNM Bylaws Committee to ensure proper Bylaws Changes are included on the SNM ballot.

2. Launch Bio-Sketch upload system in February.

Committee on Pharmacopeia

Committee Report


SNM RPSC Committee on Pharmacopeia (COP) Committee Charges for 2007-2008: - Providing leadership and expertise as the resource for SNM in acquiring, evaluating, and disseminating

information on the safe and effective use of radiopharmaceuticals for medical purposes.

- Providing input, on behalf of SNM, to the USP Expert Committees (e.g., Expert Committee on Radiopharmaceuticals, Expert Committee on Radiopharmaceuticals and Medical Imaging Agents) concerning issues related to the revision and/or development of USP monographs/chapters.

- Studying the incidence of adverse reactions involved in the administration of radiopharmaceuticals,

especially with regard to newly approved therapeutic radiopharmaceuticals. Current Working Objectives/Goals (Strategic Plan, Long-term Goals B and E): - Review and propose revisions to relevant USP monographs. - Support survey of adverse reactions related to radiopharmaceuticals or adjunct non-radioactive drug

products. - Review and propose improvements to Joint Commission Medication Management Standards. - Continue to monitor, analyze, and be the primary SNM RPSC committee working on issues surrounding

the recent USP <797> revisions.

Progress of Charge/Objectives/Goals to Date: - Proposed revision of USP monograph on ammonia N 13 injection

o Joe Hung will put together a final version of the revision (based on the comments and suggestions made by the COP members) by the end of January, and then submit it to the SNM leadership for approval to be sent to the USP.

- Proposed revision of USP monograph on sodium acetate C 11 injection

o Ron Weiner (lead), Mike Channing (a non-member of COP), and Marc Berridge are currently working on the proposed revision. The draft version should be completed by the above team by the end of January, and it will be reviewed by the COP members prior to the submission to the SNM leadership for final approval.

- Proposed revision of USP monograph on fluorodopa F 18 injection

o Sally Schwarz has recently submitted the proposed revision on this monograph to the COP. This draft version is currently reviewed by the COP members. Once the review is completed (by the end of January or mid-February), the proposed revision will be forwarded to the SNM leadership for the final approval.

- Survey of adverse reactions related to radiopharmaceuticals or adjunct non-radioactive drug products

o Ted Silberstein is responsible for the collection of quarterly reports from 18 US medical institutions. The above collection of adverse reactions associated with radiopharmaceuticals (including PET drugs) and non-radioactive drug products used in nuclear medicine procedures was initiated in the beginning of 2007, and may take a few years to complete the task.

- Proposed Standards Revisions issued by the Joint Commission

o http://www.jointcommission.org/Standards/SII/sii_ec_hap.htm

o MM.5.01.0 A pharmacist reviews all medication orders for appropriateness - please see more detailed requirements for this standard on the posted info (page 6).

o MM.5.02.0 EP 1. When an on-site licensed pharmacy is available, a pharmacist or pharmacy staff

under the direct supervision of a pharmacist compounds or admixes all compounded sterile preparations (CSP) except in emergencies or when the product’s stability is short.

o MM.5.02.0 EP 4. The [organization] uses a laminar airflow hood or other ISO Class 5

environment in the pharmacy for preparing intravenous (IV) admixture or any sterile product that will not be used within 24 hours. This is very different from the strict USP <797> requirement.

o A conference call was held on October 18, 2007 between representatives from the Joint

Commission and representatives from SNM (Joe Hung was one of the invited participants) to discuss issues related to the administration of radiopharmaceuticals (e.g., risks, roles of nuclear medicine physician and nuclear pharmacist, as well as the pros and cons of using standard protocols in lieu of direct supervision/medication review duties, etc.) as it pertains to the investigation of diagnostic radiopharmaceuticals in MM.4.10 (see SNM comments from January 2007).

- USP General Chapter <797>

o Further comments and/or suggestions with regard to the recently released final version of USP <797> - to be determined by the COP members.

- The potential of a proposed SNM/USP joint symposium. Additional Goals/Objectives Added for 2007-2008: - See Current Working Goals and Objectives section.

Practice Standards

Committee Report


Practice Standards Committee Charges for 2007-2008:

1. Develop clinical practice standards and make recommendations to the board, including provisions for incorporating documentation of patient safety in standards.

2. Review pay for performance initiatives.

3. Complete standards on the following:

a. Myocardial Perfusion b. PET/CT


1. Meet the needs for all relevant audiences in continuing professional development.


• Worked with the Cardiovascular Council to create two credentialing statements: - Conjoint Statement of the SNM and American College of Nuclear Physicians on

Credentialing and Delineation of Privileges for Cardiovascular CT - Conjoint Statement of the SNM and American College of Nuclear Physicians on

Credentialing and Delineation of Privileges for Cardiac PET

• Continuing to work with AMA Physician Consortium Group on developing physician specialty measures - Held Nuclear Medicine Workgroup Meeting in Chicago on August 22, 2007. Developed 4

accountability measures and 1 quality improvement measure among the workgroup.

• Leading efforts in creating clinical practice guideline for the SNM Additional Goals/Objectives Added for 2007-2008:

1. Work with other appropriate professional organizations (ACR, ANSC, ACC) to develop standards for hybrid cardiac imaging to include SPECT/CT and PET/CT.

Procedure Guidelines

Committee Report


Procedure Guidelines Committee Committee Charges for 2007-2008:

• Review and revise existing guidelines as necessary for re-publication in the SNM Procedure Guideline Manual.

• Develop new SNM procedure guidelines as the need arises. • Review external guidelines for consideration of endorsement by SNM. • Extended relationship with the National Guideline Clearinghouse (NGC; www.guideline.gov).

Their web posting provides broader exposure to the Society and its procedure guidelines. Current Working Objectives/Goals (please reference Strategic Plan): To improve health care by advising nuclear medicine practitioners about the appropriate ways to perform a particular imaging study. Progress of Charge/Objectives/Goals to Date:

• The Board of Directors approved the following new and revised guidelines in 2007: - Procedure Guideline for Scintigraphy for Differentiated Papillary and Follicular Thyroid

Cancer v3.0 - Procedure Guideline for Thyroid Uptake Measurement v3.0 - Procedure Guideline for Thyroid Scintigraphy v3.0 - Procedure Guideline for Diuretic Renography in Children v3.0 - Procedure Guideline for the Use of Radiopharmaceuticals v4.0 - Consensus Recommendations for Gastric Emptying Scintigraphy (A Joint Report of

The Society of Nuclear Medicine and The American Neurogastroenterology and Motility Society)


http://www.guideline.gov/

Committee on Publications

Committee Report


SNM Committee on Publications Committee Charges for 2007-2008:

• To coordinate all SNM publication activities; to continuously monitor the needs of the field and to suggest new publications; to oversee publication of The Journal of Nuclear Medicine.

• To evaluate the desirability of publications projects presented to the Society. • To research and respond to publishing trends in the field of nuclear medicine. This can include book topics, book

and journal publishers, new medical journals, medical journal practices and article topics, and journal peer-review practices and technologies.

• To research and respond to trends in the publishing industry. This can include print and electronic publishing technologies, and journal peer-review practices and technologies.

• To survey and respond to the SNM membership and journal readership regarding the Society's publications.


• Educate core members about principles and concepts on molecular imaging • Develop JNM supplement and increased articles concerning molecular imaging topics in the journal. • Launch series of primers on molecular imaging published by JNM as supplements. • Create new/revise SNM patient pamphlets.


• JNM continues in excellent health, with very low receipt-to-publication turnaround time, a very good acceptance rate, and a very good impact factor.

• Debuted publish-ahead-of-print program in JNM, decreasing the time it takes for JNM research to be published • Completed transition of all JNM archives to online, including deposit into PubMed • Completed PET/CT supplement in Jan 2007 • Implemented CME credit for manuscript reviewers • Molecular imaging initiatives including:

o A Newsline column for the MI COE o A section on molecular imaging was added to Literature Briefs beginning with the March 2007 issue o A new series of review articles on molecular imaging, one per issue, 4 printed pages each. The series

debuted with the December 2007 issue. Thus far, the following articles have been published: Comparison of Imaging Techniques for Tracking Cardiac Stem Cell Therapy Optical Imaging: Current Applications and Future Directions Multimodality Molecular Imaging with Combined Optical and SPECT/PET Modalities

o A supplement on molecular imaging, edited by Dr. Sam Gambhir, ETA April 2008 • The Clinician’s Guide to Nuclear Medicine Oncology: Practical Molecular Imaging and Radionuclide Therapies

book released on May 1 and is still selling well. • The MIRD Decay Schemes revised edition is ready to go to press when the CD is completed and sent to Reston. • CE initiatives continue, including new processes to adhere to new CE guidelines and an initiative to provide

reviewers with CE (now in the first stages of implementation). • The committee’s position, intellectually and scientifically, is that it is time to move the journal to full color; it is the

right thing to do. The committee continues to consider this and will make a recommendation to the board. • Commercial advertising in JNM is up 16% over the same time last year.


• MIRD Decay Schemes book revised and in production. • Suggestion of new publications for which there is a need in the profession. • Survey JNM readers. • Complete revision of patient pamphlets. • Form a subcommittee to develop the process and timetable to search for the next JNM editor in chief (to follow Dr.

Schelbert).

Quality Assurance

Committee Report


Quality Assurance Committee Committee Charges for 2007-2008: - To progress the Quality Assurance Committee’s commitment by issuing a comprehensive and

complete critique of the 2007 Lung Perfusion Phantom and release the 2008 Thyroid Phantom to the 130(+) participants from the Veteran’s Affairs hospital system.

- Oversee all SNM programs related to the quality of the practice of nuclear medicine as directed by

the House of Delegates. Currently these programs include: Proficiency Testing Program (PTP) assuring completion of critique and its timely distribution to all participants; and oversee ongoing development, production, distribution and results of future phantoms.

- Seeking grants and government funding in order to expand the Phantom Program to a larger

audience. Current Working Objectives/Goals (please reference Strategic Plan): To develop, implement and maintain quality assurance programs that foster continuing improvement of the quality of nuclear medicine practice.

Progress of Charge/Objectives/Goals to Date: In 2007, the QA Committee finalized the 2006 SPECT phantom and developed the 2007 Lung Perfusion phantom, along with it’s corresponding results packet and filling instructions. The Committee is in the process of accelerating the yearly cycle to send back each years critique in the parallel calendar year. Thus, the Committee hopes to issue both the 2008 Thyroid Phantom and the 2009 Cardiac Phantom in 2008. Additional Goals/Objectives Added for 2007-2008:

Committee on Radiopharmaceuticals

Committee Report


SNM RPSC Committee on Radiopharmaceuticals (COR) Committee Charges for 2007-2008: Mission Statement (currently under review by COR – subject to change): - The Committee on Radiopharmaceuticals provides a forum for concerned groups to work together to

promote the development, availability, and utilization of radionuclides and radiopharmaceuticals for clinical and research uses.

Current Working Objectives/Goals (SNM Strategic Plan Long-Term Goals B, D, and E): - SNM and RPSC’s primary governance committee on radionuclide / radiopharmaceutical topics and

related industry issues. - Work with FDA, DOE, and other government agency representatives on radionuclide /

radiopharmaceutical topics (development, review / approval, isotope production, etc.). - Evaluate mission statement, goals, working groups, etc. (See “Additional Goals/Objectives Added for

2007-2008” below).

Progress of Charge/Objectives/Goals to Date: - COR participated in the DOE Office of Nuclear Energy (NE) Isotope Programs strategic planning and

research isotope needs evaluation in Spring / Summer 2007. - COR met via teleconference prior to MWM’08, when the goals for 2007-2008 were discussed.

o The COR Chair is currently evaluating the mission statement/charge, working groups, and goals of the committee.

- Discussions regarding the Mo-99 supply crisis of December 2007 have taken place, and the COR will soon be exploring “ways forward.” A subgroup of COR will be formed to evaluate long-term domestic solutions and possibilities.

Additional Goals/Objectives Added for 2007-2008: - Revise the mission statement to allow for increase COR participation in the issues and policies. - Evaluate the interaction, communication, and coordination between the COR and other RPSC and SNM

governance groups. - Develop a series of task forces / working groups to focus on specific areas of need, starting with a

“domestic Mo-99 supply” working group. - Discuss potential ways forward in the wake of the Mo-99 supply crisis of December 2007 using available

reports and propositions, including the NAS “Advancing Nuclear Medicine Through Innovation” study and MURR propositions.

Scientific Program Committee

Committee Report


Scientific Program Committee Committee Charges for 2007-2008: SPC is responsible for the development of scientific and educational program for the 2008 annual meeting and midwinter meetings, maintaining excellent programs with limited resources and maintaining excellent communication with other entities within the SNM developing educational programs. The Committee’s responsibilities meet the following SNM goals:

• Goal A. SNM will be members’ indispensable resource for education, knowledge exchange, training and networking. • Goal C. SNM will be the leader in educating and promoting collaboration with referring physician and patient groups. • Goal E. SNM will be recognized as the society, which positions molecular medicine as an essential tool in providing

the highest standards of patient care around the world. Current Working Objectives/Goals In June, we held a very successful Annual Meeting in Washington, DC. The attendance was good and the scientific and educational programs were outstanding. This included the implementation of a new scientific component referred to as InfoSNM featuring the use of computers and information technology in nuclear medicine and molecular imaging. This program was very well received. We are now finalizing the details for MidWinter Meeting in Newport Beach, which will be held in conjunction with the ACNP for the second year. As part of this collaboration, this meeting will incorporate a session for the review of a number of CT cases. We are now planning the 2008 Annual Meeting to be held in June in New Orleans, LA including the development of a series of categorical seminars and continuing education sessions as well as the review of abstracts for the scientific oral and poster sessions. We have reviewed our abstracts categories and have modified them to better match the current practice and science within our field. This year, we are introducing a third basic science summary that will highlight the science presented at the meeting in the context of molecular imaging. The categorical sessions and continuing education sessions are almost finalized and we are in the midst of the abstract review for the scientific program. Progress of Charge/Objectives/Goals to Date:

Annual Meeting

1. Held a very successful meeting in Washington, DC. 2. Attended the preview meeting in New Orleans in August 3. Planning the 2008 Annual Meeting 4. Incorporating Molecular Imaging presence – CE sessions, abstracts, flagging activities 5. Introducing a third basic science summary session in Molecular Imaging 6. Have modified our current categories for scientific abstracts. 7.

Abstracts 1. Triage meeting will be held January 19, 2008

Mid Winter Meeting

1. Held the most successful Mid-Winter Meeting to date in San Antonio in conjunction with the ACNP for the first time. 2. Plans finalized for Mid-Winter Meeting in Newport Beach, again being held in conjunction with the ACNP. Additional Goals/Objectives Added for 2007-2008: New goals and objectives were developed at the November 2007 Strategic Planning Meeting, which included members of the Committee on Education, the Continuing Education Committee, and representatives of all SNM member types, including pharmacists, scientists, and technologists, as well as physicians.

Committee on Young Professionals

Committee Report


YPC Committee Charges for 2007-2008:

1) Provide a forum for young professionals. 2) Provide communication between young professionals and the SNM. 3) Represent the YPC on SNM Committees, councils, and centers. 4) Create future leaders. 5) Contribute to the growth of SNM.


1) Improve YPC webpage. 2) Increase quantity and quality of YPC events at the 55th Annual Meeting.


• Updated and organized member list that was transitioned to the new eCommunity. • Continues to developed and distribute newsletters, one sent out in May and one planned for Spring 2008. • Held a planning meeting, November 10, 2007. • Currently organizing Young Professionals Luncheon and business meeting at 55th Annual Meeting. • Planning 2 CE sessions at the 55th Annual Meeting, one of which will be eligible for SAM credit. • Currently organizing a game show at the 55th Annual Meeting possibly funded by Hermes. • Appointed new YPC members to represent the young professionals on SNM committees, council boards

and centers of excellence. • Will support and participate in the SNM Council Internship Program. • Will select the 2008 YPC Poster Award winners. • Will supply Cases of the Day for the 55th Annual Meeting. • Online Teaching files will be moved to the YPC homepage.


1) Increase the visibility and membership of the YPC. 2) Increase role of YPC in the SNM.

SNM Council Reports

Academic Council

From the SNM Academic Council, We have just completed celebrating the Thanksgiving Holiday, but I am continuing to be very thankful to many people in the Academic Council. Dr. Greenspan is doing an excellent job of arranging conferences at the MId-Winter, AUR, and SNM Annual Meetings. Dr. Greenspan also did an outstanding job in getting a significant grant to support one of our speakers this year. Drs. Greenspan and Gordon are both serving as members of the SNM Board, and Dr. Gordon also works hard for us by serving on the RRC in nuclear medicine for the ACGME. The named lecturers for the Annual Meeting have been chosen. We will be sponsoring a total of three ninety minute courses at the SNM Annual Meeting. I will be giving a couple of talks at the Mid Winter Meeting. Dr. Fig is doing a wonderful job of correcting some of our problems with communication with the membership. Dr. Jacene continues to edit and produce a fine Newsletter. Dr. Takalkar is working on organizing a mentorship program for the members. Our past president, Dr. Metter, is very active in the ACGME and other organizations. Our recent president, Dr. Graham, has recently been elected to eventually be President of the SNM. Dr. Smith continues to be a very able leader of the Program Directors, and graciously attended the last OPDA meeting in Chicago at my request. We will have a meeting of the Academic Council during the Mid-Winter Meeting, on Thursday, over lunch, from 11:30 am until 1 pm. A reminder to the members is that we are trying to encourage the Program Directors to attend the AUR/APDR/SCARD March meeting in Seattle to try to network with others, have an impact on some radiology decision makers on topics such as the need for nuclear medicine residents to rotate on CT, and take courses in a variety of areas, especially related to education. Panel discussions in the last two years that the Academic Council sponsored at this meeting have resulted in two papers by our members being accepted by Academic Radiology, and two more papers are in preparation. This year their meeting will include numerous hours on informatics, multiple hours on how to teach and evaluate programs, sessions on satisfying ACGME issues, 13.5 hours on molecular imaging or biology, 2 hours on radiation safety, radiopharmacy and regulatory issues, etc. One feature of the meeting is that it is a very good opportunity for young investigators including residents to give papers and present exhibits, and participate in lectures and panel discussions. Another aspect of the AUR meeting is that the program coordinators in radiology meet at this meeting, and Ms. Duane, from the Harvard program, will be applying for a scholarship to defray her expenses to attend the meeting, as our representative from the nuclear medicine coordinators. One of the problems with some of our members getting together at the SNM Annual Meeting is that the members are presenting so many lectures and papers, that they find it difficult to attend the Academic Council sessions, so the AUR meeting could provide another venue for our members to discuss issues. In general, there is a growing trend for more cooperation between radiology and nuclear medicine groups. The ACR, under the direction of Dr. Mountz, helped organize numerous excellent educational sessions at the last SNM Annual Meeting. The ACR Nuclear Medicine Commission meeting had Dr. Conti present, who gave a report. I was glad to see a number of radiology and nuclear technologist groups represented at the ACR Commission on Human Resources meeting. I am the secretary of the

ARRT Board of Directors, and there is increasing cooperation between the ARRT and various technologist organization groups due in part to the outstanding leadership of Dr. Reid. The ARRT also now is giving an exam for PACS administrators, in addition to numerous other exams. I am on the Advanced Practice Task Force of the SNM, and we are making progress in finding a suitable name for what some call in the interim, the advanced practice technologist. One meeting at the 2007 RSNA Annual Meeting solely was on this topic (and included multiple past and future presidents of the SNM, as well as Mrs. Pappas and Mr. Nelson and others), and a meeting of the ACR Commission on Human Resources also discussed this name issue in part. I am very indebted to Drs. Delbeke and Coleman, among others, for the help they gave me regarding the ACR Guideline on CT/PET passed last year. With the permission of Dr. Sandler, some of the exact verbiage from the SNM Guideline was used in the ACR Guideline. Dr. Delbeke is also doing a fabulous job in the Education Committee of the SNM and in the Guidelines area. The first 100 of the 150 CT/PET teaching cases are now available on line through the SNM. We wish the Young Professionals group continued success. We congratulate the current president, Dr. Lavely, and past president, Dr. Takalkar, for their excellent work. The YP group’s meetings at the SNM Annual Meeting have had outstanding attendance-a real tribute to the organizing abilities and enthusiasm of these people. Dr. Lull, who helped found this group, would be very proud of their achievements. We hope that the YP group will continue to work with us, and we hope that many of them will continue as members of the Academic Council after they are no longer eligible to be members of the YP group. In the future, I hope that the Academic Council will be sponsoring meetings at the Mid Winter meeting of the type that allow us to generate some money for the organization, so that we may expand the scope of our activities. The Newsletter should continue to evolve, with more on leadership, teaching, how to satisfy ACGME regulations, and a discussion of curricula issues. Indeed, this issue of the Newsletter has an article on curriculum from the Molecular Imaging Task Force. I want the objectives of the organization to be more broadly known to include courses in how to teach and in leadership and communication issues. I also want it more known, that we are open to broad membership by those who are interested in furthering the academic mission and learning more about leadership and communication issues. We also are developing a section for the nuclear medicine residency program coordinators. I would like to invite the top leaders in the ACGME to come to the SNM meeting to put on a program, but to do that, we need to have a sizable guaranteed audience. Finally, I hope we can establish a model mentoring program which eventually will have participants in it from various portions of the SNM membership. Those who wish to serve on committees or as an officer should contact me. Thank you for the opportunity to serve. Jay Harolds, MD President, SNM Academic Council

Brain Imaging Council

SNM: Brain Imaging Council

Report for the Mid Winter Meeting 2008

Activities and Accomplishments

The Council provided an exceptional program of educational activities at both the mid-winter and annual scientific meetings of the SNM in 2007. The MWM program consisted of a full day on Clinical Brain Imaging and Advances in Molecular Imaging of the Brain. The SNM 2007 meeting in Washington DC program included a full day categorical seminar, 4 CME sessions, and the Kuhl-Lassen Lecture and Award by Rich Carson. Both programs were very well attended and stimulated renewed interest in brain imaging and enthusiasm for the future. The Neuroscience Young Investigators session and awards attracted a strong field. To build upon this momentum, planning is underway, in collaboration with the Molecular Imaging Centre of Excellence, to support educational activities outside of the SNM in 2008 and beyond, aimed at neurologists, psychiatrists and geriatricians. In the last two years there has been a substantial increase in the number of publications on beta-amyloid imaging with PET in Alzheimer’s disease (New England Journal of Medicine, Lancet-Neurology, Brain, and Neurology, etc). Evidence is accumulating that beta-amyloid PET can detect Alzheimer’s disease before the development of dementia and reliably distinguish AD from frontotemporal dementia. Several companies have committed to the development an F-18 beta-amyloid ligand for clinical use with phase II and III trials likely to commence soon. The growing prevalence and community awareness of Alzheimer’s disease is increasing demand for molecular imaging techniques that permit early detection and intervention. The BIC is keeping BIC and SNM members abreast of this important development.

Looking Forward

It is an exciting time to be in the field of molecular imaging of the brain with clinical applications set to soar in the foreseeable future. The SNM through the Brain Imaging Council and the Molecular Imaging Centre of Excellence will continue to educate nuclear medicine specialists and referring physicians about current and emerging brain imaging techniques to ensure growth in this field and successful adoption of new techniques.

Officers of the council

President Chris Rowe, MD [email protected] Vice President Anissa Abi-Dargham, MD [email protected] Vice President-Elect Nicholaas Bohnen, MD, PhD [email protected] Secretary James M. Mountz, MD, PhD [email protected] Treasurer Alan Waxman, MD [email protected] Immediate Past Pres Peter Herscovitch, MD [email protected]

Mission The Brain Imaging Council (BIC) exists to develop and advance clinical and research applications of nuclear brain imaging. This is achieved through organizing research symposia, sponsoring educational courses, supporting the Society in developing policy positions for brain imaging applications, training, and fostering connections among Council members and resources for meeting educational, clinical, and research needs for successful brain imaging. The BIC seeks to benefit a range of nuclear medicine professionals from nuclear medicine specialists in hospital or the private practice of nuclear medicine, nuclear medicine technologists, and investigators with interest in the research and clinical application of brain imaging.



Cardiovascular Council

SNM: Cardiovascular Council


Fellowship award: Riika Lautamaki Mid-winter meetings: Newport Beach, CA Feb 14-17, 2008: Organization and presentation of one 3-

hour sessions Business meeting in Newport Beach

Spring Newsletter (attached). The attached newsletter draft describes in more detail the most recent CVC accomplishments and plans

Frank Bengel, M.D. elected vice president (to assume presidency 2009) Election for Vice President (to assume Presidency in 2010) and BOD positions to take place witnin

next few weeks.

Looking Forward Annual Meeting, New Orleans, LA meeting.

Following activities: Categorical course on June 14th (9:00 AM –4:00 PM)

10 CME sessions: 5 lectures, 4 RWThE, 1 debate Young Investigators competition

Hermann Blumgart session and award/lecture by the award recepient Rory Hachamovich, M.D. to assume presidency at annual meeting 2008.

Frank Bengel, M.D M.D. to be president-elect. Election for the vice-president elect to be held.

Officers of the council President: Diwakar Jain, M.D. President-elect: Rory Hachamovitch, M.D. Vice President: Frank M. Bengel, M.D. Secretary: Robert A. Pagnanelli, CNMT, NCT Treasurer: Danny A. Basso, CNMT, NCT, FSNMTS Immediate Past President: Mark I. Travin, M.D.

Mission The ultimate goal of the Cardiovascular Council (CVC) of the Society of Nuclear Medicine (SNM) is to contribute to the enhancement of quality patient care using cardiac radiotracer techniques. The society works to achieve this goal via three basic endeavors: 1). Contribute to the development and promotion of methods and procedures for proper clinical applications of current nuclear cardiology techniques, including a key role in the development of practice guidelines 2). Educate health care providers both within and outside the Society of Nuclear Medicine regarding the most up-to-date and highest quality cardiovascular nuclear medicine care, and 3). Serve as a major contributor and facilitator to the basic research development of new cardiovascular imaging techniques, and in the clinical applications of such new techniques. Members of the CVC also work with the SNM and other cardiac imaging organizations in the interaction between providers of nuclear cardiology services, and government and 3rd party payers with regard to quality and appropriate compensation for services. Finally, the CVC contributes to the presentation and explanation of nuclear cardiology methods and benefits to the general public through print and other media.

Computer and Instrumentation Council

SNM: Computer and Instrumentation Council


Our activities and accomplishments for the past year include:

1. Organized and moderated a session on Advanced Image Devices at the 2007 Mid-Winter SNM meeting,

2. Organized and moderated a Categorical seminar on SPECT/CT at the 2007 SNM annual meeting,

3. Organized and moderated Continuing Education sessions on New Nuclear Imaging Instrumentation and PET/CT at the 2007 SNM meeting,

4. Published a Fall and Spring Newsletters sent to the membership by email, 5. Organized and moderated the Young Investigator Symposium at the 2007 SNM annual

meeting, 6. Organized and moderated the Edward J Hoffman Memorial Award and Lecturer at the

2007 SNM meeting (Dr. Joel S. Karp was the 2007 recipient), 7. Introduced InfoSNM, a new track consisting of presentations of nuclear-medicine-related

computer applications, at the 2007 SNM annual meeting, 8. President Marie Kijewski completed the first year of a two-year term as the Vice- Chair

of Instrumentation and Data Analysis track for annual SNM meeting, 9. Participation of a CaIC member (Paul Kinahan) in the NCI/NIST Imaging as a

Biomarker: Standards for Change Measurements in Therapy meeting (Sept 14-15, 2006). 10. Participation of a CaIC member (Paul Kinahan) in the MI Center of Excellence Action

Planning Retreat June 23-24, 2007.

Looking Forward

Our plans for this year include: 1. Fall and Spring newsletters, 2. Organizing and moderating two 3-hour educational sessions at the 2008 Mid Winter

Meeting, 3. Organizing and moderating a categorical seminar on SPECT/CT for the 2008 SNM

annual meeting, 4. Organizing and moderating two continuing education sessions at the 2008 SNM annual

meeting, 5. Organizing and moderating the CaIC Young Investigator’s Symposium for the 2008

SNM meeting, 6. Selection of a 2008 Hoffman Memorial Award winner and arranging a time slot for the

award winner to give a presentation at the 2008 SNM annual meeting, 7. Participation in the organization and presentation of InfoSNM track at the 2008 annual

meeting, 8. Provide formal review of AAPM Nuclear Medicine Science Committee report on

PET/CT acceptance testing and quality assurance procedures. 9. Maintain Liaisons to IHE (Jerry Wallis) and ICANL (Jim Cullom),

10. Maintain Liaison to the SNM Phantom and QA Committee (Suleman Surti), 11. Establish Liaison to SNM MI Center of Excellence (Paul Kinahan), 12. Establish Liaison to AAPM science council/quantitative imaging initiative (Paul

Kinahan) 13. Nominate CaIC member to the American Board of Science in Nuclear Medicine, 14. Establish a collaborative relationship with the Physics Special Interest Group from the

Australia-New Zealand SNM, 15. President Marie Kijewski will serve the second year of a two-year term as the Vice-

Chair of Instrumentation and Data Analysis track for annual SNM meeting,


President: Marie Foley Kijewski Vice President: Gary Sayed Secretary: Suleman Surti Treasurer: John R. Votaw Immediate Past President: James R. Halama Board Members: Anna Celler, Georges El Fakhri, James Galt, Frances Keech, Julie Price

Mission The Computer and Instrumentation Council’s (CaIC) mission is to promote the dissemination of knowledge and the advancement of computers and nuclear instrumentation for diagnosis and treatment in nuclear medicine to its members and to the Society of Nuclear Medicine as a whole.

Correlative Imaging Council

SNM: Correlative Imaging Council


The Correlative Imaging Council (CIC) had a very productive year. Major accomplishments included:

o Presentation of the first Walter Wolf Young Investigator Award in

Correlative Imaging at the 54th Annual Meeting o Educational activities at the 54th Annual Meeting, including one

categorical course and four continuing education sessions o Creation of the SNM Council Internship Program o CT case review workshop in Philadelphia on Oct 5-6 o Strategic planning retreat in Philadelphia on Oct 4

The first Walter Wolf Young Investigator’s Award in Correlative Imaging was presented at the 54th Annual Meeting in Washington DC to Jan Soyka of the University Hospital in Zurich for this abstract titled, “Staging pathways in recurrent colorectal carcinoma. Is contrast enhanced 18F-FDG-PET-CT the diagnostic tool of choice?” Dr. Soyka received a certificate and $500 prize. The annual award was created to encourage the use of correlative imaging in research by young professionals. A proposal to establish an internship program was approved by the SNM Board of Directors. The CIC will select an intern to serve on the council beginning with the 2009 Midwinter meeting. The council will work with the Young Professionals Committee of the Academic Council to expand the internship program to all nine SNM councils. Financial support for the internship program will be provided by SNM in the form of reimbursement for travel expenses and meeting registration up to $1,500 per intern per year. The council organized one 6-hour categorical course and four 90-minute continuing education sessions at the 54th Annual Meeting in Washington DC. All of the sessions were well attended, and attendee evaluations were good. The council, working with the SNM education department, organized a 2-day CT case review workshop in Philadelphia on Oct 5-6, which was attended by 144 physicians. Expert radiologists reviewed 100 CT cases evenly distributed among head and neck, thorax, and abdomen/pelvis.

Looking Forward The CIC Board of Directors held a strategic planning retreat in Philadelphia on October 4,2007. The council was founded in 1978 to educate nuclear medicine professionals about the emerging technology of ultrasound. It was decided that the new mission of the

council would be to provide education in CT, MR and emerging molecular imaging technology. The focus will be on CT education in the coming year. The CIC is working with the SNM education department to develop a series of 2-day CT case review workshops where Nuclear Medicine physicians review 100 CT cases evenly distributed among head and neck, thorax, and abdomen/pelvis. Physicians attending the workshops can apply the credit earned towards the CT credentialing recommendation of 500 CT cases reviewed with an expert. The first workshop was held in Philadelphia on Oct 5-6, 2007. Three additional workshops are scheduled in 2008: Midwinter meeting in Newport Beach CA on February 15-16; 55th Annual Meeting in New Orleans on June 17-18; Seattle on August 2-3.

Officers of the council President: George Segall, MD President-Elect: Simin Dadparvar, MD Secretary/Treasurer: David Collier, MD Immediate Past President: Lalitha Ramanna, PhD SNM Board Liaison:

Mission The Correlative Imaging Council exists within the Society of Nuclear Medicine with the aim to: Establish and maintain an organization of members with an interest in correlative imaging and clinical practice for the purpose of providing a forum and a mechanism, whereby relevant basic science and clinical practice information may be discussed and disseminated. Provide a mechanism for the promotion and encouragement of correlative imaging and clinical practice research and development. Provide a source of information relating to correlative imaging and clinical practice affairs to the Society of Nuclear Medicine.

George Segall, MD President, Correlative Imaging Council

GI Council

SNM: GI Council


1. Gastric Emptying Consensus Report: A joint effort by SNM nuclear medicine physicians and gastroenterologists to

develop uniformity and a practice standard on how gastric emptying studies has been completed. The SNM GI Council and the American Neurogastroenterology and Motility Society have produced a manuscript, which was approved by the SNM Procedure Guidelines, Practice Standards committees and SNM Board. The final manuscript has been accepted for publication in J Nucl Med Technology and the American Journal of Gastroenterology. An editorial by Council President, Alan Maurer, will appear in J Nucl Med to announce this new practice standard.

2. CCK Hepatobiliary Consensus Development: The council has obtained funding from Brocco to develop normal values and

standards for performing CCK Cholescintigraphy. Goal is to produce a standardized method for performing this study similar to the above gastric emptying standard.

3. Bylaws changes. Changes to the bylaws of the GI Council were proposed and approved. The Council will have only two officers: President and a Secretary-Treasurer both to serve two year terms. The Secretary-Treasurer becomes the President at the end of the first two year prior and a new Secretary-Treasurer is then elected

Looking Forward

GI Council has committed to CME programs for the SNM Midwinter and Annual

Meetings and will be active to promote and develop standards for GI nuclear medicine procedures.


President: Alan Maurer Mark Tulchinsky Secretary - Treasurer: Mark Tulchinsky Technologist Section Representative: Margaret Stokes YPC Exec committee member: KG Bennet

Nuclear Oncology Council

SNM: Nuclear Oncology Council

Report 2008


Nuclear Oncology Council provides a forum for those members of the SNM with an interest in nuclear oncology, both therapeutic and diagnostic; Provide an informational resource to support those involved in nuclear oncology; Support the development of diagnostic and therapeutic clinical trials; Support the educational objectives of the society with respect to nuclear oncology; the interests of practitioners of nuclear oncology to the society; and Support MIRT2 activities.

Beginning in 2008, we will present a Nuclear Oncology Young Investigator Award (YIA). First-, second- and third-place winners will be announced during the NOC business meeting held during SNM’s 55th Annual Meeting in New Orleans June 14–18, 2008. The objectives of this new award are to identify promising young investigators working in nuclear oncology-related fields within nuclear medicine. To qualify for consideration for this award, authors must check the “Consider this abstract for the Nuclear Oncology Young Investigator Award” box during online abstract submissions for the 2008 SNM Annual Meeting. Eligibility criteria and application procedures were published on the SNM and nuclear oncology Web sites at the time of abstract submission for the 2008 SNM Annual Meeting. Please encourage your young colleagues to apply for the NOC YIA and to try their chances at winning this award. It is our way of encouraging and supporting young talent in the field of nuclear oncology. NOC has developed one categorical seminar and seven continuing education (CE) sessions ranging in many topics to be conducted during the annual meeting of the SNM in June 2008 – of note, one of the CE sessions will be held in collaboration with the Brain Imaging Council of the SNM. All of the CE sessions are directed at the practicing nuclear medicine physicians, focusing on a number of challenging and emerging topics of interest; while the categorical session will focus on the role of molecular imaging in personalizing cancer therapy. We are very excited about these educational sessions and are certain that the CE sessions and categorical seminar that cover many aspects of nuclear oncology would be very interesting and are bound to generate significant enthusiasm amongst the participants in promoting the cause of NOC. The Nuclear Oncology Council has continued to develop a constructive collaboration with ASTRO. In particular, a joint SNM/ASTRO (with RTOG) workshop on translational research was held in San Francisco in September 2007. We contributed to the development of the workshop in numerous ways, including: assisting and developing the program; reviewing abstracts; providing speakers and moderators, and providing

travel fellowships for three young translational researchers. The three that were selected were: Delphine Chen, MD, who is on the Nuclear Medicine faculty at Washington University in St. Louis, MO; Ted Graves, MD, on the Radiation Oncology faculty at Stanford University; and Rodolfo Perini, MD, Chief Resident, Nuclear Medicine and Clinical Molecular Imaging, University of Pennsylvania. The meeting was an exceptional venue for researchers from Radiation Oncology and Nuclear Medicine to discuss imaging applications for radiation oncology research, and methods to enhance collaboration between our two seemingly disparate specialties, which have so much in common. It was also an opportunity for new collaborations to be established and for a thorough examination of the current climate for peer-reviewed support for translational research. Chaitanya Divgi, MD, chaired a panel at the Annual Meeting of ASTRO that explored the relevance of molecular imaging in radiation oncology. Several other translational scientists and clinical experts participated and contributed to greater awareness of the value and role of molecular imaging and radiopharmaceutical therapy in cancer. Joseph Rajendran MD participated in another panel discussion titled “Practical Challenges in Incorporating Biological Information in RTP” at the same meeting. We have also made considerable progress in developing joint initiatives with the American Society of Clinical Oncology (ASCO).

Looking Forward

Establish stronger collaboration with Molecular Imaging Center of Excellence and PET center within SNM and continue to explore establishment of a speakers bureau and development of nuclear oncology MOC module. The initiatives of collaboration with ASTRO and ASCO established by Dr. Divgi, the past president of NOC would be further strengthened with the full commitment of the NOC. The primary long-term goal will be to encourage renewal of membership in the council. We are interested in establishing a listserv to be the primary conduit for the nuclear medicine community interested in oncological aspects of nuclear medicine. We will continue to explore a service to provide a monthly review of the literature on the NOC web site and “case of the week” feature on the site. Would promote closer interactions with other SNM councils with similar goals such as MICE and PET center and interests and develop joint educational programs and development of biomarkers for molecular imaging. Since many of these councils and sections have overlapping goals that can be exploited to the maximum with collaborative approaches. With the advent of molecular imaging and NM therapy, technologists play key and valuable roles in these areas. Greater participation from the NMTS in the NOC council would greatly help advance these fields. In this regard we would work towards getting representation from the SNM Technologists Section in the NOC board.


President: Joseph G Rajendran MD Secretary/Treasurer: Maroun Karam MD Immediate Past President: Chaitanya Divgi MD

Pediatric Council



SNM Annual Meeting-2007 1. Presented Categorical Seminar (with MICoE) entitled Multi-modality Molecular

Imaging: A Systems Approach” 2. Organized two Continuing Education Sessions (Small Animal Imaging and the Nuts

and Bolts of PET Radiochemistry) 3. Held Scientific Program for Radiopharmaceutical Chemistry (oral and poster

sessions) 4. Held 1st Annual RPSC Poster Session Mixer 5. Held RPSC Young Investigators Awards session and awarded 1st, 2nd, and 3rd place

awards 6. Held Radiopharmaceutical Summary Session talk (Given by MJ Welch and RH

Mach) 7. Held RPSC BOD business meeting and open business meeting of the RPSC 8. Published two Newsletters 9. Held elections for VP elect (Mike Adam), Treasurer (Michael Lewis), and two BOD

members (Sally Schwarz and Steve Dragotakes) Held Interim Board Meeting in Chicago on October 27th and set goals for 2007- 2008.

Looking Forward Publish two Newsletters Hold elections for Vice-President Elect, Secretary and 2 BOD members Explore the concept of a publication providing a periodic update (i.e. annual or every 2 years) on recent advances in Radiopharmaceutical Chemistry 2008 Mid Winter Meeting

1. Organized 2 Continuing Education Sessions 2. Presentation of request to create a Named Award for “individuals making significant

contributions to the field of Radiopharmaceutical Chemistry” to the Committee on Councils

SNM Annual Meeting-2008 1. Review and grade abstracts; organize Scientific Sessions 2. Organize two Continuing Education Sessions 3. Organize RPSC Young Investigators Awards session 4. Organize 2nd Annual RPSC Poster Session Mixer 5. Hold RPSC BOD business meeting and open business meeting of the RPSC

Note: it was decided to not hold an RPSC Categorical Seminar this year since it was felt that our session would compete with the session organized by MICoE. MICoE and the RPSC will work together on a co-sponsored Categorical for the 2009 Annual Meeting


President: Robert H. Mach Vice President: Jeff Norenberg Secretary: Scott Snyder Treasurer: Michael Lewis Immediate Past President: Jeff Clanton

Mission Has not changed.

Liaison Organizations

February 6, 2008 Dear Society President, Attached is the Preliminary Report of the Fifth Annual “Bioengineering and Imaging Research Opportunities Workshop - BIROW” completed on January 18-19, 2008 with the participation and assistance of 25 scientific and educational societies including your own (Attachment #1). The goal of the BIROW workshops is to facilitate the mission of NIBIB by encouraging emerging discovery processes through interchange between physical and biomedical sciences. The BIROW program uses intersociety input and the science infrastructure of more than 25 scientific societies to provide input to NIBIB and NIH. The goal of assisting NIH to accelerate the rate of discovery and application of emerging discoveries in bioengineering and imaging to improving health and benefiting the American public defines BIROW. The continuing assistance of your society is needed in 2008/2009 for the completion of two tasks. The first involves completion of BIROW 5 by submission of the final report including input from your society concerning the research opportunities in IMAGING AND CHARACTERIZING STRUCTURE AND FUNCTION IN NATIVE AND ENGINEERED TISSUE; 1. Heterogeneous Single Cell Measurements and Their Integration into Tissue and Organism Models, 2. Functional Molecular and Structural Imaging of Engineered Tissue in vitro and in vivo., 3. New Technologies for Characterizing Cells and Tissues in situ, and 4. Imaging for Targeted Cell, Gene and Drug Delivery. Please submit input from your Society prior to March 1, 2008 so it can be considered for inclusion in the BIROW 5 White Paper. The second task involves participation in the design of BIROW 6 at a planning meeting on April 4, 2008 and presentation in January 2009. The BIROW 6 Program Committee will meet on April 4, 2008 at the American Center for Physics adjacent to Washington DC to make decisions concerning the Program for 2009. A separate letter will be sent shortly after site arrangements are complete. Your society is invited to send two representatives to this meeting. Travel expenses for society representatives will be the responsibility of each society but meeting expenses will be borne by the BIROW Project. Thank you for your attention and assistance in promoting accelerated development of biomedical imaging research for improved health care. Sincerely Yours,

Gary D. Fullerton, Ph.D. AAPM PI for BIROW Conference Cooperative Agreement

John W. Haller, Ph.D. NIBIB, Program Officer for BIROW Conference Cooperative Agreement

Attachment 1

Roadmap for Bioengineering and Imaging Research 2008 BIROW 5 Preliminary Report

BIROW Preliminary Analysis by attendees: Imaging of Single Cells BIROW Consensus Score: _189 Imaging of Engineered Tissues BIROW Consensus Score: _160 Imaging of Tissues in situ BIROW Consensus Score: _146 Imaging for Targeted Rx Delivery BIROW Consensus Score: _154 Scoring System: 100-Outstanding to 500-No Use The BIROW Final Report will reflect consensus analysis of biomedical imaging research topics using the scientific input of more than 25 scientific and educational societies with more than 100 years of successful scientific and clinical collaboration that elevated the practice of biomedical imaging in medicine to the position of central importance that it occupies today. The final BIROW 5 report will be published as a white paper in one of the three collaborating journals, Medical Physics, Radiology or Annals of Bioengineering, with brief summaries in the other two with reference to the primary paper.

BIROW 5 Roadmap for Bioengineering and Imaging Research

BIROW Consensus

Consensus Building Process The BIROW consensus analysis of bioengineering and biomedical imaging research topics uses the scientific input of more than 25 scientific and educational societies with more than 100 years of successful scientific and clinical collaboration. Four specific aims of the NIH roadmap are addressed by answering four questions of how the topic:

A1. deepens the understanding of fundamental biology, A2. stimulates multidisciplinary teams, A3. reshapes clinical research to accelerate medical discovery and A4. improves people’s health?

The analysis also addresses four primary challenges by answering four additional questions of what are:

C1. the key scientific challenges, C2. the primary obstacles, C3. the critical technologies lacking and C4. the impediments to translation of discovery for improved health?

Topic 1: Heterogeneous Single Cell Measurements and Their Integration into Tissue and Organism Models BIROW Score: Mean 189 with 48 votes

Abstract: Many technologies for assessing organisms in vivo, such as conventional imaging methods, provide information that is aggregated over a volume of tissue, averaging the behavior of a very large number of cells. New technologies are providing unprecedented abilities to target and probe the detailed functions of individual cells in vivo. This presents a new type of challenge, in connecting such information to the function and health of the organism as a whole. This session focused on various approaches to this challenge.

Specific Aims: A1. Single cell measurements deepen understanding of fundamental biology?

• To understand population need to know what individuals are doing • Image-based screens rely on single cell measurements • Direct building of model from images allows enhanced understanding of

experiment and permits design of experiments to test model • Deepens understanding of relationships between cells which are fundamental

A2. Single cell measurements promote collaboration of multidisciplinary teams?

• All participants in the session were part of multidisciplinary teams • Imaging, image analysis and modeling require expertise from biology, chemistry,

optics, electrical engineering, computer science, statistics, mathematics • Probably among the fields where level of interdisciplinary collaboration is among

the very highest • Also need for interdisciplinary training

A3. Single cell measurements reshape clinical research and promote discovery?

• Progress from basic to translational to clinical • Fluorescence-based endoscopy blocked by failure to understand basic biology

behind measurements • Cells can be used as tool to develop methods applicable to larger systems • Look at organism in more comprehensive way – better understanding of

physiology • Measurement of single cell or small group of cells can provide better diagnostics

(e.g., field effect work of Backman) • Measurement of lymphoid subpopulations critical for understanding diseases

involving immune cells (AIDS, leukemias, lymphomas) • Single cell characterization will be critical to tissue engineering, which will have

clear clinical goal • Single cell measurements combined into models of tissue capture more complex

phenotypes than can be measured by measurements at higher levels • Rare cell detection (e.g., detection of malaria-infected cells) inherently requires

single cell measurements • Considering single cells dramatically increases sensitivity of diagnosis • Can use single cell measurements to prune tests

• Can discover new phenotypes during screens intended for other purposes • Precedent in analysis of breast biopsies by cellular assays to influence choice of

therapy – changed clinical practice • Multiscale modeling needs to include single cell measurements - eventual

personalized models A4. Single cell measurements improve people’s health?

• Already has o FACS revolutionized treatment of AIDS o Differential blood count most common test

• Single cell measurements key to personalized medicine • Simpler, less invasive tests can change patient and screening compliance (e.g.,

blood oxygenation monitoring) • Potential for drug discovery through high-content screening • Better understanding of cellular responses enables more complex drug screens

than currently used in high-content screening - can improve drug screening • Single cell measurements and models can enable better use of off-patent drugs

(important for developing countries) • Methods for rapid, automated learning of customized models from image data

will enable personalized diagnosis and monitoring Primary Challenges: C1. What are the key scientific challenges to single cell measurements?

• Improved methods for single cell segmentation methods major challenge especially in tissues

• Tools for generalizing morphologic/pattern characterization across cells and cell types

• Improving methods for imaging itself and 3D reconstruction • Building atlas of protein localization across tissues and disease states • Validation of measurement technologies to enable generalization to physiology of

cell • Understanding limitations of measurements

C2. What are the primary obstacles to development of single cell measurements?

• Insufficient resources/mechanisms for image sharing and annotating • Limited availability of large scale annotated image collections for training

machine learning systems • Limited availability of image analysis details in publications to permit reproduction

and reuse of previous work • Limited availability of state-of-the-art imaging instrumentation • Limited supply of interdisciplinary scientists • Limited availability of sufficient computational power for simulations bridging

scales C3. What are the critical technologies lacking for single cell measurements?

• Better labeling and sampling methods • Better label-free imaging methods • Better standardization of measurements

• Methods for active learning in hierarchical systems C4. What are the impediments to translating single cell measurements to improved health?

• Difficulty of linking single cell measurements to higher scale measurements • Difficulty of tracking cells in in vivo environment • Difficulty of predicting organ or organism-level behavior from single-cell drug

screens • Limited availability of in vivo biosensors

Topic 2. Functional Molecular and Structural Imaging of Engineered Tissue in vitro and in vivo BIROW Score: Mean 160 with 47 votes Abstract: The goal of this topic was to identify imaging needs and methods for non-invasive, fast, and accurate assessment of cell growth, differentiation, and tissue development, including matrix development, in engineered tissues. The talks covered two main topics: (1) Molecular imaging in vivo, including non-invasive tracking and assessment of the fate of implanted cells and 3-dimensional (3D) engineered constructs; and (2) Structural and functional imaging of 3D engineered tissue constructs in vitro. These topics encompass broad range of imaging modalities such as magnetic resonance imaging, micro PET, optical coherence tomography, multi-photon microscopy, as well as multi-modality imaging methods. The talks and discussion were designed to facilitate interaction between researchers in the field of tissue engineering and those in the various imaging fields that could benefit tissue engineering. The challenges and opportunities for applying advances in imaging technologies to tissue engineering to advance the field of regenerative medicine were discussed.

Clinical Application Clinical Application Areas for Engineered TissuesAreas for Engineered Tissues

Myocardial Patch Heart Valve

Vascular Graft Nerves

SkeletalMuscle

Liver

Cartilage and Bone

Adipose Tissue

Pancreas

Skin

Bladder

Specific Aims: A1. Imaging of engineered tissues deepens understanding of fundamental biology?

• It is well known that 2D tissue culture systems are artificial and that the cell phenotype in these systems is altered compared to their phenotype in a 3D in vivo environment.

• In vitro 3D engineered tissue model systems capture much of the relevant complexity of tissues in vivo that traditional 2D cultures do not. As such, they represent a very important research tool for cell biologists to study cell behavior and cell/cell, cell/ matrix, and cell/medium interactions.

• 3D engineered tissue models provide new possibilities for the study of complex physiological and pathophysiological processes in a controlled environment.

• Imaging of engineered constructs aids in understanding porosity of tissues and cell growth patterns.

• Studying the both the success and failure of implanted engineered tissue aids in our understanding of fundamental biological and physiological processes.

A2. Imaging of engineered tissues promotes collaboration of multidisciplinary teams? • Tissue engineering is the definition of multidisciplinary team research. Biology,

engineering and medicine have self-assembled over the years to tackle tissue engineering.

• Adding imaging expertise to these teams is essential. • Other areas of expertise missing include:

o bioinformatics and computational biology o sensor technologies for analysis/sensing of microenvironment (chemical

and physical). Cell itself is the best sensor. Need to engineer cell to do this.

o Embryology, developmental biology and stem cell biology. o Adult biology—still a lot to learn. Development/generation of tissue vs. re-

generation o People who know how to transfer the technology to commercialization

and/or patients o Scalability, manufacturing expertise

• Technology developers need to be better integrated with clinical researches and clinical needs and vice versa

A3. Imaging and tissue engineering reshape clinical research and promote discovery? • TE could provide tissues or biological fluids in short supply. Positioned to directly

address the shortage of donor tissues and organs. • Imaging is extremely important as it aids in the development of the blueprint and

design principles for 3D engineered tissues. • 3D HUMAN tissue engineered models in general could be good pre-clinical

model systems. • They are also likely to be good models for drug development because they might

be more predictive of human responses to drugs than animals but not all cases. it also depends on what you are studying. So overall, may be more predictable model of what will happen pre-clinically and clinically in some cases. Also cheaper and higher throughput than animals.

• 3D engineered tissues would be a good in vitro model for developing diagnostic imaging tools.

• Extracting info that you can’t get from animal models—pharmacogenomics (personalized medicine)

• In vitro systems allow for great control and could be a tool to better design animal studies.

• Allows imaging of things as they happen—DYNAMICS – • Imaging the host response is as important as imaging engineered tissues.

A4. Imaging of engineered tissues improves people’s health?

• Tissue engineering holds the promise to treat a long list of diseases. • After implantation, imaging will allow us to monitor function in vivo and tells us if

we are putting the right thing in. • Imaging could make the process of cell, tissue or organ replacement less

invasive overall. • Imaging can monitor function and allow for early detection of failure and lead to

corrective action. • Imaging of engineered constructs could allow for monitoring of tumorogenicity vs.

normal growth and differentiation • Need for more correlations between imaging information and clinical outcomes.

Primary Challenges: C1. What are the key scientific challenges to imaging of engineered tissues?

• Understanding which cell & tissue responses are linked to various molecular & physical factors

• Imaging & understanding the dynamics of the cells (non-invasive, real-time) ---e.g. within mechanically responsive cardiac tissue (e.g. ion fluxes, signal

propagation, gradients) ---e.g. combination of proteomics & imaging as a function of time (e.g. for cell

differentiation; assembly) ---e.g. differentiation of cells (molecular imaging of gene expression) • Imaging & understanding the integration of the engineered tissue with the host

tissue • Need ways to evaluate evolution of scaffold degradation & tissue changes over

time --- need time-dependent scaffold properties --- need time-dependent tissue mechanical properties & mass transport

properties - can we obtain these data for individual patients? - need to evaluate 3D nondestructively in vivo --- for soft tissue: need nondestructive quantification of 3D extracelluar matrix (e.g. GAG distribution, collagen I v. collagen II) --- for nerves: need nondestructive tracking of axon growth & electrical activity in

vivo • Quantitative studies at small scales (e.g. organoids) • Need better ways to track location of individual cells & subsets of cell populations ---e.g. understand why stem cells don’t go to the “proper” location when injected • Need to know whether label-free imaging could be as sensitive as imaging using

label

---collagen is an example. ---molecular level imaging for clinical applications without labels is a challenge. --Could labels be temporary, so that molecular environment is not

changed? --Same comments for cellular level. • Need ways to image deep tissue & internal organs - e.g. better molecular markers & identification of endogenous biomarkers - e.g. improved 3D image analysis & quantification [i.e. cell location within entire

organ] why are cells rejected after 3 months in the organ? • For detection of viruses, need to be able to see where the virus is (after

introduction) possible to fluorescently label the virus? Or some other approach? • Need level of quality, acceptable to FDA, to build enough scaffolds for clinical

studies are there imaging/production technologies, other than SFF & other off-the-

shelf approaches, that will provide the necessary quality of fidelity and resolution? • Need improved imaging input to develop design of engineered tissues ---e.g. CT is good for bone structure… but what is available for function? ---e.g. MR good for soft tissue structure; MRE, UEI for function; what other

elastography methods are available? • Need further development of elastography approaches for imaging tissues - need improved, automated edge detection - is OCT penetration sufficient? - can OCT be used within and/or outside a bioreactor? - What is needed for the many different tissue types? - Nonlinear elastic & viscoelastic properties

Topic 3: New Technologies for Characterizing Cells and Tissues in situ BIROW Score: Mean 146 with 48 votes

Abstract: Emerging technologies offer new approaches for quantitatively assessing tissue properties that previously could not be measured in situ. Some of these opportunities involve novel imaging technologies that exploit interactions of energy with tissue and in some cases the conversion of one form of energy to another ("energy transduction") to provide new parameters for tissue characterization. Other approaches involve bringing sensors and microscopic imaging modalities into contact with tissues of interest by minimally-invasive, image guided techniques. Many of these technologies have as much relevance to the evaluation of engineered tissue constructs as they do for in vivo imaging. This session had four speakers who provided a survey of specific emerging technologies, opportunities and unsolved problems.

Specific Aims: A1. Characterizing tissues in situ deepens understanding of fundamental biology?

• Improving tissue characterization o Direct path o Indirect path

• There are levels of biology o Measuring hemoglobin is a higher level process o New modalities can measure at cellular level

• Help characterize interplay between target tissue and surrounding tissue cells o Relationship between biology and disease

• Can lead to creation of multi-label probes o Large scale collaborative effort to determine what the normal range of

tissue is A2. Characterizing tissues in situ promotes collaboration of multidisciplinary teams?

• Work is multidisciplinary by nature • Many disciplines represented in breakout session • Potential team members

o Biology, physics, chemistry, computer science, engineering, mathematician, clinician

• Image analysis can cross scales and encourage collaboration • Need to train people to bridge disciplines and be multi-lingual

o Biomedical engineering / bioengineering is one good discipline for this

A3. Characterizing tissues in situ reshapes clinical research and promotes discovery? • In-situ characterization of tissues could fundamentally change the way clinical

trials are done o New means to monitor changes as they occur

• Need to develop models to link imaging and biology o Imaging observes underlying biological processes

• Examples o Elastography suggests tumors might be stiffer

• Biologist could investigate why this occurs • Confocal microscopy could enable in-vivo histology

A4. Characterizing tissues in situ improves people’s health?

• Can enable personalized medicine through individual specific imaging • With image-guided biopsy tissue characterization can be more specific • May lead to new screening methodologies that could be low cost for underserved

populations o Elastography for liver fibrosis o Imaging for cancer monitoring

Primary Challenges: C1. What are the key scientific challenges to characterizing tissues in situ?

• Iin vivo sensing of dynamics- transient vs chronic phenomena • Multi-scale imaging • Response of cell or tissue to stress or perturbation • Response of tissues to successive stimuli (unique advantage of in vivo imaging) • Characterize interactions between focal lesions and surrounding tissues • Precancer states in cells / tissues • Gene modulation by cell environment • Characterizing psychiatric disease • Can we image memory? • 100’s of currently inaccessible parameters – for example: hydrostatic pressure • What parameter(s) would be the equivalent of a moonshot?

C2. What are the primary obstacles to development of characterizing tissues in situ?

• Validation o If we now can measure what we could not measure previously…

… how can we validate? o what is normal?

• Prioritization and Resources o are we investing resources in a way that will promote the next technology

that would have the impact of CT or other similar breakthrough of last 50 years?

o need to prioritize o innovation should be a key criterion, emphasized by study sections o need sustained funding - developing breakthrough technologies requires

time • Approach

o we measure the things that we know o sometimes we define the problem with the tool that is available o we don’t always know what is normal – should we start with disease or

with what is normal? o a key challenge is to put aside preconceptions

• Sensitivity vs Specificity o sometimes, the main obstacle is specificity – false positives o must differentiate sensitivity in an engineer’s sense versus biological point

of view o downstream detection - high sensitivity – leads to upstream challenges

• Significance

o Drive to find cancer earlier and earlier – leads to basic problems re unknown tumor-host interaction – natural history

o Example is thyroid cancer -elevated PSA; prostate cancer

C3. What are the critical technologies lacking for characterizing tissues in situ? • Better sensors of all types: chemical sensors, x-ray detectors, coils, etc. • More sensitivity, speed, spatial resolution • Multiparametric sensing and dual/multimodal probes • More funding needs to be devoted to development of new instrumentation

C4. What are the impediments to translating characterizing tissues in situ to improved health?

• “Multi-lingual study” sections are needed. • Need appropriate level of expertise to review a proposals • Optical imaging – an example slow translation, given level of investment,

surprising how little is applied • Are we putting enough money behind grants that require a major effort to

translation? • Use of academic research model rather than applied research model • Regulatory issues – a huge impediment • Need more small grants so more ideas can be tried • Cost / Medical Economics

o Imaging is underfunded compared with impact o How to emphasize development of cost-effective technologies, care for

underserved o Why is after 30 years is CT still expensive? o 0ur perceptions of medical technology “cost” are based on charge, which

involves cost shifting in our system and introduces distortions Topic 4: Imaging for Targeted Cell, Gene and Drug Delivery BIROW Score: Mean 154 with 46 votes

Abstract: The main goal of this session was to present the data regarding the cutting edge research on the border between drug delivery and imaging. We concentrated on very recent and new topics, which currently attract a lot of attention, such as cell-penetrating peptides, siRNA and gene silencing, image-guided drug delivery, acoustic delivery and imaging, etc. Speakers were asked to concentrate more on critical areas to make the whole program remain consistent.

Multi-modal particles

Specific Aims: A1. Imaging therapeutic delivery deepens understanding of fundamental biology?

• Drug delivery imaging involves basic understanding of cell functions, receptor kinetics, cell membrane structure, biochemical pathways, signal pathways, transporters, endocytosis, etc.

• Imaging for drug delivery can non-invasively increase our understanding of disease biology.

• Imaging can show specific biomarkers involved in a disease process. • Imaging also can show the release therapeutic agents from a carrier in a

specifically targeted tissue. • Imaging for drug delivery can also explain cancer therapy failures if the drug

does not reach the cancer. The drug may be effective for the cancer, but the problem may be the lack of drug delivery into the solid tumor.

A2. Imaging therapeutic delivery promotes collaboration of multidisciplinary teams?

• Imaging for drug delivery will require a team science approach from radiologists, nuclear medicine physicians, imaging scientists, engineers, pharmacologists, biologists, and chemists as well as equipment manufacturers, image analysis experts and software specialists.

• It is a clear example of projects that will link physical and life scientists with engineers and clinicians

A3. Imaging therapeutic delivery reshapes clinical research and promote discovery?

• Drug delivery imaging is very important for conducting clinical research. • Drug delivery imaging studies can be conducted for discovery and development

of new drug delivery technologies as well as understanding of why many drugs fail to be effective in humans in spite of promising results in smaller animals.

• Imaging for drug delivery will help us understand why certain drugs do not reach the intended target and why they are not effective even they do reach the target.

• It can also involve new groups of clinicians dedicated to development and research of drug delivery systems.

A4. Imaging therapeutic delivery improves people’s health?

• Imaging for drug delivery has the potential to very specifically improve drug therapy and improve patient selection for specific drug therapies.

• Imaging can quantify the amount of drug that is delivered to a disease and it also has the potential to determine the specific local distribution of the drug in the targeted region.

• Imaging can also be used to determine patient selection and monitoring of the therapeutic response of targeted therapies. For instance, imaging could be used to screen for specific targeted receptors such as growth factor receptors.

• Therapy often requires a combination of drugs to which each patient reacts differently. Imaging for drug delivery will make possible the goal of personalized medicine. It may be possible to determine individual treatment protocols and their efficacy, accounting for patient to patient variability.

Primary Challenges: C1. What are the key scientific challenges to imaging therapeutic delivery?

• One of the key scientific challenges is that we have little knowledge of where and how a drug localizes after injection. Many drugs may fail because they fail to reach their target in adequate levels, although the drug itself may be quite effective against the particular disease if the delivery were adequate.

o Even drugs that do work effectively currently, could work even better, if the delivery of the specific drug was improved. It is also important to know where drugs that do not hit the target go, so that these unwanted localizations can be closely examined for toxicity.

o This problem of drug delivery is particularly crucial for local drug administration, such as gene delivery, in which there have been very few imaging studies of both delivery and outcome components.

o At a minimum, imaging studies are required to know the immediate distribution of the injected drug following administration and to be able to quantitatively determine distribution.

o Distribution of the drug is important not only in terms of relative organ biodistribution, but also in terms of biodistribution over the local region of the injected agent throughout the locally targeted disease process. For instance, if a tumor is targeted by local injection, the distribution should be homogeneously spread throughout the tumor and not just localized on the periphery of the tumor or in a small local portion of the tumor.

• A particular challenge is how to track viruses in the body. It is important to track the initial distribution of the virus in the body. Another very challenging goal would be to track virus that replicates and changes distribution following injection in vivo. This tracking of viral particles is thought to be particularly important for human clinical trials.

• Another challenge, which may be beyond current imaging technology, is to know whether or not the drug is in the right intracellular compartment. It is also a challenge to develop tools (labeling kits, imaging analysis software) that can be easily transferred to many labs. To assure that the drug will be delivered to the

intended target in a sufficient quantity for detection and without losing the label in the process.

• One has to notice, that the absolute majority of drug delivery imaging studies have been done for cases of cancer therapy, leaving many other pathologies without proper attention.

C2. What are the primary obstacles to imaging therapeutic delivery?

• For local drug delivery, a specific obstacle is the regulatory hurdles involved in receiving approval for labeling a specific therapy to permit imaging during the initial clinical evaluation. Some of this may be related to the fact that it is very hard to get initial approval to test a drug and then the drug is considered changed if an imaging tracer is attached to it, so that the approval process has to be redone.

o A possible approach might be to have the therapeutic agent be labeled with a radiotracer from the start. Imaging could be an integral part of the therapeutic agent because proper deposition and coverage of the agent throughout the therapeutic target may require labeling with a tracer for image-guidance as well as for verification of proper localization of the drug delivery within the target.

• Another obstacle is the high cost of some commercially available markers. Are these costs significantly affected by volume? One potential way to address the roadblocks to translating imaging is to have the NIH inexpensively disseminate some imaging tools such as imaging agents that are widely desired by a large number or research such as a specific tracer chelator, or NIR dye.

• Another obstacle may be that clinicians may not understand what they are looking at when we see an image of a new developed agent? How can the image be accurately interpreted?

• If imaging is needed for every treatment, (e.g., for infusing into large solid tumors), this is a very different challenge than if imaging is only needed for use in development and clinical trials.

• There is a need to come up with image-guided standards in animal studies that can be transferred into the clinic.

• There is a lack of quantifiable imaging for stem cells. Stem cell tracking is considered a very important requirement for the successful development of stem cell therapies.

• More attention needs to be paid to "pre-clinical imaging" standardization; standardization of small animal imaging is even worse than the clinical arena. But yet, drug development starts in pre-clinical imaging.

C3. What are the critical technologies lacking for imaging therapeutic delivery?

• Combined systems are needed for image-guided drug delivery. These systems could be composed of high resolution combined SPECT and PET systems for accurate determination of drug delivery and localization and monitoring combined with CT or MRI for accurate imaging guidance. Ultrasound systems could also be included that fuse with the CT and or MRI for image-guided therapy.

• A lack of standardization and ability reproducible quantify images was also cited as a deficiency of current imaging equipment. Emphasis should be placed on developing more standardization procedures so that images obtained in one location can be quantified in a similar manner to images obtained from imaging equipment at different locations. Standardization could be approached with

appropriate standards; improvements in equipment dedicated to better standardization are also needed.

• Small animal imaging has a major role to play in the development of better imaging agents and protocols. All protocols for planned translation to human studies should be proven feasible in small animal imaging. More funding should be dedicated for support of small animal imaging. Emphasis should be placed on small animal imaging having quantified data which should support.

• Use of optical imaging of many wavelengths can be developed to define an image-guided drug delivery methodology in animals which can then be converted to SPECT imaging of different photon energies in humans.

• There needs to be automation technologies in labeling and image analysis. Quantization methodologies for estimating drug concentration need to be developed. Technologies that are easily transferable from pre-clinical imaging to clinical imaging; e.g. the Bruker ClinScan 7T MRI scanner using the same software platform as the clinical MRI scanners. Image fusion technologies (hardware and software) are important for multi-modality imaging.

C4. What are the impediments to translating imaging therapeutic delivery to improved health?

• The challenges and obstacles are very diverse. One significant problem is the lack of funding that is being dedicated to clinical translation. More funding is needed for specifically guiding researchers with promising preclinical drug into phase I studies of these drugs so that they will have a drug delivery imaging component.

• More emphasis needs to be made of development of quantitative imaging in animals that can be translated into humans. New dedicated human imaging systems need to be developed that are specifically dedicated to drug delivery imaging.

• Training of scientists to have a basic understanding of all the multidisciplinary knowledge is important so that they will be able to integrate scientists from various disciplines.

• Research funding needs to be set aside for qualifying imaging biomarkers. For example, funding should be available not only for synthesizing novel compounds, but also for validating labeled drugs. More financial help should be available to help academic institutions set up pre-clinical imaging core labs and special attention should be paid to states with disadvantages in competing for shared instrumentation grants.

• More standard tools should be made available to imaging core labs, such as labeling kits that are shake and bake. Need to educate physicians to embrace imaging as "standard of care" in their practice.

Appendix – General Discussion

Applied Research and Development – An Opportunity Traditionally, much medical research conducted in medical institutions and funded by the NIH has been conducted under a classic American academic model. This model prizes intellectual freedom, pursuit of innovative areas of research, publication in the peer-review literature, and external recognition of the value of scientific contributions. Scholarly clinicians and researchers are encouraged to freely choose the focus of their research programs and to pursue these activities to the full extent permitted by the

intramural and extramural funding to that they are able to obtain. Academic appointment and promotion at most institutions is based on these classic criteria. Research finance policies and allocation of intramural research funding generally reflects and supports this model. Many of the most important advances in medicine of the last decades have been accomplished through this model. Yet, for over a century, a distinctly different approach has been used by the commercial sector and government agencies. Investigational talent and assets are employed in a more directed fashion. This approach is most often called “Applied Research and Development” (AR&D). Other designations are “Applied Research”, or the application of “Applied Science”. In this model, investigators and research teams are presented with goals or challenges that have been determined by the organization to represent strategic opportunities or critical responses to competition or threats. Programs are sized and resourced according to the near term importance of the goal, ongoing progress, and the financial and competitive consequences of attaining the goal. Some of the most important advances in medicine of the last decades have been accomplished through this model, as well. It is appropriate to ask whether it is now time for academic institutions and the NIH to more systematically engage the scientific talents of investigators - and to advance discovery and translation - by applying the Applied Research model as a complement (not a replacement) to an ongoing traditional academic research model. Approaches for Increasing Applied Research Activity at Academic Institutions In order to more explicitly pursue the benefits that a strategy of Applied Research and Development could provide, institutional policies and practices should be reviewed and modified to reflect this goal. Some of areas that should be reviewed include hiring, promotion, incentives, recognition, and research finance policies. Most important of all is to develop a system to provide leadership challenges, expectations, and sponsorship of AR&D in targeted areas that offer greatest opportunity.

SNM Board of Directors 2008 Mid-Winter Meeting...2008/02/15 · 2008 Mid-Winter Meeting February...

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