David Jones University of Virginia

Program Guide Bethesda Marriott

Bethesda, MD 7:00am – 5:00pm

Breakfast and Lunch: Salon C Program: Salon A-B

Study Section: Potomac Room

David Jones

University of Virginia

Grant Writing Workshop Attendee Roster

• Bassem Ayyash Yale University New Haven, CT

• George Arnaoutakis Johns Hopkins University Baltimore, MD

• Castigliano Bhamidipati University of Virginia Charlottesville, VA

• Jessica Cobb University of Florida Gainesville, FL

• Antonio Coppolino, III Weill Cornell Medical College New York, NY

• Stephen Deppen Vanderbilt University Nashville, TN

• Ismail El-Hamamsy Montreal Heart Institute Montreal, QB, Canada

• Giuseppe Faggian University of Verona Verona, Italy

• Fred Edwards University of Florida Jacksonville, FL

• James Fingleton The Miriam Hospital Providence, RI

• Timothy George Johns Hopkins University Baltimore, MD

• Lawrence Greiten Mayo Clinic Rochester, MN

• James Jordan Wake Forest University Winston-Salem, NC

• Sunjay Kaushal Children’s Memorial Hospital Chicago, IL

• Zachary Kon University of Maryland Baltimore, MD

• Damien LaPar University of Virginia Charlottesville, VA

• Eric Lehr University of Maryland Baltimore, MD

• Mohsen Mahvash Boston University Boston, MA

• Robert Marsh Rush University Chicago, IL

• Aldo Milano University of Verona Verona, Italy

• Muralidhar Padala Emory University Atlanta, GA

• Matthias Peltz University of Texas, Southwestern Dallas, TX

• Orlando Petrucci University of Campinas Campinas, Brazil

• Pranava Sinha Children’s National Medical Center Washington, DC

• Hisashi Tsukada Beth Israel Deaconess Medical Center Boston, MA

• Sheel Vatsia North Shore University Hospital Manhasset, NY

• Brody Wehman University of Maryland Baltimore, MD

• Dominik Wiederman Vienna Medical University Vienna, Austria

• James Yun Dartmouth Hitchcock Medical Center Lebanon, NH

Grant Writing Workshop Faculty Snapshots

Yolonda L. Colson, MD Brigham and Women’s Hospital

Director, Women’s Lung Cancer Program Assoc. Professor, Harvard Medical School

Pedro J. del Nido, MD Children’s Hospital Boston

Chairman, Department of Cardiac Surgery Professor, Harvard Medical School

Timothy J. Gardner, MD Christian Care Health Systems

Medical Director, Center for Heart and Vascular Health

Bartley P. Griffith, MD University of Maryland

Chief, Division of Cardiac Surgery Director, Heart and Lung Transplantation

Professor of Surgery

David H. Harpole, Jr., MD Duke University

Vice Chief, Division of Surgical Services Assoc. Professor of Surgery

Keith A. Horvath, MD NIH Heart Center, Suburban Hospital

Director, Cardiothoracic Surgery, NHLBI

John S. Ikonomidis, MD Medical University of South Carolina

Chief, Division of Cardiothoracic Surgery Head, Section of Cardiac Surgery

David R. Jones, MD University of Virginia

Chief, General Thoracic Surgery Professor of Surgery

Marc R. Moon, MD

Washington University Division of Cardiothoracic Surgery


Michael S. Mulligan, MD University of Washington

Director, Lung Transplantation, and Advances Lung Disease Programs


Mark B. Ratcliffe, MD University of California, San Francisco

Chief of Surgery, San Francisco VA Medical Center


Frank W. Sellke, MD Brown Medical School

Chief, Cardiothoracic Surgery Professor of Surgery

Y. Joseph Woo, MD University of Pennsylvania

Director, Minimally Invasive and Robotic Cardiac Surgery

Assistant Professor of Surgery

AATS 2011 GRANT WRITING WORKSHOP Friday, March 4, 2011 | 7:00 a.m. – 5:30 p.m. | Bethesda Marriott

*A copy of all PowerPoint slides will be made available after the conclusion of the program

Course Directors: David R. Jones, MD, University of Virginia and Y. Joseph Woo, MD, University of Pennsylvania

Friday, March 4th

7:00am – 7:30am Registration

7:30am – 7:35am Welcome David R. Jones, MD & Y. Joseph Woo, MD

7:35am – 8:00am Developing a Research Program in Academic Medicine David R. Jones, MD Session I – Funding Organizations and Grant Types Moderators: Y. Joseph Woo MD, David H. Harpole Jr MD

8:00am – 8:15am Postdoctoral Research Fellowships, Intramural Grants, Foundation/Society Starter Grants

Marc R. Moon, MD 8:15am – 8:30am Industry Sponsored Research Agreements (SRA)

Frank W. Sellke, MD 8:30am – 8:45am National Cancer Institute

David H. Harpole, Jr., MD

8:45am – 9:00am National Heart, Lung, and Blood Institute Keith A. Horvath, MD

9:00am – 9:15am Small Business Innovative Research / Small Business Technology Transfer Bartley P. Griffith, MD

9:15am – 9:30am Career Development Grants and Transitioning to an Independent Investigator Michael S. Mulligan, MD

9:30am – 9:45am The Career Goal: Independent Investigator (R01) John S. Ikonomidis, MD

9:45am – 10:00am Developing a Clinical Research Program, Trial Design, Patient Enrollment Timothy J. Gardner, MD

10:00am – 10:15am Question and Answer Period Break: 10:15am – 10:30am

Session II – The Components of a Grant Moderators: David R. Jones MD, Frank W. Sellke MD

10:30am– 10:50am Getting Started - Preparation/Grantsmanship/Dealing with the New Format and

Page Limits Mark B. Ratcliffe, MD

10:50am– 11:10am Hypothesis and Specific Aims - The Importance of Clarity Y. Joseph Woo, MD

11:10am – 11:30am Research Strategy - Significance - Why is Your Research Important? Marc R. Moon, MD

11:30am – 11:50am Research Strategy - Innovation - How to Make Your Grant New and Unique David R. Jones, MD

11:50am – 12:10pm Research Strategy - Approach - Your Proposed Experiments Frank W. Sellke, MD

12:10pm – 12:30pm Writing a Revision - Formulating Your Response and Rebuttal Yolanda L. Colson, MD

Lunch: 12:30pm – 1:30pm (Interactive Question and Answer Period)

Session III – Grant Submission and the Review Process 1:30pm – 2:00pm An NIH perspective - Administrative Insights into the Grant Submission

Review Process—Critical Do’s and Don’ts Joyce C. Gibson, D.Sc. – Center for Scientific Review

2:00pm – 2:30pm A Surgeon’s Perspective of the Grant Review Process Pedro J. del Nido, MD 2:30pm – 2:45pm Interactive Question and Answer Period

Session IV – Mock Study Sessions

2:45pm – 5:00pm Mock Study Sessions – Faculty

Session V – Conclusion

5:00pm – 5:30pm Interactive Question and Answer Period 5:30 pm Adjourn Accreditation: Learning Objectives: • Create Career Development and Training Grants Under the New NIH Guidelines for Applicants • Analyze Outcomes Research and Clinical Research Networks • Assess the Structure and Components of a Grant • Identify Extramural Program and Funding Opportunities - NCI and NHLBI The American Association for Thoracic Surgery is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The American Association for Thoracic Surgery designates this educational activity for a maximum of 9.75 AMA PRA Category 1 Credits.™ Physicians should only claim credit commensurate with the extent of their participation in the activity.

Grant Writing Workshop – Faculty Disclosure List Disclosure Policy: It is the policy of the American Association for Thoracic Surgery that any individual who is involved in planning, presenting or is an author on a program designated for AMA Physician’s Recognition Award Category 1 Credit™ must disclose any financial interest or other relationship (grant, research support, consultant, etc.) that individual has with any manufacturer(s) of any commercial product(s) that may be discussed in the individual’s presentation. This information is disclosed to the audience prior to an activity. The AATS has procedures in place if a conflict of interest should arise. In addition, faculty members are asked to disclose when any discussion of unapproved use of pharmaceutical or medical device occurs. Yolonda L. Colson, MD: Faculty member has nothing to disclose with regard to commercial

support. Faculty member does not plan on discussing unlabeled/investigational uses of a commercial product.

Pedro J. del Nido, MD: Faculty member has nothing to disclose with regard to commercial


Timothy J. Gardner, MD: Faculty member has nothing to disclose with regard to commercial


Joy C. Gibson, D.Sc.: Faculty member has nothing to disclose with regard to commercial


Bartley P. Griffith, MD: Faculty member has nothing to disclose with regard to commercial


David H. Harpole, Jr., MD: Faculty member has nothing to disclose with regard to commercial


Keith A. Horvath, MD: Faculty member has nothing to disclose with regard to commercial


John S. Ikonomidis, MD: Faculty member has nothing to disclose with regard to commercial


David R. Jones, MD: Faculty member received Grant/Research Support from Millennium Pharmaceuticals. Faculty Member receives Grant/Research Support from Merck, Inc. Faculty member does not plan on discussing unlabeled/investigational uses of a commercial product.

Marc R. Moon, MD: Faculty member has nothing to disclose with regard to commercial


Michael S. Mulligan, MD: Faculty member has nothing to disclose with regard to commercial


Mark B. Ratcliffe, MD: Faculty member was a Consultant for Co-Repair Inc.

Faculty member does not plan on discussing unlabeled/investigational uses of a commercial product.

Frank W. Sellke, MD: Faculty member is a Consultant for NovoNordisk Pharmaceuticals.

Faculty member is a Consultant for CSL Behring Pharmaceutical. Faculty member is a Consultant for Cubist Pharmaceuticals. Faculty member does not plan on discussing unlabeled/investigational uses of a commercial product.

Y. Joseph Woo, MD: Faculty member has nothing to disclose with regard to commercial


1


Basic Research in Thoracic Surgery“Grant Writing Workshop”

American Association of Thoracic Surgery, March 2011

David R. Jones MDGeorge R. Minor Professor of Surgery

Division Chief, Thoracic & Cardiovascular SurgeryUniversity of Virginia


What is “Basic Research”?

• The term “basic science or research” is a misnomer. • All science today is translational with clear applicability

to human diseases.• Signal transduction• High-throughput

assays• Transgenic animals• Novel animal or cell

culture model systems• Science “linked” to

clinical databases

• Genomics• Proteomics• Nanoparticle

technology• Pharmacogenomics• Bioinformatics


So You Want to be a Basic Researcher?The Assumptions

1. You’re curious, committed, and energetic.2. You have some previous history of doing

“bench” research.3. Your ego is not defined by case numbers.4. You will have different friends than your

colleagues.5. Your long-term goal is to be an independent

researcher.6. You like to compete.7. You never give up.


The Scientific MethodAsk a question

(Why do lung cancers metastasize so early?)

Do a background search(What does the literature say?

What’s new?)

HypothesisExperimental Design

(Experiments, alternatives, pitfalls?)

Data Analysis Conclusions&

Publication

2


“Culture of Research”

• Defines the research environment• Is the Chair/Division Chief/Institution

objectively supportive of research?• Do other faculty have research labs?• How successful have other young faculty

been in their research careers?• How much time is really given to do

research?• Are surgeon-scientists financially penalized

relative to others for doing research?


Beginning your Research CareerWhat’s Important?

• “Culture of research”• Scientific mentor

– Not your Division Chief– Almost always a PhD – Associate or full Professor– “My science” is a work in progress

• The academical village– All science is multidisciplinary– NIH/others increasingly supportive of cross-

disciplinary grant proposals


Beginning your Research CareerWhat’s Important?

• “Basic” Department/Divisional responsibilities– Start-up funds (around 70-100K/yr) for 3-4 years– A lab technician or post-doc– Competitive salary with annual increases– Limitations on clinical and admin responsibilities– Consider a research advisory committee

• Continuing surgeon-scientist education– Chalk talks– Graduate level courses– Mini-workshops– Be a student (and enjoy it!)


“Basic Research” in Thoracic SurgeryThe First Year

• Absolutes– Attend and present your science in your scientific

mentor’s lab meetings– Attend other conferences (Cancer Center, Heart &

Vascular Research Center, etc.)– Do the work (i.e. put the time in)

• Write grants for institutional and foundation “young investigator awards”– AATS, AHA, ACS, AACR, TSFRE, ISHLT

• Consider working with industry• Be patient; work your plan (walk, then run)

3


“Basic Research” in Thoracic SurgeryYears 2 & 3

• Generate preliminary data– Do “publication ready” experiments

• Write your first major grant– K-series (K08 or K23)– Consider K99/R00 awards– Rarely, an R01– American Cancer Society, AHA, VA merit

• Increase scientific cross-fertilization• Remain scientifically mature


Thoracic Surgeon-ScientistFive Common Misconceptions

• Surgeon-scientists can’t operate

• Collecting human tissue is doing science

• NIH won’t fund cardiothoracic surgeons

• “I’ll establish my clinical reputation first”

• Protected time


“Basic Research” in Thoracic SurgeryMeasurements of Success

• Beautifully simple and universally accepted

• Meritocratic and binary• A culture familiar to surgeons

• Quality publications (IF, “science” journals)• Successful grantsmanship


CT Surgery and NIH FundingThe Numbers Game

Ratcliffe MB, JTCVS 2008

4


CT Surgery and NIH FundingThe Numbers Game

• CT Surgery submits 0.3% (110/35,000) of all grants received by the NIH

• CT Surgery submits 5% of all surgery grantsreceived by the NIH

• Funding success rates:– CT Surgery: 14%– All NIH: 23%

• The problem is that CT surgeons are not submitting enough grants (quality grants?)

Ratcliffe MB, JTCVS 2008

Bottom line is a lower per capita funding rate To CT surgeons compared to whole of NIH


Factors that Decrease CT Surgery Applications to the NIH

• Economic pressures– Clinical workloads– Inability to cost-shift

• Time pressures– Resident work hour reductions

• Research training– Timing– Quality

• Duration of trainingRatcliffe MB, JTCVS 2008


“Fundable Science”

• Avoid descriptive or correlative studies• Link to clinical cardiovascular or thoracic

diseases and problems• Multidisciplinary collaborators• Focused specific aims• Ample preliminary data• Relevant and current methodology• Mechanistic studies preferred• Generate novel model systems


“Fundable Science”What Are the Criteria?

• Career Development Awards (K series, TSFRE, AHA, VA merit, etc.)– Environment, scientific mentor, applicant,

research proposal– Basically it always comes down to the quality of

the science• Independent awards (R series, DOD)

– Publications (number and quality)– Novel ideas– Some measure of seniority/committment

5


“Fundable Science”Who is the Competition?

• Almost exclusively PhDs, but some “hard-core” MD or MD/PhD scientists

• They are on your study sections• Have no little to no clinical responsibilities• Surgeons can’t learn these molecular or

genomic techniques – the “We are MDs, not PhDs” argument

• Remember: Academically, we almost always beat these guys soundly from elementary school on. They are not smarter than you.


You will need to write grants.

Most of those grants will not be funded, but……

It’s like qualifying for the Boston MarathonPersistence ultimately pays……


“Basic Research” in Thoracic SurgeryConclusions

• CT surgery needs basic researchers now more than ever

• Funding opportunities are ripe for well trained, committed, hypothesis-driven thoracic surgeon-scientists

• Rewards are real• Leaders in Thoracic Surgery will continue to

include thoracic surgeon-scientists• Nothing easy is worth doing …….

Page

Funding OpportunitiesFunding Opportunities““StarterStarter”” GrantsGrants

Division of Cardiothoracic Surgery &Division of Cardiothoracic Surgery &Center for Diseases of the Thoracic AortaCenter for Diseases of the Thoracic AortaWashington University School of MedicineWashington University School of Medicine

St. Louis, MissouriSt. Louis, Missouri

Marc R. Moon, M.D.Marc R. Moon, M.D.Joseph C. Bancroft Professor of SurgeryJoseph C. Bancroft Professor of Surgery

AATS Grant Writing Workshop, March 2011AATS Grant Writing Workshop, March 2011

““StarterStarter”” Grants Grants How to be successfulHow to be successful

• Typical sequence: – Submit two grants– Get discouraged– Revert to a clinical career

• Research career requires persistence / progress• The best way to learn to write a grant:

– Read old grants – successful and unsuccessful– Review old “pink sheets”– Find a mentor (someone who does research)

““StarterStarter”” GrantsGrantsHow to be successfulHow to be successful

• NIH: New investigators get a scoring benefit• New investigator ≠ Novice investigator• How do we prove that we are not novice investigators?

– Previous research experience– Preliminary data– Publications in peer-reviewed journals as primary author

(case reports and book chapters are useless)• New investigator MUST demonstrate his capability to

perform the proposed research independently• Independent investigator ≠ working alone

““StarterStarter”” GrantsGrantsImpact of CollaborationImpact of Collaboration

• Co-investigators are essential to your cause• “All ‘Basic Science’ today is multidisciplinary.” (D. Jones)

– Go to other department research conferences– Meet other scientists– Talk about your project– Ask others about their projects– Collaborate – develop ideas together

• Find experts in fields in which you are not an expert• With co-investigators, your proposal can use the term “we” to

demonstrate expertise– Co-investigator data becomes preliminary data for your grant

Page

““StarterStarter”” GrantsGrantsImpact of CollaborationImpact of Collaboration

Co-investigator, Dr. X, has extensive experience with the BARK knockout mouse model. Her molecular biology laboratory has a distinguished record of funding and publication in high-level scientific journals. Her addition as a collaborator in this project is a positive.

Co-investigator, Dr. X, has an international reputation in lung transplant for pulmonary hypertension. It is highly likely that he would provide some of the senior leadership necessary for Dr. Y to complete this research.

• Impact of co-investigators– To a new investigator:

– To an experienced investigator adding a new dimension to his research:

““StarterStarter”” GrantsGrantsPotential BenefitsPotential Benefits

• Potential benefits of Starter grants:– To get salary support– To get financial support (supplies, animals, tech)– To generate preliminary data– To develop the skills (and appearance) of an

independent investigator– Peer validation of your work

““StarterStarter”” GrantsGrantsAvailable Options Available Options

• Post-Doc Research Scholarships– NRSA (NIH), TSFRE fellowship, others (ACS/ASA/AHA)

• Intramural Grants– Hospital / University funds– Department funds

• Foundation / Society Grants– AATS, TSFRE, others (ACS / ASA)

• K08, K23 – Mentored NIH grant

““StarterStarter”” GrantsGrantsPostdoctoral Research ScholarshipPostdoctoral Research Scholarship

• Post-Doc Research Scholarships– NRSA (NIH), TSFRE fellowship, others (ACS/ASA/AHA)– Research proposals are generally a subset of mentor’s work– Preliminary data not essential (but always helpful)– Track record of mentor is important– T32 training grant position – no peer validation

salary support YESfinancial support for lab NOpreliminary data YESindependent investigator NOpeer validation YES

Page

““StarterStarter”” GrantsGrantsIntramural GrantsIntramural Grants

• Intramural Grants– Hospital / University / Department funds– Demonstrates commitment from your institution– Provides funds to develop preliminary data (2-3 yrs)– Essential for developing a successful research career– Ideally 1-2 papers as primary author

salary support NOfinancial support for lab YESpreliminary data YESindependent investigator YESpeer validation NO

““StarterStarter”” GrantsGrantsFoundation / Society GrantsFoundation / Society Grants

• Foundation / Society Grants– TSFRE, AATS others (ACS / ASA)– Research proposal describes new ideas– Previous research experience is very helpful– Preliminary data / publications are very helpful

salary supportYES/NO

financial support for labYES/NO

preliminary data YESindependent investigator YESpeer validation YES

““StarterStarter”” GrantsGrantsK08, K23K08, K23

• K08 – Mentored Clinical Scientist Research Grant– 3-5 years of support (75% effort)– Research proposal describes new ideas– NIH funded mentor is essential– Previous research experience / data are helpful

salary support YESfinancial support for lab YESpreliminary data YESindependent investigator YESpeer validation YES

““StarterStarter”” GrantsGrantsImpact of a MentorImpact of a Mentor

• Starter grants invariably require a Mentor• Find the right Scientific Mentor

– Rarely your division chief– Track record of NIH funding (associate/full professor)– Look outside your department – biochemistry, molecular

biology, immunology, cardiology, genetics– How is he/she going to help you become an independent

investigator? (not just a cog in their research wheel!)– Letter of recommendation is very important

Page

• Letter of recommendation from the Mentor– Mentors track record of research / previous mentees– How is he/she going to help you become an independent

investigator?– Comprehensive training plan – timeline is a plus– Describe previous lab experience of applicant and/or initial,

preliminary work that demonstrates PI competence – Letter should describe how your research will differ from

mentor (demonstrate innovation)

““StarterStarter”” GrantsGrantsImpact of a MentorImpact of a Mentor

• Starter grants invariably require the right Department / Chief– Chief needs to be dedicated to supporting research– Department with a track record of research is helpful (we

do not want to waste funds) – “Culture of Research”– Chief must be willing to support research endeavors

financially – tech support, animals, supplies for 2-3 years– Chief must realize important of preliminary data that HE

HAS TO FUND

““StarterStarter”” GrantsGrantsImpact of the ChiefImpact of the Chief

• Letter of recommendation from the Chief– How is he/she going to support you so that you can become

an independent investigator (financially)– Must supply funds for all research needs (cannot be

dependent on the starter grant) – dedication to research– Protected time is absolutely essential (≥40% is ideal)– We do not care about your clinical experience– We do not care about your clinical workload (except to

demonstrate that it is not going to interfere with your research)

““StarterStarter”” GrantsGrantsImpact of the ChiefImpact of the Chief


The PI has received outstanding basic research training in the molecular biology laboratory at University X with Dr. X. The PI is currently Assistant Professor at University Y, and while he appears well-poised to proceed with the experiments proposed, some preliminary data from his current institution demonstrating feasibility would be helpful.

• Progression to independent investigator:– Learn research skills as a postdoc performing mentor’s studies– Develop ability as an independent investigator using a

mentored starter grant to perform your own studies• Previous experience and preliminary data are both important:

Page

The PI received the Michael DeBakey Research Award from the American Association for Thoracic Surgery in 2008. He used this funding to develop the novel model of Disease X described in this grant andpublished two manuscripts describing his unique methodology.

As a postdoctoral research fellow, the PI received a NIH NRSA and coauthored 15 manuscript in peer-reviewed journals, 8 as primary author. This experience provided the applicant a solid research foundation.

• Impact of “starter” grants to the next level– Applying for a mentored foundation grant (not yet an

independent investigator):

– Applying for R01 funding (demonstrating capability to be an independent investigator):



This is a study that should be performed, but it is unclear how the findings from this study will guide future investigation or promote a career in translational research.

• Starter grants should describe a line of investigation that leads to future studies - No dead-end studies

• PI should be able to build on results to submit NIH grant (R01)

• Clinical studies (with no basic or epidemiologic science) are never funded as extramural starter grants

The clinical rational for pursuing this line of investigation is appropriate, although it is difficult to imagine how this study will stimulate future growth in the research arena for the PI.


• “If at first you don’t succeed, try, try again.”• The odds of getting a grant are low (but the odds are zero if

you give up)• Read the reviews carefully and thoughtfully• Do not take reviews personally• Address EVERY suggested change when you resubmit (even

if to a different agency – the reviewers may still be the same!)

Funding OpportunitiesFunding Opportunities““StarterStarter”” GrantsGrants





Industry Sponsored Research Agreements

Frank Sellke, MDDivision of Cardiothoracic Surgery

Brown Medical SchoolProvidence RI

AATS Grant Course 2011

Industry Sponsored Research Agreements

• Disclosures: • Steering Committee for Novonordisk• DSMB: Cubist Pharmaceutical• CSL Behering: Advisory Board• Chairman, DSMB CT Surgery Network,

National Institutes of Health• National Institutes of Health (RO1 HL46716, RO1 HL

69024) to FWS• Royalties from Elsevier Publishing

Why do Research for Industry? Why do Research for Industry?

Why do Research for Industry?

• Money is money, regardless of from where it comes • NIH funding and $ from other sources is decreasing• Industry often is aware of what is important clinically

and in the market place. A direct link to patients.• There is often a lot of funding available if you have

something to offer, especially if you have a niche.• The funded research often ties in with your clinical

activity and interests.• You can generally keep the left over money.• You get to travel to very interesting places and speak

with interesting and famous people.

Industry Sponsored Research

• A company wants to contract with you to do work.• The company knows what they want to demonstrate.• It is probably in an area in which you have an interest or

some niche ability.• Don’t be afraid to ask for enough money to cover all costs,

and then some.• When you negotiate, consider IDC to institution.• Generally do not ask for salary support, especially in

clinically related research.

Office of Technology Development: ISRA

• Safeguards researchers’ ability to publish the results of their research in accordance with academic custom

• Is limited in duration and tied to a specific research plan that is generated by the principal investigator and approved by OTD staff

• Negotiates who owns the results of the sponsored research and all associated intellectual property (IP), e.g., patents, copyrights and know-how

Office of Technology Development: ISRA

• Generally grants the company a time-limited option to negotiate licenses to the sponsored IP on usual and customary terms (i.e., in exchange for fair market value and with appropriate commercial diligence, including as regards global access to medical technologies) – no perpetual rights, ‘sweetheart’ deals or ability to suppress technology

• Offers no guaranteed results or other ‘deliverables’ – the research and any resulting IP are provided to the company on an ‘as is’ basis.

• Reserves the rights of researchers at the institution and elsewhere to use any sponsored IP for educational and not-for-profit research use.

Why Avoid Doing Research for Industry?

Why Not do Research for Industry?

• The money is considered tainted.• It distracts from NIH funded and real basic science or

clinical investigation.• There is a temptation for you to give the Company

what they want, or you are perceived as such.• Promotion committees consider it less than NIH grants

How to get started

• Develop a technique or expertise in a certain area: Aortic surgery, Myocardial protection, Bleeding and transfusion therapy, Mitral valve repair, etc.

• Publish and give presentations at National Meetings.

• Speak up at National Meetings.• Speak with companies: Ask if they would sponsor

your research.• If you are good, They will come.

Caution• If you get paid for the research, often you

cannot publish it.• Consult your University or Hospital Guidelines• Need to disclose relationships• Keep things in perspective• Make sure there is no limitation or restrictions

on publication or presentation of results• Don’t let industry control your academic

career• Don’t bias the results or give limited results to

support what the Company wants to hear.

Questions?

Extramural Program and Extramural Program and Funding Opportunities: NCIFunding Opportunities: NCI

David H. Harpole, Jr., M.D.Professor of Surgery

Vice Chief of Surgical SciencesDepartment of Surgery

Duke University Medical Center

NIH Funding by Adjusted LifeNIH Funding by Adjusted Life--yearsyears

Gross et al. NEJM 340 (24): 1881, 1999

Cancer Mortality: U.S. 1930Cancer Mortality: U.S. 1930--19961996

ACS Cancer Facts & Figures, 2000.ACS Cancer Facts & Figures, 2000.

NIH Funding by Disease Mortality RateNIH Funding by Disease Mortality Rate

DiseaseDisease Deaths/100,000*Deaths/100,000* NIH funding**NIH funding**HIVHIV--AIDSAIDS 4.04.0 $2,900,000,000$2,900,000,000

ColoColo--Rectal CancerRectal Cancer 19.619.6 $295,000,000$295,000,000

Breast Cancer (female)Breast Cancer (female) 25.525.5 $693,000,000$693,000,000

Prostate CancerProstate Cancer 28.128.1 $379,000,000$379,000,000

Lung CancerLung Cancer 54.954.9 $296,000,000$296,000,000

* 2007 CDC, United States (Table 1.1.1.2MF); ** 2008 NIH

Extramural Program Responsibilities: Extramural Program Responsibilities: Similar to other InstitutesSimilar to other Institutes

Scientific Program Management and Administration

Manage grant portfolioMonitor scientific progressAnalyze and evaluate grant and contract programs

Program Leadership and DevelopmentNew Initiatives

Advice and Guidance to Prospective Applicants

Respond to public, patients, and CongressRespond to scientific/professional communities

Research supported by NCIResearch supported by NCI

Basic Science StudiesTranslational Science StudiesClinical Investigations and Clinical TrialsPopulation-based studiesDemonstration and Education Projects

Unique Aspects of NCIUnique Aspects of NCIThe Good…

Largest Institute (Budget $6B+)$2.1B Supplement in Stimulus PackageNote: $6B more in 2011 Budget by Obama 3/1/10

Note: Not approved by Democrats, certainly not by Republicans

Only Institute with Political Appointment (Forces change)

50+ year history of significant Clinical Trials SupportCALGB, SWOG, ECOG,, RTOG, NCCTG, ACOSOG,COG, GOG, NCI-C, EORTC (more on this later…)Developed Secondary endpoints:, Quality of Life, Costs

Cooperative Cancer GroupsCooperative Cancer Groups

IOM report recommended streamlining process to improve efficiency and accrual9 current adult groups will be 3 (maybe 4)

Applications due 6/2012, funding 1/2013ACOSOG/CALGB/NCCTG merged

Leadership opportunities for GTSOther groups are “dating”

Unique Aspects of NCIUnique Aspects of NCI

The Bad…The vast majority of $ earmarked for administrative grants

Cancer Center, Cooperative groups, PO1, SPORE, EDRN, etc.An opportunity exists as this is evolving from single to multiple institution, multiple PI format

Historically lowest pay-line (Now 8-9th percentile)e.g., CBSS 180 R21, 5 funded 2011, RO1 at 10%

No modality-specific study sectionsException: Radiation Biology and Imaging

TS projects are mixed in with all scientists for review6 RO1 funded GTS by NCI2 GTS on NCI-CSR study sections

Unique Aspects of NCIUnique Aspects of NCIIntra-and Extramural Programs Re-organized Based on Disease Steering Committees

Thoracic Malignacy Steering CommitteeGI Tumor Steering CommitteeMembership: Modality Co-chairs

Scientists (SPORE, PO1)Clinical Investigators (Cooperative Group Disease Chairs)Community Oncology membersAdvocatesNCI Intramural scientists

Missions:Streamlining Approval of all Phase II and III Clinical Trials

Oversee accrual and DSMB’sDesigning “State of the Science” Meeting to define future research funding objectivesFacilitate Interactions across disciplines

NCI Funding OpportunitiesNCI Funding OpportunitiesWebsites: http://grants.nih.gov

http://cancer.gov

Major grant typesResearch

Single projectMulti-project

Clinical Trial SupportTraining and Career DevelopmentSmall Business

Request for Applications (RFA)Request for Applications (RFA)

Specific theme for grants, often from recommendations SOS meetings

Sent to question-specific study sectionRFA’s Located on NIH websiteMonies are be appropriated

Many R21’s are from theseBut...limited number to be fundedOften “pre-determined”

Program Announcements (Program Announcements (PAPA’’ss))Invites grant applications in a specific research areaNew or expanded interest in an area, or a reminder of an ongoing interestUsually No money!Reviewers note that a grant is responsive to a particular PA

Research ApplicationsResearch Applications

R01: Standard Research Grant for “investigator initiated research”

Single project 2-4 years5th year now by special approval

New and established investigatorsCan have Multiple PI’s

Each PI has defined role and grant creditA real advantage to synergy

Traditional “benchtop” basic scientistTranslational / clinical scientist

Research ApplicationsResearch ApplicationsR21: Exploratory/Developmental Grant

Early and conceptual stages of development2 years of funding capped at $275KGreat initial grant: requires no preliminary dataMust have statistical input

R33 validation (3 years) capped at $500K/year

P01: program project grant (and SPORE)ThematicMulti-project (requires R01 funded leaders)

Training and Career DevelopmentTraining and Career Development

All Levels of Education and ExperienceSpecials Programs for under-represented populations and researchers with disabilitiesBasic science and clinical research

Career Development Awards (Career Development Awards (KK’’ss))

K08: Mentored Clinical ScientistHealth Professional Doctoral DegreeNot necessarily clinical research

K23: Mentored Patient-Oriented ResearchAnalogous to K08Develop skills for patient-oriented researchK12 is Center-based K08 or K23

K24: Mid-career Investigator Award in Patient-Oriented Research K99: Pathway to independence (R00)

Transitions to RO1 in latter years

Note: NCI requires 75% protected non-clinical time!!!

CSR CSR –– NCI Study Sections:NCI Study Sections:Oncology 1 Basic Translational (OBT IRG)Oncology 1 Basic Translational (OBT IRG)

Cancer initiation, promotion, progression, metastasis

• Cancer Molecular Pathobiology Study Section [CAMP]• Cancer Etiology Study Section [CE]• Cancer Genetics Study Section [CG]• Molecular Oncogenesis Study Section [MONC]• Tumor Cell Biology Study Section [TCB]• Tumor Microenvironment Study Section [TME]• Tumor Progression and Metastasis Study Section [TPM]

CSR CSR –– NCI Study Sections:NCI Study Sections:Oncology 1: Clinical Oncology (CO IRG)Oncology 1: Clinical Oncology (CO IRG)

Clinical patient-oriented research /clinical trialsPharmacologic and toxicologic studies Non-behavioral alternative cancer therapiesResearch on the treatment of cancer therapy-related Age-specific issues: tumor behavior with aging, clinical / laboratory assessment of the older patient

• Basic Mechanisms of Cancer Therapeutics Study Section [BMCT]• Cancer Biomarkers Study Section [CBSS]• Chemo/Dietary Prevention Study Section [CDP]• Cancer Immunopathology and Immunotherapy Study Section [CII]• Clinical Oncology Study Section [CONC]• Drug Discovery and Molecular Pharmacology Study Section [DMP]• Developmental Therapeutics Study Section [DT]• Radiation Therapeutics and Biology Study Section [RTB]

Application Process (EApplication Process (E--forms)forms)Electronic forms are on the NIH web site

NIH Form 398 standard for most applicationswww.grants.nih.gov/grants/funding/phs398/phs398.html

Prepare biosketch and other support NOW!Each grant mechanism has a different submission deadlineR01/R21 submission

Application due February 1 for December 1 startApplication due June 1 for April 1 startApplication due October 1 for July 1 start

NCI Grant Contact InformationNCI Grant Contact Information

Funded Investigators and Surgical MentorsInstitution Grants and Contracts officeProgram staff at NIH

Each Institute has a web site with key personnel listedContact specific study section staff for questions

The NIH Guide to Grants and Contractswww.grants.nih.gov/grants/guideLists special programs for which grants are being sought

The Institutes at the NIH: NHLBIKeith A. Horvath, MDKeith A. Horvath, MDDirector, Cardiothoracic Surgery Research Program, Director, Cardiothoracic Surgery Research Program, NHLBI, NIHNHLBI, NIHChief, Cardiothoracic Surgery, NIH Heart Center @ Chief, Cardiothoracic Surgery, NIH Heart Center @ Suburban Hospital, Bethesda, MDSuburban Hospital, Bethesda, MD

NHLBINHLBI

“ T H A T ’ S I T ? T H A T ’ S P E E R R E V I E W ? ”“ T H A T ’ S I T ? T H A T ’ S P E E R R E V I E W ? ”

Study Study SectionSectionYouYou

History of the NHLBIHistory of the NHLBI

•• 1948 1948 -- Truman signs the National Health Act, Truman signs the National Health Act, creating the NHIcreating the NHI

•• 1949 1949 -- NHI Intramural Research Program NHI Intramural Research Program •• 1969 1969 -- Redesignated the NHLIRedesignated the NHLI•• 1976 1976 -- ““BloodBlood”” addedadded

Historical NHLBI TrialsHistorical NHLBI Trials

•• 1950 1950 -- Combine with AHA to sponsor conferenceCombine with AHA to sponsor conference•• 1972 1972 -- NatNat’’l High BP Education Programl High BP Education Program•• 1981 1981 -- BetaBeta--Blocker Heart Attack TrialBlocker Heart Attack Trial•• 1983 1983 -- Coronary Artery Surgery StudyCoronary Artery Surgery Study•• 1984 1984 -- Lipid Research Prevention TrialLipid Research Prevention Trial•• 1985 1985 -- Thrombolysis in MI TrialThrombolysis in MI Trial•• 1990 1990 -- Human Gene TherapyHuman Gene Therapy•• 1991 1991 -- Studies of LV Dysfunction TrialStudies of LV Dysfunction Trial•• 1995 1995 -- Bypass Angioplasty Revasc InitiativeBypass Angioplasty Revasc Initiative

Historical NHLBI TrialsHistorical NHLBI Trials•• 1999 1999 -- ARDS Network StudyARDS Network Study•• 1999 1999 -- Early Revascularization for Early Revascularization for

Cardiogenic ShockCardiogenic Shock•• 2001 2001 -- NatNat’’l Emphysema Treatment Triall Emphysema Treatment Trial•• 2001 2001 -- REMATCH TrialREMATCH Trial•• 2004 2004 -- Sudden Cardiac Death in HF TrialSudden Cardiac Death in HF Trial•• 2006 2006 -- SHOCK TrialSHOCK Trial•• 2007 2007 -- Occluded Artery Trial (OAT)Occluded Artery Trial (OAT)•• 2008 2008 -- Cardiothoracic Surgery Research NetworkCardiothoracic Surgery Research Network

NHLBI Clinical TrialsNHLBI Clinical Trials

•• EASTEAST•• Infant Heart Surgery: Neuro/HCA Infant Heart Surgery: Neuro/HCA •• CABG Patch TrialCABG Patch Trial•• SHOCK TrialSHOCK Trial•• Influence of CPB Temperature on CABG TrialInfluence of CPB Temperature on CABG Trial•• REMATCH TrialREMATCH Trial•• Tx of Post CABG Depression StudyTx of Post CABG Depression Study•• NETTNETT

Surgical Trials1994-2009

NHLBI Clinical TrialsNHLBI Clinical Trials

•• BARI 2DBARI 2D $ 59 M$ 59 M•• Surgical Treatment for Ischemic HF Surgical Treatment for Ischemic HF $ 37 M$ 37 M•• FREEDOMFREEDOM $ 18 M$ 18 M•• CT Surgery Research NetworkCT Surgery Research Network $ 18 $ 18 MM

•• Moderate Ischemic Mitral RegurgitationModerate Ischemic Mitral Regurgitation•• Severe Ischemic Mitral RegurgitationSevere Ischemic Mitral Regurgitation•• Surgical Ablation for the Treatment of AFSurgical Ablation for the Treatment of AF•• Post Cardiac Surgery Infection RegistryPost Cardiac Surgery Infection Registry

Surgical Trialsactive

Office of the DirectorOffice of the Director

Division of Prevention & Population Sciences (DPPS)Division of Prevention & Population Sciences (DPPS)

Michael Laurer, DirectorDiane Bild, Deputy Director

Epidemiology BranchEpidemiology Branch

Clinical Applications & Prevention BranchClinical Applications & Prevention Branch

Paul Sorlie, Branch Chief

Lawrence Fine, Branch Chief

Nancy Geller, DirectorOffice of Biostatistics ResearchOffice of Biostatistics Research

WomenWomen’’s Health Initiative Branchs Health Initiative BranchJacques Rossouw, Director

Office of the DirectorOffice of the DirectorDivision of Cardiovascular Diseases (DCVD)Division of Cardiovascular Diseases (DCVD)

Sonia Skarlatos, Acting Director

Advanced Technologies & Surgery BranchAdvanced Technologies & Surgery Branch

Vascular Biology & Hypertension BranchVascular Biology & Hypertension Branch

Heart Failure & Arrhythmias BranchHeart Failure & Arrhythmias Branch

Atherothrombosis & Coronary Artery Disease BranchAtherothrombosis & Coronary Artery Disease Branch

Heart Developmental & Structural Diseases BranchHeart Developmental & Structural Diseases Branch

Dennis Buxton, Branch ChiefMarissa Miller, Deputy Branch Chief

Michael Domanski, Branch ChiefAhmed Hasan, Acting Deputy Branch Chief

Gail Pearson, Branch ChiefCharlene Schramm, Deputy Branch Chief

Alice Mascette, Branch ChiefDavid Lathrop, Deputy Branch Chief

Eser Tolunay, Acting Branch Chief


Division of Blood Diseases and Resources (DBDR)Division of Blood Diseases and Resources (DBDR)

W. Keith Hoots, DirectorGeorge Nemo, Acting Deputy Director

Blood Diseases BranchBlood Diseases Branch

Transfusion Medicine and Cellular Therapeutics BranchTransfusion Medicine and Cellular Therapeutics Branch

Harvey Luksenburg, Chief

Simone Glynn, Chief

Rebecca Link, Acting ChiefThrombosis and Hemostasis BranchThrombosis and Hemostasis Branch


Division of Lung Diseases (DLD)Division of Lung Diseases (DLD)

James Kiley, DirectorGail Weinmann, Deputy Director

Airway Biology and Disease BranchAirway Biology and Disease Branch

National Center on Sleep Disorders ResearchNational Center on Sleep Disorders Research

Thomas Croxton, Chief

Michael Twery, Director

Dorothy Gail, ChiefLung Biology and Disease BranchLung Biology and Disease Branch


Division for the Application of Research Discoveries (DARD)Division for the Application of Research Discoveries (DARD)

Rob Fulwood, Acting Director

Enhanced Dissemination and Utilization BranchEnhanced Dissemination and Utilization Branch

Research Translation BranchResearch Translation Branch

Karen Donato, Acting Chief

Rob Fulwood, Acting Chief

Diane Striar, Acting ChiefHealth Communications and Social Marketing BranchHealth Communications and Social Marketing Branch

Office of the DirectorOffice of the DirectorDivision of Extramural Research ActivitiesDivision of Extramural Research Activities

Stephen Mockrin, Director

Office of AcquisitionsOffice of Acquisitions

Office of Strategic and Innovative ProgramsOffice of Strategic and Innovative Programs

Office of Grants ManagementOffice of Grants Management

Office of Committee ManagementOffice of Committee Management

Office of Extramural Policy and ReviewOffice of Extramural Policy and Review

John Taylor, Director

Kathyrn Valeda, Director

Paul Velletri, Director

Suzanne White, Director

Robert Musson, Director

NHLBI Intramural ResearchNHLBI Intramural Research

–– Translational Medicine BranchTranslational Medicine Branch–– Hematology BranchHematology Branch–– Pulmonary and Vascular Medicine BranchPulmonary and Vascular Medicine Branch–– Cardiothoracic Surgery Research ProgramCardiothoracic Surgery Research Program

•• LaboratoriesLaboratories

••Animal Medicine and SurgeryAnimal Medicine and Surgery

••Biochemistry and BiophysicsBiochemistry and Biophysics

••Cell Biology and Physiology Cell Biology and Physiology

••Genetics and Development Genetics and Development

••ImmunologyImmunology

University of Pennsylvania

Philadelphia, PA

NHLBI Obligations by Funding Mechanism: FY 2009NHLBI Obligations by Funding Mechanism: FY 2009

Funding MechanismObligated Dollars*

(Thousands)Percent of Total NHLBI Budget

Research Project Grants† $2,039,861 67.5%

SCORs/SCCORs 73,331 2.4

Sickle Cell Centers 13,567 0.5

Centers for AIDS Research 3,254 0.1

Other Research Grants 131,001 4.3

Research Careers Programs‡ 84,647 2.8

Training Programs 96,578 3.2

Research and Development Contracts 361,098 12.0

Intramural Research 181,734 6.1

Research Management and Support§ 114,128 3.8

Total Obligations $3,014,552 100%

* Excludes funds provided by other agencies by means of a reimbursable agreement.† Includes $76,341 for Small Business Innovation Research (SBIR) Grants/Small Business Technology

Transfer Grants (STTR).‡ Research Career Programs are a subset of Other Research Grants and are not added as a distinct funding

mechanism.§ Excludes OD and DIR research contracts, which are included in R&D contracts.

NHLBI Total Obligations by Budget Category: NHLBI Total Obligations by Budget Category: Fiscal Years 1999Fiscal Years 1999--2009 2009 Current DollarsCurrent Dollars

NHLBI Competing Research Project Grant NHLBI Competing Research Project Grant Applications*: Fiscal Years 1999Applications*: Fiscal Years 1999--20092009

* Includes R01, R03, U01, P01, R15, R21, R29, and R37; R33 beginning in 2001; DP2 and U19 beginning in ’07; and DP1 and R00 beginning in ’08.

Percent of Reviewed Applications FundedPercent of Reviewed Applications Funded

22%22%

ResourcesResources

•• Web HomeWeb Homewww.nhlbi.nih.govwww.nhlbi.nih.gov

•• Fact Book Fact Book www.nhlbi.nih.gov/about/factpdf.htmwww.nhlbi.nih.gov/about/factpdf.htm

11

NIH SBIR & STTR ProgramsFeatures and Nuances

22

NIH SBIR/STTR MISSION

Though investment in scientific and technological innovation the

SBIR/STTR programs develop products, processes and services

that improve the health of the American people and build a

strong U.S. economyOne small business at a time.

33

Office of the Director

National Center on Minority Health

and Health Disparities

Organizational Structure of NIH

National Instituteon Alcohol Abuseand Alcoholism

National Instituteof Arthritis andMusculoskeletal

and Skin Diseases

National CancerInstitute

National Instituteon Aging

National Instituteof Child Health

and HumanDevelopment

National Instituteof Allergy and

Infectious Diseases

National Instituteof Diabetes andDigestive and

Kidney Diseases

National Instituteof Dental andCraniofacial

Research

National Instituteon Drug Abuse

National Instituteof EnvironmentalHealth Sciences

National Institute onDeafness and Other

CommunicationDisorders

National EyeInstitute

National HumanGenome Research

Institute

National Heart,Lung, and Blood

Institute

National Instituteof Mental Health

National Instituteof NeurologicalDisorders and

Stroke

National Instituteof General

Medical Sciences

National Instituteof Nursing Research

National Libraryof Medicine

National Centerfor Complementary

and AlternativeMedicine

FogartyInternational

Center

National Centerfor ResearchResources

National Instituteof Biomedical

Imaging and

Bioengineering

No funding authority

44

1. Stimulate technological innovation

2. Use small business to meet federal R&D needs

3. Foster and encourage participation by minorities and disadvantaged persons in technological innovation

4. Increase private-sector commercialization innovations derived from federal R&D

Four Major Congressional Goals

55

• Improve human health throughprevention, detection, diagnosisand treatment of disease ordisability

• Speed process of discovery• Reduce cost of medical care• Improve research tools/ reduce

cost of research• Increase health knowledge base

SBIR/STTR Programs Are Fully Integrated With the NIH Research Mission

Bridging the Discovery to Development Gap

NIH SBIR/STTR Program Specifics 66

NIH INSTITUTE/CENTER SBIR/STTR NIH INSTITUTE/CENTER SBIR/STTR BUDGET ALLOCATIONS (FY2010)BUDGET ALLOCATIONS (FY2010)

Extramural R&D Set-Asides:SBIR = 2.5%STTR = 0.3%

NIDDKNIGMS

FY 2010 SBIR/STTR Budget Allocations to NIH ICs:

$616 M (SBIR)$ 74 M (STTR)

Total: $690 M

77

Small Business Innovation Research (SBIR)Set-aside program for small businessconcerns to engage in federal R&D --with potential for commercialization.

Small Business Technology Transfer (STTR)Set-aside program to facilitate cooperative R&D between small business concerns and U.S. research institutions –with potential for commercialization.

Program Descriptions

2.5%

0.3%

88

SBIR/STTR: 3-Phase Program

PHASE I – Feasibility Study• $150K and 6 months (SBIR) • $100K and 12 months (STTR)

PHASE II – Full Research/R&D• $1 million and 2-year Award – (SBIR)• $750K and 2-year Award - (STTR)

PHASE III• Commercialization Stage• Use of non-SBIR/STTR Funds

FAST TRACK – Combines Phase I and II Applications• Shortens funding cycle between Phase I and II

99

Organized for- profit U.S. business 500 employees or fewer, including affiliatesPI’s primary employment must be with the small business concern at the time of award and for the duration of the project period.

SBIR PROGRAMELIGIBILITY CHECKPOINTS

1010

Small business concern must be:At least 51% U.S.- owned by individuals and independently operated

orAt least 51% owned and controlled by another (one) for-profit business concern that is at least 51% owned and controlled by one or more individuals

SBIR PROGRAMELIGIBILITY CHECKPOINTS

1111

Formal Cooperative R&D Effort• Minimum 40% by small business• Minimum 30% by U.S. research institution

U.S. Research Institution• College or University; other non-profit research

organization; Federal R&D center Intellectual Property Agreement

•Allocation of Rights in IP and Rights to Carry outFollow-on R&D and Commercialization

STTR PROGRAMELIGIBILITY CHECKPOINTS

1212

PERFORMANCE of RESEARCH ACTIVITIES

“All research/R&D must be performed in its entirety in the U.S.”

• Rare cases to conduct testing of specificpatient populations outside U.S. is allowable

• Travel to scientific meeting in foreigncountry allowable

• Foreign consultants/collaborators allowable,but must perform consulting in U.S.

1313

SBIR-STTR Comparisons

RequirementsRequirements SBIR (Grants & Contracts)SBIR (Grants & Contracts) STTR (Grants only)STTR (Grants only)

PurposePurpose To support highTo support high--risk feasibility projectsrisk feasibility projects To support highTo support high--risk feasibility projects with risk feasibility projects with research institution partnershipresearch institution partnership

ApplicantApplicant Small Business (SB)Small Business (SB) Small Business (SB)Small Business (SB)

Award PeriodAward Period Phase I Phase I –– 6 months, normally6 months, normallyPhase II Phase II –– 2 years, normally2 years, normally

Phase I Phase I –– year, normallyyear, normallyPhase II Phase II –– 2 years, normally2 years, normally

Total CostsTotal Costs Phase I Phase I -- $150K, normally$150K, normallyPhase II Phase II -- $1,000 mil.$1,000 mil.

Phase I $100K, normallyPhase I $100K, normallyPhase II $750K, normallyPhase II $750K, normally

PIPI Employed by company more than 50% of time Employed by company more than 50% of time during award.during award.* * Minimum level of effort on the Minimum level of effort on the project not stipulated.project not stipulated.

Employment not stipulated.Employment not stipulated.PI must spend a minimum of 10% effort on PI must spend a minimum of 10% effort on the project the project

Subcontracts/Subcontracts/ConsultantsConsultants

Phase I Phase I –– Total amount normally may not Total amount normally may not exceed 33% of total costexceed 33% of total cost**Phase II Phase II –– Total amount normally may not Total amount normally may not exceed 50% of total costexceed 50% of total cost**

Phase I and II SB must perform minimum Phase I and II SB must perform minimum 40% of work and the single, partnering U.S. 40% of work and the single, partnering U.S. nonnon--profit research institution must perform profit research institution must perform at least 30% of the work. at least 30% of the work. No deviations No deviations allowedallowed.. There must be an IP agreement There must be an IP agreement established at time of award.established at time of award.

Performance SitePerformance Site Must be entirely in U.SMust be entirely in U.S..**Part of research must take place in companyPart of research must take place in company--controlled space.controlled space.

Must be entirely in U.S.Must be entirely in U.S.** Part of research Part of research must take place in companymust take place in company--controlled space controlled space and part in the partnering U.S. research and part in the partnering U.S. research institution.institution.

** = Deviations permitted = Deviations permitted with written justification with written justification and approvaland approval from from programprogram

1414

OUR IDEAS

1. SBIR/STTR Omnibus Solicitation (NIH, CDC, and FDA) Release: January

Topics listed reflect a range of areas of interest & are not intended to be exhaustive

2. SBIR Contract Solicitation (NIH, CDC)Release: August Early November receipt date

3. NIH Guide for Grants and ContractsRelease: Weekly Various receipt dates

4. NIH Institute Websites – see their workshop and working group meeting reports

1515

SBIR/STTR Omnibus Solicitation

• SBIR Parent Funding Opportunity Announcement(PA-10-050) http://grants.nih.gov/grants/guide/pa-files/PA-10-050.html

• STTR Parent Funding Opportunity Announcement(PA-10-051) http://grants.nih.gov/grants/guide/pa-files/PA-10-051.html

• SBIR/STTR Program Descriptions and Research Topics

http://grants.nih.gov/grants/funding/sbir.htm

Submission Dates:

April 5, Aug 5, Dec 5

AIDS/AIDS-Related Dates:May 7, Sept.7,Jan 7

1616

NIH Guide for Grants and Contracts

Targeted Funding Opportunities:http://grants.nih.gov/grants/funding/sbir_announcements.htm

New Approaches to Arrhythmia Detection and Treatment• SBIR - http://grants.nih.gov/grants/guide/pa-files/PA-10-117.html• STTR: http://grants.nih.gov/grants/guide/pa-files/PA-10-118.html

Directed Stem Cell Differentiation for Cell-Based Therapies for Heart, Lung, and Blood Diseases

• SBIR - http://grants.nih.gov/grants/guide/pa-files/PA-09-249.html• STTR - http://grants.nih.gov/grants/guide/pa-files/PA-09-250.html

Innovations in Biomedical Computational Science and Technology Initiative• SBIR - http://grants.nih.gov/grants/guide/pa-files/PAR-09-220.html• STTR - http://grants.nih.gov/grants/guide/pa-files/PAR-09-221.html

1717


Robotics Technology Development and Deployment (R43)• http://grants.nih.gov/grants/guide/pa-files/PAR-10-279.html• Receipt Date: December 20, 2010

Bioengineering Nanotechnology Initiative• SBIR - http://grants.nih.gov/grants/guide/pa-files/PA-10-150.html• STTR - http://grants.nih.gov/grants/guide/pa-files/PA-10-149.html

New Technologies for Transient Molecular Complex Characterization• SBIR - http://grants.nih.gov/grants/guide/pa-files/PA-08-110.html• STTR - http://grants.nih.gov/grants/guide/pa-files/PA-08-111.html

SHIFT Award: Small Businesses Helping Investigators to Fuel the Translation of Scientific Discoveries (R43/R44)

• http://grants.nih.gov/grants/guide/pa-files/PA-10-122.html

1818


Manufacturing Processes of Medical, Dental, and Biological Technologies• SBIR - http://grants.nih.gov/grants/guide/pa-files/PA-09-113.html• STTR - http://grants.nih.gov/grants/guide/pa-files/PA-09-114.html

Energy Efficiency and Renewable Energy System Technology Research and Development• SBIR - http://grants.nih.gov/grants/guide/pa-files/PA-09-100.html• STTR - http://grants.nih.gov/grants/guide/pa-files/PA-09-101.html

1919

Annual SBIR Contract SolicitationReceipt Date: November 8, 2010

•SBIR Only

•NIH & CDC – Various ICs

•Narrowly-focused Topics

NHLBI Topics:•Development of Pathogen Inactivation Technologies for Blood Components

•Point-of-Care Assay for Engraftment Potential of Umbilical Cord Stem Cells

•Novel Technologies for Powering Ventricular Assist Devices

•Informatics Tools and Services to Support Data Sharing and Distribution for Cardiovascular, Lung, and Blood Researchers

•Interventional MRI and X-ray Invasive Hemodynamics Telemetry

•Novel Concepts in Safe “Active” Transmission Lines for MRI Catheters

•Strategy for Finding Cases of Moderate-to-Severe COPD

•Reagents for Studying Human Lung Cell Biology and Cellular Function

http://grants.nih.gov/grants/funding/sbir.htm

2020

• Research projects related to the NIH mission

• “Other” areas of research within the mission of an awarding component

Your Ideas …

Investigator-initiated R&D

2121

• DOD SBIR/STTR• HHS SBIR/STTR• NASA SBIR/STTR• DOE SBIR/STTR• NSF SBIR/STTR• DHS SBIR • USDA SBIR• DOC SBIR• ED SBIR• EPA SBIR• DOT SBIRhttp://www.sbir.gov/

SBIR / STTR Participating Agencies

TOTAL ~ TOTAL ~ $2.3 + B$2.3 + B

2222

NUANCESNIH SBIR & STTR Programs

• Multiple Submission Dates

• Revise & Resubmit

• Multiple Funding Opportunities

• Multiple Award Mechanisms

• Investigator-initiated Research

• Communication Throughout Process

2323

NUANCESNIH SBIR & STTR Programs

• Budget & Project Duration Guidelines

• Not Phase III Customer

• Technical & Commercialization Assistance Programs

• ELECTRONIC SUBMISSION OF APPLICATIONS

2424

05

1015202530354045

SBIR STTR

Phase IPhase IIFast-Track

NIH SBIR/STTR Success Rates

Succ

ess

Rat

e (%

)

$672 M SBIR/STTR

654

262

33

54

105

40.6%

23.1%

19.6%

31.1%

14.9%

22%

PRELIMINARY -- Fiscal Year 2009

7

2525

Review Criteria

1. Significance2. Approach3. Innovation4. Investigators 5. Environment

… Protection of Human Subjects… Animal Welfare… Budget

Program staff do NOT participate in peer review process

STUDY SECTIONS DO NOT FUND!2626

• Suggest potential awarding component(s)

•• Request same or different Request same or different study sectionstudy section

•• Suggest key areas of expertise Suggest key areas of expertise requiredrequired

• Indicate individual(s) or organization(s) in conflict

Cover Letter: A Valuable Tool

2727

What Reviewers Say…Common Pitfalls with Applications

• Inadequately defined test of feasibility• Lack of sufficient experimental detail• Questionable reasoning in experimental approach• Failure to consider potential pitfalls and alternatives• Lack of innovation• Unconvincing case for commercial potential or societal

impact• Lack of experience with essential methodologies• Unfamiliar with relevant published work• Unrealistically large amount of work proposed

2828

NHLBI Phase II Competing Renewals

• Goal: Take existing, promising compound or devices developed under a Phase II award through the next step of discovery and development.

• Stipulations:– Available only to NHLBI Phase II awardees– Focus -- Diagnostics, devices, tissue engineering,

drug development, related to NHLBI’s mission– Funding level: $1M per year for maximum of 3 years– Applicant must have had interaction with the FDA

Contact Program Staff Prior to Submission

2929

Technical Assistance Programs

Commercialization Assistance (CAP)(Announced in Aug. Apps. Due mid Sept.)

Business & strategic planning

Builds alliances and investor partnerships

NicheAssessment(Announced in July)

Identify other uses of technology

Determines competitive advantages

Develops market entry strategy

(Phase II awardees)

(Phase I awardees)

3030

NIH SBIR/STTR Home Page Links

NIH SBIR/STTR Home Page: http://grants.nih.gov/grants/funding/sbir.htm

2010 SBIR FOA: http://grants.nih.gov/grants/funding/sbir.htm

2010 STTR FOA: http://grants.nih.gov/grants/guide/pa-files/PA-10-051.html

Other SBIR/STTR Funding Opportunities and Announcements:http://grants.nih.gov/grants/funding/sbir_announcements.htm

Application Guide: http://grants.nih.gov/grants/funding/424/index.htm

Other Important SBIR/STTR News:http://grants.nih.gov/grants/funding/sbirsttr_news.htm#20100204

3131

NIH SBIR/STTR Program Staff

Ms. Kay Etzler 301-435-2713Dr. Lenka Fedorkova 301-435-0921

Office of Extramural ResearchNational Institutes of Health

[email protected]

3232

Stay Informed…

Listserves

NIH Guide for Grants and Contracts (weekly notification)

http://grants.nih.gov/grants/guide/listserv.htm

NIH SBIR/STTR Notification

http://grants.nih.gov/grants/funding/listserv.htm

3333

SBIROK

• SBIR National Conference• Oklahoma City, Nov. 8-10, 2010

For small, high-tech businesses, looking to innovate, research, and create products or services, there is an opportunity to receive federal funds and assistance for your research and potential commercialization. This is the last national conference for 2010. Technology and industry program tracks include: aerospace, biotechnology, energy, information technology and nanotechnology. A poster session is available to present your company's vision.

http://www.sbirok.org/

343434

NHLBI Mission

To conduct and support basic research, clinical investigations and trials, observational studies, demonstration and education projects related to the causes, prevention, diagnosis, and treatment of heart, blood vessel, lung, and blood diseases; and sleep disorders; and to ensure the adequacy and safety of the Nation’s blood supplyThe NHLBI SBIR/STTR program fosters basic, applied, and clinical research on all product and service development related to the mission of the NHLBI

http://www.nhlbi.nih.gov/

35353


Division of Extramural Research Activities

Division for the Application of

Research Discoveries

Division of Cardiovascular

Sciences

http://www.nhlbi.nih.gov/

Division of Intramural Research

Division of Lung Diseases

Division of Blood Diseases and Resources

3636

NHLBI SBIR/STTR Staff Contacts

3

•Division of Blood Diseases and Resources:•Susan Pucie ([email protected])•Phyllis Mitchell ([email protected])

•Division of Cardiovascular Sciences:•Tim Baldwin ([email protected])•Simhan Danthi ([email protected])•Bishow Adhikari ([email protected]) •Pothur Srinivas ([email protected])•Shari Ludlam ([email protected])•Paula Einhorn ([email protected])

•Division of Lung Diseases:•Ann Rothgeb ([email protected])

37373

NHLBI Support for Small Business

– STTR & SBIR Grants:• STTR Phase I (R41)• STTR Phase II (2R42)• STTR Fast Track (1R42)• SBIR Phase I (R43)• SBIR Phase II (2R44)• SBIR Fast Track (1R44)• SBIR Phase II Competing Renewal• Administrative and Competitive Supplements

– SBIR Contracts• SBIR Phase I (N43)• SBIR Phase II and Fast Track (N44)

383838

NHLBI FY 2009 SBIR & STTR Grants

Grant Type GrantMechanism

# ofAwards

Award$Millions

STTR Phase I R41 8 $1.753 STTR Phase II R42 12 $7.072 SBIR Phase I R43 60 $11.182 SBIR Phase II R44 92 $56.334

Total 172 $76.341

3939

NHLBI SBIR/STTR Award Levels

3

• The stated Phase I and II award levels and projectperiods are guidelines not ceilings. So applicantsare encouraged to propose a budget and projectduration period that is reasonable and appropriatefor completion of the research project.

• Discuss deviations with NIH program staff prior to submission of the application.

• Institutes differ on how much deviation is allowed.

4040

Sampling of Topics of Interest to NHLBIFY 2010 Omnibus Solicitation

– Interventions to promote healthy lifestyles, adherence to medications, and cardiac rehabilitation, including stress and exerciseNew medical imaging systems, enhancements and applications Circulatory support systems

– Point-of-care (POC) devices for monitoring, diagnostics, and personalized medicineNovel use of information technology to enhance adherence to medical regimens or promote translational researchTechnologies for gene discovery, assessment, and diagnosticsTools to diagnose and treat respiratory abnormalities during sleep in infants, children, and adultsVirtual bronchoscopy (this is a radiologic 3D reconstruction of the lungs with imaging to approximate bronchoscopy)Innovative smoking cessation Personal exposure monitors for aeroallergens and other environmental pollutantsMethods to inactivate or remove microorganisms and other infectious moieties from blood, blood components, and plasma derivatives

4

4141

Sampling of Topics of Interest to NHLBIFY 2010 Omnibus Solicitation

MAIN MESSAGE

Research topics of interest to the National Heart,Lung, and Blood Institute include, but are not limited to the topics listed in the Omnibus Solicitation– Call NHLBI contacts and send an abstract of your

project. We are glad to talk to applicants about SBIR/STTR ideas and provide advice

– Visit staff and present your idea

4 4242

NHLBI SBIR Funding Allocations

Of total NHLBI SBIR funding from FY 2007-2009:

42

84% grants responsive to the omnibus solicitation

11% grants responsive to an NHLBI-issued targeted FOA

3% grants responsive to other targeted FOAs (NHLBI as secondary IC)

2% contracts responsive to RFPs

4343

OHIO SBIR/STTR Funding FY 2005-2009

FY Awards SBIR Awards STTR

2005 53 14,999 6 1,3302006 62 19,701 11 2,9902007 54 19,132 9 2,1372008 51 14,350 8 2,8482009 60 21,400 11 4,091

NIH RePORTER: http://projectreporter.nih.gov/reporter.cfm

4444

FY 2010 OHIO SBIR/STTR Companies

• ACME EXPRESS, INC., CLEVELAND - R• AEROMICS, LLC, CLEVELAND - R• ARTERIOCYTE, INC., CLEVELAND - R• ATHERSYS, INC., CLEVELAND - R• BIOINVISION, INC., CLEVELAND - R• CHANTEST, INC., CLEVELAND - R• FRANTZ MEDICAL DEVELOPMENT. LTD.,

MENTOR - NEW• GLC BIOTECHNOLOGY, INC., SOLON - R• GREAT LAKES PHARMACEUTICALS, INC.,

BEACHWOOD• GUILD ASSOCIATES, INC., DUBLIN - R• CLEVELAND MEDICAL DEVICES, INC. - R• FARADAY TECHNOLOGY, CLAYTON - NEW• H-CUBED, INC., OLMSTED FALLS - R• IDEAS, INC., KIRTLAND - R• JXT APPLICATIONS, INC., BEAVERCREEK - R• INTERTHYR CORPORATION, MARIETTA – R

Note R=Repeat Company, New = New to NIH SBIR/STTR

• LUCCELL, INC., CLEVELAND - NEW• METALLOPHARM, LLC, DELEWARE - R• MRI RESEARCH INC., CLEVELAND - R• NDI MEDICAL, INC., CLEVELAND - R• NANOFIBER SOLUTIONS, LLC, COLUMBUS -

NEW• NANOMIMETICS, INC., CLEVELAND - R• NEUROWAVE SYSTEMS, INC., CLEVELAND

HEIGHTS - R• NOVELMED THERAPEUTICS, INC., TWINSBURG

- R• ORCHARD KINETICS, LLC, CLEVELAND

HEIGHTS - NEW• OSMIC ENTERPRISES, INC., CINCINNATI - R• P2D, INC., CINCINNATI - R• PERITEC BIOSCIENCES, CLEVELAND - R• POLGENIX, INC., CLEVELAND - R• QUALITY ELECTRODYNAMICS, LLC, MAYFIELD

VILLAGE - NEW• VISION OPTIMIZATION, LLC, COLUMBUS - R

4545

Recent OHIO SBIR/STTR Technologies

Hazmat Protection Training for Health ProfessionalsObesity TherapeuticStent Fabrication TechnologyStem Cells for Neonatal Brain InjuryTherapeutic for Controlling MoodTelehealth Diagnostic for Remote Parkinson’s MonitoringSleep Apnea Treatment TechnologyBiologics for Rheumatoid ArthritisDevice for Surgical Adhesion PreventionLife Belt CPRAntimicrobial NanocoatingAdaptative Wireless Computer Mouse for Movement DisordersTelephone Speech Enhancement systemField Deployable Automatic EEGImmunotherapy Directly Targeting CocaineTumor-Targeting Chemo-Gene Therapy

4646

New Applicant Resources

• NIH eSubmission Tips for Small Business Applicants

– http://grants.nih.gov/grants/ElectronicReceipt/files/NIH_eSubmission_SmBus_Tips.pdf

• Annotated SBIR Application Form– http://grants.nih.gov/grants/ElectronicReceipt/files/small_bus_annotated_app_form.pdf

• Elimination of the Error Correction Window for Due Dates on or After January 25, 2011

– http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-123.html

Message Applicants should SUBMIT EARLY to allow time to make any necessary corrections and view the application before the submission deadline

4747

Research Portfolio Online Reporting Tool(RePORT)

47 http://report.nih.gov4848

NHLBI SBIR/STTR online search using RePORT

48 http://report.nih.gov

MRI

2008 & 2009

NHLBI

SBIR & STTR

4949

SBIR/STTR Grants With MRI Focus Funded by NHLBI in the Past Two Years

49 http://report.nih.gov5050

SBIR/STTR – NHLBI Funded Imaging Grants

50 http://report.nih.gov

5151

Overview of the NIH SBIR/STTR Programs

Susan PucieSBIR/STTR Program Coordinator

National Heart, Lung, and Blood InstituteNational Institutes of Health

[email protected]

CAREER DEVELOPMENT AWARDS The best opportunity for generating momentum in a research career occurs early. If the individual waits until their practice has been well established, the ability to step out of that practice and develop a meaningful research career is extremely limited. Before one’s clinical practice grows significantly time should be spent in designing and developing your research career. Obviously that requires funding. When first joining the faculty, startup funds from the department or division provide critical support for the generation of preliminary data. Generally, that funding should provide support for the first three years, but applications for career development awards (discussed in the presentation) should commence immediately. Requirements for preliminary data are minimal for many of these awards. However, more data is desirable when applying for K08 and K23 awards. The requirements for committed effort are not as stringent with many of the societal career development awards. Therefore these are attractive options early on. Furthermore, receipt of one of these awards typically focuses professional attention on the grantee. It can be quite beneficial to enhance awareness of the work you are doing in the laboratory among colleagues and senior members of your specialty organization. The KO8 and K23 awards, for laboratory and clinical research respectively, should outline a detailed plan for the development of expertise in research. With funding lines being as limited as they are, successful completion of a K award with a demonstrated record of productivity is one of the more potent ways to ensure successful acquisition of independent RO1 funding. Therefore using a “ladder approach” with institutional start up support leading to societal career development awards which in turn fosters opportunities for KO8/K23 funding is an excellent pathway to prepare a young surgeon/scientist for the competition for RO1 funding.

Institutional startup funds

R01

Philanthropy

Career Development Awards

Awards availableto cardiothoracic surgeons

• AGENCY: American Association for Thoracic Surgery

• AWARD NAME: David C. Sabiston Jr. Research Award 2012 - 2014

• DEADLINE: July 1, 2011

• AMOUNT: $80,000 / year for two years

• ELEGIBILITY: any board certified North American cardiothoracic surgeon

• DESCRIPTION: - provides an opportunity for research, training and experience for North American surgeons committed to pursuing an academic career in cardiothoracic surgery.

• WEB LINK: http://www.aats.org/research/grants.html

• AGENCY: American Surgical Association

• AWARD NAME: ASA Foundation Fellowship Research Award

• DEADLINE: June 15, 2011

• AMOUNT: $75,000 / year for potentially two years

• ELEGIBILITY: • US citizen or permanent resident • MD or equivalent degree• completed an ACGME approved residency in general surgery or a surgical

specialty• hold a faculty appointment in an accredited medical school or similar institution • application must be submitted within 5 years of finishing residency• can not have accepted an NIH K08 award or other career development awards• expected to devote 50% of time to research

• DESCRIPTION: Fellows will be supported in an initial year, the Fellowship can be renewed by review of the Fellowship Committee for a succeeding year. During the Fellowship years the awardee should have a primary role in research and teaching.

WEB LINK: http://www.americansurgical.info/awards_Fellowship.cgi•

• AGENCY: Thoracic Surgery Foundation for Research and Education

• AWARD NAME: TSFRE Research Grant

• DEADLINE: October 2011

• AMOUNT: $40, 000 / year up to two years

• ELEGIBILITY: Any thoracic surgeon who has completed a program leading to certification by the ABTS or its equivalent in a country outside the United States or who will successfully complete such training by the grant start date.

- expected to devote 30% of time to research project

• DESCRIPTION: up to $40,000 a year for up to two years to support the costs of original research. Preferences will be given to either clinical or laboratory based investigations that are judged likely to generate data that will, in turn, facilitate subsequent funding support for the applicant. Prior receipt of an NIH grant (K08,R01) will weigh heavily against candicacy in the absence of mitigating circumstances

• WEB LINK: http://www.tsfre.org/Awards/grants.html

• AGENCY: American Heart Association

• AWARD NAME: Beginning Grant-In-Aid

• DEADLINE: depends on affiliate which is determined by geographical region

• AMOUNT: $66,000 / year for two years

• ELEGIBILITY: • applicant must hold an MD, PhD, DO, DVM or equivalent degree• meet institutional requirements of grant submission• faculty/staff rank up to and including assistant professor (or equivalent)

not more than four years of experience at the assistant professor level • US citizen or permanent resident

• DESCRIPTION: The focus is on research broadly related to cardiovascular function and disease and stroke or to related clinical, basic science, bioengineering or biotechnology and public health problems including multidisciplinary efforts.

• WEB LINK: http://www.americanheart.org/presenter.jhtml?identifier=9713

• AGENCY: International Society for Heart and Lung Transplantation

• AWARD NAME: Norman E. Shumway Career Development Award

• DEADLINE: offered every other year, next offered in 2012

• AMOUNT: $ 40,000 / year for two years

• ELEGIBILITY: • member of the ISHLT in good standing• completed post-graduate training no more than 5 years prior to date of

application• academic appointment at an accredited institution of higher learning• must not have already received extramural funding for the same period from

any other granting agency (except from the applicant’s own institution for a different project)

• DESCRIPTION: - career development award to support research in the field of heart and lung transplantation that will lead to investigative independence.

• WEB LINK: http://www.ishlt.org/awards/awardCareerApp.asp

• AGENCY: American Lung Association

• AWARD NAME: Biomedical Research Grant (10-12 grants available)

• DEADLINE: October 21, 2011

• AMOUNT: $40,000 / year

• ELEGIBILITY: -doctoral degree and be assured of a faculty appointment or equivalent -demonstrated institutional commitment (salary support, research space)-must have completed two years of post-doctoral research training -grantee organizations must be recognized academic or other non-profit

• DESCRIPTION: to provide seed monies to junior investigators researching the mechanisms of lung disease and general lung biology. The American Lung Association is particularly interested in receiving applications relating to the following goals:- elimination of tobacco use and tobacco-related lung diseases- improve the air we breathe so it will not cause or worsen lung disease- reduce the burden of lung disease on patients & their families

• WEB LINK: http://www.lungusa.org/assets/documents/grant-descriptions/biomedical-research-grant.pdf

• AGENCY: American Lung Association

• AWARD NAME: Lung Cancer Discovery Award

• DEADLINE: letter of intent required by July 23, 2011

• AMOUNT: $100,000 / year up to two years

• ELEGIBILITY: • doctoral degree completed a training fellowship, academic faculty appointment• any level of research experience.• US citizen or foreign national / permanent resident

• DESCRIPTION: supports investigators at any level or research experience focusing on novel treatments or a cure for lung cancer.

• WEB LINK: http://www.lungusa.org/assets/documents/grant-descriptions/lung-cancer-discovery-award.pdf

• AGENCY: Thoracic Surgery Foundation for Research and Development

• AWARD NAME: Nina Starr Braunwald Award

• DEADLINE: offered every other year, next offered in 2012

• AMOUNT: $60,000 / year for up to two years

• ELEGIBILITY: • female cardiac surgeons in an academic cardiac surgery unit• applicants must have a senior mentor who is an established investigator in

cardiac surgery, cardiology or allied disciplines.

• DESCRIPTION: the award is intended to provide salary for the recipient and/or direct research support for women who wish to further their investigational skills. Emphasis will be placed on prior accomplishments, the potential of the applicant, the quality of the research and the research education that the applicant would receive as part of the award.

• WEB LINK: http://www.tsfre.org/Awards/NinaBraunwald.html

Mentored Clinical Scientist Development Award (K08)

AMOUNT: $75,000-100, 000 / year salary + fringe; 3-5 years plus TSFRE support ($50,000 10,000)

$25,000/yr expenses (up to $50,000 with budget justification)

• ELEGIBILITY: cardiothoracic surgeon with academic faculty position

• DESCRIPTION: emphasis on progression to independent funding for future research work. Development program should be comparable in scope to that which would lead to an advances research degree.Applications reviewed at CSR. Top half scored and considered for discussion.75% of time committed to research is anticipated, may request 50%.( vascular surgery has dropped that option) Can hold R01 in years 4-5 and drop salary component from the R01 budget.

Contacts: NHLBI: Jane Scott (301) 402-5264NCI: Lester Gorelic (301) 496-8580TSFRE: Rebecca Bonsaint: (978) 927-83301

Mentored Patient Oriented Research Career Development Award (K23)

AMOUNT: $75,000-100, 000 / year salary + fringe; 3-5 years plus TSFRE support ($50,000 10,000)

$25,000/yr expenses (up to $50,000 with budget justification)

• ELEGIBILITY: cardiothoracic surgeon with academic faculty position

• DESCRIPTION: emphasis on progression to independent funding for future research work. Development program should be comparable in scope to that which would lead to an advances research degree.Applications reviewed at CSR. Top half scored and considered for discussion.75% of time committed to research is anticipated, may request 50%.( vascular surgery has dropped that option) Can hold R01 in years 4-5 and drop salary component from the R01 budget.

Contacts: NIH: Jane Scott (301) 402-5264NCI: Lester Gorelic (301) 496-8580TSFRE: Rebecca Bonsaint: (978) 927-8330

….support the training of clinically trained professionals who have made acommitment to focus on patient-oriented research….human subjects ormaterial of human origin (tissue, specimens, cognitive phenomena)

Mentored Clinical Scientist Development Awards (K12)

Purpose: Institutional program support to develop independent scientistsDuration: Up to 5 years (typically 1-2 years/scholar)Effort Required: 75% with exceptions

• NHLBI: does not currently participate in the K12 program• NCI: Paul Calabresi Career Development Award for Clinical Oncology

– Up to $100,000/yr salary + fringe per scholar– $30,000/yr research costs per scholar

AATS Grant Writing WorkshopAATS Grant Writing WorkshopBethesda, MDBethesda, MDMarch 4, 2011March 4, 2011

John S. Ikonomidis MD, PhD, FRCS(C), FACS, FAHA, FACC

The Career Goal: Independent Investigator (R01)The Career Goal: Independent Investigator (R01)

Division of Cardiothoracic Surgery,Medical University of South Carolina,

Charleston, South Carolina

Presenter Disclosure InformationPresenter Disclosure InformationThe Career Goal: Independent Investigator (R01)The Career Goal: Independent Investigator (R01)

Disclosure Information:The following relationship(s) exist related to this presentation:

John S. Ikonomidis – Grant recipient: NIHConsultant: W.L. Gore and AssociatesOn-X Life Technologies, Inc.

Mission Accomplished:Mission Accomplished:Federal Grant Application Funded!!Federal Grant Application Funded!!

• Congratulations!!• The time has come to “make good” on your

promises • There is a lot of research to do• Not a lot of time to do it (!)• Non-competing renewal is less than a year

away!!!

Outline:Outline:

• Time Management• Recruiting and hiring a PhD Scientist• Strategies for completing research • Important activities• How to avoid being a “one hit wonder”

Time ManagementTime Management

• Must balance your research time with clinical, administrative, professional and teaching responsibilities

• Must understand your limitations and learn to say no to non critical opportunities

• Must learn to “minimize and streamline”


• 2007: Federal Demonstration Partnership study on research and related activities

• 73 Institutions, 6081 respondents• 90% PIs on at least one grant• Assist/Assoc/Full Prof: 22/24/54%• PI Support: 49% NIH, 32% NSF, 11% DoD• 35% Bio/Life Sciences, 16% Health Sciences


• 58% overall time spent doing research (44% active research, 14% mentoring students and postdocs)

Research Management Review 2009;16(2):1-13


• 42% of research time spent on administrative activities rather than actual research activity

Research Management Review 2009;16(2):1-13

Time ManagementTime ManagementAdministrative Burdens (In Order of Importance)

1. IRB protocols and training2. IACUC protocols and training3. Training personnel and students4. Grant report submissions5. IRB compliance issues6. IACUC compliance issues7. Personnel hiring8. Project revenue management9. HIPAA compliance10. Subcontracting and collaborations11. Safety planning and monitoring12. Equipment and supply purchases

Time Management:Time Management:Infrastructure is Critical!Infrastructure is Critical!

• Need a good business administrator to handle and be proactive about grants accounting issues.

• A second person to centralize ordering of supplies, protocol submissions, revisions, amendments and renewals, and project audits is extremely helpful

Time Management:Time Management:Infrastructure is Critical!Infrastructure is Critical!

• Cannot fund these salaries from direct costs• Indirect costs: ~ 40% of direct costs, but

usually very little comes back to the PI• Strategies:

• Negotiate indirect cost return upfront• Negotiate coverage with Division or

Department expenses• Discretionary fund from Industry

collaboration• Need $15,000 - $20,000 per $100,000 directs

for this

Consider Hiring a PhD ScientistConsider Hiring a PhD Scientist

• Individual who is genuinely interested in “bench to bedside” research

• Experience with small and large animal models would be great

• Ability to train to do animal surgery would be ideal

• Broad cellular and molecular biology experience optimal – but in particular must be aligned with your intended areas of study

Consider Hiring a PhD ScientistConsider Hiring a PhD Scientist• Negotiate with Division or Department Chair

• Helpful if you indicated you would be doing this should your application hit

• You can pay for half if the Chair can pay for half

• You will take this salary off the Chair’s books by getting independent funding for the PhD

• Roughly, a 4 year proposition.• Also means that you must renew your grant

to maintain the PhDs salary

Consider Hiring a PhD Scientist?Consider Hiring a PhD Scientist?

• Complimentary set of skills – usually synergistic rather than additive

• PhD handles the lab full time while you are busy being a doctor most of the time

• Together, you brainstorm new projects, write papers, split up the writing of new grants

• This is potentially a very powerful mechanism, with many precedents in our field, but may not work well if you do not remain engaged

Strategies For Performing The Strategies For Performing The ResearchResearch

• In theory, this is easy• You have already laid out the plan in your

grant, so just need to follow it and your timeline

• In practice, running a lab is challenging

• Set and adhere as much as possible to timelines – abstract and non-competing renewal deadlines useful!

• Have regular lab meetings and do not cancel them

• Don’t be a stranger in your own lab• Research fellows very helpful but require

time to mentor• Spend directs early, monitor your budget

carefully

Strategies For Performing The Strategies For Performing The ResearchResearch

Important Activities Important Activities

• “Positioning yourself” for continued success is important

Important ActivitiesImportant ActivitiesInstitutional Institutional

• Collaborate, Collaborate, Collaborate• Institutional teaching opportunities• Faculty committees, thesis committees• Attend institutional town hall meetings and

be a supporting voice

Important ActivitiesImportant ActivitiesExternalExternal

• Find out who is on your intended study section and invite them to your institution as visiting professor

• Hunt down study section members at meetings, attend their talks, discuss their research with them and solicit their ideas about yours

• “Volunteer” as ad hoc journal reviewer• Serve as ad hoc reviewer or member of a

study section (!)

• Serving on a study section:• Allows you to see first hand whether your

new ideas are timely and you are on right track with your future studies.

• Time consuming!!• Sometimes “backfires” on you

How to Avoid Being a How to Avoid Being a ““One Hit One Hit WonderWonder””

How to Avoid Being a How to Avoid Being a ““One Hit One Hit WonderWonder””

• At about the halfway point, need to start thinking about your competitive renewal

• What about the discoveries that you have made so far are so compelling that further study of them would form the basis for a new R01?

• Need to plan to have (at least one) publication describing your prelim data for your next grant submission.

SummarySummary

• Executing the administrative and scientific requirements of federal grant-funded research is complex

• Administrative infrastructure is critical, additional scientific expertise very helpful

• Must adhere to established timelines• Must stay current and relevant, while

keeping an eye on the future

Synopsis

Developing a Clinical Research Program, Trial Design, Patient Enrollment Timothy J. Gardner MD

AATS Grant Writing Workshop

Bethesda, March 4, 2011

Clinical research that provides evidence of the effectiveness of surgical procedures is

increasingly expected by the public and mandated by health policy administrators. In

particular, outcomes research that utilizes multicenter randomized trials is likely to be

used in the future to determine the role of surgical treatments compared to medical and

less invasive treatments for many diseases treated by Thoracic Surgeons. Furthermore, a

traditional role for academic surgeons has been the development of new treatments and

the careful analysis of established surgical procedures for safety and efficacy.

Leadership in Thoracic Surgery includes support for and participation in appropriate

clinical research. The types of clinical research available to surgeons and the hierarchy

of clinical research studies will be reviewed. Also, the components of a productive

clinical research program will be presented. In particular, the important role of

randomized controlled clinical trials for defining appropriate treatment options will be

discussed.

The unique challenges to conducting successful randomized trials in Thoracic Surgery

will be reviewed. Suggestions about how to initiate and conduct clinical research will be

discussed. Opportunities for participation in multicenter randomized trials of surgical

procedures will be mentioned.

AATS Grant Writing WorkshopDeveloping a Clinical Research Program, Trial Design, Patient

EnrollmentTimothy J. Gardner MDChristiana Care Health System

Wilmington DelawareClinical Professor of SurgeryUniversity of Pennsylvania

BethesdaMarch 4, 2011

Why should I develop a Clinical Research Program?

Importance of research in the triad of excellence as a surgeon (skilled surgeon, effective teacher, thoughtful and productive researcher)Primary importance of our clinical work mandates attention to surgical methods and outcomesClinical research is achievable by virtually all cardiac and thoracic surgeonsClinical research has become even more relevant in this current environment

Traditional progression of clinical research activities

Case Reports of small number of patients. Provides anecdotal evidence of efficacy Case Series, usually retrospective reports from a single center: Suggestive evidenceObservational Reports, larger number of cases, even from multiple centers, including non-audited Registries: Supportive evidence Prospective studies, open trials performed with standardization: Convincing evidenceRandomized Controlled Trials: comparative clinical research: Forms evidence base

Limitations to case reports and follow-up studies

Retrospective reviews are limited to medical record dataSeries are usually surgeon- or site-specificOutcome-specific information is usually quite limited, focusing on deaths and major complicationsThere are no “control” patients or groups

Treasure, Eur J Cardiothorac Surg 2009; 35:474-78

Randomized clinical trialsin surgery

Goal of any trial is to generate rigorous scientific evidence of safety and efficacyRCTs aim to eliminate selection biasDistribute confounding factors among study groups to mitigate potential biasing influences on interpretation of outcomes

Class III

Risk = BenefitNo additional studies needed

Procedure/Treatment should NOT be performed/administeredSINCE IT IS NOT HELPFUL AND MAY BE HARMFUL

Class IIb

Benefit = RiskAdditional studies with broad objectives needed; Additional registry data would be helpful

Procedure/Treatment MAY BE CONSIDERED

Class IIa

Benefit >> RiskAdditional studies with focused objectives needed

IT IS REASONABLE to perform procedure/administer treatment

Class I

Benefit >>> Risk

Procedure/ Treatment SHOULD be performed/ administered

Level C: Only consensus of experts opinion, case studies, or standard of care Very limited populations evaluated

Level B: Data derived from a single randomized trial or nonrandomized studies Limited populations evaluated

Level A: Data derived from multiple randomized clinical trials or meta-analysesMultiple populations evaluated;

Applying Classification of Recommendations and Level of Evidence

Level of E vidence:

Requirements for Developing a Clinical Research Program

Motivated surgeon-leader with Division and Department support (dedicated time and initial funding assistance)Dedicated research team with committed research coordinatorSupportive and facilitating academic and clinical environmentClinical collaborators (cardiologists, oncologists, biostatisticians, etc.)

Usual Questions for Trial Design

Clear and relevant hypothesisPrimary and secondary endpointsAppropriate patient populationsWell defined comparatorsPower – sample sizeStatistical designSites and recruitment expectations

Ann Thorac Surg 2007; 83: 1934-9

Observational Report

Ann Thorac Surg 2008; 86: 1139-46

12,812 patients from 1997 – 2006, 44% OPCABPropensity matched between CPB- and OP-CABG“OPCAB provides significant mortality & morbidity advantages, especially in womenSimilar outcomes at 10 years

RCT, but small sample size

Single surgeon trial100 patients in each armSimilar outcomes at 30 days and 1 yearReduced costs with OPCABAdequate for non-inferiority conclusion?

JAMA 2004: 291: 1841-49

RCT, with Level A evidence

2203 patients, 18 centers, qualified surgeonsComposite 30-day and 1-year clinical end pointsOPCAB patients had worse outcomes including graft patency

N Engl J Med 2009; 361: 1827-37

Observational data, Registry-based

EACTS 2010 • Three-year Outcomes of the SYNTAX Trial • Kappetein • Slide 18

Optimal revascularization strategy in patients Optimal revascularization strategy in patients with threewith three--vessel disease and/or left main vessel disease and/or left main

diseasedisease

The 3The 3--year Outcomes of the SYNTAX Trialyear Outcomes of the SYNTAX Trial

A. Pieter Kappetein, MD PhDA. Pieter Kappetein, MD PhDErasmus Medical Center, Erasmus Medical Center,

Rotterdam, The NetherlandsRotterdam, The NetherlandsOn behalf of the SYNTAX investigatorsOn behalf of the SYNTAX investigators

12 September 201012 September 2010Conflicts of Interest: NoneConflicts of Interest: None

EACTS 2010 • Three-year Outcomes of the SYNTAX Trial • Kappetein • Slide 19

The 3-year SYNTAX results suggest that CABG remains the standard of care for patients with complex disease (intermediate or high SYNTAX Scores); however, PCI may be an acceptable alternative revascularization method to CABG when treating patients with less complex (lower SYNTAX Score) disease.The 3-year MACCE rates for the CABG and PCI registry were 16.4% and 38.0% respectivelySYNTAX patients will continue to be followed for 5 years.

Summary: II Summary: II

http://www.ctsurgerynet.org/

Evaluation of Outcomes Following Mitral Valve Repair/Replacement in Severe Chronic Ischemic Mitral

RegurgitationOBJECTIVES:

The objective of this study is to evaluate the safety and efficacy of mitral valve repair and mitral valve replacement for patients with severe ischemic mitral regurgitation (MR). Specifically, this study compares mitral valve repair with annuloplasty and a sub‐valvular procedure for severe tethering to mitral valve replacement and complete preservation of the sub‐valvular apparatus. o The primary aim of this trial is to evaluate the impact of these two surgical approaches

on left ventricular remodeling. o 250 subjects; 90% power to detect an absolute difference of 15 ml/m2 in LVESVI based

on a 35% (replacement) v. 20% (repair) reduction in LVESVI.

o Secondary aims of this trial include assessment of the impact of these two surgical interventions on cardiac performance, mortality, adverse events, quality of life, functional status, severity of MR, and health resource use.

Enrollment as of Feb 23, 2011 = 165/250 (66%) 22

Note: Mitral valve replacement will include complete preservation of the subvalvar apparatus. The technique of preservation, choice of prosthetic valve, and technique of suture placement will be dependent on the surgeon’s preference. The prosthetic valve will be tested for paravalvular leaks using the left ventricular saline infusion test

Note: The annuloplasty ring will be chosen by the surgeon. The ring is sized to the anterior leaflet and intertrigonaldistane. A semi-rigid or rigid annuloplasty ring will be used and. If tethering is present, a subvalvar procedure may be performed.

Patient enrollment issues

Patients are often uncomfortable when there is uncertainty expressed by the surgeon about effectiveness of the proposed treatmentReferring physicians may expect their treatment preferences to be honored“Doctor, you do what you think is best”Program marketing may confound the patient enrollment challenges

Equipoise – mandatory concept for RCTs, but often lacking among surgeons

Uncertainty about comparative merits of 2 different diagnostic or treatment optionsEthically, the investigator should have no significant preferenceFor most RCTs, “clinical equipoise” refers to genuine uncertainty within the expert medical community about the treatment options

Freedman B, N Engl J Med 1987; 317: 141-5

Why should I develop or participate in a Clinical Research Program?

Supports and defines academic missionProvides evidence-basis for surgical practiceHelps clarify best clinical practicesAssociated with surgical leadership

Getting Started – Preparation/Grantsmanship/

Dealing with the New Format and Page Limits

Mark Ratcliffe

Facilitate changing nature of scienceFacilitate changing nature of science

Identify and encourage new and early Identify and encourage new and early stage investigatorsstage investigators

Ease burden on research enterpriseEase burden on research enterprise

Streamline time to awardStreamline time to award

Fund the best science, by the best Fund the best science, by the best scientists, with the least amount of scientists, with the least amount of administrative burdenadministrative burden

Enhancing NIH Peer ReviewEnhancing NIH Peer Review

BackgroundBackgroundYear-long Deliberative Effort

Gathering Feedback & Input:• Request for Information• NIH Staff survey• IC White Papers• Internal Town Hall Meetings• External Consultation Meetings• Data Analysis• Internal and External Working

Groups

Working Groups Established to:

1.Engage the Best Reviewers2.Improve the Quality and

Transparency of Review3.Ensure Balanced and Fair

Reviews Across Scientific Fields and Career Stages

4.Continuous Review of Peer Review

June 2007 – Feb. 2008 March 2008 – June 2008 September 2008

Identified Key Recommendations

4

Enhancing Peer Review Enhancing Peer Review Overview and TimelineOverview and Timeline

Phase out of A2 Phase out of A2 applicationsapplications

Identification of Identification of Early Stage Early Stage Investigator Investigator (ESI) R01 (ESI) R01 applicationsapplications

Enhanced review Enhanced review criteriacriteriaNew scoring New scoring systemsystemCriterion scoringCriterion scoringStructured Structured critiquescritiquesScore order Score order reviewreviewClustering of New Clustering of New Inv. ApplicationsInv. Applications

Restructured Restructured ApplicationsApplications

Shorter Page Limits Shorter Page Limits and New and New InstructionsInstructions

5







Five Scoring Criteria

SignificanceInvestigatorInnovationApproachEnvironment

11--9 Scoring System9 Scoring System

The new scoring system will use a 9The new scoring system will use a 9--point scale point scale (1 = exceptional, 9 = poor)(1 = exceptional, 9 = poor)

This scale will be used for overall This scale will be used for overall impact/priority scores AND for impact/priority scores AND for individual criterion scoresindividual criterion scores

Preliminary impact/priority scores will Preliminary impact/priority scores will help determine which applications are help determine which applications are discusseddiscussed

Scoring of Individual Review CriteriaScoring of Individual Review Criteria

Assigned reviewers will use the 9Assigned reviewers will use the 9--point point scale for five review criteriascale for five review criteria–– Each assigned reviewerEach assigned reviewer’’s criterion scores will be s criterion scores will be

reported in the summary statementreported in the summary statement–– Criterion scores will be reported for ALL Criterion scores will be reported for ALL

applicationsapplicationsReviewers will consider criterion scores Reviewers will consider criterion scores as appropriate for each application in as appropriate for each application in determining overall impact/priority determining overall impact/priority scorescore

Templates for Reviewer CritiquesTemplates for Reviewer Critiques

Templates contain a box for reviewers Templates contain a box for reviewers to write their comments for:to write their comments for:–– each of the core review criteriaeach of the core review criteria–– overall impactoverall impact–– other review criteria and additional other review criteria and additional

considerations considerations Comments will be in the form of bullet Comments will be in the form of bullet points or short narrativespoints or short narratives

The template will be uploaded to The template will be uploaded to become part of the summary statementbecome part of the summary statement

10







Major Changes to ApplicationsFor due dates on or after Jan 25, 2010

Restructured Application FormsRestructured Application Forms

Shorter Page Limits and New Instructions Shorter Page Limits and New Instructions

For ALL competing applications:For ALL competing applications:New, Renewal, Revision, and ResubmissionNew, Renewal, Revision, and Resubmission

11

Goals of Restructured Applications

Align the structure and content of the Align the structure and content of the forms with review criteriaforms with review criteria

–– To focus the applicants and reviewers on the To focus the applicants and reviewers on the same elementssame elements

–– To help ensure a more efficient and To help ensure a more efficient and transparent review processtransparent review process

12

Goals of Shortened Page LimitsGoals of Shortened Page Limits

Reduce burdenReduce burden

Focus on the essentials of the science Focus on the essentials of the science

Avoid information overloadAvoid information overload

13

Overview of the Application ChangesOverview of the Application Changes

Application forms will be revised in Application forms will be revised in three sections:three sections:

Research PlanResearch PlanBiographical SketchBiographical SketchResources and FacilitiesResources and Facilities

14

Major Changes to the Research Plan Major Changes to the Research Plan

Specific Aims will include new language Specific Aims will include new language about the impact of the proposed research.about the impact of the proposed research.

Research Strategy will be created as a new Research Strategy will be created as a new section and will include 3 of the current section and will include 3 of the current sections sections –– Background and SignificanceBackground and Significance–– Preliminary Studies/Progress ReportPreliminary Studies/Progress Report–– Research Design and MethodsResearch Design and Methods

15

New Research Plan ComponentsNew Research Plan Components

IntroductionIntroduction

Specific AimsSpecific Aims

Background and SignificanceBackground and Significance

Preliminary Studies/Progress Report Preliminary Studies/Progress Report

Research Design and MethodsResearch Design and Methods

Inclusion Enrollment ReportInclusion Enrollment Report

Bibliography and References CitedBibliography and References Cited

Human Subjects SectionsHuman Subjects Sections……..protections, women/minorities, enrollment, protections, women/minorities, enrollment,

childrenchildrenOther Research Plan SectionsOther Research Plan Sections……..

animals, select agents, multi PD/PI, consortium, animals, select agents, multi PD/PI, consortium, support, resource sharingsupport, resource sharing

AppendixAppendix

Research Research StrategyStrategy

16

Research Strategy

Background and Significance, Preliminary Data and Research Design and Methods sections are now included in the Research Strategy section.Organization of the Research Strategy section is often not clear.It is often difficult to distinguish preliminary data from proposed work.

Research Strategy

3. Research StrategyA. SignificanceB. InnovationC. ApproachThe approach section is organized with 3.C.1 Preliminary data (Including Progress report) first, followed by 3.C.2 Research Design, 3.C.3 Methods and then 3.C.4 Potential Problems and Alternative Strategies

Changes to Biographical SketchChanges to Biographical Sketch

Personal Statement added: Personal Statement added: –– ““Briefly describe why your experience and Briefly describe why your experience and

qualifications make you particularly wellqualifications make you particularly well--suited for your role in the projectsuited for your role in the project””

Publications revised: Publications revised: –– Limit the list of publications or manuscripts Limit the list of publications or manuscripts

to no more than 15to no more than 15–– Applicant is encouraged to make Applicant is encouraged to make

selections based on recency, importance selections based on recency, importance to the field, and/or relevance to the to the field, and/or relevance to the application application 19

Changes to Resources and FacilitiesChanges to Resources and Facilities

Instructions added to Resources:Instructions added to Resources:–– Provide a description of how the scientific Provide a description of how the scientific

environment will contribute to the environment will contribute to the probability of success of the projectprobability of success of the project

–– For Early Stage Investigators (ESIs), For Early Stage Investigators (ESIs), describe the institutional investment in the describe the institutional investment in the success of the investigatorsuccess of the investigator

20

Application Alignment with Review Criteria:Application Alignment with Review Criteria:Major Examples Major Examples

CriteriaCriteria ApplicationApplicationSignificance Research Strategy

a. Significance

Investigator(s) Biosketch

Innovation Research Strategyb. Innovation

Approach Research Strategyc. Approach

Environment Resources

21

Overview of Shorter Page LimitsOverview of Shorter Page Limits

Current Page Limit (Section 2-5 of the Research

Plan)

New Page Limit (Research Strategy)

<25 625 12

>25 Follow FOA Instructions

Note: Follow FOA page limit requirements if Note: Follow FOA page limit requirements if different from the application instructions.different from the application instructions.

Full table of page limits available at:Full table of page limits available at:http://enhancinghttp://enhancing--peerpeer--review.nih.gov/page_limits.htmlreview.nih.gov/page_limits.html22

What Has Not Changed

Need to have a good idea about how to Need to have a good idea about how to answer an important questionanswer an important question

Reviewers need to be able to Reviewers need to be able to understand WHAT you want to do, understand WHAT you want to do, WHY it is important, and can YOU do WHY it is important, and can YOU do it?it?

Need to align YOUR goals with the Need to align YOUR goals with the funding agency goals.funding agency goals.

23

On line resources

NIH Grantsmanship Site:http://www.niaid.nih.gov/ncn/grants/write/index.htm

AHA Grant Writing Tips:http://www.heart.org/downloadable/heart/1133366256870Grantwriting_Tips.pdf

For Additional Information:

Enhancing Peer Review at NIH Web SiteEnhancing Peer Review at NIH Web Site

http://enhancinghttp://enhancing--peerpeer--review.nih.gov review.nih.gov

25

General CommentsFind out in advance as much as possible about the potential reviewers.1

Study section rosters can be found at:

http://www.csr.nih.gov/Committees/rosterindex.asp

1. Inouye SD and Fiellin DA, Ann Int Med 142:274 2005

General CommentsMake your grant easy to read.

Tell a story.“It would be good if your (husband)/ wife can understand.”1

“Err on the side of starting off simple. Write the engineering part for the surgeons and the clinical piece for the engineers.”1

1. Rob Gorman, CT Surgery, UPenn

FontUse an Arial, Helvetica, Palatino Linotype or Georgia typeface and a font size of 11 points or larger. (A Symbol font may be used to insert Greek letters or special characters; the font size requirement still applies.)Type density, including characters and spaces, must be no more than 15 characters per inch.Type may be no more than six lines per inch.Use black ink that can be clearly copied.Print must be clear and legible.

Page MarginsUse standard size (8 ½" x 11") sheets of paper.Use at least one-half inch margins (top, bottom, left, and right) for all pages, including continuation pages.

PHS398

Formatting of Sections

• Make it easy for reviewers to find key points within the story:– Bold face type– Underlining– Outline

• a (aims), b (background), c (preliminary data), d (methods)

• d.1, d.1.1, d.2 etc

• There is nothing worse than pages of text without headings and/ or figures.

Formatting of Paragraphs

• 1 main idea per paragraph• Use topic sentences• Use transitions (e.g., however, in contrast,

next, although, nevertheless, likewise, etc)• End paragraphs with closing sentences.• Examples:

– These studies demonstrate the importance of….

– These studies provide important background for this study in…

– The proposed project will build on this previous work, [or will address limitation in the previous work by ____ ]…

General Comments

“Don’t use jargon” 1

“Avoid abbreviations unless used repeatedly.” 1

If multiple abbreviations are necessary provide a list of definitions.

1. Rob Gorman, CT Surgery, UPenn

Pictures, Figures and Cartoons

“Pictures/Figures are good but they should be easy to understand and add something besides color to the grant.”1

“Make sure the regions of interest in figures/images are highlighted, have arrows, etc, so the reviewer does not have to guess at what they are looking for.”2

1. Rob Gorman, CT Surgery, UPenn2. David Saloner, Surgery and Radiology, UCSF

General CommentsCheck to see that the references are correctly numbered.1

A reference manager such as Endnote is strongly recommended.2

References can be downloaded directly from PubMed thereby avoiding errors in the bibliography (very irritating when the reviewer wants to look something up).More efficient when reformatting is necessary.

“Check carefully for typos. In the age of spellcheck, typos are extremely annoying to reviewers, especially if there are a large number of them.”3

1. Kessel D, Chest 130: 296 20062. www.endnote.com3. Joel Karliner, Cardiology, UCSF

Hypothesis and Specific Aims – The Importance of Clarity

Y. Joseph Woo, MD University of Pennsylvania

There is probably no more singularly important part of a grant application than the Hypothesis and Specific Aims page. Just as an abstract of a manuscript summarizes a paper and convinces a reader to continue reading the body of the manuscript, or an executive summary condenses the findings and key points of a document, the Hypothesis and Specific Aims page summarizes the fundamental scientific core of a grant. The abstract of a federal grant is not like an abstract of a manuscript. A grant abstract is for general public use, not scientific assessment. Hypothesis and Specific Aims page is the executive summary of the grant for scientists. You have essentially 5 minutes to convince someone to read on, to convince a reviewer that your proposal is scientifically sound and exciting. Consider the HSA page like a 1-2 minute movie preview trailer. Use highly edited segments of the very best scenes in the movie. Consider very carefully who your audience will be and tailor the page to that audience. In the current era of ever tightening budgetary constraints, the importance of the initial impact, the first impression, cannot be overstated. When constructing the HSA page, generate and state very clear, concise, and scientifically definitive hypotheses. Answer each with a well designed experiment which will prove or disprove the hypothesis. In general the number of specific aims should directly correlate with the grant duration. 1yr Grant(Student) 1 Aim 2yr Grant (Fellowship) 2 Aims 4-5yr Grant (K, R) 3 Aims Use bold, italic, font, indent, formatting variation to provide organization, flow and contrast. Avoid Sub-Hypotheses and Sub-Aims if possible. When considering options for presenting the hypotheses, chronologic sequence is often most logical. However a very compelling scientifically logical sequence which may not occur entirely chronologically may be used. Clarity is everything. This lecture will discuss the critical importance of the Hypothesis and Specific Aims page, suggest key language to incorporate, provide formatting templates, and discuss techniques to create high-impact summary statements.

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Research Strategy Research Strategy –– SignificanceSignificanceWhy is your research important?Why is your research important?





Research Strategy Research Strategy –– SignificanceSignificanceStructure of the ProposalStructure of the Proposal

• Text of a grant:– Specific Aims - Statement of the problem (introduction)– Significance (includes background) (1-2 pages)– Innovation (½ page)– Approach – how the problem will be solved

– Start with general overview of the plan / team (optional)– Address each Specific Aim –

– preliminary / progress data, experimental plan, anticipated results / potential problems (limitations) / alternative approaches

Research Strategy Research Strategy –– Significance Significance Structure of the ProposalStructure of the Proposal

• Virtual “Page 1” is most important - Hypothesis-driven:– Introductory paragraph - Significance– Specific Aims– Hypotheses

• Develop hypotheses and state them clearly (and significance)• Specific Aims :

– Outline a reasonable number to address the hypotheses– Aims should represent a prediction than can be tested

experimentally• Be focused – don’t take on too much


• Introduction to Specific Aims:– Catch the reviewers attention – significance of grant – Start with broad, long-range, often grand objective

– Not necessarily achievable within the time-frame– Then focus on more short-term goals and how these are

essential to ultimately solve long-term goals– Ties current proposal to your previous work – Specific Aims must be achievable in the proposed time-frame

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PPH, which most often afflicts young, otherwise healthy young women is incurable and culminates in RHF and death in the majority of patients, but the molecular and biomechanical mechanisms responsible for the progression from compensated to decompensated failure remain unknown.

• Introduction to Specific Aims:– First place to describe significance– “There is a significant problem or unknown with a critical

need to solve, and solving this problem is aligned with the mission of the funding agency.” (Y. Colson)

– 3-4 key facts – critical problem with significance to the society and funding agency


Since 1999, our laboratory has had as its focus: 1.) Characterization of A, 2.). Determination of B, and 3.) Mechanistic confirmation of C. Having built this solid methodologic foundation, consisting of novel techniques to assess D, we now have the unique ability to … This will facilitate completion of the studies outlined in this proposal, designed to address the following Specific Aims:

• Introductory Paragraph:– Show them you are competent– What makes you (and your co-investigators) unique?– How will your unique skill set permit you to complete this

important work?

Research Strategy Research Strategy –– SignificanceSignificanceWhat makes a topic significant?What makes a topic significant?

• It impacts a large number of people with substantial consequence

CPH develops in 60% of patients with COPD, including emphysema and chronic bronchitis, diseases that affect over 16 million American today and claimed more than 120,000 lives in 2002.

Apicomplexa are important human pathogens responsible for numerous severe diseases around the World. These include the various forms of malaria, as well as opportunistic infections associated with AIDS (which impacts over one million Americans and has claimed over 500,000 lives).

Boris Striepen, Ph.D., University of Georgia Boris Striepen, Ph.D., University of Georgia National Institute of Allergy and Infectious Disease, 2011National Institute of Allergy and Infectious Disease, 2011


• Someone important says it is significant - Politician

“We can, and we will do more to better treat this devastating disease.”U.S. Senator John Cornyn (R-Texas)October 8, 2004 – Floor of the U.S. Senate

In 2004, the Disease X Research Act was introduced to “expand, intensify, and coordinate” the activities of the NHLBI with respect to research on Disease X.

Senator Cornyn emphasized that, “This important bill has the potential to help tens of thousands of Americans and their families who are struggling with Disease X.”

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• Someone important says it is significant – Respected clinician / Researcher

Dr. Robyn Barst, a renowned clinician in the field, confessed: “Unfortunately, despite the demonstrated efficacy of [new treatment options], … we often are only delaying an inevitable fatal outcome for many patients.”

Dr. Stuart Rich, a renowned investigator in the field, concludedemphatically in a recent editorial that, “Atrial septostomy needs to be studied further as an alternative treatment… when no other option exists.”


• Know your audience – review the committee roster• AATS (http://www.aats.org)

– Research Scholarship Committee• TSFRE (http://www.tsfre.org)

– Research Committee• NIH:

– Center for Scientific Review (http://cms.csr.nih.gov)– Office of Extramural Research (http://era.nih.gov/roster)


• Someone important says it is significant – Committee member

Dr. L. Henry Edmunds, the immediate past Chairman of the NIH Surgery and Bioenginnering Study Section, wrote in his 1997 textbook Cardiac Surgery in the Adult that “… ischemic mitral regurgitation is an extremely common complication of MI. The incidence of IMR in the United States is estimated to be 1.2 to 2.1 million patients … with a 1-year mortality of 17 to 40 percent.” These data indicate that IMR is a common problem, but underappreciated.


• An important organization says it is significant

The House of Representatives identified Disease X as an “Item of Interest” in the FY2011 budget.

As outlined in the World Health Organization Executive Summary, essential areas for research include:

• What are the mechanisms responsible for …• What is the optimal timing of…

The American College of Chest Physicians Consensus Statement inauspiciously admits: “There is no cure for Disease X, nor is there a therapeutic approach which is uniformly accepted or successful.”

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• Make sure the organization to which you are applying considers the organization you are quoting to be important

• Funding agencies generally do not care about the goals, objectives, or strategic plan of other funding agencies

The mechanisms responsible for the progression of Disease X and its treatment are recurring themes throughout the NHLBI Strategic Plan for the years FY 2001-2005.


• FOA: Funding Opportunity Announcement– Identify areas of increased priority and/or emphasis– May be sponsored by one or more NIH institutes.

• PA: Program Announcements• RFA: Requests for Applications

– PAs may or may not have set-aside funds. If not, some applications are funded beyond the payline. RFAs always have set funds.

– PAs are usually broader:– PA may focus on biodefense research opportunities – RFA will

focus on developing therapies for a particular disease– Applications in response to a PA are not reviewed together – go to study

section with the best match. RFAs are reviewed together.

Research Strategy Research Strategy –– SignificanceSignificanceWriting the Significance sectionWriting the Significance section

• Significance and Innovation– Avoid jargon– Make it understandable to all (write science for the

clinicians, and write clinical aspects for the scientists)• Logical, clear compelling argument

– Why the proposed study is necessary– Highlight “Gaps” in knowledge and how your project

addresses the gaps– How it differs from previous work– Specific ways it is innovative

• SF424 (R&R) Application Guide for NIH– http://grants.nih.gov/grants/forms.htm

• Significance / Innovation / Approach (12 pages)


(a) Significance• Explain the importance of the problem or critical barrier to progress in the field that the proposed project addresses.• Explain how the proposed project will improve scientific knowledge, technical capability, and/or clinical practice in one or more broad fields.• Describe how the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field will be changed if the proposed aims are achieved.

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• Multiple Specific Aims– http://grants.nih.gov/grants/forms.htm

• A combination of both is appropriate


If an applicant has multiple Specific Aims, then the applicant may address Significance, Innovation and Approach for each Specific Aim individually, or may address Significance, Innovation and Approach for all of the Specific Aims collectively.

• Significance section includes background:– Summarize important results outlined by others

– Know your audience – Check study group members for publications

– Critically evaluate existing knowledge → tell us what is missing.

– Answer 3 questions:– What is known?– What is not known?– Why is it essential to find out?


• Health Relevance– Congress appropriates NIH funds with the goal of finding

solutions to important public health problems– Discuss health relevance – specifically towards the disease

processes the organization studies (AHA – cardiovascular)– Reviewers will discuss the health impact of your project

• Scientific Relevance– The best proposals describe how they will increase both

scientific knowledge and improve health


• Background / Significance:– Identify gaps (contradictions in previous studies) and describe

how they will be filled by this project– Convince us that these gaps are important– Do not be one-sided on controversies– Three Goals:

– Justify the line of investigation (significance)– Establish competence of investigator– Educate a reviewer who is unfamiliar with you and topic


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• Start with a general significance statement (organization & expert):

• Follow with some background, and a gap statement:

The NIH is committed to translating basic biomedical research into clinical practice and thereby impacting global human health,1 and Francis Collins identifies high-throughput technology as one of five areas of focus for the NIH’s research agenda. 2

For many diseases, researchers have identified successful novel therapeutics orresearch probes by applying technical advances in automation to high-throughput screening (HTS) using either biochemical or cell-based assays. However, the molecular mechanisms of many diseases that deeply impact human health worldwide are not well-understood and thus cannot yet be reduced to biochemical or cell-based assays.

Carolina WCarolina Wäählby, Ph.D., (Broad Institute)hlby, Ph.D., (Broad Institute)National Institute of Allergy and Infectious Disease, 2011National Institute of Allergy and Infectious Disease, 2011


• Significance – Organization (NIH PA)

• Authoritative expert opinion related to planned experimentation

Enabling high throughput screening (HTS) in whole organisms is recognized as a high priority (NIH PA-08-024).

The bottleneck that remains for tackling important human health problems using C. elegans HTS is image analysis (NIH PA-07-320). It has been recently stated, “Currently, one of the biggest technical limitations for large-scale RNAi-based screens in C. elegans is the lack of efficient high-throughput methods to quantitate lethality, growth rates, and other morphological phenotypes”. Our proposal to develop image analysis algorithms to identify regulators of infection and metabolism in high-throughput C. elegans assays would bring image-based HTS to whole organisms, and have the following impact:



• Background / Significance:– Integrate your previous findings within the background – show

reviewers the relevance of your previous contributions

– Bridge your hypotheses and long-term objectives to the background review (and ideally your previous work)


For some diseases, unique mechanisms of action may be necessary to break new therapeutic ground. Our work recently identified six novel classes of chemicals that cure model organisms … through mechanisms distinct from directly killing the bacterium itself. Manipulation of C. elegans may yield clinical cures.


Research Strategy Research Strategy –– SignificanceSignificanceBackground / CompetenceBackground / Competence

• Previous methodology development and mechanistic investigation– From other investigators:

– From your own laboratory:

We have developed a technique to assess A, which, to the best ofour knowledge, is a novel approach. Preliminary studies outline our unique methodology which is necessary to study …

Altered levels of SERCA have been found in monocrotaline-treated rats, …

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Research Research StrategyStrategy –– SignificanceSignificanceBackground / CompetenceBackground / Competence

– From your co-investigators:

– From your institution:The Wash U approach, analyzing high-speed tissue-tagged MRI images in real-time, has provided novel insights into the pathogenesis of Disease X. In the current proposal, we plan to use this well-developed methodology to identify the mechanistic precursor of Disease Y (Hypothesis 2.1).

Co-investigator, Dr. X, has previous reported receptor X upreguation and enhanced Ca2+ release from the SR in ischemia and hypoxia. Our preliminary studies demonstrate a similar change in Disease Y, which we hypothesize represents the mechanism responsible for the progression from compensated to decompensated failure (hypothesis 1.3).

Research Research StrategyStrategy –– SignificanceSignificanceBackground / CompetenceBackground / Competence

• Peer-reviewed validation of the importance of your line of research– Awards and Honors:

– Foundation “Starter” Grants:

It is noteworthy that our preliminary investigation of the impact of CPH on expression of calcium-handling proteins by Dr. X, postdoctoral research fellow, won the prestigious American College of Cardiology Young Investigator Award, reflecting the translational importance of this line of investigation.

The development of our unique methodologic approach was supported by a research grant from the Thoracic Surgery Foundation for Research and Education.

• Tie or relate background from others to PI’s previous work:

• Tie the PI’s previous work to a gap statement:

For some diseases, a whole organism screen may actually be necessary to break new therapeutic ground. Our work recently identified six novel classes of chemicals that cure model organisms … through mechanisms distinctfrom directly killing the bacterium itself.

Anti-infectives with new mechanisms of action, [specifically agents that evolve from those previously identified in our laboratory,] are urgently needed to combat widespread antibiotic resistance in pathogens.


Research Strategy Research Strategy –– SignificanceSignificanceCompetence / Knowledge GapCompetence / Knowledge Gap

• Significance of each specific aim – includes gap statements, importance to society (significance to health), innovation, mechanistic approach that can be used for future studies

Identifying novel modulators of infection by the NIH priority pathogen Microsporidia (Aim 1). Microsporidia are emerging human pathogens whose infection mechanisms are almost completely unknown. Further, they inflict agricultural damage and are on the EPA list of waterborne microbial contaminants of concern. This screen could identify not only useful chemical research probes and compounds that kill these pathogens outright, but also those that enhance host immunity.Identifying novel regulators of fat metabolism (Aim 2). Disregulation of metabolism

results in many common and expensive chronic health conditions; diabetes alone affects 24 million Americans. Screening with a strain of C. elegans will likely reveal novel energy regulators of therapeutic value.Identifying novel regulators of infection by the pathogen S. aureus (Aim 3). S. aureus is life-threatening for immune-compromised patients. Recently, MRSA strains have created an urgent need for therapeutics with a new mechanism of action. We will identify genetic regulators of C. elegans host’s response to infection by S. aureus. These will lead to potential drug targets useful for boosting human immunity.


Research Strategy Research Strategy –– SignificanceSignificanceSignificance for each Specific AimSignificance for each Specific Aim

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• Not a specific aim, but a byproduct – significance and data sharing

• Summarize significance in the final paragraph

Creating open-source software for the C. elegans community. C. elegans is used … by more than 11,000 researchers in 750 laboratories worldwide (http://www.WormBase.orgJanuary 2010), and the close-knit community rapidly shares methods.

Thus, in addition to the discovery of potential drugs and drug targets related to metabolism and infection, which could significantly impact the global burden of human disease, our aims will yield open-source software for automated, accurate, quantitative scoring for a wide range of C. elegans image-based assays that are currently intractable. The impact will be multiplied by laboratories worldwide using the resulting software to study a wide variety of pathways relevant to basic biological research and human disease.


Research Strategy Research Strategy –– SignificanceSignificanceSignificance beyond Specific AimsSignificance beyond Specific Aims

• Preliminary Data:– Describe preliminary data that are relevant – Show the Data! – Tie your own data to the hypothesis – Ideally, use findings from

previous work to develop new hypotheses and design studies• Important in new applications to document credibility, experience,

and competence (in innovation if a novel approach)• Important in renewals to show progress and how the old project

guides the hypotheses of the new project

Research Strategy Research Strategy –– SignificanceSignificancePreliminary Data / Progress ReportPreliminary Data / Progress Report

• Preliminary Studies– Relate to proposed Specific Aims– Can be included in Significance, Innovation, or Approach

Preliminary Studies for New Applications: For new applications, include information on Preliminary Studies. Discuss the PD/PI’s preliminary studies, data, and or experience pertinent to this application. … preliminary data can be an essential part of a research grant application and help to establish the likelihood of success of the proposed project. Early Stage Investigators should include preliminary data (however, for R01 applications, reviewers will be instructed to place less emphasis on the preliminary data in application from Early Stage Investigators than on the preliminary data in applications from more established investigators).


• Progress Report for Renewal and Revision Applications – Relate to previous specific aims (and new specific aims, ideally)

Progress Report for Renewal and Revision Applications. For renewal/revision applications, provide a Progress Report. … Summarize the specific aims of the previous project period and the importance of the findings, and emphasize the progress made toward their achievement. Explain any significant changes to the specific aims and any new directions including changes to the specific aims and any new directions including changes resulting from significant budget reductions. A list of publications, patents, and other printed materials should be included (Progress Report Publication List).


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Research Strategy Research Strategy –– SignificanceSignificanceHow to be successfulHow to be successful

• Hypothesis-Driven, Mechanistic Studies (not descriptive)– Old grants: descriptive / correlative

– Impact of CPH on RA function – see what happens– Descriptive hypothesis: “With Disease X, RV function is impaired

and RV expression of SERCA falls”

– Modern grants: mechanistic / translational– Why does what we know already happens, happen? – How can we change what we know already happens?– Mechanistic hypothesis: “If we modulate SERCA expression

up/down in Disease X, RV function will improve/deteriorate”

• Preliminary studies can include descriptive studies, but Specific Aims should be mechanistic






1

Research Strategy – Innovation – How to Make your Grant New and Unique

David R. Jones, MDUniversity of Virginia

Research Strategy: Approach

Frank Sellke, MDDivision of Cardiothoracic Surgery

Brown Medical SchoolProvidence RI

AATS Grant Course 2011

Strategies to Obtain Funding for CV Surgery Research

• Disclosures: • Steering Committee for Novonordisk• DSMB: Cubist Pharmaceutical• CSL Behring: Advisory Board• Chairman, DSMB CT Surgery Network,

National Institutes of Health• National Institutes of Health (RO1 HL46716, RO1 HL

69024) to FWS• Royalties from Elsevier Publishing

NIH Funding: RO1 Approach

The Idea• I have a great idea, now what do I do with it?• Define the problem clearly. You want make sure

you convey that it is very important, the most important proposal ever submitted!

• Provide information and support as to why this is the most important project ever submitted!

• Focus, Focus, Focus• Feasibility, feasibility, feasibility• Assume the reviewer understands science, but has

no idea of what you are talking about.• Submit a clear, concise, well-written application

The Submission• Abstract-Summary (Assume it is the only thing they will

read)• Background and Significance- Why is this important?• Specific Aims-Need hypothesis for each aim• Approach-Methods, Stress Innovation, Novel Techniques• Provide as much preliminary data as possible to prove or

suggest feasibility• Experimental approach to test Specific Aims-tell reviewer

exactly what you are going to do in as much detail as possible.

• Methods can and should be brief with reference to prior work. Mechanistic in nature.

The Submission• Discuss statistical analysis and anticipated results. Provide

power analysis, esp. for clinical projects• Alternative approaches need to be listed• Pictures are easier to understand than text.• Include expert collaborators, especially in areas of relative

weakness. This is not a sign of weakness.• Animal welfare, budget, human issues, consent forms need

to be addressed• Reference members of the Study Section• Give yourself time to write (2-4 months)• Know the local process (IRB, IACUC, grants office)• Use innovative technology at your institution

New Format: Research Strategy

• 12 pages total• Organize the Research Strategy in the specified

order and using the new instructions. • Start each section with the appropriate section

heading—Significance, Innovation, Approach. • Cite published experimental details in the

Research Strategy section and provide the full reference in the Bibliography and References Cited section


• Organization of Research Strategy (1)

• Aim 1 Significance, Innovation, Approach. • Aim 2 Significance, Innovation, Approach• Aim 3 Significance, Innovation, Approach


• Organization of Research Strategy (2)

• Significance of Aim 1, Aim 2, Aim 3• Innovation of Aim 1, Aim 2, Aim 3• Approach of Aim 1, Aim 2, Aim 3


• Approach • Describe the overall strategy, methodology, and analyses to be

used to accomplish the specific aims of the project. Include howthe data will be collected, analyzed, and interpreted as well asany resource sharing plans as appropriate.

• Discuss potential problems, alternative strategies, and benchmarks for success anticipated to achieve the aims.

• If the project is in the early stages of development, describe any strategy to establish feasibility, and address the management ofany high risk aspects of the proposed work.

• Point out any procedures, situations, or materials that may be hazardous to personnel and precautions to be exercised.


• Preliminary Studies. For new applications, use this section to provide an account of the PI's preliminary studies pertinent to this application

• Discuss the PI’s preliminary studies, data, statistical methods and/or experience pertinent to this application.

• Including preliminary experience with methods and patient populations and/or animal models.


• Final Comments• Need to include anticipated results, alternative

methods and potential problems. • If the project is in the early stages of development,

describe any strategy to establish feasibility, and address the management of any high risk aspects of the proposed work.

• BE SURE to emphasize clinical importance or novelty and innovation of the proposal!

How do I increase my chances of getting funded?

• Write a good grant-good idea, well thought out, clearly written, follow correct format-? Translational

• Do not misspell words, make it look good• Submit to correct study section• If revised, follow recommendations of

reviewers, do NOT argue with reviewers, do NOT insult reviewers

How do I increase my chances of getting funded?

• Submit often• Have a senior, funded colleague read

the grant proposalHave an English major read the proposal

• Collaborate with senior investigators

How is the process changing?

• Shorter applications• Only 2 vs 3 reviews• Scored 1 thru 9• Shortened and

? Improved peer review process

Questions?

WRITING A REVISION: Formulating Your Response and Rebuttal ‐Yolonda L. Colson MD, PhD ‐

Getting your grant together and submitted to the NIH is an exciting, albeit stressful, milestone in your research career. However, looking up your score and reading the reviewer comments (i.e. previously called pink sheets) after the Study section (SRG) has met is likely to be much less exciting and a lot more frustrating. Grants are rarely funded on the first submission, but now only a single resubmission is allowed, making the art of the revision even more important . When you first read the reviews, it is natural to be discouraged and angry. Who are these idiots that reviewed your grant anyway? Clearly you need to call your program officer and get a re‐review and appeal this score or at the very least get this grant reviewed in another study section ‐ all of these are normal thoughts and reactions but rarely are they correct. Start by reading the reviews in a general manner to get the gist of the different reviewer’s thoughts and then put the review away for a week or so, while you think about what you were trying to communicate the reviewers. Then re‐read the review again and this time make a list of strengths and weaknesses mentioned in the review and write down any experiments that you think will be necessary before you can resubmit this grant for funding. Are there any fatal flaws? Do the reviewers think the problem is not significant or does your grant not address the hypothesis? Is the research not seen as innovative? Study your grant and look at your grant as the reviewers see it? If you still think there is a major mistake in the review, then graciously and calmly speak with your program officer and get feedback about the discussion at the study section ‐ was it generally favorable but one weakness prevented a fundable score? Does the focus of your grant seem to be an area of interest for this study section etc? Get help from experienced researchers in determining if your grant can be significantly improved to be potentially fundable with the next review? Do not expect your mentor to do a line‐by‐line edit but they can read your review and grant and give you an idea of how far off you really are. It does not matter if you improve your score on your RO1 from the 50th to the 25th percentile as neither is unlikely to get funded. But if you can improve your score from the 18th to the 14th percentile it may make a significant difference, particularly if you are a new NIH investigator? This session will discuss some of the common "fixable" and more difficult problems identified in grants, how you go about writing your response to the reviewers, and what is involved in a resubmission. Show your reviews (and a draft of your response) to other experienced grant writers before you spend a lot of time on your rebuttal and talk with them about what you think you can (and cannot) correct and how. See if they think you have adequately answered the criticisms and how much difference these changes are likely to make in your score. If possible, get your preliminary data accepted for publication (in as high an impact journal as you can) before you resubmit‐ it makes a strong statement as to the credibility and importance of your work. Take your time to make your grant as perfect as you can before you resubmit ‐ it is your last chance for that grant so work on answering the criticisms completely, succinctly and without anger. If you disagree with a reviewer, respectfully make your case with facts and acknowledge that you may not have made this clear in the original proposal. Getting NIH funding is the holy grail of any academic research career so it is not surprising that it takes lots of work, is difficult to obtain and it will likely take several attempts. Remember, there is always another grant cycle, another idea, another grant you can submit, so if you don't get your first grant funded don't give up – think of it more like a batting average than a sure thing and just keep on swinging, learn with each submission, use the resources you gain here and on the web from the NIH, and seek out mentors to help you succeed. Grant Basics, includes links to planning and writing applications: http://grants.nih.gov/grants/grant_basics.htmI Peer‐review and Summary statements: http://grants.nih.gov/grants/peer_review_process.htm#Summary General Good “How‐to” Advice: http://grad.georgetown.edu/doc_pool/Grant_Writing.J.Neale.pdf Sample R01 grants & summary statements: http://funding.niaid.nih.gov/researchfunding/grant/pages/appsamples.aspx

Yolonda L. Colson MD, PhDAssociate Professor of SurgeryBrigham and Women’s Hospital

Harvard Medical School

2011 AATS Grant Writing Workshop

WRITING A REVISION: Formulation Your Response

and Rebuttal

“PINK SHEETS”

Reading your Summary Statement

Summary Statements

Anger, Denial and Despair

are a normal part of reading a critical review of your

“perfect” grant…

©Henry T. Kaiser/Photolibrary & www.avantipress.com

The 2nd Stage of Reading Your Summary Statements ..

Let’s agree to respect each others views,

no matter how wrong yours may be …

©Ashleigh Brillant on despair.com

Summary Statements: Acceptance

Before you can write a successful revision and make your grant better,

you must accept the criticism as constructive and address each point.

Parts of a Summary Statement

Summary of DiscussionDescription (rephrasing what you said)

Public Health Relevance3‐4 Reviewer Critiques with scores for each of 5 criteria (scale of 1‐9)

The Reviewer Critique

Summary of Strengths and WeaknessOverall ImpactIndividual Scores in Each of 5 Criteria: ‐ Significance, Investigators, Innovation, Approach, Environment

Other Critical Areas that must be addressed:‐ Protection of Human Subjects, Vertebrate Animals, Biohazard, Resubmission (response to prior critique), Budget and period of support, Resource Sharing Plan

Understanding your ScoreImpact Score Descriptor Additional Guidance on Strengths/Weaknesses

High

1 Exceptional Exceptionally strong with essentially no weaknesses

2 Outstanding Extremely strong with negligible weaknesses

3 Excellent Very strong with only some minor weaknesses

Medium

4 Very Good Strong but with numerous minor weaknesses

5 Good Strong but with at least one moderate weakness

6 Satisfactory Some strengths but also some moderate weaknesses

Low

7 Fair Some strengths but with at least one major weakness

8 Marginal A few strengths and a few major weaknesses

9 Poor Very few strengths and numerous major weaknesses

Minor Weakness: An easily addressable weakness that does not substantially lessen impactModerate Weakness: A weakness that lessens impactMajor Weakness: A weakness that severely limits impact

Impact/Overall Priority Score:Mean score from all eligible members' impact/priority scores x 10. Final overall impact/priority scores range from 10 (high impact) through 90 (low impact).

*.* means not scored, generally rank in the lower half of all submitted applications.

REALITYREALITY

One Chance to Revise a Grant and Raise The Score

Into the “Fundable” Range

• How Significant & Innovativeis your proposal ‐‐ really?

• Identify Critical Strengths and Weaknesses

• What areas can and cannot be improved?

• Can you address the criticisms scientifically without using the word “Idiot”?

• Get Advice from your Program Officer

Critically Evaluate Your Grant

Critically Assess Likelihood of a Revised Grant Getting Funded

Did the Reviewers –• Like the Overall Concept?

•Agree with Significance and Innovation?

•Identify Discrete “Fixable” Items that will yield Major Improvements?

•Identify Any Fatal Flaws?

Can You Improve Your GrantEnough to Get it Funded ?

It does not matter if you improve the score on your RO1 from the 50th to the 25th percentile – neither is fundable

It will likely matter significantly, however, if you can improve your score from the 18th to the 14th percentile, especially if you are a new investigator.

LISTENLISTEN

There is value in what the Reviewers are saying to you

Set Your Ego Aside and Listen

Make a worksheet that outlines the REVIEWERS Opinion …

The Important Clinical Problem Addressed

Strengths and Weaknesses

Areas/Questions NOT addressed

New Experiments Required

Fatal Flaws in Design or Concept

Common “Fixable” Problems

Poor writing

Significance not clear

Feasibility of approach not clearInsufficient information in experimental details, preliminary dataFailure to discuss alternatives and obstacles as part of research design

Too Ambitious – Cut Aims, Experiments

More Difficult Issues

• Reviewers question significance‐ Rarely benefit from change in Study Section

• Hypothesis not supported or not credible

• Work previously described ‐ (i.e. nothing new)

• Methods or experimental design are inaccurate or not appropriate for hypothesis

WRITING A REVISION: WRITING A REVISION:

Giving your Grant a Second Chance!

Writing a Grant Revision

Highlight StrengthsUse reviewer’s own words

Address WeaknessesDirect positive responses

Answer QuestionsRespectful, factual data

Risky to Add Unrequested New Ideas/Aims

Seek Advice of “Experts” and Mentors

Befriend an Experienced Mentor

Show your Reviews and a draft of your response to an NIH‐funded investigator• Talk about what you can/cannot fix and how• Have you answered the reviewers’ criticisms?• How much difference is it likely to make in your score?

Remember they have been through this themselves … learn from their mistakes and experience

Example of Grant RevisionIntroduction (1 page ):The proposal received many favorable reviews from the Study Section, including

comments such as: “The local drug delivery approach they propose to understand and develop is at the cutting edge of materials science and therapy.”; “The proposed work could have very significant impact…”; “They have a clear vision for taking the science through to the translational research.”; “The idea of creating a scaffold that delivers drugs and must serve some mechanical function is challenging, and their solution to this is innovative.”…“Well‐articulated proposal, with very few weaknesses.”; “The PI has a strong publication record… and significant preliminary data.”; “…experimental design is excellent, with logical progression ….”; ”Choice of models and imaging methods using dual labels …are excellent aspects of the experimental design.”; “… and innovation is high.”

The reviewers made insightful comments and provided valuable feedback on areas that have now been improved. Our responses are summarized below and new text in the proposal is highlighted by a * at the nearest paragraph indent. In addition, our first paper demonstrating prevention of tumor recurrence following resection in vivo is in press and was highlighted as a work of special interest to this field (Annals of Surgical Oncology, 2009, Epub Dec. 3).

Example of Grant RevisionDetailed Responses to Reviewers (included in 1‐page intro):

Q: “it is not clear that this will prevent reoccurrence.”

A: Our preliminary data show that we can prevent local recurrence after resection in a murine model (see section 3.3.2.3) using the paclitaxel loaded films. Although metastatic disease was not prevented given the aggressive nature of the LLC model, the longest surviving recipients all received drug‐eluting copolymer films.

Q: “Biggest weakness of the proposed work (which overall is excellent) is their proposed mechanical characterization. The two big issues are (1) Cyclic loading is inherent to this application and a thorough test plan is not included, and (2) the fluidic environment and degradation will have a huge impact….”

A: We have included a test plan and will evaluate film performance in a fluid environment using an Instron equipped with a fluid chamber located in the BioInterface Technologies (BIT) center at BU.

Revised Grant

• Entire revised grant application + 1‐page introduction

• Make clear what changes were made in answer to reviewers questions

• Incorporate new changes into grant proposal ‐ “Free‐standing” proposal with new improved science

• Mark changes in grant text‐ Sidebar marks, parentheses, or underline

PUBLICATIONSOne of the most important things you

can do to support your revised grant is to publish papers supporting your grant hypothesis etc.

Peer‐review in a high impact journal is very powerful

• Builds Basic Science Reputation – Credibility

If at First you Don’t Succeed

Remember‐‐‐

You Have to Just Keep Trying!

We Have All Been There ‐‐ Because Eventually You Succeed!!

© Stuart Crossett & www.avantipress.com

An Overview of Peer Review at CSR – Critical Do’s and Don’ts

Joy Gibson, D.Sc. Director, DTCS

American Association for Thoracic Surgery

March 4, 2011

National Institutes of HealthU.S. Department of Health and Human Services

National Institutes of HealthNational Institutes of Health

National Instituteon Alcohol Abuseand Alcoholism

National Instituteof Arthritis andMusculoskeletal

and Skin Diseases

National CancerInstitute

National Instituteon Drug Abuse

National Instituteof Environmental Health Sciences

National Instituteon Aging

National Instituteof Child Health

and HumanDevelopment

National Institute onDeafness and Other

CommunicationDisorders

National EyeInstitute

National HumanGenome Research

Institute

National Instituteof Mental Health

National Instituteof NeurologicalDisorders and

Stroke

National Instituteof General

Medical Sciences

National Instituteof Nursing Research

National Libraryof Medicine

Center for Center for Scientific ReviewScientific Review

National Centerfor Complementary

and AlternativeMedicine

National Instituteof Allergy and

Infectious Diseases

FogartyInternational

Center

National Centerfor ResearchResources

Clinical Center

National Center on Minority Health andHealth Disparities

National Institute of Biomedical Imagingand Bioengineering


Center for InformationTechnology

National Heart,Lung, and Blood

Institute

National Instituteof Dental andCraniofacial

Research

National Instituteof Diabetes andDigestive and

Kidney Diseases

National Institutes of Health

Center for Scientific ReviewCenter for Scientific Review

Study SectionStudy Section

Institute

Advisory Councils and Boards

Institute Director

Assigns to IC & I IRG/Study Section

Reviews for Scientific Merit

Evaluates for Relevance

Recommends Action

Takes Final Action

InitiatesResearch Idea

ConductsResearch

Allocates FundsAllocates Funds

Submits ApplicationSubmits Application

Review Process for a Research GrantReview Process for a Research Grant

Research Grant Application

School or Research Center

Scientific Review ProcessScientific Review ProcessDual Review System for Grant ApplicationsDual Review System for Grant Applications

Second Level of ReviewSecond Level of ReviewNIH Institute/Center NIH Institute/Center

CouncilCouncil

First Level of ReviewFirst Level of ReviewCSR or Institute ReviewCSR or Institute ReviewScientific Review Group Scientific Review Group

(Study Section)(Study Section)

• Receives all NIH applications

• Refers them to NIH Institutes/Centers and to scientific review groups

• Reviews majority of grant applications for scientific merit

Your Application Goes to the Your Application Goes to the NIH Center for Scientific Review (CSR)NIH Center for Scientific Review (CSR)Focal Point for Initial Review at NIH

CSR Mission StatementCSR Mission Statement

To see that NIH grant applications receive fair, independent, expert, and timely reviews – free from inappropriate influences – so NIH can fund the most promising research.

Translational and Clinical Sciences

Cardiovascular and Respiratory Sciences

Surgical Sciences, Biomedical Imaging and

Bioengineering

Musculoskeletal, Oral Musculoskeletal, Oral And Skin Sciences And Skin Sciences

Oncology 2 Oncology 2 ––Translational Clinical Translational Clinical

Vascular and Vascular and HematologyHematology

Physiological and Pathological Sciences

Endocrinology, Endocrinology, Metabolism, Metabolism, Nutrition &Nutrition &

Reproductive SciencesReproductive Sciences

ImmunologyImmunology

Infectious DiseasesInfectious Diseases& Microbiology& Microbiology

Digestive, Kidney &Urological Systems

Neuroscience, Development and Aging

Brain Disorders &Brain Disorders &Clinical NeuroscienceClinical Neuroscience

Molecular, Cellular &Molecular, Cellular &Developmental NeurosciencDevelopmental Neuroscience

Integrative, Functional & Integrative, Functional & Cognitive NeuroscienceCognitive Neuroscience

Emerging Technologies &Emerging Technologies &Training in NeuroscienceTraining in Neuroscience

Biology of Development and Aging

Biobehavioral &Biobehavioral &Behavioral ProcessesBehavioral Processes

Risk, Prevention& Risk, Prevention& Health Health BehaviorsBehaviors

Epidemiology & Epidemiology & Population Sciences Population Sciences

Healthcare Delivery Healthcare Delivery & Methodologies& Methodologies

AIDS &AIDS &Related ResearchRelated Research

AIDS, Behavioral and Population Sciences

Basic and IntegrativeBiological Sciences

Biological Chemistry & Biological Chemistry & Macromolecular Macromolecular

Biophysics Biophysics

Bioengineering SciencesBioengineering Sciences& Technologies& Technologies

Genes, Genomes Genes, Genomes & Genetics & Genetics

Oncology 1 Oncology 1 –– Basic Basic TranslationalTranslational

Cell BiologyCell Biology

Interdisciplinary Interdisciplinary Molecular Molecular & Training& Training

CSR Review Divisions

Integrated Review GroupsMusculoskeletal, Oral and Skin Sciences

Surgical, Biomedical Imaging and BioengineeringCardiovascular and Respiratory SciencesVascular and Hematology

Oncology, Clinical and Translational

Division of Translational and Clinical SciencesDivision of Translational and Clinical Sciences

Clinical and Integrative Cardiovascular Sciences

Cardiac Contractility and Heart Failure

Electrical Signaling, Ion Transport and Arrhythmias

Myocardial Ischemia and Metabolism

Cardiac Differentiation and Development

Lung Injury, Repair and Remodeling

Respiratory Integrative Biology and Translational ResearchLung Cellular, Molecular and Immunobiology

Help Get Your Application to the Right Study SectionHelp Get Your Application to the Right Study Section

• Review CSR Integrated Review Group and Scientific Review Group (Study Section) guidelines to identify a home for your application.

• Submit a Cover Letter!


http://www.csr.nih.gov/


Integrated Review Group


Study Section

Cardiovascular and Respiratory Sciences IRGCardiovascular and Respiratory Sciences IRG

• Cardiac Contractility, Hypertrophy and Failure• Cardiovascular Differentiation and

Development (CDD)• Clinical and Integrative Cardiovascular

Sciences (CICS) • Electrical Signaling, Ion Transport and

Arrhythmias (ESTA) • Myocardial Ischemia and Metabolism (MIM)• Lung Injury, Repair and Remodeling (LIRR)• Lung Cellular, Molecular and Immunobiology• Respiratory Integrative Biology and

Translational Research (RIBT)

Surgical, Biomedical Imaging and Bioengineering IRGSurgical, Biomedical Imaging and Bioengineering IRG

• Clinical, Molecular Imaging and Probe Development (CMIP)

• Medical Imaging (MEDI)

• Surgery, Anesthesiology and Trauma (SAT)

• Bioengineering, Technology and Surgical Sciences (BTSS)

• Biomedical Imaging Technology A & B (BMIT)

Division of Translational and Clinical Sciences Division of Translational and Clinical Sciences (DTCS) Trans(DTCS) Trans--IRG Imaging SEPIRG Imaging SEP

• Goal - review of multidisciplinary, translational research with a focus on imaging

Transformative in nature (translational research)Include humans Use imaging as a measure of diagnosis, intervention or treatment success/efficacy

• Editorial Board (Two Stage) ReviewFirst stage – 3 mail reviews (technical focus)Second stage – 3 clinical impact reviews

• Crosses disciplines of cancer, cardiovascular, musculoskeletal and neuroscience

15

Submit a Cover LetterSubmit a Cover Letter

The cover letter should be used for a number of important purposes: •Suggest Institute/Center assignment•Suggest review assignment•Identify individuals in conflict•Identify areas of expertise needed to evaluate the application •Discuss any special situations•Required for an electronic changed/corrected submission

It is NOT appropriate to use the cover letter to suggest specific reviewers.

At Least Three Reviewers Are Assigned to At Least Three Reviewers Are Assigned to Your ApplicationYour Application

• If you are a New Investigator or Early Stage Investigator

• If you submit an R01 grant application

• If NIH has correct info on your career stage

Your Career Stage Is ConsideredYour Career Stage Is Considered

•• New Investigator (NI): New Investigator (NI):

PD/PI who has not yet competed successfully for a substantial NIH research grant

o For multiple PD/PIs-all PD/PIs must meet requirements for NI status

•• Early Stage Investigator (ESI):Early Stage Investigator (ESI):

PD/PI who qualifies as a New Investigator AND is within 10 years of completing the terminal research degree or is within 10 years of completing medical residency (or equivalent)

Peer Review in CSRPeer Review in CSR

• CSR Study Sections are managed by a Scientific Review Officer (SRO) who is a doctoral-level professional, whose scientific background is close to the focus of the study section.

• Each CSR standing study section has 12-25 regular members who are from the scientific community.

• Temporary members are recruited as needed.

• About 60-100 applications are normally reviewed at each study section meeting.

Your Study Section Meeting Your Study Section Meeting The Role of Your Scientific Review The Role of Your Scientific Review OfficerOfficer

Designated Federal Official responsible for the overall review process

Your Application Is Reviewed In OrderYour Application Is Reviewed In Order

Clustered and Ordered for Fairness

•New and Early Stage Investigator applications are usually reviewed first

•Applications in each cluster are reviewed in order of their preliminary scores

• Reviewers discuss about 50-60% of the applications

• The panel will discuss any application a reviewer wants to discuss

Discussions Focus on the Best Applications Discussions Focus on the Best Applications

Additional Review PlatformsAdditional Review Platforms

• Helps to recruit reviewers

• Electronic review modes reduce travel

• Electronic ReviewsTelephone Assisted MeetingsVideo Assisted MeetingsTelepresenceInternet Assisted Meetings

• Editorial Board Review – multidisciplinary

Review CriteriaReview Criteria

• Overall Impact: Assessment of the likelihood for the project to exert a sustained, powerful influence on the exert a sustained, powerful influence on the research field(s) involvedresearch field(s) involved

• Core CriteriaSignificanceInvestigator(s)InnovationApproachEnvironment

oo Review criteria each scored from 1Review criteria each scored from 1--99

How Your Application Is Aligned to the ReviewHow Your Application Is Aligned to the Review

Criteria Application Section

Significance Research Strategya. Significance

Investigator(s) BiosketchPersonal Statement

Innovation Research Strategyb. Innovation

Approach Research Strategyc. Approach

Environment ResourcesEnvironment

9-Point Score Scale Descriptors

Impact Score Descriptor Additional Guidance

High

1 Exceptional Exceptionally strong with essentially no weaknesses

2 Outstanding Extremely strong with negligible weaknesses

3 Excellent Very strong with only some minor weaknesses

Medium

4 Very Good Strong but with numerous minor weaknesses

5 Good Strong but with at least one moderate weakness

6 Satisfactory Some strengths but also some moderate weaknesses

Low

7 Fair Some strengths but with at least one major weakness

8 Marginal A few strengths and a few major weaknesses

9 Poor Very few strengths and numerous major weaknesses

• Scores for each review criterion

• Essentially unedited critiques

• Administrative notes if any

If your application is discussed, you also will receive:

• An overall impact/priority score and percentileranking

• An Summary of review discussion

• Budget recommendations

Your Summary StatementYour Summary Statement

• Read instructions• Never assume that reviewers will know what you mean• Refer to literature thoroughly • State rationale of proposed investigation• Include well-designed tables and figures• Present an organized, lucid write-up• Obtain pre-review from faculty at your institution

NIH Grant Writing Tips

http://grants.nih.gov/grants/grant_tips.htm

When Preparing an ApplicationWhen Preparing an Application

Additional Factors to ConsiderAdditional Factors to Consider

• Focus on significance/impact• Make it exciting• Be very clear• Do not assume too much• Have realistic aims and timelines -- Don’t be too

ambitious• Be brief with things that everybody knows• Note the study’s limitations• Proofread the application

Who Can Answer Your Questions?Who Can Answer Your Questions?

Before You Submit Your Application

• A Program Officer at an NIH Institute or Center

After You Submit

• Your Scientific Review Officer

After Your Review

• Your Assigned Program Officer

Key NIH Review and Grants Web SitesKey NIH Review and Grants Web Sites

NIH Center for Scientific Reviewhttp://www.csr.nih.gov

NIH Office of Extramural Researchhttp://grants.nih.gov/

Helpful HandoutsHelpful Handouts

Insiders Guide What Happens to NIH Grant Application to Peer Review Your Grant Application Useful Web Links

http://cms.csr.nih.gov/publications/

Pedro J. del Nido

only for internal agency use- will not be shared with reviewers.

Review 50 to 120 grants per cycle (Feb, June, October)Cover specific areas of scientific research“Peer review”Assign priority score and provide critiques

Study Section MeetingUsually lasts 2 daysChair (member of section) and SRA in chargeInstitute representatives can attend but can’t discussReviews/discussion occursMembers privately write a priority score for each grant

ImpactImpact addresses:

Probability of whether the research will exert a sustained, powerful influence on the research field.

SignificanceSignificance addresses:

Does the project address an important problem or a critical barrier to progress in the field?

If the aims are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved?

Does application challenge/seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions?

Concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broadsense?

Refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

•• Personal Statement: Personal Statement:

• Why their experience and qualifications make them particularly well-suited for their roles in the project

•• Publications:Publications:

•• Recommended: no more than 15Recommended: no more than 15------up to five of the up to five of the bestbest; up to five of ; up to five of the the most relevant most relevant to the proposed research; up to five of the to the proposed research; up to five of the most most recentrecent

• If Early Stage Investigators or New InvestigatorsEarly Stage Investigators or New Investigators, do they have appropriate experience and training?

• If Established,Established, have they demonstrated ongoing record of accomplishments that have advanced their field(s)?

Lack of clarity and focus in the specific aims

Lack of acceptable scientific rationale

Lack of knowledge of published relevant work

Lack of pilot data, no-one in your team has

experience in essential methodology

Lack of attention to detail in your research methods – superficial, overly ambitious

Lack of a critical approach

Lack of recognition of potential problems and proposed solutions

Lack of value of the proposal – result and methods already well established

Lack of confidence that you will complete the protocol

It must be clear that you (and other relevant

people) will spend enough time on the project

Demonstrate that you have all the necessary

people, PATIENTS and laboratory resources to be

successful

STARTING TOO LATE

Remember the “pros” take months (full-time)

preparing grants – you are being compared with

them

NIH: www.nih.govOffice of Extramural Research

www.nih.gov/grants/oer.htmGrants Policy

www.grants.nih.govCenter for Scientific Review

www.csr.nih.govOverview of Peer Review Process

www.csr.nih.gov/review/peerrev.htmCSR Study Section Rosters

www.csr.nih.gov/review/ssroster.htm

Mock Study Session Grants will be

distributed onsite

David Jones University of Virginia

Documents

Transcript of David Jones University of Virginia