Opportunities for Collaboration at the NIH Clinical...

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Opportunities for Collaboration at the NIH Clinical Center The Johns Hopkins Institute for Clinical and Translational Research John I. Gallin, M.D. Director, NIH Clinical Center November 28, 2012

Transcript of Opportunities for Collaboration at the NIH Clinical...

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Opportunities for Collaboration at the NIH Clinical Center

The Johns Hopkins Institute for Clinical and Translational Research

John I. Gallin, M.D. Director, NIH Clinical Center

November 28, 2012

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NEI

NCI NHLBI NIAID

NIDCR

NIH Institutes and Centers

NIDDK NIAMS

NIDA

CIT

NIEHS

NIMH

NINDS

NCCAM

NIMHD

NIDCD

NIGMS NINR

NIAAA

NICHD

NLM

CC

OD

NIA

NHGRI

FIC

NIBIB

CSR

NCATS

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Mission

Science

Patient Care/ Safety

Training

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Clinical Center Profile • More than 450,000 patients since opening in 1953

• 240 beds; FY 2012 Budget $395.2M

• Hospital surrounded by research labs

• Every patient is on a research protocol

• Care is free

• Patient travel/housing provided as needed

• 2,250 CC employees + ~4,000 employees from 17 ICs that use hospital

• 1,255 credentialed physicians

• Over 1,500 active protocols

• Interventional/Clinical Trials - 707 (47%) • Natural History - 713 (47%) • Screening - 71 (5%) • Training - 22 (1%)

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Major Emphasis

•First in human with new therapeutics •Study of patients with rare diseases ~400 cohorts currently

18 – 25 million people in the United States have a rare disease!

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Rare Diseases at the NIH Clinical Center

The Clinical Center has the ability to assemble cohorts of patients with rare diseases

• Number of Rare Diseases 383

• Number of Protocols 603

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Specialized Services and Facilities

• Phenotyping

o Biomechanics laboratory

o Metabolic chambers • Cell Processing/GMP Facility

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• PET Program o 3 cyclotrons

o Radiochemistry/GMP Facility

o 3 scanners

Specialized Services and Facilities

Imaging Capabilities

• MRI Center

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3T integrated simultaneous MRI-PET

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• Product formulation

• Analytical and quality control

• Pharmacokinetics

• Manufacturing capability (8 hour day)

o 75,000 capsules

o 150,000 tablets

o 220 liters

o 5,000 syringes

o 8,000 vials (includes vaccines and biologics)

Pharmaceutical Development Service GMP Facility

Specialized Services and Facilities

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Training Clinical Investigators

The Clinical Center has trained many of the leaders

of academic medicine throughout the United States

and abroad.

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NIH Curriculum in Clinical Research

Ethical and Regulatory Aspects of Human Subjects Research 4,603 participants since course began in 1999

Introduction to the Principles & Practice of Clinical Research 11,965 participants since course introduced in 1995

Principles of Clinical Pharmacology 7,525 participants since course began in 1998

October 2011 http://clinicalcenter.nih.gov/training/index.html

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Lima, Peru

New Delhi, India

Athens, Greece

San Juan, Puerto Rico

Monterrey, Mexico

Buenos Aires, Argentina

Singapore

Rabat, Morocco

Beirut, Lebanon

Riyadh, Saudi Arabia

Republic of Kenya

Pretoria, South Africa

Sui nin, China

Wuhan, China

Cali, Colombia

Santa Maria, Brazil

Burkina Faso,

West Africa

Busan, S. Korea

Malaysia

Chengdu, China

Live Archived

Bergen, Norway

Pune, India

Irbid, Jordan

Bangalore, India

Santiago, Chile

Beijing, China

Ibadan, Nigeria

Karachi, Pakistan

Masan-City, S. Korea

Seoul, S. Korea

Since 1995,

Over 26,000 students world-wide

have participated

in the NIH Curriculum

in Clinical Research

Guatemala City, Guatemala Incheon, S. Korea

Sao Paolo, Brazil

Rotterdam, The Netherlands

Mysore, India

Canberra, Australia

Colonia Roma, Mexico

Mexico City, Mexico

• Live course in China: 2008-2009

• Live course in Nigeria: May 2010

• Live course in Russia: November 2011

• Live course in India: October 2012

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Sabbatical in Clinical Research Management http://clinicalcenter.nih.gov/training/sabbatical/index.html

Modules • Module 1: Critical Infrastructure • Module 2: Support Services • Module 3: Legal & Regulatory Infrastructure • Module 4: Communications and Outreach • Module 5: Strategic Management • Module 6: Funding Opportunities

Popular Electives

• Protocol Writing & Tracking • CTSA • Planning & Budget Development • Patient Recruitment • Quality and Performance Metrics • Food & Drug Administration • NIH Office of Human Subjects Research

Flexible advanced training in management of a clinical research enterprise

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Funding Opportunities

for Collaborative Research

with Investigators

at the NIH Clinical Center

•Bedside to Bench Awards •New Funding Opportunity

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Bedside-to-Bench Awards

• A program established in 1999 to promote new partnerships between basic

science & clinical investigators

• Goals:

• Develop new clinical protocols

• Discover new therapeutics and devices

• Foster long standing collaborations

• Since 2006 Intramural and Extramural Investigator partnerships

To-date: Over 800 PIs and AIs have collaborated on 205 projects with ~ $48M in total funding

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B2B Partnerships 2006 – 2012 146 Partnerships at 73 U.S. & International Sites

Hospital A.C. Camargo, Brazil

Hospital for Sick Children, Canada

Imperial College, London

Intl. Agency for Research on Cancer,

France

Makerere University, Uganda

Sackler Sch. of Med, Israel

University of Toronto, Canada

University of Oxford, UK

Zaria, Nigeria

MT

WY

ID

WA

OR

NV

UT

CA

AZ

ND

SD

NE

CO

NM

TX

OK

KS

AR

LA

MO

IA

MN

WI

IL IN

KY

TN

MS AL GA

FL

SC

VA WV

MI NY

PA

MD DC

DE

NJ CT

RI MA

ME

VT NH

AK

HI

NC

OH

26 CTSA

sites

partnered

on

B2B awards

since 2006

CTSA site

Non-CTSA partnership

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JHU Bedside-to-Bench Awardees Since 2006:

• 26 JHU investigators have partnered on 16 B2B projects

• Total funds to JHU: $1,269,206

• JHU Collaborators: 1. Frank Bengel, MD 2. Dana Boatman, PhD, CCC-A 3. Peter Calabresi, MD 4. Allen Chen, MD, PhD, MHS 5. Steve Yoon-Ho Cho, MD 6. Harry (Hal) Dietz, MD 7. Christopher Endres, PhD 8. Dr. Qin Fu 9. Ronald Gray, MD, MSc 10. Joany Jackman, PhD 11. Gregory Kirk, MD, MPH, PhD 12. Shenghan Lai, MD, MPH 13. Ryan Lee, MD

14. Joao Lima, MD, MBA 15. Joseph Margolick, MD 16. Alan Meeker, PhD 17. Susumu Mori, PhD 18. James Mudd, MD 19. Deborah Persaud, MD 20. Martin Pomper, MD, PhD 21. Richard Rothman, MD, PhD 22. Chloe Thio, MD 23. David Thomas, MD, MPH 24. Elaine Tierney, MD 25. Jennifer Van Eyk, PhD 26. Ilan Wittstein, MD

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Next Cycle: Bedside-to-Bench Awards

• Proposed Award Categories: • AIDS • General • Rare Diseases • Behavioral & Social Sciences • Women’s Health • Stem Cell Research

• Timeline: • Call for proposals: January 2013 • Letters of Intent Due: March 2013 • Notification of LOI Decision: April 2013 • Full Proposal Due: May 2013 • Awards: Fall 2013, pending NIH FY 14 budget

• Contact Information: • Email: [email protected] • Website: http://clinicalcenter.nih.gov/ccc/btb/index.html

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New Funding Opportunity

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“The role of the NIH Clinical Center should be to serve as a state-of-the-art national resource, with resources optimally

managed to enable both internal and external investigator use.”

Response: New NIH funding opportunity: “Opportunities for Collaborative Research at the NIH Clinical Center”

http://grants.nih.gov/grants/guide/notice-files/NOT-HD-12-025.html

http://smrb.od.nih.gov/

Congressional NIH Scientific Management Review Board 2010

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NCI

NEI

NHGRI

NHLBI

NIAAA

NIAID

NIAMS

Institutes Signed on to FOA

NIBIB

NICHD

NIDA

NIDCD

NLM

ORWH

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•Goal: to support collaborative research projects aligned with NIH efforts to enhance the translation of basic biological discoveries into clinical applications that improve health

•Up to $500K/year in direct costs x 3 years, renewable

•Teams must have one extramural and one intramural co-principal investigator

•U01 cooperative agreement mechanism

• Some of the work must be done at the CC

Funding Opportunity Announcement (FOA) Highlights

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•Receipt dates: March 20, 2013 (also 2014 & 2015) •One award cycle/year

•Council dates: October 2013, 2014 & 2015

•Award date: Early in FY

•Application Special Requirements: •Collaboration Plan •Collaboration Letters

FOA Highlights (continued)

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Grantees (all applications are U01s) submit Letter of Intent

LOI assessed by CC Director and Sponsoring

Institute

Grant submission

Grant peer review

Funded grants queued (if required) for

implementation by CC

Strongly recommended

At discretion of IC (IC study section/CSR)

Batched annually with single closing date. If no LOI, full grant assessed by CC Director and sponsoring IC for resource availability and program alignment

Queue based on assessment of current capacity (awards early in FY)

Review Process

Assessed for resource availability and program alignment

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•Is the Collaborative Plan well defined with identifiable responsibilities for the NIH intramural & extramural investigators?

•Is a plan for management of the collaboration presented, as well as descriptions of what each participant proposes to provide to the collaborative partnership?

•Is there a clear, well described advantage to bringing intramural & extramural investigators together in a collaborative partnership?

•Is it clear what unique CC research opportunities will be utilized?

Review Criteria

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U01 Grant Money Flow

IC

Collaborating PI

Clinical Center

Extramural Intramural*

*ICs have flexibility how these programs will be funded. Funds flow to be determined before award.

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Cost Model for CC Activity

•Maintain services for the Intramural Research Program

•Simple and transparent

•CC determines patient care costs based on standard templates provided by PI o No overhead costs o No charge for existing patients unless new services o IC costs for patient care included o No charge for professional services o Costs constant for life of grant

•Annual evaluation of cost model

Key Principles

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Overview of Proposed CC Cost Model Charge Type

Cost* Comments

Inpatient days ~30% of total cost* Costs based on PCU to which patient assigned as determined by DRG (diagnosis-related group)

Outpatient visits ~30% of total cost for tests or procedures*

Traceable to CC Service Master; direct costs only

Specialized Services

Full cost Includes fee for service items (e.g., research PET, Dept. Transfusion Medicine) and special services (e.g., Pharmacy GMP)

*Calculated to capture full cost of drugs, supplies, temp labor plus margin to cover unforeseen risks; overhead costs excluded

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Preparing the Budget

Extramural PI

• Detailed budget required; no modular budgets.

• Budget request for the intramural investigator and the Clinical Center should be listed separately in “Section F. Other Direct Costs”.

Intramural PI

• The intramural PI will create a budget request limited to the proposed work.

• Budget may include contract staff, but not federal employees.

Clinical Center

• Identify Clinical Center costs for grant as defined by the template provided.

• CC to work with ICs to define resource requirements for IC services (e.g., pulmonary function tests).

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Sample Budget Template Clinical Center Budget Template

General Information

Inpatient Services

Cost per Inpatient Day (Based on DRG)

Year 1/etc.

PI Name Dr. Jones Collaborating IC NCI

PI Institute Johns Hopkins Univ Collaborating PI Dr. Smith

Grant/Study Name

Gross Anatomy

Projected # of Patients

Projected # of inpatient/ day/patient

Total # of IP Days

ICD-9 Code

Cost/ IP Day

Estimated Cost

10 5 50 $1,000 $50,000

Technical Services

Year 1/etc.

Test/ Procedure/Service

CPT code if applicable

Projected # of patients

Projected # of services/pt

Total # of Services

Cost/ Service

Estimated Cost

MRI w/ and w/o contrast

70553 10 2 20 $435.12 $8,702

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Preparing the Budget Urge early contact with Clinical Center staff

for assistance

Clinical Center Partnerships Mailbox: [email protected] Phone: 301.496.4121

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Upcoming Webinar for New FOA

• January 11, 2013 •2:00PM – 4:00PM

•Key NIH leadership for Q & A

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