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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
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
Mission
Science
Patient Care/ Safety
Training
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%)
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!
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
Specialized Services and Facilities
• Phenotyping
o Biomechanics laboratory
o Metabolic chambers • Cell Processing/GMP Facility
• PET Program o 3 cyclotrons
o Radiochemistry/GMP Facility
o 3 scanners
Specialized Services and Facilities
Imaging Capabilities
• MRI Center
3T integrated simultaneous MRI-PET
• 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
Training Clinical Investigators
The Clinical Center has trained many of the leaders
of academic medicine throughout the United States
and abroad.
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
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
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
Funding Opportunities
for Collaborative Research
with Investigators
at the NIH Clinical Center
•Bedside to Bench Awards •New Funding Opportunity
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
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
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
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
New Funding Opportunity
“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
NCI
NEI
NHGRI
NHLBI
NIAAA
NIAID
NIAMS
Institutes Signed on to FOA
NIBIB
NICHD
NIDA
NIDCD
NLM
ORWH
•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
•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)
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
•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
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.
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
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
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).
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
Preparing the Budget Urge early contact with Clinical Center staff
for assistance
Clinical Center Partnerships Mailbox: [email protected] Phone: 301.496.4121
New Website
http://www.cc.nih.gov/translational-research-resources/
Upcoming Webinar for New FOA
• January 11, 2013 •2:00PM – 4:00PM
•Key NIH leadership for Q & A