Fishing in DoD Waters
Medical Research Playbook &
Beyond
Dr. James K. Gilman, MD
Executive Director
Johns Hopkins Military & Veterans
Health Institute
1
Guest Appearances
• Dr. Eva Lai
• Mike McLoughlin
• Dr. Steve Kaminsky
2
(1) Basic Research, (2) Applied Research, and (3) Advanced
Technology Development to prove tech-base concepts for
medical products (drugs, biologics & devices) and information
START
Strategic Guidance
and Requirements,
Good Ideas
Contracting
Activities,
Regulatory
INTRAMURAL &
Compliance,
EXTRAMURAL
RESEARCH
Funding
Not
Vehicle,
Etc.
Approved
Recommended for
Funding (Approval)
Internal
Programmatic
Review
PI Responds to
Review
• JPC: Joint Program Committee
• IIPT: Integrating Integrated Products Team
• RAD: Research Area Directorate
Program
Defined
PROGRAM DECISIONS
Broad Agency
Announcement,
Program
Announcement,
Etc.
SOLICITATIONS
EVALUATIONS
RESEARCH PROPOSALS
INTERNAL PROGRAMMATIC REVIEW
• JPC / IIPT / RAD conduct programmatic
review and integration
• Comprised of Army, Air Force, Navy, DoD,
NIH, VA, Others
• RADs coordinate and integrate with each
other, CDMRP, and TATRC
• RADs maintain research portfolios for
research areas
• Evaluates programmatic relevance
• Comparison-based evaluation
• Evaluates proposals evaluated across
multiple disciplines
• Considers External Scientific Peer Review
(criteria-based)
• Integrates across research areas and
capability gaps
Preproposal
Submitted
• TAM: Task
Area
Manager
• PM:
Program /
Project Mgr
• SME: Subject
Matter
Expert
TAM / PM / SME
Review for
Relevance and
Impact
Not
Approved
Full Proposal
Requested and
Received
External
Scientific Peer
Review
3
Slide Courtesy of USAMRMC
Yin & Yang Framework
Programmatic Review
Science & Technology
Grants
Requirement
Pre-proposal
Core Program
Research Program
ACQUISITION
PA
Requirements
Driven
Research Project
Cooperative Agreements
Hypothesis
Driven
BAA
Congressional
Special Interest
Proposal
Capability
Scientific Review
Advanced Development
4
Just a Few Acronyms
(at least to me)
•
•
•
•
•
•
•
•
DoD – Department of Defense (Department)
MHS – Military Health System
DHP – Defense Health Program
DARPA – Defense Advanced Research
Projects Agency
DTRA – Defense Threat Reduction Agency
ONR – Office of Naval Research
USAMRMC – US Army Medical Research &
Materiel Command
Services – Army, Navy, Air Force, Marines
5
Yin & Yang Framework
Programmatic Review
Requirement
Pre-proposal
Core Program
PA
Requirements
Driven
Science & Technology
Grants
Research Program
Hypothesis
Driven
BAA
Congressional
Special Interest
Research Project
Proposal
Capability
Cooperative Agreements
Scientific Review
6
Advanced Development
Requirement vs Capability
• Requirement
• Problem to be solved
• Determined by the
funding organization
• More requirements
than money
• Prioritization is key
• Not determined by
research community
• Priorities may shift
• Capability
• Solution to a problem
• Not the solution that
works in the lab
• Not the solution that
works once
• Solution has to work
at scale under
operational conditions
7
Yin & Yang Framework
Programmatic Review
Requirement
Pre-proposal
Core Program
PA
Science & Technology
Grants
Research Program
Hypothesis
Driven
BAA
Requirements
Driven
Research Project
Cooperative Agreements
Congressional
Special Interest
Proposal
Capability
Scientific Review
Advanced Development
8
Fundamental Nature of Research
Hypothesis Driven
Requirements Driven
• Researcher’s bright ideas • Customer specified
• Acquisition model
• Knowledge focused
• Problem focused
• Stable long-term funding
• Must answer the question • Solve problem with
fewest resources
and determine
• Empiric problem solving
mechanism
accepted
• Publication &
• Publications,
presentations are the coin
presentations are byof the realm
products
Requirements driven and sponsored research are synonymous.
9
Yin & Yang Framework
Programmatic Review
Requirement
Pre-proposal
Core Program
PA
Science & Technology
Grants
Research Program
Hypothesis
Driven
BAA
Requirements
Driven
Research Project
Cooperative Agreements
Congressional
Special Interest
Proposal
Capability
Scientific Review
Advanced Development
10
Grants vs Cooperative Agreements
• Grants used by NIH
• No pre-specified
deliverables
• Major risk is to next
grant
• Other than reports,
the gov’t is hands off
• Used extensively by
NIH
• Cooperative
Agreement - used by
DoD
• Specific deliverables
• Periodic reviews can
result in loss of funds
• Gov’t is a participant
in planning work
• Used by DoD
Contracts (DARPA) are the most prescriptive.
11
Yin & Yang Framework
Programmatic Review
Requirement
Pre-proposal
Core Program
PA
Science & Technology
Grants
Research Program
Hypothesis
Driven
BAA
Requirements
Driven
Research Project
Cooperative Agreements
Congressional
Special Interest
Proposal
Capability
Scientific Review
Advanced Development
12
Core Program vs Congressional
Special Interest
• Core program
• Money requested by
DoD in Pres Budget
• Enduring military
requirement
• Money available over a
number of years (aka
programmatic funding)
• Plans cover multiple
years
• Intramural expertise
• CSI
• Money not requested
by DoD
• Money added by
Congress
• Not a military
requirement (priority)
• No assurance of money
in subsequent years
• Very little goes inside
DoD
CSI:$$ with disease attached. Earmark:$$ with Zipcode attached.
13
Research Priorities
•
•
•
•
•
Core programs
Behavioral health
TBI,Cognition
Suicide prevention
Infectious diseases
(malaria, dengue,
diarrhea, HIV)
• Orthopedics
• Combat casualty care
• Congressional
Special Interest
• Breast cancer
• Prostate cancer
• Ovarian cancer
• ALS
• Spinal cord injury
• Autism
CSI programs much more like civilian priorities.
14
Yin & Yang Framework
Programmatic Review
Requirement
Pre-proposal
Core Program
PA
Science & Technology
Grants
Research Program
Hypothesis
Driven
BAA
Requirements
Driven
Research Project
Cooperative Agreements
Congressional
Special Interest
Proposal
Capability
Advanced Development Scientific Review
15
Scientific vs Programmatic Review
• Scientific Review
• Much like NIH
processes
• Usually done outside
the DoD (AIBS)
• Done by subject matter
experts when available
• Objective –criteria
known
• Pick the best projects
• Programmatic Review
• Unique to DoD
• Done by group inside
DoD
• Criteria are more
subjective
• Pick the best group of
projects based on a
plan (program)
16
Yin & Yang Framework
Programmatic Review
Requirement
Pre-proposal
Core Program
PA
Requirements
Driven
Research Project
Science & Technology
Grants
Research Program
Hypothesis
Driven
BAA
Congressional
Special Interest
Proposal
Capability
Cooperative Agreements
Advanced Development Scientific Review
17
PA vs BAA
• Program
announcement
• Boundary conditions
specified
• Relatively specific
• Money has been
allocated and will be
awarded
• Broad agency
announcement
• Trolling for good
ideas
• Fewer constraints
• Boundaries may be
vague
• No dollar limit
• May be little (or no)
All will appear on grants.gov money to spend
18
Yin & Yang Framework
Programmatic Review
Requirement
Pre-proposal
Core Program
Science & Technology
Grants
Research Program
Hypothesis
Driven
PA
BAA
Requirements
Driven
Research Project
Cooperative Agreements
Advanced Development
Congressional
Special Interest
Proposal
Capability
Scientific Review
19
Pre-proposal vs Proposal
• Pre-proposal
• Short
• Focused – easy to
read
• Screened – not
necessarily by SME’s
• Can someone reading
this quickly
understand its
relevance
• Proposal
• More detailed
• Focused – easy to
read
• Scientific and
programmatic reviews
• Will both appeal to
SME’s and have
obvious relevance
20
Yin & Yang Framework
Programmatic Review
Requirement
Pre-proposal
Core Program
Science & Technology
Grants
Research Program
Hypothesis
Driven
PA
BAA
Requirements
Driven
Research Project
Cooperative Agreements
Advanced Development
Congressional
Special Interest
Proposal
Capability
Scientific Review
21
Project vs Program
• Stand alone effort
• If designed well, can
answer important
questions
• Works well for simple
problems, incremental
benefit
• Requires assurances of
money before beginning
• Linear, stepwise, each
step complete before next
one starts
• Group of projects
• Must be arranged in
proper sequence – some
processes in parallel,
others in sequence
• Usually required for
complex problems
• Multi-year funding profile
• Completing a group of
projects in non-linear
fashion to achieve results
while conserving
resources
Understanding DoD’s programs is paramount for success.
The most expensive resource is time.
22
DoD/VA HBO2 Research Program
USAFSAM Pilot
Study (n=50)
We must know these before we
start pivotal trial:
VA/VCU/USN Dose Ranging Study
(n=60)
IND
Filed
- sham method validated
Type C
meeting
End
Phase II
TMA & UHMS
Submission
HOPPS IND Pilot Study (n=96)
Outcome Validation Project
- dose selection of HBO2
- outcome measure
validated to detect change
after intervention
- establish range of placebo
effect to determine
sample size
Mechanisms of Action Study (BIMA) (n=60)
Chambers
Installation at 4
MTFs
Outcomes in Normals Study (n=75)
Long Term Follow-Up
DSMB
DSMB
DSMB
DSMB
Multicenter Pivotal Trial?
(n=300+)
Jan ‘11
Jul’11
Jan ‘12
Jul ‘12
Courtesy of COL Robert S. Miller
Jan ‘13
Jul ‘13
Jan ‘14
Jul ‘14
Jan ‘15
23
Consortium Awards
• AFIRM – regenerative medicine
• CAP / STRONGSTAR – PTSD
• CENC – TBI
May request proposals from outside the
consortia but loyalty to charter members is
certainly an expectation.
24
(1) Basic Research, (2) Applied Research, and (3) Advanced
Technology Development to prove tech-base concepts for
medical products (drugs, biologics & devices) and information
START
Strategic Guidance
and Requirements,
Good Ideas
Contracting
Activities,
Regulatory
INTRAMURAL &
Compliance,
EXTRAMURAL
RESEARCH
Funding
Not
Vehicle,
Etc.
Approved
Recommended for
Funding (Approval)
Internal
Programmatic
Review
PI Responds to
Review
• JPC: Joint Program Committee
• IIPT: Integrating Integrated Products Team
• RAD: Research Area Directorate
Program
Defined
PROGRAM DECISIONS
Broad Agency
Announcement,
Program
Announcement,
Etc.
SOLICITATIONS
EVALUATIONS
RESEARCH PROPOSALS
INTERNAL PROGRAMMATIC REVIEW
• JPC / IIPT / RAD conduct programmatic
review and integration
• Comprised of Army, Air Force, Navy, DoD,
NIH, VA, Others
• RADs coordinate and integrate with each
other, CDMRP, and TATRC
• RADs maintain research portfolios for
research areas
• Evaluates programmatic relevance
• Comparison-based evaluation
• Evaluates proposals evaluated across
multiple disciplines
• Considers External Scientific Peer Review
(criteria-based)
• Integrates across research areas and
capability gaps
Preproposal
Submitted
• TAM: Task
Area
Manager
• PM:
Program /
Project Mgr
• SME: Subject
Matter
Expert
TAM / PM / SME
Review for
Relevance and
Impact
Not
Approved
Full Proposal
Requested and
Received
External
Scientific Peer
Review
25
Slide Courtesy of USAMRMC
USAMRMC Basic Process Slide
Preparing to
Fish
Congress
approves
a budget
Program
Announced
Proposal
Scientific
Review
Got a
bite
Programmatic
Review
Got a
Fish!
Award is Made
Preproposal
Starting
to Fish
Cooperative
Agreement is
Negotiated
26
Preparation
• Today is part of it
• Determine whether DoD is interested in
the kind of research you do (or get ready
to do research they want done)
• Find the people doing research inside DoD
– connect
• Attend the Military Health System
Research Symposium
27
2013 Military Health System
Research Symposium
$1.2
Billion
(2013)
Hopkins – 1 abstract, 1 podium presentation, 4
attendees
28
The Competition
•
•
•
•
Other academic centers
Commercial laboratories
Not-for-profit labs (e.g. Battelle)
In contrast to NIH, no preliminary
data required
Played
this game
longer
29
DARPA & ONR
Michael
McLoughlin
Senior Scientist
JHUAPL
jgilman5@jhu.edu
443-287-5060
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