CDMRP. The Congressionally Directed Medical Research Programs. Overview, Funding Process, and Strategies for Success. Rebecca Fisher, Ph.D.

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1 The Congressionally Directed Medical Research Programs Overview, Funding Process, and Strategies for Success Rebecca Fisher, Ph.D. Program Management Lead, CDMRP The views expressed in this presentation are those of the author and may not reflect the official policy or position of the Department of the Army, Department of Defense, or the U.S. Government CDMRP Department of Defense 29 March 2017

2 Outline Overview of the CDMRP CDMRP Funding Process Program Cycle Strategies for Success Finding the Announcement Application Submission Process Components of a Successful Application Summary 2

3 Who is the CDMRP? Department of Defense Department of the Army Army Medical Command Medical Research and Materiel Command Congressionally Directed Medical Research Programs 3

4 4

About CDMRP CONGRESSIONAL PROGRAMS: Manages extramural research programs directed by Congress Started in 1992 with Breast Cancer, now 27 programs Congress specifies disease area, CDMRP determines

high-impact, innovative medical research to find cures, reduce the incidence of disease and injury, improve survival, and enhance the quality of life for those affected DoD PROGRAMS: Provide support

Substance Abuse Disorders Amyotrophic Lateral Sclerosis Autism Bone Marrow Failure Breast Cancer Duchenne Muscular Dystrophy Epilepsy Gulf War Illness Joint Warfighter Medical Lung Cancer Military

Prostate Cancer Reconstructive Transplant Spinal Cord Injury Tick-Borne Disease Trauma Clinical Tuberous Sclerosis Complex Vision Additional Supported DoD Programs Defense Medical R & D Defense

5 About CDMRP CONGRESSIONAL PROGRAMS: Manages extramural research programs directed by Congress Started in 1992 with Breast Cancer, now 27 programs Congress specifies disease area, CDMRP determines research strategy and competitively selects the best projects Unique public/private partnership encompassing the military, scientists, disease survivors, consumers, and policy makers Funds high-impact, innovative medical research to find cures, reduce the incidence of disease and injury, improve survival, and enhance the quality of life for those affected DoD PROGRAMS: Provide support to Program Area Directorates (PADs) / Joint Program Committees (JCPs) for managing extramural and intramural research portfolios to advance their missions DIRECTOR: Col Wanda Salzer Alcohol and Substance Abuse Disorders Amyotrophic Lateral Sclerosis Autism Bone Marrow Failure Breast Cancer Duchenne Muscular Dystrophy Epilepsy Gulf War Illness Joint Warfighter Medical Lung Cancer Military Burn Multiple Sclerosis Neurofibromatosis Orthotics and Prosthetics Outcomes Ovarian Cancer Parkinson s Peer Reviewed Alzheimer s Peer Reviewed Cancer Peer Reviewed Medical Peer Reviewed Orthopaedic Prostate Cancer Reconstructive Transplant Spinal Cord Injury Tick-Borne Disease Trauma Clinical Tuberous Sclerosis Complex Vision Additional Supported DoD Programs Defense Medical R & D Defense Medical R & D Restoral Psychological Health and Traumatic Brain Injury Vision Setting Congressional Appropriations Program Announcement Release Application Receipt Peer Review Programmatic Review Funding Recommendation Approval Authority Decision Pre-Application Receipt Pre-Application Screening & Invitation Awards Management 1-7 Years Negotiations 5

Vision and Mission Transform healthcare for Service Members and the American public through innovative and impactful research Responsibly

6 Vision and Mission Transform healthcare for Service Members and the American public through innovative and impactful research Responsibly manage collaborative research that discovers, develops, and delivers health care solutions for Service Members, Veterans and the American public 6

7 History In the early 1990 s, grassroots efforts heightened political awareness of breast cancer Congress appropriated $210M to the FY93 DoD budget for a new Breast Cancer Research Program (BCRP) USAMRMC was directed to manage the BCRP The Army sought the advice of the National Academy of Medicine (previously Institute of Medicine), which resulted in: A two-tier review process A new model for research incorporating consumers into program policy, investment strategy, and research focus Since 1996, additional research programs and topics have been added by Congress and administratively managed by CDMRP 7

Hallmarks Targeted research funds added to DoD budget by Congress Consumers

for application review Funds high-impact innovative research Each program s vision

needs Avoid Duplication with other funding agencies Fills Unfunded/Unmet Gaps

Limited continuation funding No pay line; funding recommendations based on

8 Hallmarks Targeted research funds added to DoD budget by Congress Consumers participate throughout process National Academy of Medicine (IOM) recommended model for application review Funds high-impact innovative research Each program s vision and investment strategy are adapted annually, allowing rapid response to changing needs Avoid Duplication with other funding agencies Fills Unfunded/Unmet Gaps Funding flexibility Funds obligated up-front; limited out-year budget commitments Limited continuation funding No pay line; funding recommendations based on portfolio composition, adherence to intent of mechanism, relative impact in addition to technical merit 8

9 Unique Partnerships Demonstrate need Participate at all levels Passion and perspective Add funds to budget Targeted guidance IMPROVE HEALTH OUTCOME Innovation and gaps Risk/Benefit Product-oriented Program management Contracting actions Regulatory requirements 9

10 Consumers Grassroots consumer efforts led to targeted research funding and creation of the CDMRP The voices and experiences of consumers play a pivotal role in the establishment and growth of CDMRP research programs. Over 2,100 consumers representing over 1,000 organizations have served on CDMRP Peer Review and Programmatic Review panels 10

11 A Major Funder The CDMRP is THE leading U.S. funder for Neurofibromatosis research The CDMRP is the 2 nd largest U.S. funder for research in: Breast cancer Gulf War Illness Lung cancer Ovarian cancer Prostate cancer Tuberous sclerosis complex 11

12 FY16 Funding Program $M Program $M Alcohol and Substance Abuse Disorders $4.0 Peer Reviewed Alzheimer s $15.0 Amyotrophic Lateral Sclerosis $7.5 Peer Reviewed Cancer (13 Topics) $50.0 Autism $7.5 Peer Reviewed Medical (39 Topics) $278.7 Bone Marrow Failure $3.0 Peer Reviewed Orthopaedic $30.0 Breast Cancer $120.0 Prostate Cancer $80.0 Breast Cancer Research Semipostal $0.2 Reconstructive Transplant $12.0 Duchenne Muscular Dystrophy $3.2 Spinal Cord Injury $30.0 Epilepsy $7.5 Tick-Borne Disease $5.0 Gulf War Illness $20.0 Trauma Clinical $10.0 Joint Warfighter Medical (1) $50.0 Tuberous Sclerosis $6.0 Lung Cancer $12.0 Vision $10.0 Military Burn $8.0 Additional Supported DoD Programs: (1) Multiple Sclerosis $6.0 Centers of Excellence $3.1 Neurofibromatosis $15.0 Defense Medical R&D $120.5 Orthotics and Prosthetics Outcomes $10.0 Defense Medical R&D Restoral $31.6 Ovarian Cancer $20.0 Psychological Health and Traumatic Brain Injury $69.6 Parkinson s $16.0 Small Business Innovation Fund $3.6 * CDMRP is assisting with the management of a specified portion of a larger appropriation(s) (1) Approximate funding to be managed on behalf of others TOTAL = $1.1B 12

13 CDMRP Cancer Research Programs Breast Cancer (BCRP) FY92-FY16 = $3,261.3 Million (M) with 6,592 awards* Prostate Cancer (PCRP) FY97-FY16 = $1,530.0M with 3,050 awards Ovarian Cancer (OCRP) FY97-FY16 = $276.45M with 372 awards Lung Cancer (LCRP) FY09-FY16 = $101.5M with 166 awards Peer Reviewed Cancer (PRCRP; topics vary each year) FY09-FY16 = $149.8M with 323 awards *All award counts are through FY15; FY16 awards are still under negotiation 13

14 BCRP Overarching Challenges Prevent breast cancer (primary prevention) Identify determinants of breast cancer initiation, risk, or susceptibility Distinguish deadly from non-deadly breast cancers Conquer the problems of overdiagnosis and overtreatment Identify what drives breast cancer growth; determine how to stop it Identify why some breast cancers become metastatic Determine why/how breast cancer cells lie dormant for years and then re-emerge (recurrence); determine how to prevent recurrence Revolutionize treatment regimens by replacing them with ones that are more effective, less toxic, and impact survival Eliminate the mortality associated with metastatic breast cancer 14

15 PCRP Overarching Challenges and Focus Areas Develop better tools to detect clinically relevant disease in asymptomatic men Distinguish aggressive from indolent in men newly diagnosed with prostate cancer Develop effective treatments and address mechanisms of resistance for men with high risk or metastatic prostate cancer Develop strategies to optimize the physical and mental health of men with prostate cancer Biomarker Development Genetics Imaging Mechanisms of Resistance Survivorship and Palliative Care Therapy Tumor and Microenvironment Biology 15

16 OCRP Focus Areas Novel therapies and associated predictive biomarkers Non-invasive surveillance and assessment of disease Treatment resistance Immunotherapy Etiology, epidemiology, and prevention Early detection Rare subtypes Host-tumor interactions Survivorship and quality of life 16

17 LCRP Areas of Emphasis Identify or develop noninvasive or minimally invasive tools to improve the detection of the initial stages of lung cancer. Identify, develop, and/or build upon already existing tools for screening or early detection of lung cancer. Screening may include, but is not limited to, computed tomography scans, X-rays, imaging biomarkers, genetics/genomics/ proteomics/metabolomics/transcriptomics, and assessment of risk factors. Understand predictive and prognostic markers to identify responders and nonresponders. Understand the molecular mechanisms of initiation and progression to clinically significant lung cancer. Understand susceptibility or resistance to treatment. Identify innovative strategies for prevention and treatment of early and/or localized lung cancer. Understand contributors to lung cancer development other than tobacco. 17

FY16 Topic Areas for Peer Reviewed Cancer Research 1. Bladder Cancer 2. Colorectal Cancer 3. Immunotherapy 4. Kidney Cancer 5. Listeria Vaccine for Cancer 6.

Stomach Cancer Applicants must address at least one of the Topic Areas as directed by Congress The PRCRP offers funding opportunities that focus on addressing

18 FY16 Topic Areas for Peer Reviewed Cancer Research 1. Bladder Cancer 2. Colorectal Cancer 3. Immunotherapy 4. Kidney Cancer 5. Listeria Vaccine for Cancer 6. Liver Cancer 7. Lymphoma 8. Melanoma and other Skin Cancers 9. Mesothelioma 10. Neuroblastoma 11. Pancreatic Cancer 12. Pediatric Brain Tumors 13. Stomach Cancer Applicants must address at least one of the Topic Areas as directed by Congress The PRCRP offers funding opportunities that focus on addressing potential environmental cancer risks, and answering the gaps in the cancer care spectrum from prevention, through detection and diagnosis, prognosis, treatment, and survivorship. 18

FY16 Topic Areas for Peer Reviewed Medical Research 1. Acute Lung Injury 2. Antimicrobial Resistance 3. Chronic Migraine and Post- Traumatic Headache 4. Congenital Heart Disease 5.

Hydrocephalus 14. Inflammatory Bowel Disease 15. Influenza 16. Integrative Medicine 17. Interstitial Cystitis 18. Lupus 19. Malaria 20. Metals Toxicology 21. Mitochondrial Disease 22.

19 FY16 Topic Areas for Peer Reviewed Medical Research 1. Acute Lung Injury 2. Antimicrobial Resistance 3. Chronic Migraine and Post- Traumatic Headache 4. Congenital Heart Disease 5. Constrictive Bronchiolitis 6. Diabetes 7. Dystonia 8. Emerging Infectious Diseases 9. Focal Segmental Glomerulosclerosis 10. Fragile X Syndrome 11. Hepatitis B 12. Hereditary Angioedema 13. Hydrocephalus 14. Inflammatory Bowel Disease 15. Influenza 16. Integrative Medicine 17. Interstitial Cystitis 18. Lupus 19. Malaria 20. Metals Toxicology 21. Mitochondrial Disease 22. Nanomaterials for Bone Regeneration 23. Non-Opioid Pain Management 24. Pancreatitis 25. Pathogen-Inactivated Dried Plasma 26. Polycystic Kidney Disease 27. Post-Traumatic Osteoarthritis 28. Psychotropic Medications 29. Pulmonary Fibrosis 30. Respiratory Health 31. Rett Syndrome 32. Rheumatoid Arthritis 33. Scleroderma 34. Sleep Disorders 35. Tinnitus 36. Tuberculosis 37. Vaccine Development for Infectious Disease 38. Vascular Malformations 39. Women s Heart Disease Applicants must address at least one of the Topic Areas as directed by Congress 19

PRMRP Overview Vision: Improve the health and well-being of all military Service members, Veterans, and beneficiaries

7M Direction from Congress to support research of clear scientific merit and direct relevance to military health in

strategy established annually by the Joint Programmatic Review Panel, with representation of Services and VA

20 PRMRP Overview Vision: Improve the health and well-being of all military Service members, Veterans, and beneficiaries Established in FY99 Total appropriations: $1.37B FY16 appropriation: $278.7M Direction from Congress to support research of clear scientific merit and direct relevance to military health in specified topic areas Program funds and topic areas designated by congress annually Program vision and investment strategy established annually by the Joint Programmatic Review Panel, with representation of Services and VA Supported 840 awards (FY99 FY15) totaling over $963.44M in 122 topic areas (FY16 awards pending) Program is highly competitive - over 1700 pre-applications received in FY16! 20

21 Program Webpages Visit program webpages for additional information 21

Defense Health Agency and CDMRP As directed by the Assistant Secretary of Defense for Health Affairs, the Defense Health Agency (DHA) J9 Research and Development Directorate oversees the Defense

22 Defense Health Agency and CDMRP As directed by the Assistant Secretary of Defense for Health Affairs, the Defense Health Agency (DHA) J9 Research and Development Directorate oversees the Defense Health Programs (DHP) Research, Development, Test, and Evaluation appropriations Vision of the DHA J9 Research and Development Directorate: Advance collaborative, innovative medical research and development to improve military community health and save lives on and off the battlefield Joint, integrated focus includes Army, Navy, and Air Force CDMRP provides program and award management support to the DHA through USAMRMC DHP Congressional Special Interest (CSI) medical research programs Six DHP core research program areas (CDMRP Defense Medical Research and Development) 22

23 Joint Program Committees (JPCs) DHP Core Research Areas Medical Simulation and Information Sciences (JPC-1) Medical Modeling, Simulation, and Training Health Information Technology and Informatics Military Infectious Diseases (JPC-2) Bacterial Diseases Viral Diseases Diagnostics Development Military Operational Medicine (JPC-5) Musculoskeletal Injury Cognitive Health and Performance Psychiatry and Clinical Psychology Disorders Behavioral Health, Wellness, and Resilience Warfighter Physical Performance Nutrition and Weight Balance Sensory Performance, Injury, and Protection Millennium Cohort Study Environmental Toxicant Exposure Aircrew Health and Performance Combat Casualty Care (JPC-6) Damage Control Resuscitation Neurotrauma, Neuroprotection, and Neurodiagnostics Patient Movement/En Route Combat Casualty Care Extremity Trauma Systems of Critical Care Delivery Burn Injury Maxillofacial Trauma and Combat Dentistry Pre-Hospital Tactical Combat Casualty Care Military Medical Photonics Radiation Health Effects (JPC-7) Radiation Medical Countermeasures Development Clinical & Rehabilitative Medicine (JPC-8) Neuromusculoskeletal Rehabilitation Pain Management Regenerative and Rehabilitative Medicine Sensory Systems (Vision, Hearing, and Balance) 23

24 USAMRMC Strategic Process Fielded Medical Knowledge Fielded Medical Materiel Research to produce medical knowledge RESEARCH AND TECHNOLOGY ADVANCED DEVELOPMENT PROCUREMENT AND FIELDING Congressional Special Interest (CSI) Programs Programs directed by Congress Targeted Outcomes 24

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26 Program Cycle 26

27 Congressional language Current research landscape Emerging technologies Research gaps Impact Portfolio composition Vision Setting At Vision Setting each Year, the Programmatic Panel recommends an investment strategy, considering factors such as: 27

Award Mechanisms Pipeline Funding for all career stages Predoctoral Postdoctoral Physician Scientist New Investigator Established Investigator

28 Award Mechanisms Pipeline Funding for all career stages Predoctoral Postdoctoral Physician Scientist New Investigator Established Investigator Initial Concepts Early Ideas Clinical/ Translational Team Science Clinical Trials Closing gaps in research through innovative and impactful research 28

29 Funding Opportunities Numerous types of award mechanisms Tailored to the goals of each program May vary from year to year Each funding opportunity is made available through a Program Announcement (PA) or program-specific Broad Agency Announcement (BAA) Pre-announcement release CDMRP website and blast Funding Opportunity Postings Grants.gov electronic Biomedical Research Application Portal (ebrap) system CDMRP website FedBizOps.gov (BAAs) 29

30 Program Cycle 30

Goal of the Two-Tier Review Process Responsibly manage collaborative research that discovers, develops, and delivers

Partnership Criterion-based evaluation of full proposal Determination of absolute scientific merit Outcome: Written

and applicants Comparison among proposals of high scientific merit Determination of adherence to intent and program

31 Goal of the Two-Tier Review Process Responsibly manage collaborative research that discovers, develops, and delivers health care solutions for Service Members, Veterans and the American public. Partnership Criterion-based evaluation of full proposal Determination of absolute scientific merit Outcome: Written critique and scores for individual criteria and overall merit No standing peer review panels No contact between reviewers and applicants Comparison among proposals of high scientific merit Determination of adherence to intent and program relevance Outcome: Funding recommendations No pay line (portfolio balance) Funds obligated up front; no out-year budget commitments (but milestones imposed) No continuation funding 31

32 First Tier: Peer Review How the evaluation process works Technical merit assessment based on an ideal application Criteria-based evaluation of entire application Peer Reviewers Panels comprised of scientific and consumer reviewers No standing panels Reviewers recruited based on expertise needed Identities are not made known to applicants; contact between applicants and reviewers not permitted Outcome: Summary Statement 32

33 Second Tier: Programmatic Review How the evaluation process works Comparison-based Strong scientific merit Adherence to award mechanism s intent Potential for impact Program relevance Consideration of portfolio composition Programmatic reviewers Programmatic Panel Ad hoc reviewers Outcome: Funding recommendations 33

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35 Funding Opportunities on the CDMRP Website Funding Opportunities Visit Us At: 35

36 Funding Opportunities on ebrap Funding Opportunities & Forms Visit the Electronic Biomedical Research Application Portal (ebrap) at: 36

37 Funding Opportunities on Grants.gov SEARCH GRANTS Search for funding opportunities through Search Grants 37

38 Funding Opportunities on Grants.gov Search Grants by CFDA# for USAMRMC opportunities 38

39 Subscribe to notifications Sign up for listserve through CDMRP website or in ebrap 39

40 Subscribe to notifications Select the Program(s) you want to receive notices about 40

41 Synopses of Program Award Mechanisms On CDMRP website - provides a brief description and key elements of the current award mechanisms offered 41

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applicant organization ebrap: Electronic Biomedical

43 Application Process Overview BO: Business Official from applicant organization PI: Principal Investigator from applicant organization ebrap: Electronic Biomedical Research Application Portal SAM: System of Award Management 43

44 Pitfalls to Avoid in Application Submission Do not include Programmatic Panel members for the program and fiscal year to which you are applying Do not exceed the page limits; check files after creating PDF version Do not miss the submission deadline Grants.gov validation may take up to 72 hours System-to-system submissions are sometimes problematic Application verification in ebrap is possible before the deadline Submit the correct Project Narrative and Budget These components cannot be modified during the verification period in ebrap 44

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46 About Grant Application Understanding the intent of the award mechanism and review criteria is critical for a successful grant application 46

47 Review Announcement Single most important tip: Read the announcement carefully The announcement (PA or BAA) contains information on: Program Goals Focus Areas Award Intent Required Elements, Eligibility, and Funding Review Criteria Deadlines 47

48 Review Announcement These dates are critical There is no grace period for late submissions Start early do not leave until the last day Use the application verification period The Program Announcement and the General Application Instructions - read both 48

49 Review Announcement 49

50 Review Announcement 50

include both Focus Areas (mandatory) and Areas of

51 Review Announcement Some Focus Areas include detailed specifications (from FY15 Military Burn PA) Some PAs include both Focus Areas (mandatory) and Areas of Encouragement (from FY15 Orthotics and Prosthetics Outcomes PA) 51

52 Review Announcement 52

Review Announcement Award Information section includes key details such as: Intent: How the announcement aligns with program goals Examples of the types of research supported: Basic, Applied,

53 Review Announcement Award Information section includes key details such as: Intent: How the announcement aligns with program goals Examples of the types of research supported: Basic, Applied, Clinical Definitions: Knowledge Product, Clinical Trial, Proof of Concept Requirements: Inclusion of preliminary data Support for conduct of clinical trials and if so what type Military relevance and alignment Requirements for use of active-duty military or Veteran populations, research involving human subjects, human cadavers, animals Investigational New Drug/Investigational Device Exemption 53

54 Review Announcement PAs may have funding limits on Direct Costs or Total Costs (Direct + Indirect), so be sure to check Mistakes here can put your budget over the limit 54

55 Review Announcement All PAs use a two-step submission process: Pre-apps (Preproposal or Letter of Intent) via ebrap Full apps via grants.gov Familiarize yourself (and your Business Official [BO]) with ebrap and grants.gov requirements in advance Use the Verification Period! 55

56 Review Announcement Pre-application screening is done according to the criteria in the PA (typically by the Programmatic Panel) Applicants do not receive feedback Applicants must be invited to submit a full application 56

57 Review Announcement The Project Narrative and the Budget cannot be changed during the verification period in ebrap Detailed guidance is provided in the PA for the contents of these sections 57

58 Review Announcement Peer Review Criteria Scored Unscored Research Strategy and Feasibility Environment Impact Budget Transition Plan and Regulatory Strategy Application Presentation Personnel 58

59 Review Announcement Program Panel membership lists are available on the CDMRP website Consist of scientists, clinicians, consumers, and program staff from a wide variety of representative organizations 59

60 Review Announcement 60

61 Strategies for Success - Summary RELEVANCE Address program-specific goals Align the proposed work with specific guidance from the announcement IMPACT Propose solutions to important problems Clearly articulate translatability how will this work make a difference? INNOVATION Identify gap(s) that will be filled and novel approaches used FEASIBILITY Justify a technically sound plan with clear approaches for contingencies Include evidence of appropriate EXPERTISE (collaboration, consultants, etc.) Ensure the study is APPROPRIATELY POWERED for the proposed research outcome Demonstrate AVAILABILITY and ACCESS to critical resources, reagents, and/or subject populations 61

Strategies for Success - Summary PLANNING/TIMELINES Include and allow adequate time in project plan for regulatory approvals if required For multi-organizational efforts, show a clear plan for

62 Strategies for Success - Summary PLANNING/TIMELINES Include and allow adequate time in project plan for regulatory approvals if required For multi-organizational efforts, show a clear plan for COORDINATION and communication For DoD collaborations, understand rules and plan for differences in funding process GRANTSMANSHIP Explain the proposed work with CLARITY and UNBURDENED by jargon Respect the different audiences of the peer and programmatic reviews and COMMUNICATE effectively REVIEW application documents carefully before submission Enlist experienced colleagues to help Don t break the rules for deadlines or requirements BE COMPLIANT 62

63 Questions? Thank you! 63

The Congressionally Directed Medical Research Programs Funding Opportunities: Peer Reviewed Cancer Research Program

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