Department of Defense Congressionally Directed Medical Research Programs

Department of Defense Congressionally Directed Medical Research Programs US Army Medical Research and Materiel Command (USAMRMC) An Overview of Medical Research Opportunities in the Department of Defense (DOD) “DTRA, DARPA, USAMRMC, CDMRP, and Other Exciting Acronyms” Presented to The American Physiological Society Presented by Janet Harris, Ph. D. , RN Colonel, US Army Nurse Corps Director, CDMRP 30 April 2007 US Army Medical Research & Materiel Command 1

Department of Defense Congressionally Directed Medical Research Programs Goals For This Discussion: t General overview of DOD-related biomedical research t Highlights of 3 large funding agencies: v DARPA (Defense Advanced Research Projects Agency) v DTRA (Defense Threat Reduction Agency) v CDMRP (Congressionally Directed Medical Research Programs) ² Mix of specific cancer therapies, prion disease ² The “Peer Reviewed Medical Research Program” – Infectious Diseases, CBN-Defense, Chronic Diseases (including Gulf War) t Advice on how to “navigate” the system t One manager’s advice on ways to succeed…. US Army Medical Research & Materiel Command 2

Department of Defense Congressionally Directed Medical Research Programs Some Realistic Generalizations about DOD Medical Research t Several different programs - each with its own mission, administration, rules t Difficult to follow diversity + timelines t Generally, less paperwork is required than the standard RO 1 grant (submission and management) t Many are “annual” or periodic competitions t Majority focus on very “specific” goals/objectives t The competitive programs follow the Federal Acquisition Regulation (FAR) – apolitical US Army Medical Research & Materiel Command 3

Department of Defense Congressionally Directed Medical Research Programs Comparison of the Three Programs: Characteristic Budgets Performers Technology levels, focus Solicitation (Concepts) Review DARPA 3 Billion/100 -200 M Biomedical Primarily extramural Proof of concept, Variety of topics Broad mix - Open BAA’s and investigator-driven Send to multiple expert reviewers DTRA 160 M – Core 100 -300 M–TMTI DOD with EM “Partners” – Core CDMRP 350 M – 400 M Mix of DOD and extramural EM with DOD “Partners” - TMTI (Primarily extramural) Proof of concept to pre-clinical – all WMD Clinic research, mainstream problems Specific goals, objectives to meet DOD requirements Open programs advocated by Congress NIH-style review 2 step US Army Medical Research & Materiel Command 4

Department of Defense Congressionally Directed Medical Research Programs Defense Advanced Research Projects Agency (DARPA) t DARPA is the central research and development organization for the DOD t DARPA’s mission is to maintain the technological superiority of the US military and prevent technological surprise from harming our national security by sponsoring revolutionary, high-payoff research that bridges the gap between fundamental discoveries and their military use t Defense Sciences Office (DSO) programs in the biological sciences explore four key areas: defending against biological warfare agents and naturally emerging pathogens, maintaining human combat performance, enhancing system performance via biologically inspired designs, and biomaterials US Army Medical Research & Materiel Command 5

Department of Defense Congressionally Directed Medical Research Programs DSO Biological Research Programs Biological Warfare Defense Maintaining Combat Performance t Accelerated Manufacture of t Preserving Combat Performance Pharmaceuticals t Control of Protein Conformations t Femtosecond Adaptive Spectroscopy Techniques for Remote Agent Detection t Battlefield Medical Care and Soldier Recovery from Injury t Automated Battlefield Trauma Pods t Intestinal Fortitude t Novel Pain Medications t Protein Design Processes t Development of Neural- t Rapid Vaccine Assessment controlled Upper Extremity Prosthesis t Self Decontaminating Surfaces Enhancing System Performance Bio-Materials t Biological Sensory Structure Emulation t Bio-Magnetic Interfacing Concepts t Biologically Inspired Multifunctional t Bio-Molecular Motors Dynamic Robotics t Bio-Optic Synthetic Systems t Engineered Bio-Molecular Nano Devices/Systems t Stealthy Sensors US Army Medical Research & Materiel Command 6

Department of Defense Congressionally Directed Medical Research Programs DSO Future Areas of Interest Biology and Biomedical t New approaches to understand mitigate the deleterious effects of environmental stresses (stress, fear, etc. ) that address both the physiological and the psychological effects of those environments t Research to advance the understanding of neuroscience for the improvement of learning, memory, and training t New approaches for developing a fundamental understanding of the response of the body to blast in order to improve the design of protection Biological Warfare Defense t New concepts for reliable and minimally invasive pre-symptomatic diagnosis t New ideas to revolutionize the large-scale manufacture of vaccines and therapeutics such that millions of doses can be produced within a few months of the discovery of a threat US Army Medical Research & Materiel Command 7

Department of Defense Congressionally Directed Medical Research Programs Website – http: //www. darpa. mil/dso/index. htm US Army Medical Research & Materiel Command 8

Department of Defense Congressionally Directed Medical Research Programs Defense Threat Reduction Agency (DTRA) t DTRA serves two key roles in support of the DOD Chemical and Biological Defense Program - Funds Manager and Joint Science and Technology Manager t Intramural (i. e. , Service lab research) and extramural research directed toward medical chemical and biological defense is programmed and managed by the DTRA Joint Science and Technology Office (JSTO) US Army Medical Research & Materiel Command 9

Department of Defense Congressionally Directed Medical Research Programs JSTO Medical Mission t Primary: Develop new products/processes that interfere with the action of chemical, biological, toxicological agents of WMDs t Specific: Protect/treat “those in harm’s way” US Army Medical Research & Materiel Command 10

Department of Defense Congressionally Directed Medical Research Programs JSTO CBM S&T Goals t Deliver on the vaccines promised to JPEO t Push at least one multi-agent vaccine to the Advanced Developer t Deliver on a short-term CWA protection (bioscavenger) t Establish rapid “bug-to-drug” anti-viral/toxin/microbial program t Develop and implement strategy on broad-spectrum countermeasures for emerging threats t Deliver data packages supporting FDA approval for medical diagnostic assays and devices t Adapt existing medical countermeasures against nontraditional agents (NTAs) t Exploit technologies for early indicators of exposure/infection US Army Medical Research & Materiel Command 11

Department of Defense Congressionally Directed Medical Research Programs JSTO CBM S&T Strategy t Accelerate development cycle… (Rapid vaccine and drug development) t Exploit cutting edge technologies… To improve medical countermeasures against established highpriority CB agents and against emerging CB agents and effects t Leverage existing capability… Found in other federal agencies, industry, academia, and international partners t Sustain long-term investment… In developing candidates for capability gaps t Ensure knowledge base… To support future technology development US Army Medical Research & Materiel Command 12

Department of Defense Congressionally Directed Medical Research Programs Transformational Medical Technology Initiative (TMTI) Strategy Future Solutions Today’s Threats Continue today’s program Modes of Action Anthrax Receptor Binding Smallpox Signal Transduction Botulinum Decoys Plague Immune Avoidance Tularemia Translation/Transcription Ebola/Filo Immune Deregulation Hemorrhagic Fever Replication Encephalitis Virulence Expression SARS Parallel Systems Approach Target Commonalities t Agents v Essential pathways- survival, virulence t Host v Modulate immune response v “Final common pathways” of pathogenesis Influenza Ricin, SEB, others v Most likely broad spectrum v No “antibiotic selection Bioengineered One PIECE at a time pressure” (resistance) Process Analysis Broad Spectrum US Army Medical Research & Materiel Command 13

Department of Defense Congressionally Directed Medical Research Programs Website – http: //www. dtra. mil US Army Medical Research & Materiel Command 14

Department of Defense Congressionally Directed Medical Research Programs USAMRMC Scope of the Mission US Army Medical Research & Materiel Command 15

Department of Defense Congressionally Directed Medical Research Programs Life-Cycle Management: Uniting the Effort US Army Medical Research & Materiel Command 16

Department of Defense Congressionally Directed Medical Research Programs USAMRMC Core S&T Programs Military Infectious Diseases t t t t Medical readiness Vaccines Biotechnology Prophylaxis/treatment drugs Diagnostics/prognostics Vector control Medical C 4 ISR HIV countermeasures Combat Casualty Care t t Lightweight medical equipment Medical C 4 ISR Trauma care Health monitoring & diagnostic technology Military Operational Medicine t t t 17 Soldier selection & sustainment Soldier performance Warrior system modeling Health hazards protection Diagnostics/prognostics Health monitoring Combat Casualty Care 11% Military Infectious Diseases 17% Med Chem Defense 15% Military Operational Medicine 12% Core RDTE includes Army P 6 & Do. D funds Medical Chemical Defense t Medical management of CW casualties t Medical readiness t Drug prophylaxes/ pretreatments t Diagnostics/therapeutics Medical Biological Defense t Vaccines/therapies t Field-portable diagnostic systems t Medical readiness t Biotechnology US Army Medical Research & Materiel Command Med Bio Defense 45%

Department of Defense Congressionally Directed Medical Research Programs Collaborative by Nature & Necessity SUCCESSFUL LIFECYCLE MANAGEMENT COMMAND INTEGRATION OF DOD AND FDA REGULATIONS CBER COLLABORATIVE COMMAND Industry International Academia US Army Medical Research & Materiel Command 18

Department of Defense Congressionally Directed Medical Research Programs CDMRP History t 1992: Grassroots advocacy heightened political awareness of breast cancer t 1993: Congress appropriated $210 million (M) to the DOD budget for breast cancer research, managed by the CDMRP, after consultation with the Institute of Medicine (IOM) in fiscal year 1993 (FY 93) t 1997: IOM re-reviewed the breast cancer program t 1996 -2007: Additional research programs added: v 1996: Neurofibromatosis v 1997: Prostate Cancer and Ovarian Cancer v 1999: Peer Reviewed Medical Research v 2002: Prion, Tuberous Sclerosis Complex, and Chronic Myelogenous Leukemia v 2004: Myeloproliferative Disorders v 2006: Gulf War Veterans’ Illnesses v 2007: Autism US Army Medical Research & Materiel Command 19

Department of Defense Congressionally Directed Medical Research Programs CDMRP Funding History Millions ($) Research Program US Army Medical Research & Materiel Command 20

Department of Defense Congressionally Directed Medical Research Programs CDMRP Philosophy THE CENTRAL THEME IS INNOVATION t Vision: Find and fund the best research to eradicate diseases and support the warfighter for the benefit of the American public t Mission: We provide hope by promoting innovative research, recognizing untapped opportunities, creating partnerships, and guarding the public trust US Army Medical Research & Materiel Command 21

Department of Defense Congressionally Directed Medical Research Programs CDMRP Unique Features t Funds added to the DOD budget by Congress, generally as DHP (RDT&E) t Respond to targeted guidance from Congress t Two-tier formal review of proposals – IOM Model t Consumer advocate participation throughout process t Vision is adapted yearly to facilitate rapid change and address research gaps t Fund highly innovative research US Army Medical Research & Materiel Command 22

Department of Defense Congressionally Directed Medical Research Programs Filling Research Gaps and Taking Risks t Fund meritorious research that other agencies will not risk funding, supporting creativity and innovation t By funding early concepts, new research can be pursued to produce preliminary data needed to receive traditional research funding t Find innovative research that can leapfrog advances, rather than fund incremental steps US Army Medical Research & Materiel Command 23

Department of Defense Congressionally Directed Medical Research Programs Investment Strategy Based on Award Mechanisms US Army Medical Research & Materiel Command 24

Department of Defense Congressionally Directed Medical Research Programs Peer Reviewed Medical Research Program (PRMRP) t From FY 99 through FY 06, Congress appropriated a total of $344. 5 M through the PRMRP to fund peer-reviewed research focused on military health t Congress appropriated $50 M to continue the PRMRP in FY 06. The PRMRP requested proposals in 5 award mechanisms spanning 22 topic areas including: Chronic Pain and Fatigue Research, Eye and Vision Research, and Post-traumatic Stress Disorder t Many projects funded by the PRMRP have begun to yield combat health support technologies and products in the areas of combat casualty care, military infectious diseases, military operational medicine, chronic disease management, and medical chemical and biological defense US Army Medical Research & Materiel Command 25

Department of Defense Congressionally Directed Medical Research Programs Website – http: //cdmrp. army. mil US Army Medical Research & Materiel Command 26

Department of Defense Congressionally Directed Medical Research Programs General Advice for Success with DOD Submissions t Do the work we solicit – we have specific goals, look to see if your areas of interest match our needs t Be straightforward and honest – we have good scientists to review the work t Recent trends support “collaborations” with existing DOD labs (this may change over time) t Contact our people – see the website, each solicitation has several points of contact t If “recycling” work, put a little time into matching our format – we recognize old RO 1! t Be positive and enthusiastic! US Army Medical Research & Materiel Command 27

Department of Defense Congressionally Directed Medical Research Programs Resources t CDMRP – http: //cdmrp. army. mil t USAMRMC – https: //mrmc. amedd. army. mil t SBIR/STTR – https: //mrmc. amedd. army. mil/mrdpapspec. asp t New Products & Ideas Submissions – http: //www. usamraa. army. mil/pages/Baa_Paa/baa_choice. cfm t DTRA – http: //www. dtra. mil t DARPA – http: //www. darpa. mil t Fed. Biz. Opps – http: //cbd. cos. com t Grants. gov – http: //www. grants. gov US Army Medical Research & Materiel Command 28