Thomas S. Bundt, PhD., FACHE COL, MS Commander, USAMRIID Contracting Opportunities at USAMRIID 20 November 2015 Disclaimer: Opinions, interpretations, conclusions, and recommendations are those of the presenter and are not necessarily endorsed by the U.S. Army.

Discussion Topics Who is USAMRIID What kinds of programs do we support Mission & Vision of the Laboratory Core Competencies What kinds of programs do we support Medical Biological Defense Countermeasure Research & Development What do we procure and how do we procure it Commercial Goods Services R&D Who are the contacts at USAMRIID Logistics & Procurement Research & Development

USAMRIID Mission and Vision Provide leading edge medical capabilities to deter and defend against current and emerging biological threat agents Vision To be the leader in the advancement of medical biological defense with world renowned experts dedicated to protecting our military forces and the nation Main points: Established by General Order No. 6, 27 January 1969, Office of the Surgeon General of the Army $480 Million in facilities and equipment ~900 Personnel military, civilian and contractor Over 200 physicians, veterinarians, and Ph.D. scientists from all allied medical sciences The unique national capabilities of USAMRIID in Biodefense are expensive to maintain Historically, the Biodefense program has provided the majority of the funding, and the transfer of program funding responsibilities from Army to ATSD(NCB) in 1994 and from NCB to DTRA in 2003 have not changed this. The Army’s core competencies and infrastructure supporting the MCBDP extend beyond RIID to other USAMRMC laboratories and the HQ. USAMRIID can not be effective as a stand alone lab. There are no sources of available Army S&T funding to supplant the OSD funding. The total of Army medical S&T (infectious disease, combat casualty care and military operational medicine) is equivalent to the MCBDP, and those funds are invested in internal laboratory operations at a higher percentage than the MCBDP. New NHP holding facility 13,000 GSF with 384 NHP capacity. Currently BSL-2. Medical Biological Defense Insurance Policy for the Nation

Core Competencies Prepare for Uncertainty Rapidly Identify Biologic Agents Provide World Class Expertise in Medical Biological Defense Train & Educate the Force Develop, Test & Evaluate Medical Countermeasures Biosafety & Biosecurity 4

Full Spectrum of Medical Biodefense Support PREVENTION DETECTION DIAGNOSIS TREATMENT MINUTES MONTHS HOURS DAYS YEARS PLANNING OPPORTUNITY REACTIVE Attack BIOLOGICAL DEFENSE VACCINES DRUGS IMMUNE GLOBULINS Diagnostics

Medical Countermeasure Research & Development Industry Universities Pharma Biotech HHS Research Product Evaluation Large-scale, medical product-evaluation capability Animal model development High-containment labs and animal facilities Aerosol exposures FDA-regulated studies Efficacy Testing DoD DHS HOW THIS SLIDE WORKS THE TOP ROW is a pictorial overview of the Medical R&D process Pharmaceutical research and development is a lengthy expensive process that can take a commercial pharmaceutical company 20 years and $850M on average to yield one licensed drug. Research -- is basic science and discovery Learning about how a disease processes works and discovering ways to control it. This photo here is of a high-throughput screening (HTS) production line that is capable of testing hundreds of thousands compounds looking for hits. One component of discovering promising countermeasures. Development – is the applied science of turning discoveries into useful products. The picture here shows a industrial fermenter capable of manufacturing vaccines Medical Product Testing – is the link between them Before a promising vaccine or drug can be licensed for use, it undergoes rigorous testing for safety and efficacy. Candidate vaccines and drugs must be proven safe and effective first in animals This is USAMRIID’s forte. If you have a promising vaccine for smallpox or Ebola, you have to come to USAMRIID to test it. This photo in the center shows several non-human primates undergoing tests for the new Ebola vaccine. USAMRIID is at a critical juncture in the interagency pipeline for biodefense R&D UPSTREAM increase investment in basic research and discovery phase Should produce a surge in promising candidate vaccines and drugs that need to be tested. DOWNSTREAM – Increased financial incentives for advanced development and stockpiling MIDSTREAM – Need proportional investment in the future for medical testing INCREASING DEMAND FOR USAMRIID’s UNIQUE CAPABILITIES USAMRIID has already seen agreements with government, academia, and industry expand rapidly since 2000, doubling and tripling year over year since year 2000. Animal studies increase X 3 Diagnostic studies increase X 8 Agreements with government X 3; academia X 3; industry X 3

What Do We Procure to Support our Mission? Commercial Goods Lab materials and supplies, capital equipment (administrative and scientific), administrative materials and supplies, animals and animal supplies Construction Services Renovation Research Services CFR-regulated research and development services (GLP, cGMP), laboratory testing, DNA sequencing, protein expression & purification Consultants, non-personal services Research & Development Innovative R&D integrated with in-house research projects in support USAMRIID’s core program

How Do We Obtain Products and Services ? Commercial Items & Commercial Services Credit Card Orders Established Contracts New Contracts R&D Contracts (Procurement, SBIR, STTR) Grants & Cooperative Agreements (BAA) Cooperative Research and Development Agreements (CRDA) Commercial Test Agreements (CTA) Interagency Agreements

How Much Do We Acquire ? Service contracts (USAMRAA) Approximately $50M Expendable medical – lab supplies, reagents (USAMRAA) Approximately $2.3M Expendable medical - credit card (USAMRIID) Approximately $10.4M Equipment Maintenance (USAMRAA) Approximately $6.2M Equipment Procurement (USAMRAA) Approximately $9.8M R & D (Contracts, Grants & Cooperative Agreements - USAMRAA) Approximately $3M - $11M 7. Construction – Renovation (USAMRAA - USACE) Approximately $3M - $10M

Where to look for procurement opportunities http://www.usamraa.army.mil/

USAMRIID POCs Logistics & Procurement Research & Development Ms. Beverly Williams Chief, Logistics Division USAMRIID 301-619-4719 Research & Development Ms. Cindy K. Fuchs, J.D. Director, Office of Research & Technology Applications 301-619-9835

USAMRIID In 2017 NIAID IRF BSL3/4 147K GSF 170-200 staff NBACC BSL3/4 160K GSF 120 staff New RIID BSL3/4 835K GSF 1000+ staff $511M construction cost Current ~140K GSF BSL3 21K GSF BSL4 Greater capacity, more capabilities for supporting medical countermeasure development! * Image courtesy of CUH2A, the contractor responsible for designing the new USAMRIID facility