UNITED STATES ARMY MEDICAL RESEARCH INSTITUTE OF INFECTIOUS DISEASES USAMRIID Overview

for the Frederick County Containment Laboratory Community Advisory Committee

Colonel John P. Skvorak, DVM, Ph.D. Commander www.usamriid.army.mil USAMRIID History

„ First US biowarfare facility was started in April 1943 at Camp Detrick in quickly built facilities and in Air National Guard buildings that were adapted for use. „ The US Army Medical Unit (USAMU) was created in 1956 to develop the means to diagnose, treat, and prevent diseases caused by biological warfare agents. „ President Nixon ended the Biowarfare R&D Program in 1969 but allowed continued development of medical countermeasures. „ USAMU was renamed USAMRIID, 27 January 1969. Chain of Command

U.S. Army Medical Command LTG Eric Schoomaker US Army Surgeon General

U.S. Army Medical Research and Materiel Command MG James Gilman

USAMRIID COL John P. Skvorak

USAMRIID Mission and Vision

We conduct research on current and emerging biodefense threats, resulting in medical solutions to protect the Warfighter.

%HWKH1DWLRQ¶VSUH-eminent research laboratory for medical biological defense, providing innovative solutions to protect the Warfighter. First Things First

What we do: Who we are: Develop and test vaccines, About 850 civilians and military drugs and diagnostic tests to personnel, with jobs ranging protect against known from administration to research biological threats Most of us live in Frederick Publish and present our County research findings :KDWZHGRQ¶WGR Educate and train medical Conduct classified research personnel Conduct offensive research Provide expert consultation and assistance on emerging Develop new biological threats diseases and other issues DoD Chem/Bio Defense Program Organization Convergence of Military & Civilian Biodefense Requirements Post-9/11

PA RT N E RSH IPS

Biosecurity Biosecurity Biosecurity Requirements Requirements Requirements

to the by the Military to the Military and the Nation Nation

DoD ± US Department of Defense D H HS ± US Department of Health and Human Services Biological Agents in USAMRIID Research

Category A Category B Bacillus anthracis (Anthrax) Coxiella burnetti (Q fever) Clostridium botulinum (Botulism) Burkholderia pseudomallei Burkholderia mallei (Glanders) Yersinia pestis (Plague) Brucella species (Brucellosis) Variola major (Smallpox*) & other Ricin toxin pox viruses Staphylococcus enterotoxin B Francisella tularensis (Tularemia) VEE, WEE, EEE (Equine Lassa Fever Virus Encephalitis Viruses) South American Hemorrhagic Fever Viruses Category C Hantaviruses Crimean-Congo Hemorrhagic Fever Rift Valley Fever Virus Ebola Virus Yellow Fever Marburg Virus Influenza

* Only at the CDC Lab in Atlanta 86$05,,'¶V&ULWLFDO&RUH&RPSHWHQFLHV

Biocontainment Laboratories

Bio Agents Animal Care and Use

Potential Exposure Rate

20.0 17.4 15.0

10.0 9.1 9.5

6.6 6.4 5.0 4.6

rate/1000emp 0.0 FY 2000 FY 2001 FY 2002 FY 2003 FY 2004 FY 2005 Subject Matter Expertise

Safety, Security, Surety Aerobiology 86$05,,'¶V8QLTXH)DFLOLWLHV

‡Biosafety level (BSL)-4 -- 8,400 gsf (9,600 after renovation complete) ‡ 3 suites, 11 laboratory rooms ‡BSL-3 -- 41,800 (gsf) ‡ 14 suites, 108 laboratory rooms ‡ BSL-2 -- 53,700 gsf ‡ 96 laboratory rooms ‡ Animal care facility ‡ 75 rooms in BSL-2,3,4 ‡ Center for Aerobiology ‡ 9 Class 3 biosafety cabinets (BSC) (7 BSL-3, 2 BSL-4) ‡ Field laboratory training center USAMRIID Science

Program Overview „ Pretreatments 9 Vaccines for bacterial, toxin, and viral agents with the current focus on Burkholderia, ricin, and Filoviruses 9 Multi-agent vaccines „ Therapeutics for bacterial, toxin, and viral agents 9 Current focus on plague, Burkholderia, botulinum, and Filoviruses 9 Special interest in broad spectrum ± Focus on hemorrhagic fever viruses and intracellular bacterial pathogens ± Looking for common disease causing or host response pathways „ Diagnostic technologies 9 Current focus on assay development for existing platforms, assay standardization, evaluation of next generation diagnostic capabilities „ Animal Models 9 Safety 9 Evaluate efficacy of vaccines and therapies following infection Vaccine protects from disease Therapeutic enables recovery Best delivery method 9 Efficacy/mode of exposure to pathogen 86$05,,'¶V&XUUHQW2SHUDWLRQDO0RGHO

Leverage From External Sources ~650 active agreements (selected examples) Product Candidates ‡ Antisense Oligos (ex. AVI Biopharma, Tekmira) ‡ Novel antimicrobials (ex.Novartis, Siga, Combinatorx) ‡ Vaccine candidates (ex.AlphaVax, NIAID VRC) USAMRIID ‡ Pathogenesis studies Technologies ‡ Diagnostic systems (ex. BioVeris, Idaho Technologies) ‡ Adaptation of technology to ‡ Antibodies (ex. VaxDesign, BioFactura, Abgenix) biodefense countermeasures ‡ Vaccine delivery devices (ex. Pfizer, Ichor, Inovio, B-D) ‡ Animal model development ‡ Vaccine vectors (ex. RML, Vical, Crucell) ‡ Evaluation of ‡ Adjuvants (ex. Pfizer, Novartis) countermeasure

Concepts & Capabilities ‡ DNA vaccination ‡ siRNA ‡ Reverse genetics (ex. LANL, Columbia U., NMRC) Provide to Customers ‡ Host targets for viral assembly (ex. Prosetta) ‡ Bioinformatics (ex. JCVI, VBI, LANL, BHSAI) ‡ Product candidates ‡ Transgenic Mice (ex. Lexicon Genetics, Jackson Labs) ‡ Technical information

We apply cutting-edge approaches to our problem sets! Major Partnerships/Collaborations

Academia Industry Government/Military

Arizona State University Inovio Biomedical Centers for Disease Control and Baylor College of Medicine Integrated Biotherapeutics Prevention (CDC) Duke University Abgenix, Inc. Integrated Nano-Technologies Central Intelligence Agency (CIA) Akonni Biosystems, Inc. Invitrogen Corporation Frederick Community College Defense Intelligence Agency (DIA) Akubio Limited/T.R.U.E. (Grant) Isis Pharmaceuticals, Inc. Dept. of Health & Human Services George Mason University Aldevron, LLC Kemp Biotechnologies, Inc. Federal Bureau of Investigation (FBI) Hood College Allergan, Inc. Large Scale Biology Corporation Food and Drug Administration James Madison University Alnylam Pharmaceuticals Lexicon Genetics, Inc. Lawrence Livermore NL Johns Hopkins University Alpha Gamma Technologies, LigoCyte Pharmaceuticals, Inc. Los Alamos National Lab (LANL) Inc. Mapp Biopharmaceutical, Inc. Johns Hopkins University School of Medicine National Biodefense Analysis and AlphaVax Human Vaccines, Maxygen, Inc. Countermeasures Center (NBACC) Johns Hopkins University School of Public Health Inc. Meso Scale Diagnostics, LLC National Cancer Institute (NCI) Mount Sinai School of Medicine AOAC, International Microbiotix, Inc. National Institute of Allergy and Ohio University AVI BioPharma Inc. MicroFluidic Systems Infectious Diseases (NIAID) Oklahoma Medical Research Program Becton, Dickinson & Company MIDI Inc. National Institute of Environmental BioFactura, Inc. Morphotek, Incorporated Purdue University Health Sciences (NIEHS/NIH) BioReliance Corporation NanoVec National Institutes of Health (NIH) Rutgers - The State University BioSante Pharmaceuticals National Food Research Institute Secret Service Stanford University BioVeris Corporation Northrop Grumman Systems U.S. Department of Agriculture Thomas Jefferson Medical School Callisto Pharmaceuticals, Inc. Nuvelo, Inc. U.S.Postal Service Trudeau Institute Cepheid, Inc. Oncovir, Inc. 18th MEDCOM Chimerix Inc./TRUE Ordway Research Institute Tufts University Armed Forces Institute of Pathology Chiron Corporation Orion Integrated Biosciences, Inc. Army Research Laboratory Tulane School of Public Health and Tropical Medicine CombiMatrix Corporation Point Therapeutics, Inc. JPEO-CBD/JPM-CBMS Tulane University Health Sciences Center CombinatoRx, Inc. PowderMed Ltd. USAMRMC Laboratories University of Alabama CreatV MicroTech, Inc. Protiva Biotherapeutics, Inc. USUHS University of Arkansas CUBRC and Prosetta Protiveris, Inc. 1st and 9th AML Corporation Pulmatrix, Inc. University of California at San Francisco Cyto Pulse Sciences, Inc. Qiagen University of California, Santa Barbara Diversa Corporation Quaestech, LLC International University of Georgia Research Foundation DOR BioPharma, Inc. Roche Diagnostics Corporation University of Maryland DynPortVaccine Company, LLC SIGA Technologies, Inc. CBR MOU University of Massachusetts Medical School EluSys Therapeutics, Inc. Southern Research Institute (SRI) Defence Science & Technology Functional Genetics Structural Bioinformatics, Inc. Laboratories University of Michigan GenPhar, Inc. The Institute for Genomic Research PowderMed Ltd. University of North Carolina - Chapel Hill Gilead Sciences, Inc. The McConnell Group Public Health Agency Canada University of Pennsylvania Goodwin Biotechnology, Inc. VaxDesign Corporation Robert Koch Institute University of Pittsburgh GTC Biotherapeutics, Inc. VaxGen, Inc. University College London University of Texas Medical Branch ID Biomedical Corporation Vical Incorporated University of Calgary IGEN International, Inc. Virion Systems, Inc. University of Freiburg University of Utah Imigene, Inc. VivoMetrics, Inc. University of Glasgow University of Virginia Innovative Biosensors, Inc. University of Marburg University of Wyoming Virginia Tech / Virginia Bioinformatics Institute Washington University USAMRIID Biodefense Products

‡ Tularemia Vaccine (IND) ‡ Venezuelan Equine Encephalitis (VEE) Vaccines (IND) ‡ Eastern Equine Encephalitis (EEE) Vaccine (IND) ‡ Western Equine Encephalitis (WEE) Vaccine (IND) Available ‡ Botulinum Pentavalent Toxoid Vaccine (IND) ‡ Smallpox Vaccine (cell culture derived vaccinia virus) For ‡ Botulinum Antitoxin (human & horse) Use ‡ Vaccinia Immune Globulin ‡ Ribavirin Today ‡ Joint Biological Agent Identification and Detection System (JBAIDS) ‡ Anthrax Gammaphage Diagnostic ‡ Antibiotic Treatment of Pneumonic Plague and Inhalational Anthrax ‡ H5N1/H1N1 JBAIDS Influenza Diagnostic Kit (510 k/EUA) ‡ rPA-Based Anthrax Vaccine In ‡ Botulinum Neurotoxin Bivalent Vaccine ‡ Plague Vaccine (F1-V) Advanced ‡ Staphylococcal Enterotoxin B Vaccine Development ‡ Hantavirus Vaccines

‡ Ricin Vaccine ‡ Ebola/Marburg Vaccine and Therapeutics ‡ ST-246 for Treatment of Smallpox Emerging ‡ 73 Diagnostic Assays Submitted to the FDA for pre-EUA review Products ‡ Botulinum Neurotoxin Heptavalent Vaccine ‡ Next-Generation Immunodiagnostics ‡ Next-Generation EEE/WEE Vaccines ‡ Burkholderia Vaccine and Therapeutics ‡ Venezuelan Equine Encephalitis Virus Vaccine USAMRIID scientists develop at least one new medical countermeasure per year. USAMRIID Biodefense Products

Knowledge Products (FY10) Abstracts 97 Presentations 364 Manuscripts 143 MCBC Students 341 FIBWA Students 51

Intellectual Property Active Foreign Applications Filed 59 Active Foreign Patents Issued 25 Generated $280K Active US Applications Filed 39 Active US Patents Issued 72 in Royalty Income Active License Agreements 18 in 2009

Agreements Active CRADAs 188 Active MTAs 300 Active EPAs 2 Generated $35.5M Active CTAs 10 in Reimbursable Active Intergovernmental 151 Income in 2009 TOTAL 651 Biodefense Education & Training

Publications Training Courses ‡ Medical Management of Biological ‡ Medical Management of Biological Casualties Handbook Casualties (MCBC) ‡ Textbook of Military Medicine: Medical ‡ Field Management (FCBC) Aspects of Biological Warfare (2007) ‡ Hospital Management (HM-CBRNE) ‡ Joint Pub (FM 8-284) Treatment of ‡ More than 120,000 students taught in Biological Warfare Agent Casualties resident, off-site, and Distance Learning ‡ More than 35,000 educational DVD courses products distributed ‡ Field Identification of Biological Warfare Threat Agents (FIBWA) ‡ More than 100,000 Handbooks 86$05,,'¶V distributed MEDICAL MANAGEMENT OF BIOLOGICAL CASUALTIES HANDBOOK

Leader in medical biological defense training & education Sixth Edition April 2005

U.S. Army Medical Research Institute of Infectious Diseases

Fort Detrick Frederick, Maryland Outbreak Investigations

1969 Venezuelan Equine Encephalitis (VEE), Honduras 1971 VEE in horses, Central America, southern Texas 1984 Eastern Equine Encephalitis in whooping cranes, Patuxent Wildlife Preserve, MD 1977 Rift Valley fever (RVF), animals and humans, Egypt 1983 Chikungunya fever, Indonesia 1988 Infant botulism, San Francisco 1988 RVF in animals and humans, Senegal and Mauritania 1989 Simian hemorrhagic fever, New Mexico 1990 Reston Ebola virus outbreak in primate colony, Reston, Virginia 1993 Hantavirus outbreaks in United States 1993 RVF outbreak in Egypt 1995 Ebola outbreak in Zaire 1995 VEE in Colombia 1996 Ebola Reston virus NHP outbreak, Alice, Texas 1997 Ebola Ivory Coast 1999 West Nile Virus 2000 West Nile Virus 2000 Anthrax outbreak, Minnesota 2000 Potential Ebola virus case, Uganda 2001 Support for Florida, New York City, and Washington, DC Anthrax cases 2003 SARS, 8 confirmed U.S. cases, CA, NJ, NM, NC, PA, UT, VA 2003 Monkeypox, Indiana, Illinois, Wisconsin 2003 Malaria Outbreak among Marines in Liberia 2006 Plague, Colorado 2006 Chikungunya fever, La Réunion, Mayotte, Maurice, Seychelles and India 2007 Burkholderia, Australia 2007 RVF outbreak in Kenya 2007 Tularemia in Thailand Ongoing Monkeypox in Democratic Republic of the Congo Ongoing Lassa fever in Sierra Leone 86$05,,'¶V([LVWLQJ)DFLOLWLHV

Built in 1950s and 1960s for 325 personnel Combined size of ~ 500,000 gsf (in 18 buildings) Currently house ~ 850 personnel Major utilities and support systems cannot readily accept new technologies Maintenance consumes an increasingly greater DPRXQWRI86$05,,'¶VRSHUDWLQJEXGJHW Description of the New USAMRIID

„ Estimated Size: ~ 810,000 gsf

„ Cost: $683M

„ Staff: ~ 950

„ Estimated Operation: 2015 „ Purpose: 9Expand laboratory capacity 9Expand animal space 9Expand administrative Mechanical area BSL-3 HEPA/Mech BSL-3 9Incorporate new BSL-4 Biowaste

capabilities Office BSL-2 Atrium Containment Block 9Flexible design to allow incorporation of future technologies National Interagency Biodefense Campus (NIBC)

New CUP USA M RIID C C A B N

S H D

SSP NI A ID IR F

USA M RIID 1425 World Class Staff

Important Mission for the DoD and Nation

Outstanding Record of Safety, Compliance, and Security

Partnering for Success

Developing the Next Generation of Leaders