1. JOINT PROJECT MANAGERCHEMICAL BIOLOGICAL MEDICAL SYSTEMS (JPM-CBMS) April 26, 2005Advanced Planning Brief to Industry COL STEPHEN BERTÉ JPM-CBMS Joint Program Executive Office for Chemical and Biological Defense stephen.berte@us.army.mil 050426_APBI_JPM_CBMS

2. Outline • Program Overview • Warfighter Needs • Technical Challenges • Acquisition Strategy/ Funding/ Schedule • Upcoming Business Opportunities • Contacts 050426_APBI_JPM_CBMS

3. Overview • Develop, Procure, Field, and Sustain Premier Medical Protection and Treatment Capabilities Against Chemical and Biological Warfare Agents • Ultimate Outcomes are FDA Licensed Drugs, Medical Devices and Vaccines 050426_APBI_JPM_CBMS

4. Warfighter Needs • Provide the Capability to Protect Service Members from the Effects of Chemical, Biological, Radiological, and Nuclear (CBRN) Agents Before the Appearance of Symptoms • Medical Identification & Treatment Systems (MITS) • Bioscavenger: Prevent Incapacitation and Death from Exposure to Nerve Agents • Joint Vaccine Acquisition Program (JVAP) Uses the Prime Systems Contract Integrator Approach with DynPort Vaccine Company (DVC) to Meet DoD Biological Defense Vaccine Requirements • DVC Obtains and Maintains FDA Licenses • Special Studies Allows DVC to Evaluate and Integrate Emerging Technologies into Vaccine Systems 050426_APBI_JPM_CBMS

5. Warfighter Needs (cont’d) • Provide the Capability To Treat Service Members for the Effects of CBRN Agents After the Appearance of Symptoms. • Advanced Anti-convulsant System (AAS) will Replace Convulsant Antidote Nerve Agent (CANA) System • Intramuscular Auto-injection of Drug (midazolam) for Enhanced Control of Seizures • Effective Against Broader Spectrum of Nerve Agents and Non-Traditional Agents (NTAs) • Improved Nerve Agent Treatment System (INATS) Active Ingredient will Replace and Provide better Protection than Current Oxime, 2-PAM • System Approach Will Also Develop Broader Indications for Pretreatment Pyridostigmine Bromide • INATS will Use Current Delivery System 050426_APBI_JPM_CBMS

6. Warfighter Needs (cont’d) • Provide a Reusable, Portable, Modifiable Biological Agent Identification and Diagnostic System Capable of Simultaneous Reliable Identification of Multiple Biological Warfare Agents and Other Biological Agents of Operational Significance • Joint Biological Agent Identification and Treatment System (JBAIDS) Will Provide Portable Diagnostic Capability to Warfighter. Evolutionary Approach: • JBAIDS Block I System Capable of Identifying 10 BWAs • JBAIDS Block II System Will Add Capability to Identify 5 Toxin Types • JBAIDS Block III System: Reduce to Hand Held Device 050426_APBI_JPM_CBMS

7. Technical Challenges • Proving Product Efficacy • FDA ‘Animal Rule’ Allows Use of Data From Animal Instead of Human Trials to Prove Product Efficacy • Full Spectrum of Human Safety Studies Still Conducted • ‘Animal Rule’ Approach Not Necessarily Cheaper or Faster • Requires Facilities Capable of Animal Testing for Biological and Chemical Warfare Agent Countermeasures • Manufacturing • Complexity of Biological Manufacturing Process • FDA Process is Averse to Technology Insertion 050426_APBI_JPM_CBMS

8. Technical Challenges (cont’d) • AAS • Ability of the CANA Drug-containing Chamber to Hold Midazolam Instead of Diazepam • Stability of the Midazolam in the Drug-containing Chambers of the CANA • INATS • Active Ingredient is New Active Pharmaceutical Ingredient (API) in U.S. • Ability to Make the Candidate Oximes IAW cGMP • Formulation, Stability of the Formulation or Toxicology Problems with Candidate Oximes • Ability of Oxime-containing Chamber of ATNAA to Contain Candidate Oximes 050426_APBI_JPM_CBMS

9. Technical Challenges (cont’d) • Plasma-Derived Bioscavenger • Aggressive 2 year Schedule • Hand-off of pBioscavenger to DHHS • Recombinant Bioscavenger • Program Initiation in FY06 • Process Development and Small Scale (cGMP) Manufacturing Required • Full Development Program to FDA Approval • JBAIDS • FDA Approval of Device and Multiple Assays • Miniaturization & Interoperability 050426_APBI_JPM_CBMS

10. Acquisition Strategy • Addresses User Requirements Based on Capabilities Needed and Chairman of the Joint Chiefs of Staff Priorities • Develops FDA Licensed Chemical and Biological Defense (CBD) Medical Products • Leverages Other Government Agencies, International Partnerships, and Industry • Manages Product Line Within Available Resources • Funds Product Development Efforts to Minimize Schedules • Expands or Contracts Product Line Based on Available Funding 050426_APBI_JPM_CBMS

11. FY04 FY05 FY06 FY07 FY08 FY09 FY10 FY11 Licensure DoD Funded Programs AVA In Production VIG 18 Feb 05 MS C rBOT (A/B) 2012 MS B MS C Plague 2010 MS A MS B MS C VEE 2013 DHHS Programs MS B Smallpox VIG NGAV BOT (CEF) Tularemia DoD Unfunded Programs Ricin TBD SE TBD IND Submission Initiate Phase 1 Clinical Trial Initiate Phase 2 Clinical Trial Initiate Phase 3 Clinical Trial BLA Submission LEGEND: Milestone Licensure NDA Submission Transfer to DHHS Transition JVAP: Meeting Warfighter Needs 050426_APBI_JPM_CBMS

12. DoD Funded Programs FDA Approval FY04 FY05 FY06 FY07 FY08 FY09 FY10 FY11 In Production SERPACWA In Production ATNAA In Production SNAPP AAS* MS B 2011 INATS MS B MS A MS C MS A 2012 MS A MS B 2012 MS A MS B DoD Unfunded Programs ANTI-VESICANT *Currently unfunded after MS B Program Schedule: MITS pBIOSCAVENGER rBIOSCAVENGER RADIOPROTECTANT IND Submission Initiate Phase 1 Clinical Trial Initiate Phase 2 Clinical Trial Initiate Phase 3 Clinical Trial BLA Submission LEGEND: Milestone Licensure NDA Submission Transfer to DHHS Transition 050426_APBI_JPM_CBMS

13. FY04 FY05 FY06 FY07 FY08 FY09 FY10 FY11 FY12 FY13 FY14 DoD Funded Programs JBAIDS BLOCK I MS C JBAIDS BLOCK II MS B MS C DoD Unfunded Programs JBAIDS BLOCK III MS B MS C Full Operational Capability LEGEND: Developmental Test Operational Test Initial Operational Capability FRP Decision Milestone Transition Program Schedule: MITS 050426_APBI_JPM_CBMS

14. Upcoming Business Opportunities 050426_APBI_JPM_CBMS

15. Points of Contact • Project Manager Medical Identification & Treatment Systems (MITS) • LTC Keith Vesely • (301) 619-8425 • keith.vesely@us.army.mil • Project Manager Joint Vaccine Acquisition Program (JVAP) • LTC Travis Bernritter • (301) 619-7083 • travis.bernritter@us.army.mil • DVC • Business Development Director: • Barbara Solow, 301-607-5241 • Director of Contracts: • Donna Dawson, 301-607-5009 • President: • Terry Irgens, 301-607-5001 050426_APBI_JPM_CBMS