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

2. Joint Program Executive Office for Chemical and Biological Defense 050426_APBI_JPM_CBMS 2 Outline Program Overview Warfighter Needs Technical Challenges Acquisition Strategy/ Funding/ Schedule Upcoming Business Opportunities Contacts

3. Joint Program Executive Office for Chemical and Biological Defense 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

4. Joint Program Executive Office for Chemical and Biological Defense 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

5. Joint Program Executive Office for Chemical and Biological Defense 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

6. Joint Program Executive Office for Chemical and Biological Defense 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

7. Joint Program Executive Office for Chemical and Biological Defense 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

8. Joint Program Executive Office for Chemical and Biological Defense 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

9. Joint Program Executive Office for Chemical and Biological Defense 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

10. Joint Program Executive Office for Chemical and Biological Defense 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

11. Joint Program Executive Office for Chemical and Biological Defense 050426_APBI_JPM_CBMS 11 JVAP: Meeting Warfighter Needs Smallpox VIG NGAV BOT (CEF) Tularemia DoD Funded Programs DoD Unfunded Programs FY04FY05FY06FY07FY08FY09FY10FY11 Licensure Ricin TBD DHHS Programs Licensure IND Submission Initiate Phase 1 Clinical Trial Initiate Phase 2 Clinical Trial Initiate Phase 3 Clinical Trial LEGEND: BLA Submission Milestone Transition NDA Submission Transfer to DHHS VIG MS C MS BMS AMS C 2010 Plague MS BMS C 2012 rBOT (A/B) In Production AVA MS B 2013 VEE TBD SE 18 Feb 05

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

13. Joint Program Executive Office for Chemical and Biological Defense 050426_APBI_JPM_CBMS 13 Program Schedule: MITS DoD Funded Programs JBAIDS BLOCK I JBAIDS BLOCK II JBAIDS BLOCK III DoD Unfunded Programs Milestone FRP Decision Developmental Test Operational Test LEGEND: Full Operational Capability Initial Operational Capability Transition FY04 FY05 FY06FY07FY08 FY09FY10FY11FY12FY13FY14 MS BMS C MS B MS C

14. Joint Program Executive Office for Chemical and Biological Defense 050426_APBI_JPM_CBMS 14 Upcoming Business Opportunities ProgramDescriptionYear Estimated Contract Value MITS JBAIDS (Block II)FedBizOpps releasedFY05 Fly OffFY05$65k/offeror RFP to Fly Off “winners”FY06$15-20M AAS Pursuing P.O. with Meridian Medical Technology (MMT) bulk drug purchase and develop analytical assays. MS B is tentatively scheduled for Sep 06 FY05$15-25M Recombinant BioscavengerRFP for Prime Systems ContractorFY06$40-50M INATSRFP for Prime Systems ContractorFY06$12M JVAP – subcontract through DVC Plague Vaccine Clinical Research Organization (CRO) and multiple clinical site management for Plague vaccine Phase 2 clinical trial FY05 Cost is evaluated separately from technical DVC’s Award based on Best Value Venezuelan Equine Encephalitis (VEE) Vaccine Lyophilization process development for VEE vaccine FY05 Vaccinia Immune Globulin (VIG) Technology transfer and manufacture of VIGFY06

15. Joint Program Executive Office for Chemical and Biological Defense 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