Joint Vaccine Acquisition Program

1. JVAP: AFEB 21 May 2002 Joint Vaccine Acquisition Program

2. JVAP: AFEB 21 May 2002 Charter for the Joint Program Office The JPO was set up to specifically address Biological Defense and JVAP is a direct reporting PM.The JPO was set up to specifically address Biological Defense and JVAP is a direct reporting PM.

3. JVAP: AFEB 21 May 2002 New Relationships

4. JVAP: AFEB 21 May 2002 JVAP Mission Develop and Produce FDA Licensed Medical Products to Protect the Warfighter in a Biological Warfare Environment Vision: Eliminate the threat of biological warfare by protecting the individual warfighter with safe and effective medical products Become the DoD�s �Merck� operation Vision: Eliminate the threat of biological warfare by protecting the individual warfighter with safe and effective medical products Become the DoD�s �Merck� operation

5. JVAP: AFEB 21 May 2002 JVAP Background Requirement for BD vaccines 1.2 million doses for the two high threat agents, and 300K for all others. Will be affected by national and international requirements DEPSECDEF directed Prime Systems Contract approach (PBD 724) The JVAP office was established in December 1996 and the Prime Systems Contract was awarded to Dynport Vaccine Company in November 1997. Requirement for BD vaccines 1.2 million doses for the two high threat agents, and 300K for all others. Will be affected by national and international requirements DEPSECDEF directed Prime Systems Contract approach (PBD 724) The JVAP office was established in December 1996 and the Prime Systems Contract was awarded to Dynport Vaccine Company in November 1997.

6. JVAP: AFEB 21 May 2002 Managing the Complex Process of Vaccine System Integration

7. JVAP: AFEB 21 May 2002 Challenges Single vaccine against multiple agents fewer doses or no shots at all fewer or no side effects long lasting Policy for immunization of other than US Forces / Changing FDA requirements Defining battlefield exposure levels and protection against incapacitation Major players do not want DoD work (low quantities and uncertain ordering frequency, biological weapons convention, adverse publicity). Small players interested but with limited capabilities IND Stockpile Primarily used for at-risk laboratory personnel through the Special Immunization Program (SIP) Assessment underway to determine suitability for emergency/contingency scenario use Single vaccine against multiple agents fewer doses or no shots at all fewer or no side effects long lasting Policy for immunization of other than US Forces / Changing FDA requirements Defining battlefield exposure levels and protection against incapacitation Major players do not want DoD work (low quantities and uncertain ordering frequency, biological weapons convention, adverse publicity). Small players interested but with limited capabilities IND Stockpile Primarily used for at-risk laboratory personnel through the Special Immunization Program (SIP) Assessment underway to determine suitability for emergency/contingency scenario use

8. JVAP: AFEB 21 May 2002 DoD acquisition model is designed around planes, ships and tanks (engineering). Must be adapted to biologics development DOD acquisition ensures that vaccine development is reviewed by independent stakeholders and that funding is available for critical events and manufacturing and clinical trials. DoD acquisition model is designed around planes, ships and tanks (engineering). Must be adapted to biologics development DOD acquisition ensures that vaccine development is reviewed by independent stakeholders and that funding is available for critical events and manufacturing and clinical trials.

9. Acquisition of Biological Defense Medical Products The opportunities that have presented themselves as a result of the draft revision of the DoD 5000-series has been reviewed by the Joint Vaccine Acquisition Program (JVAP) Project Management Office (PMO). The result is an integrated management scheme that is represented by this chart. The remainder of this briefing dissects each element of the chart and offers explanations and rationale for the selected approach and management processes.The opportunities that have presented themselves as a result of the draft revision of the DoD 5000-series has been reviewed by the Joint Vaccine Acquisition Program (JVAP) Project Management Office (PMO). The result is an integrated management scheme that is represented by this chart. The remainder of this briefing dissects each element of the chart and offers explanations and rationale for the selected approach and management processes.

10. JVAP: AFEB 21 May 2002 JVAP Products Products in Advanced Development Smallpox vaccine and Vaccinia Immune Globulin Tularemia vaccine Multivalent Recombinant Botulinum vaccine (A,B) Current Products - Products currently working and funded in Advanced Development Planned Products - Products programmed for Advanced Development with some funding programmed Potential Products - Are products that are unfunded requirements that will transition to advanced development in the next 2 - 3 years. Some products have commercial interests: Staph Enterotoxin vaccine; International interest - Brucella vaccine; or orphan vaccines for emerging diseases such as ebola and marburg. Little or no funding available for new product development Current Products - Products currently working and funded in Advanced Development Planned Products - Products programmed for Advanced Development with some funding programmed Potential Products - Are products that are unfunded requirements that will transition to advanced development in the next 2 - 3 years. Some products have commercial interests: Staph Enterotoxin vaccine; International interest - Brucella vaccine; or orphan vaccines for emerging diseases such as ebola and marburg. Little or no funding available for new product development

11. JVAP: AFEB 21 May 2002 BD Vaccine Development Schedule 4 products in Advanced Development 1 pending - DVC expertise also impacting on products in tech base - cGMP production - �manufacturability� - Early FDA consults 4 products in Advanced Development 1 pending - DVC expertise also impacting on products in tech base - cGMP production - �manufacturability� - Early FDA consults

12. JVAP: AFEB 21 May 2002 IND Contingency Stockpile Stockpile was produced over last 30 years by various manufacturers. Salk institute Michigan Department of Public Health PerImmune Inc The products are aging and numbers of available doses are decreasing. We are currently re-evaluating each of the products for emergency use. Stockpile was produced over last 30 years by various manufacturers. Salk institute Michigan Department of Public Health PerImmune Inc The products are aging and numbers of available doses are decreasing. We are currently re-evaluating each of the products for emergency use.

13. JVAP: AFEB 21 May 2002 International Collaboration Goals: Ensure availability of licensed BD medical products for US and allied forces Reduce program costs Ensure interoperability Achievements: Completed CANUKUS CBR MOU Project Arrangement (PA) with Canada to co-develop smallpox vaccine and VIG Request to negotiate new PA for plague vaccine

14. JVAP: AFEB 21 May 2002 Summary Vaccine Development Substantial time, effort and resources investment Complex contractual and regulatory environment involving many different organizations Now Dr. Winegar will address the vaccine production facility being planned by the department.Vaccine Development Substantial time, effort and resources investment Complex contractual and regulatory environment involving many different organizations Now Dr. Winegar will address the vaccine production facility being planned by the department.

15. JVAP: AFEB 21 May 2002 Joint Biological Agent Identification and Diagnostic System (JBAIDS)

16. JVAP: AFEB 21 May 2002 Joint Biological Agent Identification and Diagnostic System (JBAIDS) JBAIDS is a portable biological agent identification and diagnostic device capable of simultaneously identifying multiple biological agents of operational concern and other pathogens of clinical significance

17. JVAP: AFEB 21 May 2002 JBAIDS Acquisition Strategy JBAIDS Block 1 will be NDI or modified NDI A two step selection process will be used to determine which contractor will develop and manufacture the system platform, agent specific kits and the protocols/operating procedures for using the sytem The contractor will begin efforts for FDA approval of the platform, kits and protocols Pending FDA approval, the Block 1 device will be used for medical surveillance, but not as a diagnostic device for patient treatment Anticipated procurement of >400 devices in FY03/04

18. JVAP: AFEB 21 May 2002 (DRAFT) Performance Parameters

19. JVAP: AFEB 21 May 2002 Schedule Milestones

20. JVAP: AFEB 21 May 2002 (DRAFT) BD Pathogen Assays Block 1 Anthrax Brucella Ebola-Marburg Venezuelan Equine Encephalitis Glanders Plague Q-fever Smallpox Tularemia Typhus Block 2 Botulinum toxins A and B Ricin Staphylococcal Enterotoxins A and B

21. JVAP: AFEB 21 May 2002 Issues BD program cannot fund development and FDA approval of assays for ID Availability of ID funding for JBAIDS assay development and FDA approval?