Report on Biological Warfare Defense Vaccine Research &

2,43

MB

Development Programs

190

stron

6110

ID

Science Applications International Corporation

2001

rok

TABLE OF CONTENTS

Executive Summary ii

1.0 Introduction.1

2.0 Scope of Task and General Understanding1

3.0 Industry Best Practices for Vaccine Production 2

4.0 DoD Organization, Management, and Capabilities .10

5.0 Integration of DoD and Industry Vaccine Objectives15

5.1 Resources . 16

5.1.1 Market Needs. 16

5.1.2 Size and Scope of DoD Vaccine Requirement 17

5.1.3 Capital Investment . 17

5.1.4 Infrastructure Maintenance 18

5.1.5 Adoption of Vaccine Industry Product Development Process 19

5.1.6 Multiyear Contract Awards 19

5.1.7 Commercial Sales of Vaccines 19

5.1.8 Personnel Requirements in Vaccine Discovery and Production 21

5.1.9 GOCO Facility. 21

5.2 Policies. 24

5.2.1 Confidentiality . 24

5.2.2 Management of BW Perceptions and Treaty Compliance Issues 24

5.2.3 Use of Non-U.S. Owned or Based Manufacturers. 24

5.2.4 User Acceptance of Vaccine 25

5.2.5 Use of IND Vaccines . 26

5.2.6 Vaccine Liability and Indemnification 26

5.2.7 Vaccine License Holder. 27

6.0 Findings and Recommendations27

Appendix A Conduct of the Study of Department of Defense Acquisition of Vaccine Production A-1

Appendix B Generic Industry Process for Biologics Product Development.B-1

Appendix C Several Categories of Consideration for Vaccine Discovery through the Manufacturing

Process C-1

Appendix D Briefing – DoD Acquisition of Vaccine Production (Report to the Deputy Secretary of

Defense by the Independent Panel of Experts), November 29, 2000 D-1

Appendix E Acronyms E-1