PARTNERSHIPS AND ALTERNATIVE BUSINESS MODELS

 

30

   

 Venture Philanthropy and Orphan Product Development Models,

 

30

   

 Pharmaceutical Shared-Risk Approaches,

 

31

   

 Planning for Failure,

 

32

   

 Open Innovation Business Strategies,

 

33

   

 Public–Private Partnerships,

 

34

   

 Independent Third-Party Facilitation of Collaboration,

 

37

   

 Strategic Investor Model,

 

37

 

 

ENGAGING INDUSTRY

 

38

   

 Incentives: Push vs. Pull,

 

38

   

 Incentives Not Needed?: Making a Strong Business Case,

 

41

 

 

NEW PARADIGMS, STRATEGIES, AND TACTICS FOR ENHANCING THE COUNTERMEASURES DEVELOPMENT ENTERPRISE

 

43

   

 Outsourcing Program Management,

 

43

   

 Government as a Strategic Partner,

 

45

   

 Platform Technologies,

 

45

   

 Revised PHEMCE Implementation Plan,

 

46

 

 

EXISTING REGULATORY TOOLS AND APPROACHES THAT CAN BE APPLIED TO ADVANCE COUNTERMEASURES DEVELOPMENT

 

47

   

 Opportunities for Accelerating Approval of Medical Countermeasures: Evolving the Regulatory Framework,

 

47

   

 The Way Forward: Themes from the Workshop,

 

49

 

 

CONCLUSION

 

53

 

 

APPENDIXES

 

 

A

 

References

 

57

B

 

Workshop Agenda

 

59

C

 

Registered Workshop Attendees

 

79

D

 

Case Studies of HHS Chemical, Biological, Radiological, and Nuclear Medical Countermeasure Development Programs, Executive Summary

 

91

E

 

Synthesis of Business Models and Economic and Market Incentives for Vaccines and Therapeutics

 

113



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