review, given the ASPR’s responsibility for directing and coordinating HHS’s activities relating to protecting the U.S. population from acts of terrorism and other public health and medical threats and emergencies. This white paper will be used by the ASPR and by subsequent planning committees to develop public and stakeholder workshops to examine alternative methods and models for achieving successful product development, approval, procurement, and delivery to the U.S. populations.

As part of the larger public health enterprise review, this white paper explores the following topic: Synthesis of Business Models and Economic and Market Incentives for Vaccines and Therapeutics.

The objective of this paper is to explore alternative policies, business models, and incentives that can be used to foster a more effective and sustainable medical countermeasure enterprise. Particular focus will be placed on identifying ways to further the pharmaceutical industry’s engagement in the MCME to move candidate medical countermeasures through advanced development and provide approved or licensed products for operational use. To this end, this paper will identify

1. challenges to engaging industry in the MCME and what is needed to overcome those challenges;

2. new and innovative policies, strategies, and incentives to encourage industry participation in the MCME; and

3. issues related to pursuing these new and innovative policies, strategies, and incentives.

This paper focuses primarily on policies, business models and incentives for increasing industry involvement in the MCME’s programs for medical countermeasures for CBRN threats. The paper does not focus on the Pandemic Influenza program, given the already high level of involvement of multiple large-scale commercial vaccine manufacturers in the program, although the program is considered within the context of other models that may offer some approaches that could be applied to CBRN.