Attachment

but in general there was no vibrant discussion of the platform approaches being considered by the industry at this meeting. There was a quick question as to whether stimulus funding should be applied to these broad-based platform technologies • Action item would be to expand inquiry regarding this approach to other companies, or to hold more one-on-one conversations with individual companies if there was a reluctance to disclose possible technologies now being addressed by these companies. • Another action item would be to determine what specific platform technologies would be estimated by industry as offering best return on investment. Other areas Regarding clinical studies, a suggestion was made that FDA should be allowed to explore less parametric and more Bayesian approaches to analysis of clinical trials data with a hope that it would allow for faster approval of products. The approaches for using the Animal Efficacy Rule were quickly discussed as needing much greater clarity from the FDA on how to accomplish approval under the rules. It was felt that there was a great deal of expertise in the DoD and NIH that would also contribute to industry's needs. Regarding approval of medical products in general for public health emergency applications, one must account for the risk/benefit ratio of these products, relative to everyday products used for standard medical conditions and ask whether there needs to be some other lower threshold for approval of products that would be used under these higher risk scenarios.