Keywords: vaccine, biomarkers , Endpoints, FDA-NIH, designs, analyses, validation
Room: Marriott Balcony B
The FDA-NIH has a web site (BEST) on which they precisely define various types of biomarkers and also give detailed requirements needed to validate a biomarker. These requirements include the types and number of trials and the kinds of data that should be collected. The FDA recently released a draft guidance on Biomarkers that extends these requirements and gives more details. But they nowhere give details of the required statistical models and analyses. The idea of biomarkers in vaccine development has become a pressing issue due to the cost of development and the desire to possibly get earlier answers or directions. At the same time technology has progressed allowing a much greater diversity in the types of immune measurements that might be candidate biomarkers. In this round table we will discuss types of possible designs and analyses. We hope to hear of some preliminary success and find how extensive efforts have progressed.