The New Jersey Chapter Co-sponsors Benefit/risk Workshop

The New Jersey Chapter of the ASA and Bayer Pharmaceuticals co-sponsored a benefit/risk workshop at Bayer in November 2013. Nearly 100 attendees heard informative talks about FDA’s current plans for incorporation of a structured approach to benefit-risk in its review process and pragmatic considerations for endpoint selection and display in cardiovascular benefit-risk assessment by Bennett Levitan. They also heard a case study using the BRAT framework and quantitative methods for benefit-risk assessment by Chistoph Dierig and examining benefit and risk simultaneously at the individual patient level by Christy Chuang-Stein. The speakers and Gary Koch addressed questions from the audience during the panel discussion.