Modernization of Biosafety: Thoughts on Improving NIH Guidelines in a Deregulatory Environment

While the NIH’s current efforts to modernize biosafety by overhauling NIH Guidelines could improve the quality and efficiency of biosafety oversight, deregulatory pressures could weaken biosafety. This presentation will look at the pros and cons of different approaches for overhauling NIH Guidelines while referring to real world case studies and publications to point out possible areas for improvement or pitfalls. This talk will also explore other federal regulations that could be utilized for reinforcing biosafety oversight through federal agencies outside the NIH.

Dan Eisenman is Executive Director of Biosafety Services at Advarra, a large clinical research compliance company. Dan heads a commercial IBC overseeing over 1,600 clinical and basic science research sites. Prior to joining Advarra Dan was the Biosafety Officer at the Medical University of South Carolina and UNC Chapel Hill. Dan holds a PhD in molecular biology and immunology, various biosafety certifications (RBP, SM(NRCM), CBSP) and a Regulatory Affairs Pharmaceuticals certificate from the Regulatory Affairs Professionals Society (RAPS). He is a member of the Editorial Board for Applied Biosafety and frequently speaks at major conferences on topics involving biosafety, gene therapy and clinical trials.