Andrew Weiskopf

Andrew Weiskopf is Vice President of CMC Regulatory Affairs at Sana Biotechnology in Cambridge, MA, where he oversees regulatory CMC strategy for the company’s portfolio of gene and cell therapy programs. As regulatory lead for several in vivo and ex vivo therapy assets, Dr. Weiskopf provides guidance to CMC teams and program teams on quality and regulatory matters such as analytical and control strategy, process development, manufacturing, and regulatory meeting/submission planning and writing.
Prior to his current role, Dr. Weiskopf oversaw CMC regulatory strategy for in vivo gene therapies at Biogen after having held various roles in the biopharmaceutical firm’s technical development organization. Over the past decade, he has been a contributing author and/or senior CMC reviewer on over two dozen regulatory submissions, including BLA/MAA approvals for four marketed products. Dr. Weiskopf was a co-chair of the inaugural CASSS Cell and Gene Therapy Products (CGTP) conference in 2018 and continues to serve on its program committee. He has been a CASSS Associate Director since 2013, and he previously served on the program committees for both the CASSS CMC Strategy Forum and WCBP.