Satish Singh PhD Astria Therapeutics

Dr. Satish Singh is currently Vice President, Drug Product at Astria Therapeutics in Boston, where he is responsible for all aspects of drug product - from early-stage discovery support to validation and commercialization. Prior to Astria, he was Head of Drug Product Development at Moderna Inc, where he was deeply involved with the development, launch, commercialization, and manufacture of the Covid-19 vaccine. Satish has held related positions at Lonza Pharma and Biotech and was Research Fellow and Group Leader at Pfizer’s BioTherapeutics Pharmaceutical R&D unit prior to 2016. Satish has long experience in the biopharma industry in product development activities and is an internationally recognized expert in all aspects of (bio)pharmaceutical product (biologics, vaccines) development. His experience includes ophthalmics and parenterals, encompassing primarily biologics but also small molecules. He has been involved with submission of numerous INDs and several BLAs. Satish has a strong technical background in (biological) drug product development, complemented by a deep understanding of regulatory challenges and the evolving regulatory landscape, and has more than 100 peer-reviewed scientific publications as well as several book chapters covering multiple topics. He is involved in various professional groups through the AAPS as well as the USP and is a member of the expert panels that wrote USP<787>, <1787>, and <771>. He was elected as a Fellow by the AAPS in 2018. His research interests also include the investigation of impact of freezing processes on proteins, use of computational approaches to mitigate develop-ability issues, protein aggregation and immunogenicity. Satish obtained his B.Tech. Chemical Engineering from the IITD Delhi and an M.S. and Ph.D. in Chemical Engineering from Kansas State University. Satish also holds the positions of Adjunct Professor at the Dept. of Physical Pharmaceutical Chemistry at Uppsala University, Sweden, and at School of Pharmacy, University of Michigan, Ann Arbor, USA.