Gene Therapy Analytics: How to Make the Right CMC Investments for Your Business
July 11, 2023
In this episode of Evaluating Biopharma, Mike Kelly, Senior Vice President at Atsena Therapeutics, shares his experiences and provides his advice on how your company can make proper CMC investments to reduce risk and maximize ROI, including: the make or buy decision, ensuring CMC investment to provide regulators what they need, scalability considerations, identifying technologies and assays to support your strategy, controlling COGS, and building a commercially feasible program profile. He also discusses factors that smaller businesses need to consider when choosing who to work with, such as fully understanding your needs and the compatibility between the sponsor and service provider in terms of technical capability, operational capability, management experience, and problem-solving tactics.
GUEST BIO
Mike Kelly, SVP, Atsena Therapeutics
Michael Kelly serves as Atsena’s VP of Chemistry, Manufacturing and Controls (CMC). Mr. Kelly has over 25 years of experience in the field of gene therapy, serving in a range of scientific, technical, and operational roles. Mr. Kelly has had oversight of early and late stage CMC for AAV, lentiviral, retroviral, and adenoviral vectors and associated ex-vivo cell therapy programs in ophthalmology, CNS, neuromuscular and oncology indications.
Prior to joining Atsena, Mr. Kelly was VP of Process Development at Avrobio, where he was responsible for the development of CMC for the companies ex-vivo cell therapies. Prior to that he was responsible for CMC oversight for Biogen’s gene therapy portfolio, including business development activities in support of gene therapy transactions. Mr. Kelly held various senior roles in gene therapy CMC at Sanofi-Genzyme, Cell Genesys and Somatix Therapy Corporation. Mr. Kelly also serves as the chair for viral vector sector of the Standards Coordinating Body for Gene, Cell and Regenerative medicine and is a member of its board of directors.
Mr. Kelly holds B.Sc. and M.Sc. degrees from the National University of Ireland, Galway.
MODERATOR BIO
Ben Locwin
Ben Locwin is a healthcare executive and industry expert. His work has involved bringing new and innovative medical treatments (drug therapies, vaccines and medical devices) to patient populations with unmet needs across a variety of indications and health conditions. He has also worked with investors on the ‘next big things’ in the industry. He has been featured in The Wall Street Journal, Forbes, USA Today, The Associated Press and other top-tier media.