Gene Therapy Analytics: Identifying and Overcoming CMC Challenges in Gene Therapy

June 13, 2023

In this episode of Evaluating Biopharma, Ben Locwin, Vice President of Project Solutions at Black Diamond Networks, speaks with Susan D'Costa, Chief Technology Officer at Alcyone Therapeutics, who shares her experiences and provides advice on how your company can identify and overcome CMC challenges in gene therapy, including: understanding and monitoring DNA constructs, identifying starting material challenges, prioritizing potency assays, and the impact of viral vector delivery and development of capsid tropism. D'Costa also talks about her hopes for the future of gene therapies and building better CMCs, processes, and characterization tools that will provide more accessible treatment for patients.

GUEST BIO

Susan D’Costa, PhD
Dr. D’Costa is a molecular virologist with over 25 years of experience in virology and viral vector analytics, process development, and manufacturing. Prior to Alcyone, Dr. D’Costa held leadership roles at Thermo Fisher Scientific, Viral Vector Services and its predecessor companies – Brammer Bio and Florida Biologix. Dr. D’Costa holds a PhD in biology, specializing in molecular virology, from Texas Tech University; an MS in biochemistry from Mumbai University (Grant Medical College) and a BS in microbiology/biochemistry also from Mumbai University (St. Xavier’s College).

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.