ANALYTICAL DEVELOPMENT STRATEGIES FOR GENE THERAPIES
- A conversation with Jim Richardson, Interius Biotherapeutics

Jim Richardson, Senior Director, Analytical Development at Interius Biotherapeutics shares his experiences and provides advice on how your company can implement better analytical strategies for gene therapies, including: (1) Understanding the early development analytical learning curve; (2) Managing comparability; (3) Addressing potency; (4) Regulatory considerations.

IDENTIFYING AND OVERCOMING CMC CHALLENGES IN GENE THERAPY
– A conversation with Susan D’Costa, Alcyone Therapeutics

Susan D'Costa, chief technology officer at Alcyone Therapeutics shares her experiences and provides advice on how your company can identify and overcome CMC challenges in gene therapy, including: (1) Understanding and monitoring DNA constructs; (2) Identifying starting material challenges; (3) Prioritizing potency assays; (4) Impact of viral vector delivery and development of capsid tropism

MAKING PROPER CMC INVESTMENTS TO REDUCE RISK AND MAXIMIZE ROI
– A conversation with Mike Kelly, Atsena Therapeutics

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: (1) The make or buy decision; (2) Ensuring CMC investment provide regulators what they need; (3) Scalability considerations; (4) Identifying technologies and assays to support your strategy; (5) Controlling COGS; (6) Building a commercially feasible program profile