Planning For A Successful Initial IND And Moving Beyond

In biotherapeutics, encompassing cell and gene therapies, the strategic development of products and regulatory planning for CMC (Chemistry, Manufacturing, and Controls) initiates at the pre-IND stage and spans the entire developmental journey. Whether you are an early-phase sponsor seeking to transition successfully from laboratory experimentation to full-scale manufacturing facilities or a mid-phase program working on refining processes, product enhancements, and facility adaptations, meticulous planning for manufacturing, comparability, and analytical programs plays a pivotal role in mitigating regulatory risks.

During this webinar, the following experts in Regulatory CMC from Veristat delve into critical topics, addressing key challenges, outlining effective strategies, and highlighting important considerations for analytical programs aimed at demonstrating comparability:

• Kevin Hennegan, Director of US Regulatory Affairs, Veristat
• Sarah Roemer, Ph.D., Principal Regulatory CMC Strategist, Veristat
• Lisa Erickson, Principal Regulatory CMC Strategist, Veristat 

By watching or reading through this presentation, viewers and readers alike can explore the world of biotherapeutics (specifically cell and gene therapies), understand the significance of demonstrating comparability during the early to mid-phase stages of development, gain insights into analytical methods — including a discussion of common challenges, viable strategies, and important considerations — and benefit from real-world case studies.