How a Sponsored CMC Platform Accelerates mRNA Projects into the Clinic

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On the pathway to GMP manufacturing in support of clinical trials, multiple technology transfers may correlate to an increase in complexity and risk to both product and timeline. The hand-off of new technologies, protocols, and materials can lead to delays or project failures.

This Webinar will highlight the comprehensive set of tools that Aldevron developed to support advancing mRNA projects to clinic. In addition, an overview of the technology transfer program, analytical and process characterization, release, and stability will be discussed with an insight into Aldevron’s integrated CMC capabilities ranging from transcript design and product profile definition through encapsulation and fill/finish.

Jon Cooper, PhD

Senior Director of RNA Sciences and Analytical Development - Aldevron

Jon Cooper, PhD. Senior Director of RNA Sciences & Analytical Method Development at Aldveron, has 20+ years of published method, product, and process characterization experience across a variety of companies including the NIH. He has led and contributed to myriad FTIH clinical projects including mAb, VLP, self-assembling nano particles, trimeric and heavily glycosylated trimeric proteins, and DNA and RNA based vaccines. Dr. Cooper has a continued interest in applying the efficient statistical approaches of DOE combined with the power of high throughput and automated approaches afforded through emerging technologies to control timelines and manage project risks.

Bo Chung

Director of Regulatory Affairs and Compliance - Aldevron

Bo Chung currently serves as the Director of Regulatory Affairs and Compliance at Aldevron with nearly 8 years of direct experience focused on regulatory affairs and compliance in advanced therapy development. He currently holds a JD in Law and a MS in Pharmacology from the University of Dayton School of Law and University of Cincinnati College of Medicine, respectively. He has supported and advised many of Aldevron’s clients through successful regulatory filings including INDs, CTAs, BLAs, and rest of world marketing applications, some of which include mRNA and LNP programs. Bo is a current member of RAPS and has coauthored chapters on Orphan Products and Rare Diseases in the Fundamentals of International Regulatory Affairs. Bo is a strong believer that one of the most important values in choosing a profession in the life and health sciences is that We make lives better.