Podcast - Facing CMC Challenges in CDMO-Sponsor Relationships for Rare Disease Platforms with Nesredin Mussa

Facing CMC Challenges in CDMO-Sponsor Relationships for Rare Disease Platforms with Nesredin Mussa

February 13, 2023

In this month’s episode of Evaluating Biopharma, host Ben Locwin speaks with Nesredin Mussa, PhD, president of Dynamica Biologics, about navigating the challenges of securing successful CDMO-sponsor relationships for a rare disease manufacturing and testing paradigm, the key contributing factors that may pose within the partnership between the sponsor and CDMO, and how small companies can manage with the enhanced regulatory demands due to the nascent nature of these particular therapeutic platforms. Mussa also provides advice on how to reframe one’s thinking when facing challenges, as well as techniques on keeping grounded when the going gets tough.

GUEST BIO

Nesredin A. Mussa, PhD, president of Dynamica Biologics
Dr. Nesredin A. Mussa is a Biopharmaceutical executive with over 24 years of experience in the development and commercialization of traditional Biologics and advanced medicines including Protein therapeutics, mRNA and Gene Therapy platforms. Dr. Mussa is the president of Dynamica Biologics LLC, a CMC, drug development and operations consulting company. Dr. Mussa has lead global development teams and established multiple Biological process analytics, Analytical development and QC labs. Dr. Mussa worked in multiple global pharmaceutical and leading small Biotech companies where he led and supported CMC for dozens of IND and BLA filings. Dr. Mussa holds a PhD in Protein Biochemistry and a Master’s in Clinical Biochemistry.

MODERATOR BIO

Ben Locwin, vice president of Project Solutions, Black Diamond Networks
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, Axios, NPR, and other top-tier media.