Welcome
Agile Biologics Consulting LLC
Navigating the CMC challenges of bringing therapies to patients.
Navigating the CMC challenges of bringing therapies to patients.
Welcome to the Agile Biologics Consulting website. After working in the biotech industry for over 30 years I became a consultant to help companies navigate the CMC challenges of bringing therapies to patients. Explore this site to learn about biologics CMC and how I can help your company succeed.
With an average cost of over $10M, advancing a novel biologic product from discovery through early-stage clinical trials is often the most significant expense for an emerging biologics company.
Biologic products are inherently complex and often challenging to manufacture. This must be balanced against FDA regulatory requirements and a rapidly evolving regulatory landscape. Without careful planning and oversight, these create a significant risk of cost overruns, timeline delays, and regulatory approval issues.
Many executives are unaware of the CMC development and manufacturing challenges that can significantly affect the success of their company. Download this CMC risk guide to learn more.
An Overview of an Emerging Biologic Company’s CMC Risk (pdf)
DownloadBefore becoming a consultant, I served as Vice President of CMC at Cue Biopharma and bring over 30 years of experience in biopharmaceutical CMC operations at Chiron, Aventis, Medarex, Morphotek, Mersana Therapeutics, and Eisai.
During this time I established the CMC departments, developed the manufacturing processes, and built the CMC due diligence data packages at Morphotek, Mersana, and Cue Biopharma, which separately led to significant partnerships with Eisai, Takeda, and LG Chem. I also led the CMC development of Farletuzumab for over nine years, from pre-IND through early and late phase clinical trials, and authoring the CMC sections of a BLA. During my career I have supported over 40 biologic products.
My hands-on practical approach helps companies develop robust CMC plans, resolve CMC development and manufacturing issues, select and manage CDMOs, and identify and mitigate CMC risks so they can successfully advance their product from discovery through clinical trials.
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