Merck licenses SciBrunch's preclinical KRAS G12D inhibitor for $2.13B, raising tech transfer and scale-up questions for oral cancer drug development.
|Podcasts|April 3, 2023
CMC Challenges in the Evolving Small Molecule Development Pipeline
Author(s)Lonza
A growing proportion of drugs in the development pipeline nowadays start out life at small biotech companies, rather than big pharma businesses. While this means the biotechs are taking on more risk, they will also reap greater rewards in the event of success. When it comes to choosing your CDMO partner, there is no substitute for a careful selection process to determine the right CDMO to make and manage your precious potential drug. In this podcast, David Hall, Senior Director, Commercial Development at Lonza Small Molecules, provides insights on how small and emerging pharmaceutical and biotech companies can navigate the evolving pharma development pipeline.
Related to this article
Ronald Piervincenzi, USP, urges drugmakers and purchasers to act on supply chain resilience to curb drug shortages and shape better policy.
Content on PharmTech.com this week ranged from fundamentals on the use of digital pathology in drug development, discussions on the use of AI in pharma, and regulatory actions impacting the industry.
This article discusses risk-based lifecycle governance, system implementation considerations, and the progression of batch record control from paper-based to fully electronic systems.
Ronald Piervincenzi, USP, explains why manufacturers should act now and how benchmarking could reward reliable generic drug suppliers.
The FDA approves Lilly's once-weekly insulin efsitora for type 2 diabetes, raising Fc-fusion manufacturing, high-concentration pen, and capacity questions.
Florin Muraru, Gourav Pandey, and Richard Jaenisch explain where human sign-off belongs as multi-agent AI and document-parsing models reach GxP.
In this episode of Ask the Expert, Siegfried Schmitt, PhD, vice president, Technical at Parexel, and Susan J. Schniepp, distinguished fellow at Nelson Labs, discuss how companies should approach post-approval changes to their CMC regulatory filings.