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.
This week addressed AI accountability, CPHI award winners, NFC anticounterfeiting, first-in-class FDA approvals, and a shelved FDA voucher pilot lead this week’s roundup.
Cole and Jaenisch explain why defending against AI poisoning in pharma manufacturing calls for a data steward role, immutable instruction ledgers, and automation.
Terry Katz, CEO and co-founder of ForgeStop Technology Corporation, explains how the company’s product is worth the investment by protecting products and patients.
The FDA has shelved its National Priority Voucher pilot, leaving sponsors that built CMC and launch-readiness plans around 1- to 2-month reviews facing uncertain timelines.
Regulators will test pharma companies against their own internal AI policies. Jaenisch, Muraru, and Pandey explain how to build defensible, inspection-ready AI practices.
Terry Katz, CEO and co-founder of ForgeStop Technology Corporation, explains how its connected technology can enhance anticounterfeiting and how data are handled within the product.
Celtic Renewables won the CPHI Award for Sustainable Pharma Excellence for its green chemicals used in pharmaceutical manufacturing. Bettina Brierley, chief commercial officer, talks about the adoption, capacity, and pricing of biosolvents.