10.11.25 -- Outsourced Pharma Best Of September

A homegrown manufacturer — USAntibiotics of Bristol, Tennessee — says it can cover America’s demand under a new arrangement with two titans of distribution and retail: McKesson and Walmart. The other “titan” in the deal is President Trump. Chief Editor Louis Garguilo takes a nuanced look at this breaking news that again puts drug manufacturing on the front pages.

The FDA embraced "radical transparency” by publishing over 200 complete response letters (CRLs) for drug and biologics applications submitted between 2020 and 2024. Hooray for the FDA; good for drug developers hard at work today. Good for developers, writes Chief Editor Louis Garguilo, because he can identify patterns to help us outsource better.

“We would be in meetings, and someone would disparage a certain CDMO. But one of our leaders would almost always have the opinion that we could make the relationship work. ‘No one is perfect, including us,’ he said.” Outsourcing is an attitude, explains Dan Marasco. Here's the attitude he says you should bring to your external partnerships.

CDMOs play a critical role in TPD development by offering specialized infrastructure and analytical capabilities to support the transition from preclinical research to clinical supply and commercialization.

Partnering with an experienced sterile CMO is essential for small-batch injectables, requiring clear communication, quality alignment, and regulatory compliance to ensure manufacturing success.

Learn about strategies that can help build an understanding of risk assessment, in addition to how a study’s protocol requirements, packaging specifications, and more must be identified and addressed.