10.10.26 -- Outsourced Pharma Newsletter - Best Of September

Would you like a shortcut to failure in regulatory CMC? Hire extensively based on what candidates already know. That’s a provocation underlying a number of conversations with senior leaders in regulatory CMC, and it feels especially relevant to outsourcing. With the correct attitude and leadership, learning (yes, on the job) may beat credentials for long-term success.

Where CDMOs first flourish, and clinical trials pick up, biotech innovation follows. It has been the China model, and now the addition of biotechs and biotech investment from within and without has South Korea as the new attention-grabbing nation participating throughout our industry. Here's an in-depth analysis from Chief Editor Louis Garguilo.

A few times in life you hear something that precipitates a pause – a reality recalibration. Like experienced by Amit Kumar, chairman and CEO, Anixa Biosciences, when he came upon a technology he thought could enable a prophylactic vaccine to prevent breast cancer – perhaps eliminate the disease like we've done for polio. He personally invested over $2.5 million, and his development/commercialization strategy is all-outsourcing all the way.

Operational excellence meets ethical stewardship. Data-driven strategies and renewable energy integration are shaping a responsible future for global manufacturing and community engagement.

Watch as our CGT experts explore the evolving landscape of viral vector manufacturing, overcoming production bottlenecks, and the strategies necessary to bring life-changing therapies to more patients.

High‑content imaging enables optimization of small‑molecule protein degraders by delivering single‑cell insights that accelerate hit identification, SAR development, and lead advancement.