Louis Garguilo's Articles

31. Regulatory-CMC: A Core Practice For Successful CDMO Partnerships 2/6/2025

    Regulatory-CMC is the denominator through the career of Sai Prathyusha Bhamidipati, currently at Moderna. Regulatory-CMC focuses on ensuring compliance with regulations regarding the production and quality control of your pharmaceutical products. Bhamidipati explains the importance for the practice of which when dealing with CDMOs.

32. Training Specifically For Tech Transfer Skills Does Exist 2/3/2025

    Professionals in our development and manufacturing outsourcing ecosystem are worried about inadequate training – in-house at their biotechs, and at their CDMOs. A main concern is a lack of sufficiently trained personnel to perform the various technology transfers to keep our industry running efficiently.

33. From JP Morgan: CDMOs Have A Change Of Heart 1/29/2025

    CDMOs seem determined to do two things more strategically and with a greater focus: build on what they do best (instead of spreading across services); and differentiate themselves by a devotion to customer service. Part two from JPM25.

34. An Outsourcing Vibe At JP Morgan 25 1/28/2025

    The JP Morgan Healthcare conference has never been a venue for directed discussion on outsourcing. That’s not to say such discussions aren’t held. This year, Kurt Nielsen co-hosted an evening devoted to the topic. Nielsen, a veteran outsourcing-industry executive, shares his initial thoughts on the vibe this year.

35. How Biotech Academy In Rome Is Reshaping Workforce Readiness 1/27/2025

    As the biotech industry continues to evolve, a growing gap in workforce readiness has emerged, driven by insufficient training for both new graduates and experienced professionals transitioning to advanced bioprocessing. Biotech Academy in Rome's Leonardo Sibilio addresses this challenge.

36. The Intelligent CDMO: A Vision With Agentic AI 1/20/2025

    Agentic AI is the next artificial-intelligence iteration for the biopharma industry. It propels prediction to autonomous decision-making. It can usher in transformative efficiencies to CDMOs. If you've day-dreamed of more effective external-support, this may be a ticket to that destination.

37. Autonomous Decision-Making: Are We Ready For Agentic AI 1/15/2025

    The biopharma industry has generative artificial intelligence (AI) in its employ. After a long wait, we’ve adopted it rather suddenly. Just in time for a new kid in town. Next to ride in is Agentic AI. It will more robustly revolutionize our drug development and manufacturing. A preview of what's to come.

38. It's Partly Personal (Medicine): In 10 Years Outsourcing At $315 Billion 1/13/2025

    You’ve got to give Towards Healthcare credit. They've the fortitude to publish a 10-year projection of how much development and manufacturing outsourcing will add up to globally. Interestingly, personalized medicine may play an outsized role in that growth. Chief Editor Louis Garguilo takes a deeper dive into the Pharmaceutical CDMO Market Companies, Advantages and Segmental Analysis.

39. 2024 Made Us Nervous. Will 2025 Be A Happier New Year? 1/6/2025

    Chief Editor Louis Garguilo doesn't recall a time of more collective concern over development and manufacturing outsourcing than exhibited during last year's news of Novo Holdings’ purchase of Catalent, and the sale of certain Catalent facilities to Novo Nordisk. That angst was aggravated by the simultaneous drama known as the BIOSECURE Act. Will we have a calmer 2025?

40. 2025: Navigating Partnerships Amid Political And Economic Shifts 1/2/2025

    Brace for a potentially turbulent 2025. That’s the collective message members of the Outsourced Pharma Editorial Advisory Board provided Chief Editor Louis Garguilo for his first editorial of 2025. They reveal a landscape where geopolitical tensions, regulatory evolutions, and emerging technologies will affect how you develop and manufacture drugs.