"We’re there to help service providers continue to be healthy, viable businesses,” says Phil Roberts, Senior Vice President, Technical Operations, Orexigen. “I’m open to the concept that a static CDMO, is really a dead CDMO,” he concludes. But for Orexigen and its supply chain, it’s been much more of a mutually assured existence. Here’s part two of the journey.
Just like with pictures, every company tells a story. For its true grit and determination in the face of regulatory and market adversity, and its survival due to the ability to quickly establish a commercial supply chain and work with outsourcing partners, no company tells us a better story than Orexigen.
Release blockchain technologies from the jaws of serialization. Unleash it on tech transfer, data integrity, project management, supply-chain relationships, and all components that make up our drug development and manufacturing outsourcing industry.
Our industry would benefit from the sourcing function focusing less on narrow cost reductions, and more on broader corporate objectives; and from drug owners who allow external partners more control of their own environments. These would add up to a better functioning supply chain, and improved overall business outcomes.
Let’s look at two practical activities for tech transfer to CDMOs, and two pieces of just as practical advice for working with those service providers, all four to help you increase your Chemistry, Manufacturing and Control (CMC) effectiveness.
CMC stands for chemistry, manufacturing and controls, part of any new pharmaceutical product application to the FDA. How virtuals, biotechs, and pharma companies get through the nicely arrayed acronym to an IND or NDA is no easy task. Industry veteran David Hennings says it helps to practice “interdisciplinary CMC.”
Companies in every industry are defining their next generation of value chains. In doing so, they are increasingly integrating with third parties, and their platforms. Savvy leaders leverage these relationships to unlock their next waves of strategic growth. Here are 9 steps to move the process forward, based on a new report from Accenture.
Quickly: What three technologies impact your drug development and manufacturing? How do those technologies impact your outsourcing partners, processes, and decisions? Thanks for joining today’s flash mind exercise. You’ve also joined executives on the Outsourced Pharma Editorial Advisory Board who did the same. Let’s compare.
Discerning growth opportunities (or business contractions) in the drug development and manufacturing outsourcing space is a challenging exercise. Among other things, it requires reading between the lines of various industry reports concentrating otherwise, for example on comparing commercial product sales and R&D pipelines. An “otherwise” focused report worth our attention is the EvaluatePharma World Preview 2017, Outlook to 2022.
Paraphrasing Henry Hoppe of Xenetic Bioscience, companies on the bleeding edge of innovative technology in drug development and manufacturing should treat visits to the FDA more like Socratic dialogues than stressful duels. Mark Butchko, who’s charted over a decade with Lilly, advises holding some of those dialogues during “pre-operational visits,” or POVs.
