Max Moore, Executive Director, Manufacturing & Operations, Ionis Pharmaceuticals, lays down a challenge to certain drug developers and manufacturers: Try to find a better scientific or economic outcome for bulk API production than lyophilization. He says you won’t. Not if you consider outcomes correctly. (And by the way, expect a lot more of all kinds of “lyo" in your future.)
Part 2 of our look at the unique business model and ambitious plans of Civica Rx.
Can it be that today, when we expect increasing demand for CDMO services, biopharmaceutical companies have decided to outsource less of their commercial production needs than in the past? Some new data provided exclusively to Outsourced Pharma by PharmSource, an organization of GlobalData Plc., seems to suggest so. But if so, why that apparent trend reversal?
The hypothesis is bold: Our emphasis on generics is a detriment to U.S. patients and the entire healthcare system. Instead, these past decades we should have focused intently on increasing the life cycle and distribution of innovator drugs.
What if we’ve been going at this all wrong for decades? If generics – and biosimilars – are not a sound solution for patients, hospitals, healthcare systems, governments, pharmaceutical companies, or CDMOs, when it comes to all parties profiting from the miracles of our best drugs? Part one in our investigative series.
It's the immutable law: You can have good, you can have cheap, and you can have fast, but you can only have two together. However, when it comes to drug development outsourcing, veteran biopharma executive Robert Discordia has a “magic” formula of sorts. He presented it at this year’s Outsourced Pharma Boston conference.
Our future appears to be in good hands after all. Following on our earlier editorial, here’s a broader measure of the motivations and modus operandi of the youth inhabiting our drug development industry as we head into the 2020s … a decade they can conquer utilizing our outsourcing industry.
I hope Outsourced Pharma readers will enjoy this editorial with Civica Rx President & CEO Martin VanTrieste, featured in this month’s issue of Life Science Leader magazine. VanTrieste has a business plan that could set the generics industry on a new path of full disclosure of drug-manufacture origin, and direct delivery to the point of patient use. Part 2 of this feature will be released next month, with a direct focus on CDMOs and Civica.
The FDA wants continuous processing and manufacturing to move forward. CDER’s even sending emails and writing Impact Stories about the technology. Here’s what three biopharma industry experts — from Merck, BMS, and MIT — think about the pace of adoption.
Justin Klee and Joshua Cohen were just 21 and 22 when they co-founded Amylyx Pharmaceuticals in 2013, while pursuing undergraduate degrees at Brown University. Today, their insights about drug development and manufacturing outsourcing are nothing short of remarkable.