Imagine you are a virtual biopharma developing a plant-based biopharmaceutical, and you contact the CDMO with the most experience in the field. The CDMO offers its technology/knowhow, to help file an IND, and supply the clinical material and launch quantities. Then it'll assist you in building your own commercial facility in your home market. Sound too good to be true?
“There is the old adage that you cannot test quality into a product. By the same token, you cannot manage service and quality into a CDMO,” says Roger Graben, biopharma industry veteran and president of Vitruvias Therapeutics. But he’s got some sage advice on how to select your service provider, and work best within those limitations.
Ours is a responsive Editorial Advisory Board, but no question posed to them elicited the range and rate of response as this one: “What are the biggest challenges you face with outsourcing fill finish services – what keeps you up at night?” Chances are Outsourced Pharma readers are also experiencing the challenges board members told us about.
According to the recent DCAT Benchmarking Study, after all the jaw-boning, modeling, conferences, reports, articles, and analysis … biopharma customers and CDMOs still don’t see eye-to-eye on the topic and practice of “long-term” service and business relationships.
The new chief executive slowly made her way to the makeshift stage in the largest of the three meeting rooms at the young biopharma where she was taking leadership. She had a degree in chemistry, and a PhD in philosophy. Perhaps not your typical candidate for chief executive at a start-up biopharma. She’d thought deeply about the company and its future. What was at its core?
Can a smaller biopharma have any leverage with bigger, multinational CDMOs? Biotech Genisphere is giving it a try. So far, so good. Here’s why.
As I spoke to Tom Bliss, veteran pharma and bio executive (e.g., Amgen, Baxter, Kyocera), and most recently CEO of platform-biotech Genisphere LLC, I kept recalling Chicago’s iconic 70s rock song, “25 or 6 to 4.” That’s because Bliss was detailing how Genisphere went from a list of 35 or 6 candidate CDMOs to 2 selected as its development and manufacturing partners.
Readers may recall some spirited back-and-forth last year between me and Industry Standard Research (ISR) Vice President Kate Hammeke over conclusions on biopharma capacity at CDMOs. To measure more adequately, and get us on the same page, Hammeke inserted some specific questions on this subject into a recent ISR survey. That data is now in, and exclusive to Outsourced Pharma readers.
What industry trends, developments or outcomes did not shape up as you had expected at the start of 2018? Here are replies to this question from the Outsourced Pharma Editorial Advisory Board, starting with an insightful list from Darren Dasburg, VP, Head Learning and Development, Global Operations, AstraZeneca. Considering what didn’t work out should help us focus in 2019.
Will bigger biopharma successfully streamline supply chains by capturing the capacity and technologies under the umbrellas of bigger service providers? Will start-ups and smaller biotechs find new options for the unique solutions they need? Here’s a look at what transpired in 2018 to help answer both these questions. Oh, and Happy Holidays.