Great questions elicit enlightening answers. Especially when the first come from a wise moderator (Brendan Crowley, President, Brendan Crowley Advisors LLC), and the second a seasoned industry veteran (Remo Colarusso, Vice President, Janssen Supply Chain, Johnson & Johnson). Here’s what they had to say about drug development and manufacturing partners.
Biopharma executives have warned they need more biologics development and manufacturing capacities, particularly in North America. They haven’t been howling at the moon. Four announcements – within two days of each other – offer a sign of relief. And Amgen has provided Outsourced Pharma with its first public estimate of costs for one of those facilities.
Regarding drug development and manufacturing – including outsourcing – Bob Betzig of Pfizer says technology has led and continues to drive change. And by the way, so do the global regulators of biopharma.
Why has the biopharma industry insisted upon dual (or triple) sourcing for materials? Why does Big Pharma perform outsized due diligence on offshore CDMOs and CMOs? Why do we focus on costs of all materials and supply? One reason is so we can calmly weather uncertainties such as the current tariff troubles between the U.S. and China.
Whether it’s innovative product-development; the need to operate globally; dealing with aging and unhealthy populations; stopping counterfeiting and theft; or facing un-harmonized serialization … biopharma packaging has its challenges.
This is the story of a man and a building, and their tracing of decades — and hints of the future — at Pfizer, and indeed the entire biopharma industry.
It’s conference season: Time for you — biopharma CEO and new employee alike — to learn and lead among others in the industry. Unfortunately, you may come up short. Here are 3 questions of existential importance to ensure that doesn’t happen at your next conferences.
Industry Standard Research (ISR) has released two reports – one on the API outsourcing preferences and practices of small-molecule drug sponsors, and the other on those of large-molecule sponsors. I also undertook some additional analysis by comparing the reports. My driving question: Are there strategic and tactical differences for the two programs when outsourcing to CMOs?
The world’s first biopharma built on blockchain technology has arrived. “We’ve created a new generation of pharmaceutical company, focused on dispersed product development through the use of today’s technology,” says Dr. Matthew Lee, Caywon Pharmaceutical Group’s VP of Innovations.
There’s a quotidian calculation to outsourcing at Allena Pharmaceuticals that's well worth studying.
“As a small biotech, we could get kicked to the curb because somebody else has more dollars, and can occupy longer those assets at a CMO that we need. Because of this, we’ve evolved a concept of portability for our manufacturing process that may be anathema to a lot of companies …"
