ARTICLES BY LOUIS
Remember when a lack of capacity was going to feel like a massive concrete slab blocking the road to a biopharmaceutical revolution? Instead, it's felt like so many bricks placed in the paths of individual drug development programs. Now CDMOs are building to meet demand. Is it the right kind of capacity?
2.4 million sq ft of dormant industrial space undergoing adaptive reuse development as a biomanufacturing center in the heart of Philadelphia. Do we have your attention? Cell and gene therapy companies, CDMOs, Big Pharma: All are welcome to the renaissance.
Today, cell-and-gene companies need knowledge support, and thus a “new sort of consultancy partnership focused on process development and advice-giving, not just routine CDMO contracts for services.” “CDMO 2.0” can materialize in an increasingly familiar form – drug-developer/service-provider hybrid organization.
Massimo Dominici is on a mission to “GMP-ify” the cell-and-gene industry, and create a ubiquitous new “culture of cell culture,” as he puts it. To do that, the company he co-founded set out as an emerging, clinical-stage biopharma, and also became a service provider to other emerging CGT developers.
Happy about it or otherwise, many readers will face a level of “site selection” – some of you coming face-to-face with economic development agencies at state, regional or local levels. What should you expect? We've got answers and advice.
You are an emerging biopharma outsourcing to a trusted CDMO that has selected its location wisely – an important factor in your selecting it. Now you’ve determined to establish some of your own development or manufacturing facilities. Would it be beneficial to build close to your CDMO?
With a more flexible and relational approach, CDMOs and emerging drug sponsors can end up putting together a different contract altogether – one driving a new pricing and calculation that works for both sides. Here's details to one example.
Somebody has to set the strategic integration of in-house development and manufacturing with external activities; identify for investors why that is the wisest strategy; explain why the CDMO selected is the best fit. Those somebodies are CEOs. Here’s more from ISR Reports.
What's really in it for your independent advisors and board members? We've some firsthand answers that will catalyze some thoughts on how you receive potentially invaluable advice from a trusted executive-level mentor, advisor, and additive governing voice – and not only regarding outsourcing.
In the beginning, there were Big Pharma concentrations. Decades later, biotech centers emerged. Now we have our first CDMO cluster. It’s in North Carolina. And it’s worth giving this some thought if you are outsourcing drug development and manufacturing.