ARTICLES BY LOUIS

• The Practice Of Interdisciplinary CMC

  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.”

• Outsourced Pharmaceutical Manufacturing Grows To $76 Billion

  The outsourced manufacturing sector should continue its growth at a clip of 6.6% over the next five years, faster than the projected annual growth rate of the overall pharmaceutical industry (5.5%). That’s according to a new report from Results Healthcare, Pharma & Biotech 2017 Review of outsourced manufacturing.

• 4 Concepts For Supply Chains And Your Good Supply Practices (GSPs)

  Readers who’d like to set down and then put their Good Supply Practices (GSPs) in motion, practice the core concepts that need to surround that effort, and align both internally and externally for a more successful supply-chain experience, might want to look over this well-worth-the-wait report. 

• Supply Chain Acronyms Lead Bristol-Myers Squibb

  Bristol-Myers Squibb focuses on reduction in total cost of ownership (TCO) while capturing value-based savings (VBS) in its supplier relationship management (SRM) strategy. A bit to unpack there. We get help from Keith Robinson, Associate Director at BMS, and an originator of the BMS Global Supplier Performance and Development Initiative.

• 4 Tech Transfer Keys For CMC Success

  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. 

• Most Of What I Know About CMC I Learned At A CDMO

  How does the modern-day CMC leader at drug sponsors get the job done? Michael Markey, newly appointed CMC Director, Pharmaceutical Sciences, Radius Health, Inc., says applying past experiences from working at CDMOs helps. However, there’s a lesson he’s learned since joining Radius, and it has to do with branding and the marketing of contract services.

• Comfortable CMO Consolidation And Biopharma Convergence

  The biopharma industry has been calling for more consolidation and convergence in the CRO, CDMO and CMO market. Well, we are now getting our share of it. And it is bringing on some creative deal-making, and unexpected developments. But we seem comfortable with what is transpiring. Here’s why.

• Continuous Manufacturing In The Mediterranean Sea

  Leaders from organizations such as Lilly, Janssen, the EMA, Rutgers University and the University of Malta, gathered in a Mediterranean setting to dive into the waves of continuous manufacturing adoption and regulatory challenges for global drug development and production.

• Biologics Staying Home, CMOs Destination For Small Molecules

  Jim Miller, President, PharmSource Information Services, Inc., sounds as much like a travel agent as a pharma outsourcing prognosticator at his DCAT Week ’17 market overview on pharmaceutical contract development and manufacturing: Pharma’s billions for biologics are staying home; small molecules continue to hit the road.

• The Future Of CMC Leadership At Radius Health

  New CMC leader — and former colleague — Mike Markey says, “What’s most important to remember about a virtual company is all of our functions work at a desk. None of us actually have hands on; we rely on our CMO partners to get the work done. For me, the external project managers become an integral part of my day-to-day work.”