ARTICLES BY LOUIS

• 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.

• 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.

• CMC Hiring And Practice: 6 Lessons For Outsourcing

  Things have progressed nicely for Ruby Casareno, Vice President, Chemistry, Manufacturing and Controls (CMC), Allakos Inc. For executives wishing the same for your CMC leadership and organization, there are lessons on why that’s the case. Those lessons also recall for Casareno an earlier experience where progression traversed a rockier road. It all adds up to 6 best practices particular to outsourcing drug development and manufacturing.

• Continuous Cruising The Pharma Highway

  Jim Bonner of Shire, Eric Jayjock of Patheon, and Doug Hausner, of  Rutgers University, all agree continuous manufacturing is the pharmaceutical industry’s future. They also agree on the map and vehicle to get us past some of the roadblocks to that destination.

• 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.”

• Sanofi-Genzyme Together On CMO Reputation Management

  Not long after Sanofi tied the knot with Genzyme in 2011, Piet Houwen was asked to lead contract-manufacturing operations. Now about 5 years into the marriage, I visit with Houwen to learn about this combination of Big Pharma and Big Bio, his role, and an attitudinal adjustment for better biologics outsourcing.

• 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.

• 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.

• 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.

• Novartis And The Arrival Of The Continuous Manufacturing Facility

  The journey to implementation of the disruptive technology of continuous manufacturing began in 2005, according to Markus Krumme of Novartis, with a single question on a slide presented to Novartis development and manufacturing executives. “Why don’t we have facilities that can continuously produce materials?” then-CEO Daniel Vasella asked.