ARTICLES BY LOUIS

• 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. 

• 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.”

• Continuous Much More Than Manufacturing

  Bernhardt Trout of the Novartis-MIT Center for Continuous Manufacturing, and Salvatore Mascia of CONTINUUS Pharmaceuticals, Inc., reveal the “true benefits” of this disruptive innovation. It’s not all about enabling new forms of manufacture, but also the discovery and development of novel molecular entities, and all the processes by which we will bring new drugs to patients.

• 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.

• 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.”