ARTICLES BY LOUIS

• FDA Leads, C-Suite Lags Continuous Manufacturing Acceptance

  6/13/2019

  What happened to the continuous manufacturing (CM) revolution that was barreling down the biopharma turnpike? One measurement of progress is the five FDA-approved drugs utilizing CM. I’ve heard positive dispositions on how the FDA is doing all it can to break down the adoption doors. But there’s a sentiment within the industry CM gets stuck in the C-Suite.  

• How Important Is Geography To Today's Outsourcing?

  6/10/2019

  A recent CDMO press release essentially asserted superiority via proximity: Geography as God of outsourcing. I contacted two biopharma executives familiar with the Boston/Cambridge scene for reactions: Michael Kaufman, Senior Vice President, CMC, Mersana Therapeutics, and 15-year veteran of Merck; and George Avgerinos, Senior Vice President of Biologics Operations, Fortress Biotechnologies, and 22-year veteran of BASF/Abbott/Abbvie.

• New FDA Quality Report – A World Full Of Inspections

  6/3/2019

  In 2018, FDA investigators performed 1,346 Drug Quality Inspections, covering 29% of what the agency calls it’s “site catalog.” Of those inspections, the majority (53%) were performed outside of the U.S. Here’s why that’s important, and more insight on these worldwide inspections from a newly issued FDA report.  

• Novartis And the Price Of A Child's Life

  5/29/2019

  We’ve been thrust from ruminating around the worth of a generic “human life” towards contemplating starker terms of specific two-year-old children. This thanks to Novartis’ gene-therapy Zolgensma, priced at $2.125 million. However, is this our hoped-for future of gene and cell therapies? The irony of life-saving drugs that financially cancel their celebration at the point of FDA approval?

• “We Do Everything” CDMO Pitch Not Pleasing Everybody

  5/23/2019

  Recent CDMO marketing extolling “the only end-to-end services" hasn’t been universally well received by the biopharma professionals it is targeting. Might we start questioning how truthful all CDMO marketing is as a result? That wouldn’t be good for the drug development and manufacturing outsourcing industry. 

• 10 Questions For “Make Vs. Buy” In Drug Development And Manufacturing

  5/16/2019

  The questions for “make vs. buy" raised by Bristol-Myers Squibb’s Christopher Sinko, SVP and Head of Product Development, are news because of this: Sinko reaffirms for us they remain cemented within the otherwise changing dynamics impacting drug development and manufacturing outsourcing decisions.

   

• Didn't Get The Memo On High Potency And Analytical Services?

  5/9/2019

  Didn’t you get the memo? Actually, the series of memos: Biopharma customers need more HP and analytical support. These two services keep popping up as limiting factors for drug development and manufacturing outsourcing programs. Now another of these memos has been written, by Doug Bakan, Arena Pharmaceuticals’ Executive Vice President, Technical Operations.

• The Remarkable Rise Of Japan's CDMOs

  5/2/2019

  According to the CPhI Japan Trend Report 2019, there are some interesting cross currents in the Japan market for innovative medicines. But allow me to also alert Outsourced Pharma readers to a separate trend I’ve been following for a while: The CDMO industry in Japan is on the rise.

• Arena Pharmaceuticals Straightens Out The “Tech Ops” Circle

  4/25/2019

  Technical operations personnel – “Tech Ops” – can feel like they are running in circles as much as advancing programs forward. To straighten out those loops, Arena Pharmaceuticals relies on Doug Bakan, EVP Technical Operations. But complicating matters for Bakan is that today Arena is an all-outsourcing development and manufacturing organization. 

• Don't Put “Descartes Before The Horse” When Outsourcing

  4/18/2019

  Robert Ward of Eloxx Pharmaceuticals is on his second tour of duty as chief executive officer of an early-stage biotech. That makes him the perfect “real-life” CEO to react to a recent editorial about a “speculative” CEO who says to her colleagues: “We outsource, therefore we exist.” Ward’s initial thought? “Don’t put Descartes before the horse."