ARTICLES BY LOUIS

• 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."

• Sub-Second Blockchain Verification: Next Up, CDMO Interoperability?

  4/15/2019

  I asked Susanne Somerville, leader of the MediLedger Project, and now CEO of Chronicled, for an update on blockchain technology and supply-chain adaption in the biopharma industry. She came back with excited talk of “sub-second drug verification,” and a new "interoperability creating effective channels of communication," including with your CDMOs. Glad I asked.  

• Internal Processes And Attitude Drive Outsourcing Outcomes

  4/8/2019

  Take it from an organic chemist, who transitioned from the bench to cross-functional leadership and CMO management at companies such as Amgen, Baxter/Baxalta, Shire, and now ImmunoGen: Outsourcing effectively starts with realizing "the value of establishing consistent internal processes for all activities.” And, he adds, bring a bit of attitude to your service providers. 

• Solutions Needed For Automated And Analytical Services In Fill Finish

  4/1/2019

  For fill finish services at CDMOs, two items high on biopharma executives’ wish list are increased analytical and testing capabilities, and automation to replace manual product-line inspection. However, it appears to the CDMOs that customers are saying, ‘The onus is on you to figure it out … and pay it forward.” Is there a mutually acceptable solution?

• JPMorgan Chase CEO Jamie Dimon And Outsourced Pharma Readers

  4/1/2019

  Each year, Jamie Dimon’s annual letter to shareholders is considered required reading by folks on Wall Street and elsewhere. Dimon is Chairman and CEO of JP Morgan Chase, the largest of the big four American banks. Reading through his letter this year, I found three areas we might consider directly relevant to Outsourced Pharma readers. 

• CDMOs Respond: Paying For A New Fill Finish Paradigm

  3/26/2019

  As vivaciously as our board members responded to a question regarding their biggest challenges when contracting fill finish services, CDMOs have now reacted in kind. The reactions come from around the world, including four CEOs of CDMOs. One thing both sides agree: They are operating within an encompassing paradigm shift.