ARTICLES BY LOUIS

• FDA Should Make “Quality Metrics” Public

  11/10/2015

  Whether or not you agree with the FDA in its determination to collect “quality data” directly from all drug manufacturers – including CMOs – if the agency moves forward, the real question is this: Should that data, and any rating the agency assigns to individual manufacturing plants for quality standards or “quality culture,” be kept internal at the FDA or made public?    

• GSK's Discovery Fast Track Contract Starts With Super-Moon Eclipse

  10/30/2015

  “Even the heavenly bodies aligned perfectly. Our partnership with GSK was announced the day of the super-moon total-lunar eclipse.”

       -- Richard Leduc, professor, Department of Pharmacology-Physiology, assistant  vice-dean for knowledge transfer, Université de Sherbrooke, Sherbrooke, Québec

• Who Wants To Work At A CMO Anyways?

  10/23/2015

  Are graduating students and newly trained professionals aware there is an AMRI as well as an Amgen, a Cambrex as well as a Celgene, or a Lonza as well as a Lilly? Even if they are, why would they select the service providers? And why is it positive for for the biotechs and pharma companies if they do?

• Service Provider In “Arbitrage Opportunity Of The Century”

  10/9/2015

  A brand-name outsourcing provider plays a role in an historic “arbitrage opportunity.” “I  truly believe these deals represent the most interesting models – China capital and U.S. technology – for the coming decade,” says  Tiecheng “Alex” Qiao of Ambrx Inc.

• The Paradox In Measuring Your CMO

  10/6/2015

  Something Denise McDade of Capricor Therapeutics said during a session at Outsourced Pharma West stuck in my mind: “Metrics are fundamentally important in measuring and managing any relationship, but there’s a paradox when it comes to outsourcing.”

• Pfizer Says Science First In Alliance Management

  10/2/2015

  Effective alliance managers with an underlying scientific fortitude allow for the growth of outsourcing, without a corresponding growth in the number of alliances, says Pfizer’s Sylvie Sakata.

• Don't Sing The BioPharma Supply-Chain Blues

  9/29/2015

  I’ve got 6 shipments in limbo; 47 days on a tarmac; 58 borders in Europe … And they’re taxing me at every step I take …

• Should You Search Globally For A CMO?

  9/21/2015

  I’m amazed in 2015 just the proposition of searching globally for CMOs is still a difficult decision for biotechs and other drug-developers. But because it is, I’ve captured some comments from industry experts at Outsourced Pharma West that may help.

• New-Era Drug Rx: C-Corp Per Compound And Large Dose Of Outsourcing

  9/14/2015

  Dauntless Pharmaceuticals isn’t the only company with a drug-development model based completely on outsourcing. Dauntless separates itself by where it takes the virtual-biotech model: It establishes a C-Corp for each compound it in-licenses. "From my management style, and viewpoint as a venture capitalist, this is how biotech should be done,” says Joel F. Martin, president and CEO.

• BioPharma Striving For LifeCycle Outsourcing™

  9/8/2015

  I’m usually pretty good at plucking overall themes from the various topics that swirl around international conferences. (Well, at least I think so.) That’s why initially failing to do so for the recent Outsourced Pharma West San Diego (OPW) conference was bothering me.