ARTICLES BY LOUIS

• How Can We Create A More Perfect CDMO?

  6/21/2022

  We the People of the Outsourcing Industry, in Order to form a more perfect Union, establish Service, ensure Reliability, and secure the Blessings of our system of drug development and manufacturing, establish this Constitution for working with CDMOs. (Preamble to the Outsourcing Constitution)

• Launch Your Career At A CDMO

  6/20/2022

  Irfan Ali Mohammed went from university in New York directly to working at a CDMO in Maryland. Years later, I ask him on behalf of professionals starting out in the drug industry today: Is starting a career at a CDMO a wise decision? Here's Mohammed's reply, and more.

• Build A Great Company, Not An Acquisition Target

  6/13/2022

  A biotech’s notable success along the development/clinical path likely results in an acquisition by a larger organization. The paradox: Not planning for such acquisition brings a higher probability of that transpiring. Plan instead to build a great and sustainable company.

• Did The CDMO Industry Just Go Woke?

  6/9/2022

  The last time I covered a CDMO waltzing on Wall Street was in 2014. It felt like a game-changer. Have we now taken a further leap of some sort? I suspected as much when learning of the rebranding of Recro CDMO as: Societal CDMO. The company responded.

• Beware The Manufacturing Bottleneck: Lessons From Inside

  6/6/2022

  Steven Kelly, President & CEO, Carisma, a biotech with a CAR M therapy in phase one, is a repeat-CEO. “I’ve had a varied experience, and different functional responsibilities,” he says, "but when I think about manufacturing, two experiences stand out for me.” 

• How Do You Due-Diligence Novartis?

  6/1/2022

  An emerging biotech needed to find a CDMO to scale up its cell-therapy product. The search was proving difficult, until a relatively untested CDMO emerged: Novartis. Carisma Therapeutics CEO Steven Kelly explains how his company did due diligence on a Big Pharma.

• An Infantile Supply Chain

  5/27/2022

  Imagine a country with a $4 billion, government-regulated market for a life-vital product supplying a large and vulnerable part of its population. And a woefully inefficient supply chain and management of it all. 

• Optimism Is Not A Strategy For Outsourcing

  5/26/2022

  When you embark upon your drug development program, and connect that to patients, you have to be optimistic. Optimism is a biopharma’s opening gambit. Danger lurks, though, when optimism gets codified in unrealistic, aspirational planning and timelines.

• We Need More University-Based CDMOs

  5/24/2022

  What the outsourcing world needs now is university-based or -affiliated, CDMOs. So says Joanne Beck, COO, Boston Pharmaceuticals, and whose career has spanned Amgen, Abbott/AbbVie, Shire, and Celgene.

• Breaking Down The CDMO Size Barrier

  5/16/2022

  We recently discussed a “mutual growth” strategy for working with smaller to mid-sized CDMOs. Now we’re on to a “bigger-than-you” strategy for biotechs working with “Big CDMO.”