ARTICLES BY LOUIS

• Erase Generics From Your Vocabulary

  7/20/2022

  I first described Cosette Pharmaceuticals as an “innovative specialty generics” organization, but President & CEO Apurva Saraf had us questioning all three of those words, and how we use them (or shouldn't) today.

• Safe At Home With Generics

  7/13/2022

  “I have not wanted to go to India or China for most of my API needs, and to the extent possible I do not want to go there for formulations either,” is part of a surprising sentiment from a long-tenured generics outsourcing professional.  

• “Hypercare” When It's Critical At Your CDMO

  7/11/2022

  When it reaches criticality at your CDMO – like the potential delivery delay of clinical material – it’s "Hypercare" time. That’s the word coined at Alexion Therapeutics for an intensified coordination and managing of activities at CDMOs in crucial moments. Read on: Hypercare might be right for you, too.

• An Unexamined Life Is Risky Business

  7/1/2022

  Have you sufficiently examined the “life” of your drug development and manufacturing outsourcing? If you rely on outsourcing as an external life force to get you into and through the clinic (and perhaps beyond), how you answer that has never been more important.

• 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.