ARTICLES BY LOUIS

• Serendipity And CDMO Catapult COVID-19 Candidate

  7/14/2021

  This gets filed in the scientific realm of: “Hey, look what we might have here?” A key ingredient for advanced, oral-solid-dose opioid medicines in clinical study, developed and manufactured with assistance from a reliable CDMO, turns out to have investigative potential for the treatment of COVID-19. Here’s how sponsor and service provider swung into action.

• CDMOs “Bumping” Cell And Gene Companies

  7/8/2021

  Why did GenVivo, a Southern California-based gene therapy developer, decide to establish its own facility, something not in their original strategy? “We had trouble outsourcing,” says Robert Johnson, COO and Scientific Advisory Board member. Not the first time we’ve heard this from a biopharma, but Johnson provides striking insight into the state of drug development and manufacturing outsourcing.

• Advanced Manufacturing Training In Academia, New Jersey To California

  7/1/2021

  To learn more about the biopharma manufacturing training program at Thomas Jefferson University’s Jefferson Institute for Bioprocessing (JIB) in Philadelphia, I was sent to Los Angeles. Here’s what I learned there to help our readers facing challenges in recruiting skilled workers.

• Leaders Have An Appetite For Adaptability When Outsourcing

  6/23/2021

  In part one - "Five Maxims For Outsourcing Success" - we tackled Lisa Wyman's first three of five tenets to better outsource by. Here we explore her belief that leveraging capabilities and capacities of CDMOs is predicated on an appetite for adaptability and flexibility, and that is exhibited as a quality of leadership.

• “In And Out Sourcing” At An Advanced Therapy Biopharma

  6/10/2021

  “I’d say the paradigm has heavily shifted,” says Todd Mabe on his joining the ranks of other ex-Big Pharma moving to cell and gene therapy companies to drive build-buy decision-making, and manage both in-house and CDMO relationships. “In and Out Sourcing” we might start to call this advancing hybrid model.

• Five Maxims For Outsourcing Success

  6/8/2021

  "Outsourcing is really about positioning your CDMO to your competitive advantage," says Lis Wyman of Acceleron Pharma. That might just be the "maximum maxim" for outsourcing strategy. But Wyman has four more to offer, all enlightening to your craft of drug development and manufacturing.

• The Biotech Path To An Outsourcing Eden

  6/5/2021

  “The outsourcing baseline for a biopharma is envisioning success, and putting together a well-defined package for the CDMO to get started and enabled to work independently and holistically throughout the product life cycle.” More insight into our provocative discussion on optimal outsourcing.

• Pharma's Lack Of Leadership On Coronavirus Origins

  6/2/2021

  Pharma has a China problem. In at least one regard, it uncomfortably mirrors that of the media. But the media has (tentatively) begun a mea culpa of sorts. Should Pharma? An editorial on how Pharma has handled the (lack of a) Wuhan Coronavirus Lab investigation.

• What Orphan Drug Developers And CDMOs Expect From Each Other

  6/1/2021

  Although broad in target and modality – FDA lists ~6,000 designations – the orphan drug “industry” presents specific challenges for outsourcing development and manufacturing. CDMOs must respond to both the common and unique needs of these specialized drug developers.

• What Happens When IP is Redistributed? CDMOs Without Borders

  5/24/2021

  Would any respectable contract development or manufacturing organization agree to utilize intellectual property “waived” by the WTO or other body from a reputable innovator? We say no, and for valid reasons.