ARTICLES BY LOUIS

• Market Mash: Bigger CDMOs, Smaller Biopharma Customers

  8/16/2021

  The fundamental challenge in today’s drug development and manufacturing outsourcing space is a misaligned market. CDMOs are getting bigger; emerging drug developers are getting smaller. Something has to give. Actually, that give has begun.

• An Independent Board Member Advises Emerging Biopharma On Outsourcing

  8/11/2021

  James Mackay, President & CEO, Aristea Therapeutics, serves as an independent board member to two other San Diego-based biopharma companies, and one in Massachusetts. What exactly is his role? What advice does he give on outsourcing? And should you have an independent board member as well?

• A Biopharma’s Guide To Staying Virtual Through Commercial

  8/4/2021

  Eight professionals in CMC, working together but virtually, in unchartered orphan-disease and precision-medicine spaces, overseeing a fully outsourced development and manufacturing model, generated a commercial product and filled a pipeline resulting in six clinical trials, two in phase three. Here's how.

• Hepatitis B “Functional Cure” On The Way? A CDMO Helps Out

  8/2/2021

  Vaccines for the Hepatitis B virus (HBV) have been around for a long time. They’ve proven less than optimal. Here's a company looking to change the narrative via a novel platform, new ideas for developing a “functional cure,” and the use of the right CDMO.

• Wanted: Right-Sized CDMOs For Advanced Therapy Developers

  7/28/2021

  “I’ve changed my perspective on this drug-substance/drug-product, end-to-end, ‘one-stop-shop’ services trend,” says Rick Panicucci, QED Therapeutics (a BridgeBio Pharma company). Even more, he's an idea of how to change CDMO consolidation dynamics to serve smaller drug sponsors.

• CDMOs Won’t Respect What You Don’t Inspect

  7/21/2021

  “I learned the hard way,” says veteran biopharma executive, and current Senior Vice President CMC, QED Therapeutics, Rick Panicucci. “Even the best of outsourcing facilities won’t respect what you don’t inspect.” Months of COVID-19 lockdown could not dissuade him from living by his outsourcing canon. Here is how you can, too.

• 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.