ARTICLES BY LOUIS

• CDMOs Cluster In North Carolina: Why It Matters To You

  9/7/2021

  In the beginning, there were Big Pharma concentrations. Decades later, biotech centers emerged. Now we have our first CDMO cluster. It’s in North Carolina. And it’s worth giving this some thought if you are outsourcing drug development and manufacturing.

• How Involved Should Biopharma CEOs Be In Outsourcing Activities?

  9/1/2021

  When outsourcing drug development and manufacturing, how involved should the CEOs of emerging biopharma be in the requisite day-to-day activities and processes? James Mackay, CEO of Aristea Therapeutics, and independent board member to emerging biopharma, says: “The CEO is likely to be the ultimate decision-maker on more activities related to outsourcing than they might expect.” Here are some best practices.

• Are You Outsourcing Your Future?

  8/20/2021

  Today drug development and manufacturing outsourcing is a ubiquitous business-enabling activity to gain entrée to advanced technologies and capabilities. Those are the capabilities upon which your programs and overall organization are centered. Are you, then, outsourcing your future?

• Not Particularly For A Pandemic, But The Supply Chain Was Ready

  8/18/2021

  A discussion on lessons learned from the pandemic featured Remo Colarusso, Vice President, Janssen Supply Chain, Johnson & Johnson, and Ken Kent, Senior Vice President, Chemical Development and Manufacturing Operations, Gilead Sciences, at a recent DCAT Virtual Week event.

• 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.