ARTICLES BY LOUIS

• Analytical Development Outsourcing At “Platform” Biopharma

  2/18/2021

  A new report from the BioPhorum Development Group (BPDG) includes interesting findings on outsourcing habits for analytical development by “platform”-focused biopharmaceutical companies. Here’s what we found, and our further analysis.

• 503B Or Not To Be? Worthy Contemplation For Biopharma And Your CDMOs

  2/15/2021

  Some of your CDMOs have taken a look at whether they’d like to join the ranks of 503Bs, specialized “outsourcing facilities,” licensed to compound – or “manufacture” – drug products in shortage but with a clinical need. Drug sponsors should also consider how doing so might benefit you, and end up serving your patients.

• Should Your CDMO Become A 503B?

  2/7/2021

  A reader pulled me down an Alice-In-Wonderland rabbit hole. I’m glad she did. If you read the headline above and thought, “What exactly is a 503B?” you’ll be, too. We’ll learn what this designation means, and answer key questions such as: Would a CDMO that became a 503B benefit existing biopharma customers – i.e., Outsourced Pharma readers?

• Novartis Manufacturing For Pfizer: It's Not Unusual

  2/4/2021

  Breaking news: This isn’t quite the breaking news it’s been made out to be. It sure is good news. And the attention it’s getting is deserved and understandable. However, to be clear: Big Pharma manufacturing for other pharma is not uncommon.

• You Are Not A “Virtual Biopharma”

  2/1/2021

  If you claim as much, and declare utilization of a “fully outsourced model,” you are headed for an identity crisis. Robert Discordia thinks that would be beneficial. Few have thought more about how those components – virtual and outsourcing – should interact at the purest level of intent and opportunity. 

• Nationalism And Voting For U.S.-Based Supply Chains

  1/27/2021

  One election is over, but the results are still coming in on a second. Some self-examination is in order on how our political perceptions may influence our supply-chain decisions.

• From Peaks To Patients: Natural Product Development And CDMOs

  1/20/2021

  PellePharm is in phase three with a natural product (NP)-based candidate derived from the roots of a plant harvested 8,000 feet high in the Rocky Mountains of Utah and Idaho. If that’s not lofty enough, turning roots into drug involves four CDMOS, and a twelve-step chemical synthesis. “A four-year supply chain,” says Gerd Kochendoerfer. How does he manage? “Basically, you are always working backwards,” he says.

• The Human Touch: Another View Of Virtual Audits

  1/11/2021

  The debate over the utility of the virtual CDMO audit continues. Recently, we’ve even pondered whether we might more or less eliminate the on-site experience. Greg Birrer of Elusys Therapeutics says not so fast.

• Emerging Biopharma: Grab A Supply Chain Professional Now

  1/4/2021

  "Supply chain” has been elevated. It should be highly visible within all biopharma organizations. So says Lenwood Grant, long-time practitioner at Bristol Myers Squibb. A young company that doesn’t bring in a supply chain professional may not have an opportunity to grow older.

• New Year's Resolution: Teach Industry About COVID-19 Supply Chain Challenges

  1/1/2021

  When vaccines have been administered and COVID-19 is at bay, hopefully the vaccine makers and their partners will provide the entire drug development and manufacturing industry with details about the challenges they encountered in their supply chains.