ARTICLES BY LOUIS

• 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.

• Remembering The Year We'd Rather Forget

  12/19/2020

  We verified through a dismaying pandemic, outsourcing drug development and manufacturing is sustainable. But this annus horribilis also laid bare supply-chain vulnerabilities. Here’s the best and worst of your 2020.

• Do Your CDMO And Consultants Get Along? They Better

  12/15/2020

  "As biopharma companies become more virtual, the relationship between your CDMOs and consultants is really key to your success,” says Evelyn Kelly, founder and managing director, Orphan Drug Consulting Ltd.