Louis Garguilo's Articles

  1. Supply Chain Agility: Did You Have It Last Year? What About Now? 2/24/2021

    Who wants to revisit the challenges of 2020? Perhaps we should – and focus that retrospection on supply chain agility. Did you have it then? Do you now? In an as-it’s-happening whitepaper based on a survey and interviews, IDC chronicled the thoughts of supply chain executives during COVID disruptions.

  2. 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.

  3. 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.

  4. 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?

  5. 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.

  6. 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. 

  7. 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.

  8. 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.

  9. 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.

  10. 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.