ARTICLES BY LOUIS

• Canadian Biopharma “Enables” CDMO For mRNA Vaccine Production

  3/3/2021

  An investigation into the amazing story of how an emerging mRNA Biopharma is “enabling” the creation of a CDMO for an “all-Canada” supply chain, for COVID-19 and precision medicines.

• Uncertainty In Quality: A Primer For Emerging Biotechs

  3/1/2021

  An introduction of a quality risk-management concept – Uncertainty – specifically for emerging biopharma organizations less attuned to the intricacies of quality deliberations, from Yash Sabharwal, CEO, CherryCircle Software, and a QbDVision whitepaper titled: “Quality Risk Management: Understanding Uncertainty.”

• 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.

• 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.