ARTICLES BY LOUIS

• Outsourcing Challenges For Emerging mRNA Biopharma

  3/19/2021

  Recent mRNA vaccine successes conceal the long-term challenges emerging mRNA companies have faced with finding experience and capacity at CDMOs. Here’s sound advice for emerging mRNA when forming scientific, investment, and overall plans for commercial success.

• Nations Should Be Able To Take Care Of Their Own

  3/10/2021

  A Biopharma and CDMO lead a positive nationalism in Canada. In fact, ‘Canada First’ hasn’t the political corollaries felt by “America First” deliberations in the U.S. Jared Davis, CEO of Providence Therapeutics, believes every country should be able to take care of their own during a health-care crises. 

• 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.