ARTICLES BY LOUIS GARGUILO

• U.S. Manufacturing On The Rise: Add Another CDMO To The Heartland

  Ascending U.S.-based CDMOs may exemplify a national taking back of our own supply-chain destiny. Now there’s another CDMO, Andelyn Biosciences, taking shape in Central Ohio, and targeting gene-therapy services.

• Equipment You Need At Your Cell-And-Gene CDMO

  What equipment is essential at the CDMO assisting with your cell and gene therapy development and production? I’ve received some details via an investigation into Harvard’s Center for Advanced Biological Innovation and Manufacturing, and a discussion with the CEO & President of GE Healthcare Life Sciences.

• A Harvard Assist For Cell And Gene Bottlenecks

  Bottlenecks and backlogs in development and production of cell and gene therapies. Harvard to the rescue. Actually, Harvard with partners, such as companies familiar to Outsourced Pharma readers. But what will  go into the the $50 million Center for Advanced Biological Innovation and Manufacturing? We’ve got exclusive details.  

• Straight Talk From BeiGene On Quality, Compliance, And Outsourcing

  It was time within our ruminations on China to speak directly with a quality executive at a drug developer and manufacturer based there. That’s now accomplished via a discussion with Diana Francis, Vice President, Quality & Compliance, BeiGene, Ltd., a biopharma some have dubbed as a potential “Genentech of China.” Francis spoke openly about her role, BeiGene’s global strategy, and outsourcing within and from China. 

• How Important Is Geography To Today’s Outsourcing?

  A recent CDMO press release essentially asserted superiority via proximity: Geography as God of outsourcing. I contacted two biopharma executives familiar with the Boston/Cambridge scene for reactions: Michael Kaufman, Senior Vice President, CMC, Mersana Therapeutics, and 15-year veteran of Merck; and George Avgerinos, Senior Vice President of Biologics Operations, Fortress Biotechnologies, and 22-year veteran of BASF/Abbott/Abbvie.

• 10 Questions For “Make Vs. Buy” In Drug Development And Manufacturing

  The questions for “make vs. buy" raised by Bristol-Myers Squibb’s Christopher Sinko, SVP and Head of Product Development, are news because of this: Sinko reaffirms for us they remain cemented within the otherwise changing dynamics impacting drug development and manufacturing outsourcing decisions.

• Novartis And the Price Of A Child’s Life

  We’ve been thrust from ruminating around the worth of a generic “human life” towards contemplating starker terms of specific two-year-old children. This thanks to Novartis’ gene-therapy Zolgensma, priced at $2.125 million. However, is this our hoped-for future of gene and cell therapies? The irony of life-saving drugs that financially cancel their celebration at the point of FDA approval?

• We Weren’t Prepared For CAR-T: Lessons From An Industry Executive

  Joanne Beck, Executive Vice President of Global Pharmaceutical Development and Operations,Celgene, says what has needed to be said more clearly than it has: With CAR-T, the future arrived, and we weren’t ready for it. Here’s what we missed, and where to go from here, according to Beck.

• Japan Pharma: Top Tier With Tons Of Opportunity

  Opportunities related to the world’s third largest pharma industry tend to get drowned out by U.S. domestic events, and news from Europe, China, and even India. But if you haven’t been, it’s time to start paying attention to Japan again. There are opportunities for partnering, providing services to Japan Pharma, and for market penetration by foreign biopharma companies.

• Our 2018 Outsourcing Outlook: Focus On … Amazon?

  It’s time for our 2018 industry outlook. But don’t worry if you’ve already had your share of forecasts slipped into your stockings. I promise ours brings something different to the prognostication party. And it should help readers to consider carefully what you need to focus on to make it another successful year.

• Magenta Therapeutics Finds A “Support Chain” Beyond CDMOs

  Biotechs focused on cell and gene therapies need support beyond the traditional outsourcing of development and manufacturing to CDMOs. These elongated “support chains” start within the healthcare system, run cells out to a CDMO for processing, and then circle back to the patient. Jason Gardner, co-founder, CEO and president of Magenta Therapeutics, believes he’s found a partner to help.