ARTICLES BY LOUIS

• Biologics Dose And API Outsourcing: A Decade of Decline?

  Can it be that today, when we expect increasing demand for CDMO services, biopharmaceutical companies have decided to outsource less of their commercial production needs than in the past? Some new data provided exclusively to Outsourced Pharma by PharmSource, an organization of GlobalData Plc., seems to suggest so. But if so, why that apparent trend reversal? 

• Bury The Hatch-Waxman: Generics Were Not The Answer

  The hypothesis is bold: Our emphasis on generics is a detriment to U.S. patients and the entire healthcare system. Instead, these past decades we should have focused intently on increasing the life cycle and distribution of innovator drugs.

• What If Our Generics Strategy Has Been All Wrong?

  What if we’ve been going at this all wrong for decades? If generics – and biosimilars – are not a sound solution for patients, hospitals, healthcare systems, governments, pharmaceutical companies, or CDMOs, when it comes to all parties profiting from the miracles of our best drugs? Part one in our investigative series.

• This Biotech Failed At Outsourcing: Here’s How You Succeed Instead

  It's the immutable law: You can have good, you can have cheap, and you can have fast, but you can only have two together. However, when it comes to drug development outsourcing, veteran biopharma executive Robert Discordia has a “magic” formula of sorts. He presented it at this year’s Outsourced Pharma Boston conference.

• The Next Generation Appreciates Our Outsourcing Industry

  Our future appears to be in good hands after all. Following on our earlier editorial, here’s a broader measure of the motivations and modus operandi of the youth inhabiting our drug development industry as we head into the 2020s … a decade they can conquer utilizing our outsourcing industry.

• Ending Generic Drug Shortages At Hospitals: A Capitalist Goes Nonprofit

  I hope Outsourced Pharma readers will enjoy this editorial with Civica Rx President & CEO Martin VanTrieste, featured in this month’s issue of Life Science Leader magazine. VanTrieste has a business plan that could set the generics industry on a new path of full disclosure of drug-manufacture origin, and direct delivery to the point of patient use. Part 2 of this feature will be released next month, with a direct focus on CDMOs and Civica. 

• CDER: Continuous Shouldn’t Be Continuously Delayed

  The FDA wants continuous processing and manufacturing to move forward. CDER’s even sending emails and writing Impact Stories about the technology. Here’s what three biopharma industry experts — from Merck, BMS, and MIT — think about the pace of adoption.

• The New Outsourcers: Amylyx And The Next-Gen Biotechs

  Justin Klee and Joshua Cohen were just 21 and 22 when they co-founded Amylyx Pharmaceuticals in 2013, while pursuing undergraduate degrees at Brown University. Today, their insights about drug development and manufacturing outsourcing are nothing short of remarkable.

• Biopharma Leaders Need Lengthier Lists For Outsourcing Competency

  Essential at biopharma: comprehensive lists and analyses to ensure all aspects of your outsourcing (and internal activities) are thoroughly considered as you chart your path forward. "Think big, think long, and think detailed.” So says one biopharma professional who's done it successfully for decades.

• Ranbaxy Revisited: Why We Need To Look Back

  The fraud, deception and damage Ranbaxy Laboratories Ltd. of India perpetrated around the world a decade ago in the form of shoddy and dangerous drug manufacturing practices, is legendary. It’s time to look back. Katherine Eban, author of “Bottle of Lies: The Inside Story of the Generics Drug Boom” has provided us the means.