ARTICLES BY LOUIS

• 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.

• 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.

• 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.

• New Year’s Resolution: Teach Industry About COVID-19 Supply Chain Challenges

  1/1/2021

  When vaccines have been administered and COVID-19 is at bay, hopefully the vaccine makers and their partners will provide the entire drug development and manufacturing industry with details about the challenges they encountered in their supply chains.

• Remembering The Year We’d Rather Forget

  12/19/2020

  We verified through a dismaying pandemic, outsourcing drug development and manufacturing is sustainable. But this annus horribilis also laid bare supply-chain vulnerabilities. Here’s the best and worst of your 2020.

• Do Your CDMO And Consultants Get Along? They Better

  12/15/2020

  "As biopharma companies become more virtual, the relationship between your CDMOs and consultants is really key to your success,” says Evelyn Kelly, founder and managing director, Orphan Drug Consulting Ltd.

• How To Find Your Safe-Harbor Consultant

  12/8/2020

  Dublin-based Orphan Drug Consulting founder Evelyn Kelly explains how to navigate to the consultants right for you. Hint: It doesn’t include longer term contracts, but may a good dose of advice – free of charge.

• Meet Your New “Person”-In-Plant: iPad On IV, Ph.D.

  12/1/2020

  Joseph Graskemper of Translate Bio was recently involved in a process to create a V-PIP [virtual person-in-plant] at his CDMO. Turns out to be something that should carry on post-COVID-19, and prompt readers and your service providers to some ingenuity of your own.

• Primal Motivations: Stop Drug Shortages, Start Domestic Supply Chains

  11/21/2020

  “So in the spring of 2019,” recalls Eric Edwards, “I put my doctor’s white coat back on, and shadow Dr. Marshall Summar at Children’s National Hospital for a week ...” Part 3 of my exclusive interview w/ the CEO of Phlow Corporation – the motives, mission, and message.

• What’s A “Biopharma CDMO”?

  11/15/2020

  In part two of my exclusive interview with Phlow Corporation's CEO Dr. Eric Edwards, we turn our attention to biopharma business models and CDMO partnerships.