ARTICLES BY LOUIS

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

  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

  “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”?

  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.

• You Don’t Know Phlow: The Backstory Of A Misread Biopharma Start-Up

  No biopharma start-up has been as misconstrued, hastily judged in strategy and capability, or even labeled “political.” Now Phlow Corporation’s CEO Eric Edwards sets the record straight in an exclusive interview.

• Where Have All The “Early Amgens” Gone? To Tech Transfers, Every One

  “My opinion is not theoretical. It reflects having seen it in action at Amgen, from 1986 to 1995, with the launching of Epogen & Neupogen.” Like biopharma’s Nietzsche, Mark Witcher wants us to slay outdated beliefs – “tech transfer” being a prime target.

• The Witcher Way: Can We “Eliminate” Tech Transfer?

  “You can call me a revolutionary, if you like,” responds Mark Witcher upon my comment he is. His thesis on the elimination of "tech transfer" is detailed, and provocative. But is it practical? Readers will make the ultimate judgment.

• Tech Transfer, Self-Esteem, And A Fitting Facility

  “This is akin to making the process for the tech transfer as efficient as you are trying to make the process to produce the actual material.” Part 2 of our “dissertation” on the mental and physical state of tech transfer in drug development and manufacturing outsourcing.

• A Real Dissertation On Tech Transfer

  A biopharma professional is earning a degree in tech transfer. Literally. Here’s some of what he’s learned, including the four thorns in the side of those transferring drug development and manufacturing projects to CDMOs.

• Outsourcing Trend Of The Year? The CDMO Synergy Sprint

  Two more CDMOs – this time in Germany – announce their best-in-breed alliance. What are these partnerships all about? Will this trend benefit readers looking for the best outsourcing outcomes? 

• Hello From The Other Side: Advice On Drug Development Outsourcing

  Some colleagues worked at CDMOs before joining your biopharma organization. Given the opportunity, they can guide you to enlightened vendor management and improved outsourcing outcomes.