Cell & Gene Collaborative Blog

31. “Risky Business:” How Cell & Gene Therapies Are Upending Partnership Models 10/25/2022

    This article is the final installment of a three-part series examining how advanced therapy scientific and quality expectations are impacting outsourcing business practices/models today and, hopefully, creating a foundation for greater risk-sharing in the future.

32. Beyond “The Building Phase”: Evolving The Cell & Gene Outsourcing Paradigm 10/18/2022

    This article is part two of a three-part series examining how advanced therapy scientific and quality expectations are impacting outsourcing business practices/models today and, hopefully, creating a foundation for greater risk-sharing in the future.

33. “Science Over Steel:” Exploring The Foundations Of A Hybrid CGT Outsourcing Strategy 10/11/2022

    This article is part one of a three-part series examining how advanced therapy scientific and quality-related challenges are impacting outsourcing models. We start first by unpacking the considerations ATMP innovators are faced with as they evaluate the increasingly popular hybrid outsourcing model.

34. Bluebird Bio FDA AdCom: 3 Key Takeaways For The Cell & Gene Therapy Industry 7/6/2022

    Below, I’ve boiled down the 15 dizzyingly technical hours comprising bluebird bio's two FDA AdCom meetings into three high-level takeaways that speak to the opportunities and limitations facing CGTs and their all-important CMC frameworks.  

35. From Manufacturing To C-Suite: “Scaling Up” C&G Therapy Communication 6/20/2022

    Though "communicate often" is a commonly offered best practice in the CGT space, what is rarely discussed is what this can and should look like, especially when it comes to elevating information from the manufacturing floor/team up to the C-suite. Mark Gergen, CEO of Poseida Therapeutics, gives us a great idea of what this can look like for growing CGT companies.

36. The “Renaissance” Approach To Cell & Gene Therapy Manufacturing 6/13/2022

    We’re all familiar with the concept of the “Renaissance Man/Woman". In the context of the CGT space, however, can there be such a thing as a “Renaissance Company”? My conversation with Poseida Therapeutics' CEO Mark Gergen proves that there can be and establishes why a generalist mindset is necessary to bring the CGT manufacturing paradigm to maturity.

37. ARW's C&G (+RNA!) Manufacturing Must-Reads (Dracula Edition!) 6/3/2022

    Day-in and day-out, I write, read, listen to, and watch as much content as I can about C&G therapy manufacturing, in particular, and/or other C&G industry-related topics that you should at least be aware of in the manufacturing facility. Every two weeks, I compile the articles and industry updates I think are most worthy of your time into an unconventional newsletter format (below) and send them out via email. But inboxes can be shifty places. (Cue George Carlin on “Losing Things.”)

38. Can USP, NIST, & NIIMBL Conquer The Biggest AAV Quality Challenge? 5/18/2022

    As the CGT industry continues struggling to sufficiently characterize its AAV, USP's Fouad Atouf and I unpacked the ins-and-outs of this ongoing USP, NIST, and NIIMBL AAV quality initiative — as well as the CGT industry’s greatest needs from such a collaboration.

39. ARW's C&G Manufacturing Must-Reads (The Simpsons Edition!) 5/9/2022

    Day-in and day-out, I write, read, listen to, and watch as much content as I can about C&G therapy manufacturing, in particular, and/or other C&G industry-related topics that you should at least be aware of in the manufacturing facility. Every two weeks, I compile the articles and industry updates I think are most worthy of your time into an unconventional newsletter format (below) and send them out via email. But inboxes can be shifty places. (Cue George Carlin on “Losing Things.”)

40. ARW's Cell & Gene Manufacturing Must-Reads (Classic Literature Edition!) 4/25/2022

     Every two weeks, I compile the articles and industry updates I think are most worthy of your time into an unconventional newsletter format and send them out via email. For this April 21 edition, I decided to play with the “Thank You For Libraries Day” theme. Below, each section of articles includes a quote and several not-so-subtle references to classic works of literature you’d likely find in any of the world's most glorious libraries.