Cell & Gene Collaborative Blog

  1. What Fly-Fishing Can Teach Us About mRNA Immunogenicity 5/17/2023

    In part one of this two-part article, I spell out some of the decisions fly-fishermen must make to “trick” a fish, and how these decisions are akin to those of the mRNA industry as we strive to successfully navigate “the enigmatic beast” that is the human immune system. 

  2. ARW's CGT+RNA Manufacturing Must-Reads (Pizza Cake Edition!) 4/21/2023

    Day-in and day-out, I write, read, listen to, and watch as much content as I can about CGT and RNA therapy manufacturing, in particular, and/or other ATMP 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.

  3. ARW's CGT+RNA Manufacturing Must-Reads (Epitaph Edition!) 4/6/2023

    Day-in and day-out, I write, read, listen to, and watch as much content as I can about CGT and RNA therapy manufacturing, in particular, and/or other ATMP 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.

  4. Moderna & The Global mRNA Supply Chain: Regulatory Lessons Learned 3/29/2023

    One of the most important reminders I took away from Moderna’s experiences ushering its mRNA vaccine onto the global market is that a commercial manufacturing process must also be accompanied by a commercially ready supply chain. Though sufficient physical volumes of each raw material and a redundant supplier network are necessities, physical scale is not the only “CQA” for which we must account when commercializing our supply chain. 

  5. Moderna's Global mRNA Manufacturing Strategy: A Closer Look 3/27/2023

    In part 2 of this 3-part series, I argue Moderna’s strategy for scaling its mRNA vaccine manufacturing paradigm globally is one of the best examples the ATMP space has today of what it means to begin with and keep the end in mind.

  6. Beyond Moderna's Regulatory Legacy: (Re)defining The mRNA Regulatory “Norm” 3/22/2023

    It’s unlikely we will need to burn nearly as much “midnight oil” as Moderna and the regulatory bodies did during the pandemic. However, I share Moderna's unique experiences because they’re a great reminder that the mRNA therapeutics industry is set to face a much different regulatory challenge moving forward.

  7. Moderna's Regulatory Journey: 3 Takeaways To Foster The mRNA Renaissance 3/22/2023

    We may no longer be living in the fast-and-furious days of Emergency Use Authorization, nor are we all working strictly on mRNA vaccines. But after listening to Moderna’s Director of Regulatory CMC Chris Kelly share his whirlwind regulatory experiences, there were still several broad takeaways for companies navigating this nascent space.

  8. ARW's C&G+RNA Manufacturing Must-Reads (International Women's Day Edition!) 3/9/2023

    Day-in and day-out, I write, read, listen to, and watch as much content as I can about CGT and RNA therapy manufacturing, in particular, and/or other ATMP 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

  9. Cell & Gene Therapy COGS: Words Of Wisdom To 'Keep The End In Mind’ 3/7/2023

    As a delightfully diverse space, it goes without saying that understanding a product’s process and COGS drivers will be a highly individualized and complex undertaking. However, there were a few valuable points that came up in my conversation with Dark Horse Consulting's Katy Spink that were worthy of sharing as we step back and consider what "keeping the end in mind" will look like for our development paradigm and its COGS.

  10. Cell & Gene Therapy COGS: Progress & Pitfalls In Our Quest For Affordability 2/28/2023

    We regularly talk about “getting to know” our products. This can mean a lot of different things depending on the functional area in which we work. But as conversations about affordability and commercial sustainability increase pressure on manufacturing teams, I wanted to get Spink’s thoughts on how we can understand our products from a COGS standpoint and how this will continue to challenge us in the years ahead.