Anna Rose Welch

ARTICLES BY ANNA ROSE WELCH

• FDA To Sarepta’s Gene Therapy: “Express Yourself…Maybe?”

  8/21/2023

  Though we cling to — and simultaneously despair over — the fact that regulatory experiences are product-specific, the hurdles/debates Sarepta faced remind us of the scientific and clinical complexities our future CGT products will no doubt be faced with during their own BLA reviews.

• “Alice In [mRNA] Wonderland:” 3 Realities Facing The mRNA Industry

  8/7/2023

  The mRNA industry is an exciting place to be, and I have no doubt we will celebrate some significant triumphs in the future. But there are three critical realities (or perhaps difficult truths) I was reminded of during the mRNA Therapeutics Summit worth reiterating to keep us grounded through all our uninhibited dreaming.

• “Our CMC, Ourselves:” 3 Iterative [Self] Improvements In Cell & Gene Manufacturing

  6/30/2023

  Here, I’ll outline the three areas in which I felt the discussions at the PDA ATMP conference revealed how we can better “close the gap” between where we currently are and where we know our manufacturing processes can be in the future. 

• The “Corps de Manufacturing:” Defining Flexibility In Cell & Gene Therapy Tech Platforms

  6/15/2023

  Though the word “flexible” will inevitably appear in any conversation about a manufacturing facility, paradigm, or platform, we rarely stop to flesh out what such flexibility can mean and/or may look like. Here, in part two of this series, Abe Maingi of Inceptor Bio and Jason C. Foster of Ori Biotech help me chisel out how they are thinking about flexibility in tech provider partnerships in the heterogenous ATMP space. 

• Defining Risk-Sharing In Cell & Gene Therapy Manufacturing Partnerships

  6/7/2023

  In part 1 of this two-part article, Jason C. Foster, CEO and executive director of Ori Biotech, and Abe Maingi, VP of business development and co-founder of Inceptor Bio, share their perspectives on how partnerships must evolve to mitigate the unique scientific and financial risks facing autologous cell therapies. 

• 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.

• 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.

• GMP Principles: The True Star Of Cell & Gene FDA Interactions

  2/2/2023

  The questions posed to the FDA during both the cell and gene town halls indicate that we are trying to better define “phase appropriate” development and understand where our material/vendor selection and qualification need to be more diligent. Despite the murkiness of this topic in general, there were a few best practices I took away from the FDA’s recommendations.

• 4 “Hot Takes” On Cell & Gene Therapy Manufacturing From Advanced Therapies Week 2023

  1/24/2023

  There is truly no article more difficult to write than a takeaway article from a conference. But as I recently spent the past week attending various panels and hearing different perspectives at Phacilitate’s Advanced Therapies Week, I wanted to attempt to do “the impossible” (for me): Share four of the burning manufacturing takeaways that jumped out at me most during the week.

• Defining The RNA Therapeutics Industry In 2023

  1/16/2023

  Four executives outline which industry challenges, strategic considerations, and opportunities should be top of mind as RNA therapeutics companies establish their to-do lists for 2023.