Anna Rose Welch’s Post

View profile for Anna Rose Welch

Editorial & Community Director, Advancing RNA

Though #genetherapy is a serious topic facing serious development challenges, I think we can all appreciate it when a leading regulator has a great sense of humor and the capacity for making creative analogies (i.e., using automated soda machines) to illustrate the directions in which we need to move with #advancedtherapies #manufacturing, whether it be by employing more #automation, continuous manufacturing in USP and/or DSP, or by establishing new internal #fda dept. structures and more consistent communication. My fav. piece of advice to sponsors to arrive at more consistent #regulatory communications in particular: don’t hesitate to let the agency know if any advice is ‘crazy.’

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Kevin Curran

Molecular biologist / Healthcare industry educator / Science advisor / Focused on Cell and Gene therapies

1y

Here's a link to AAV manuf. article in your slide. https://www.frontiersin.org/articles/10.3389/fceng.2022.830421/full

Jon O'Connell

I collaborate with experts to share meaningful stories, best practices and discoveries in biologics manufacturing.

1y

Make mine a strawberry vanilla Coke. Marks brings some refreshing humanity to the post. You know a top regulator means business when he wears hiking sneakers to work.

Cynthia Pussinen

🧬Chief Executive Officer at Sernova | Board Member in Biotech, Advanced Therapies, Precision Medicine & Pharmaceuticals

1y

Great talk, wasn't it? I am looking forward to the panel discussion later this morning with Peter Marks, Yoshiaki Maruyama (PMDA) and Jim Wang, PhD, MBA

Nicola Ambler

Content strategist, writer and specialist in the cell and gene therapy industry

1y

Ooo I remember a talk at Phacilitate back in the Washington DC days from Invetech using the microfluidics of a soda machine to illustrate the possibilities in CGT! Wonder if I can dig it out...

Beth Willers

Expert in brand, marketing and PR sustainability for the life sciences industry

1y

He’s the most active I’ve seen in my whole career and I think that access really matters.

Working as partner is critical and I like his point about “This is really crazy, do you really mean it !” And then challenge again FDA…

William Swaney

President of EXPRESSION MANUFACTURING LLC

1y

Well said

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