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.’
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.
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
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...
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…
Well said
Molecular biologist / Healthcare industry educator / Science advisor / Focused on Cell and Gene therapies
1yHere's a link to AAV manuf. article in your slide. https://www.frontiersin.org/articles/10.3389/fceng.2022.830421/full