23 Questions with Claire Marasco
23 Questions with Forge is our fast-paced series where our team members are challenged to answer 23 rapid-fire questions about trending topics in gene therapy development.
Forge's regulatory team keeps a pulse on the evolving global regulatory landscape to help gene therapy developers with their program strategy. Hear from Forge's Associate Director of Global Regulatory Strategy, Claire Marasco, on the new clinical trials regulation in the EU, IMPD-Q only submissions, and what gene therapy developers need to know about this new process. Watch the full video!
Read the interview:
Question: Hi Claire, can we ask you 23 questions about your job?
Question: Great! That was our first question. Next question, what do you do here?
Claire: I’m the Associate Director of Global Regulatory Strategy.
Question: What does that mean?
Claire: At Forge we’re a CDMO, and my team plans for us to be ready to enter into countries around the globe. We also lead the regulatory development of FBX-101, our in-house therapy.
Question: Who is pictured at your desk?
Claire: Luna, my old English sheepdog!
Question: Ok, Ms. Global Regulatory Strategy, how global are we talking?
Claire: Forge has direct experience in the US, the EU, and Canada, and we are building our expertise in the UK, Japan, Korea, and more regions!
Question: What’s your favorite place that Forge has sent you?
Claire: It’s gotta be Edinburgh, Scotland, but I also have a soft spot for Washington, D.C.
Question: Down to brass tacks, what is the biggest global regulatory challenge you’ve been facing lately?
Claire: It’s an ever-changing landscape, and the new Clinical Trials Regulation (CTR) in Europe is currently the big challenge.
Question: What is the purpose of the new Clinical Trials Regulation?
Claire: It was created to harmonize the EU clinical trial application process and to strengthen transparency with the public.
Question: When did this go into effect?
Claire: The new submission portal opened in January 2022 and as of this January, all new applications must be submitted under the regulation.
Question: Most important question of the day: what is your favorite road trip snack?
Claire: Skittles, specifically the wild berry ones. Actually, I have some right here!
Question: What’s the deal for gene therapy developers under the Clinical Trials Regulation?
Claire: There’s a lot to it, but I’m focused on managing timelines and as a CDMO especially, IMPD-Q only submissions.
Question: Tell me more about the timeline and review procedure?
Claire: CTA review timelines are long—up to 156 days, which includes an extra 50 days of expert review for gene therapies. And then, responses to information requests have tight turnaround times too.
Question: Tell me more about timelines?
Claire: They can be as long as 12 days, but as few as 1 day!
Question: That’s quick! If you could be great at any Olympic sport, which would it be?
Claire: Boxing, for sure. Can you ask me a question about IMPD-Q only submissions? Because that’s a cool new tool!
Question: Can you tell me about IMPD-Q only submissions?
Claire: Under the CTR, there is now a way for manufacturers to submit quality information on behalf of clinical trial sponsors. Forge has already developed a template document for this so we can be ready when clients need it. It’s a little bit like our United States drug master file.
Question: Let’s jump right back into it. What do clients need to be thinking about for submissions in Europe?
Claire: Before submitting the clinical trial application, clients need to be sure they have qualified person or QP declaration for their product.
Question: What is the process for QP declaration?
Claire: Forge has a QP who has already audited our facility, which may save clients time and money. Clients just need to make sure that their own QP grants declaration for their product specifically.
Question: And then what happens?
Claire: You submit your application with your declaration included, and then after approval your QP will release your product for use in Europe by granting certification. This is called the two-step process.
Question: What show are you currently binging?
Claire: I’m obsessed with Jury Duty.
Question: Let’s get a little personal, what is the first thing you think of when you wake up?
Claire: Global regulatory convergence.
Question: And what keeps you up at night?
Claire: Global regulatory convergence.
Question: What do you hope gene therapy researchers know about Forge Biologics?
Claire: The Forge team is unmatched, and we REALLY CARE about our clients.
Question: This is an epic facility, isn’t it?
Claire: Of course it is, and that is your 23rd question. I gotta get back to work!
Question: Thanks for your time and expertise, Claire!