Why I’m Attending the 2025 Policy Summit—and Why You Should, Too

For me, as I suspect is the case for many of my fellow ASGCT members, it seems the path from marketing approval of a novel gene or cell therapy to its reimbursement and accessibility to patients is shrouded in mystery. However, we’re about two weeks away from the time of year when ASGCT shines a light to help illuminate the complexities of this journey: the 8th Annual ASGCT Policy Summit.  

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I know you have heard me on my podcast, The Issue, talk about the Policy Summit at length, as I’ve been a big fan since its inception. I realize that just attending the Policy Summit won’t reveal all the secrets of the universe as it pertains to reimbursement and access. But I can attest that you will leave this meeting smarter. You will be armed with new insights about how to ensure you are starting with the end in mind from even the earliest stages of discovery and development.  

Now if you, like me, find yourself often working on novel therapies in their infancy, you might reasonably ask: Why is a working knowledge of reimbursement and access considerations important for me? Well, my answer is simple. Central to the work we do in gene and cell therapy is the concept that we want to provide patients with decades-long benefit from a minimal number of treatments. This means that your first clinical trial is actually your most important clinical trial. Those first patients who volunteer to receive your therapy will provide you with the longest duration of clinical data when you come to marketing authorization. They will also provide you with your longest duration of clinical data when it comes to negotiations with payors regarding access to the therapy.  

So, even from the time of IND, you should be thinking about what sorts of endpoints and concerns the FDA and payors will have for you, should you be lucky enough to steward your program all the way to approval.  

Considerations around the regulatory, financial, and policy impacts that change the path to access are not surprisingly complex. When you leave this day-and-a-half event, you’ll at least have the beginnings of a framework you can take back to your colleagues and get them curious and invested in asking the right questions before you even file the IND. I strongly encourage you to take the time and join me at the Policy Summit—you won’t regret it! 

Hope to see you in D.C. soon! 

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Dr. Walsh Martin is principal at Tremont Therapeutics Consulting and a former member of the Communications Committee. 

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