Why I Launched the Expanded Access Summit

Share on twitter
Share on facebook
Share on linkedin
Share on email

I am not an event planner. In my early life as an investment manager and, more recently as a life science entrepreneur, I doubted the value of most “can’t miss” conferences. The energy and enthusiasm, the inspirational speeches, the provocative on-stage remarks – great for morale. But how often did they truly impact the landscape their attendees were working in? Or, on a practical level, did any of them clarify the riddles that could unlock real opportunity? We can all answer this for ourselves. Some events are better than others.

Occasionally a topic comes along that is so impactful to the industries involved and so critical to the public welfare -and all the while remains poorly understood- that a central forum of true subject matter experts and high-level stakeholder representatives needs to take place. That’s why the inaugural Expanded Access Summit was launched in 2017 with 100 attendees, grew to 200 attendees in January 2019, and is expected to fill the National Press Club capacity of 350 this upcoming January 2020. The Expanded Access Summit was launched to meet the need for centrally established best practices and policy guidance on pre-market medicines access worldwide.

Having committed my professional work to this space in 2009 – completing years of interviews with past stakeholders and policy makers and advising public and private organizations – I came to the conference production business with the simple advantage of knowing my topic. I also brought a strong network of industry and FDA leaders who collectively had dealt with every wrinkle of this topic imaginable, from operations to bioethics, economic viability, data utility, and health care provider feasibility. The Summit was positioned to be the first event in this space to fundamentally explore ways to make pre-market access programs larger, more attractive to stakeholders, and more effective at meeting the overall unmet need for treatment options in diseases with grave prognoses. We could actually focus on how to do it, when other conferences were mired in soft-science polemics of “whether to do it” and how to diplomatically say no to patients and their doctors.

For these reasons, the Expanded Access Summit will continue as the annual leadership event in pre-market access. My team and I believe, through our careful program design and preparation, that this is the most academically pristine forum in the space. The Summit speaker faculty has the largest concentration of FDA, NIH, and policy institute leaders of any clinical research industry conference. We feature a thorough regulatory workshop preceding the main plenary sessions, a special Innovator Showcase to allow organizations to share their work separate from the academic discussions, and Expanded Access poster sessions of newly released meta and clinical findings from novel Expanded Access programs.

Every year, I have a fantastic team that helps put this together, but making it a truly exceptional event takes extra work. As a subject matter expert, I run two other ventures intended to improve the treatment landscape for patients. My partners ask me why in the world I put so much into the annual conference when there is so much work to be done on our more profitable businesses. The answer: I have to. This event needs to happen, and everyone involved in providing new treatment options to people with serious unsolved diseases should try to be there.

The third annual Summit, “Expanded Access 3.0” takes place January 27-29, 2020 at the National Press Club of Washington DC. We have a full program and a fully confirmed, world-class speaker faculty. If you’re a difference-maker in clinical research, regulation, or patient advocacy, I hope you will join us. See you there!