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42 | EYEWORLD DAILY NEWS | MAY 5, 2023 ASCRS ANNUAL MEETING DAILY NEWS honorable mentions for Best of Show Presenting Companies. Gil Kliman, MD, John Berdahl, MD, and Julie Schallhorn, MD, closed out the meeting. They discussed a survey that had been conducted among ophthalmologists. One thing they discussed was challenges that practices are facing. Dr. Schallhorn said that she's not surprised that cuts to reimbursement remain a big fear among ophthalmol- ogists, but she also noted that hiring and staffing shortages are something that she also has noticed, especially after the COVID-19 pandemic. "We need to find meaningful ways to connect with our employees," Dr. Berdahl added. Award winners were announced. Honorable Mention company winners: NeuroTrigger and ViaLase People's Choice Award #1: Toku People's Choice Award #2: LENZ Therapeutics Editors' note: The presenters have financial interests with the companies they represent. A session at Eyecelerator cov- ered first-in-human studies, with a panel of experts from the FDA, academia, biotech, and ophthalmic research. Elizabeth Yeu, MD, moderated the session with panelists David Bingaman, PhD, Ora, Doug Kelly, MD, Food and Drug Administration, Greg Kunst, Aurion Biotech, Ayman Naseri, MD, UCSF Department of Ophthalmology, and Kevin Waltz, MD, Ophthalmic Re- search Consultants. Dr. Bingaman started by discuss- ing the best practices and strategies for initial human trials, noting his experience with Alcon, PanOptica, Oculis, and Ora. He specifically used PanOptica's topical VEGF receptor inhibitor for nAMD/DME/PDR as a case example. First, it's important to think about where to start. Dr. Yeu ques- tioned panelists about what point to engage the FDA and what the FDA would like to see. Dr. Kelly said, "We try to encour- age more and more people to do first-in-human studies in the United States." He also said the FDA en- courages people to "talk to us when you're thinking about your study as soon as you can." It's important to bring stakeholders together at the beginning of the process to talk about evidence that needs to be seen, he said, adding that it's important to think about who needs to be in the conversation from the beginning. Mr. Kunst mentioned the cell therapy for corneal endothelial dis- ease that Aurion is working on, and he discussed the process of moving this technology from Japan to the U.S. Aurion was attempting this process during the pandemic, adding to the challenges, and ultimately de- cided to move to El Salvador to test the technology before actually going to the U.S. and the FDA. In a best case, you would go to the FDA early, he said. The reality is that in almost all first-in-human trials, you're still working out the technology and endpoints. We want- ed the ability to move quickly and adapt, Mr. Kunst said. Dr. Bingaman discussed his experience with PanOptica. You need to think about your go-to-market strategy from the very beginning, he said, and building a development plan is the next step. Economics are always a consid- eration in study design, Dr. Yeu said. Dr. Naseri said the funding part is critical. In terms of the decision of where to start, if you think you have a device that will need several itera- tions, it might be expensive to start in the U.S., he said. The funding and the way it affects timeline and itera- tions are important strategic factors to work through, he said. The panelists discussed execut- ing the clinical development plan. Dr. Bingaman shared pearls and pitfalls from his experience: hire the best people and organizations that you can afford; you really do get what you pay for. Expect the unexpected, and value contrary opinions. Quality, speed, and cost is the mantra. Keep the end goal of achieving benefit for patients with unmet needs while overcoming short-term obstacles. Mr. Kunst stressed the impor- tance of building a team of experts to help with the technology. "You can't underestimate the value of having good practitioners with you along the journey to make sure you get it right," he said. The final session of the day, "The Closing Bell," featured presentations of the People's Choice Awards and First-in-human studies and final awards Dr. Schallhorn, Dr. Kliman, Dr. Berdahl, and winners of the People's Choice Awards for presenting companies ring the "closing bell" at the conference.

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