Designing and Executing Studies That Deliver

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How should you design your first-in-human study? Richard L. Beckman, M.D., principal of RLB, M.D. Consulting, LLC, and Malvina Eydelman, M.D., CEO of the Collaborative Community on Ophthalmic Innovation, sit down on a panel at OIS Ignite 2025, moderated by Barbara Wirostko, M.D., FARVO, CMO and co-founder, Qlaris Bio, to discuss what goes into designing first-in-human studies, including the preclinical work, the right people to advise you, and considering the population and patients. Also, stay tuned for updates on the next OIS Ignite, taking place on March 2027!

In this episode, learn about:
🔹How the FDA can help and if it’s ever “too early” to reach out to them
🔹The FDA’s perspective
🔹Establishing a target product profile
🔹If a DSMB is recommended for trials

Resources:
Barbara Wirostko: https://ois.net/barbara-wirostko-md-farvo/
Richard L. Beckman: https://ois.net/richard-rick-l-beckman-md/
Malvina Eydelman: https://ois.net/malvina-eydelman/