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Virtual

Sep 22, 2026 10:00 AM - Sep 22, 2026 11:00 AM

DIA Direct: Unlocking the Plausible Mechanism Framework: Advancing Innovation in Cell and Gene Therapies

An overview of the Plausible Mechanism Framework and its role in supporting the development of Advanced Therapies.

Presenters

E'Lissa  Flores, PhD

E'Lissa Flores, PhD

Senior Director, Science & Regulatory Affairs, Biotechnology Innovation Organization (BIO), United States

Dr. E’Lissa Flores is Senior Director of Science & Regulatory Affairs at BIO, where they lead regulatory and policy initiatives supporting biomedical innovation and modernized drug development. Since joining BIO in 2023, they have overseen the Rare Disease & Orphan Drug and Cell & Gene Therapy Committees, advancing regulatory policy and FDA engagement. Previously, Dr. Flores served as a Scientific Program Manager at HESI and advised biomedical ventures at the Milken Institute. They hold a B.S. in Biology from Stony Brook University and a Ph.D. in Translational Biomedical Science from the University of Rochester, and remain active in STEM outreach and mentorship.

Phillip  Kurs, JD

Phillip Kurs, JD

Associate Director for Policy, FDA, Center for Biologics Evaluation and Research, United States

Phillip Kurs is CBER’s Acting Associate Director for Policy. He has served in CBER since 2021 and held a succession of positions of increasing responsibility on the Policy Staff, dealing with a range of high priority policy issues. Prior to joining CBER, Phillip worked for over four years as a regulatory counsel in CDER's Office of Generic Drugs and as a litigation attorney in a private law firm. Phillip received a Bachelor of Arts degree from Oberlin College, and his Juris Doctor from Boston University.

Rumi Raquel Young, MS

Rumi Raquel Young, MS

Director, Regulatory Policy, Novo Nordisk A/S, United States

Rumi Young is the Director of Regulatory Policy at Novo Nordisk, ensuring future growth and innovation by promoting effective biopharmaceutical policies. Previously, she led BD’s Global Regulatory Policy team to shape future policies for medical devices, diagnostics, and combination products. As Assistant Director – Injection Devices at FDA, she managed reviewers and set technical and regulatory expectations for combination products and drug delivery devices. Before FDA, Rumi worked in R&D for a number of years at Genentech and AstraZeneca. She holds a Bachelor’s in Chemistry and Chemical Biology and a Masters in Material Science Engineering from Cornell University.

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