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Virtual

Sep 15, 2026 11:00 AM - Sep 15, 2026 12:00 PM

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

E'Lissa Flores

, Biotechnology Innovation Organization (BIO), United States

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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