Executive Roundtable: Shaping the Future of Obesity Drug Development

This Executive Roundtable is an invitation only event.

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Roundtable Discussion 1: Improving the Efficiency of Obesity Drug Development

Session Chair(s)

Maria Vassileva, PhD

Chief Science and Regulatory Officer, DIA, United States

Alissa Goodale, DrMed

Regulatory Executive Director, Genentech, A Member of the Roche Group, United States

Monique Carter

Senior Director, Global regulatory Strategy - Internal Medicine, Pfizer, United States

Topics for discussion:

Quality of weight loss: endpoints for lean muscle retention and maintenance

Functional endpoints: COAs, PROs, assessment approaches, endpoints for holistic evaluation of weight management benefit

Comparator: size of placebo control; placebo or active control (how to choose the most appropriate comparator), how to retain patients in clinical trials for obesity (how to avoid excessive weight loss)

Pharmacovigilance and Safety: size of safety database, patient population, efficiency across similar conditions (minimum core data set that would allow harmonization across indications and organizations)

Speaker(s)

Mitra Rauschecker, MD

Senior Medical Director, Astra Zeneca, United States

Speaker

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