Webinar on Budget, Workload, and Other Priorities for CDER

The Alliance will be hosting a webinar with Acting CDER Director Patrizia Cavazzoni, MD and Director of the Office of New Drugs Peter Stein, MD on October 16 from 9:30-10:30 a.m.The event is limited to Alliance members and media. To sign-up, please contact Reed Diskey. If you are not an Alliance member and would like to participate, please contact Steven Grossman.Here are some of the areas and questions that we hope to address with Dr. Cavazzoni and Dr. Stein:

• CDER Budget: What are CDER’s long-term budget priorities? Has FDA’s budget kept up with the demands being placed on CDER?
• Hiring and Recruitment: Is CDER staffed at a level that allows you to carry out your critical public health mission?
• COVID-19: What is CDER learning from the COVID-19 pandemic? Are there ways to rethink the review process to improve it for the future?
• Overall CDER Workload: How is CDER doing on its non-COVID-19 responsibilities? Generally, how have you prioritized the workload to keep activities going?
• Evolving Nature of Clinical Trials: The pandemic has accelerated the trend toward decentralized trials. How do you envision that clinical trials will be different five years from now? Do you believe additional funding will be needed?
• Status of Program Initiatives: What is the status of CDER’s involvement in advanced manufacturing?
• Collaboration Within and Across Centers: To what extent, and in what areas, are CDER and CBER able to work together to create greater efficiencies?

Background on Our Speakers:Patrizia Cavazzoni, MD, is the Acting Director of the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration and has continuing responsibilities as the Center’s Deputy Director for Operations. She joined the agency at the beginning of 2018.Dr. Cavazzoni received her medical degree at McGill University and completed a residency in psychiatry and a fellowship in mood disorders at the University of Ottawa. She subsequently joined the faculty of medicine at the University of Ottawa as an assistant professor, where she was engaged in clinical work, teaching, and research on genetic predictors of mood disorders, authoring numerous peer-reviewed scientific publications. Following this, Dr. Cavazzoni worked in the pharmaceutical industry for several years, and held senior leadership positions in clinical development, regulatory affairs, and safety surveillance.Peter Stein, MD, is the Director of CDER’s Office of New Drugs (OND). OND is responsible for the regulatory oversight of investigational studies during drug development and decisions regarding marketing approval for new (innovator or non-generic) drugs, including decisions related to changes to already marketed products. OND provides guidance to regulated industry on a wide variety of clinical, scientific, and regulatory matters.A nationally-recognized leader in pharmaceutical research and development, Dr. Stein joined CDER in 2016 as the OND Deputy Director. He has more than 30 years of academic, clinical, and industry experience. Dr. Stein holds a medical degree from the University of Pennsylvania. He trained at Yale University and Yale-New Haven Hospital in internal medicine and in endocrinology and metabolism.Editorial Note: The Analysis and Commentary section is written by Steven Grossman, Deputy Executive Director of the Alliance for a Stronger FDA.