Integrated Assessment of US Marketing Applications: A View into FDA Internal Operations

We will take a deep dive into FDA’s integrated review for marketing applications from an operations perspective. We will hear about the new review templates and how FDA has changed internal processes, review content, and role responsibilities.

We will take a deep dive into FDA’s integrated review for marketing applications from an operations perspective. We will hear about the new review templates and how FDA has changed internal processes, review content, and role responsibilities.

Session Chair(s)

Amy  Bertha

Amy Bertha

Executive Director, Regulatory Policy

Bayer, United States

Amy Bertha is currently Executive Director, Regulatory Policy and Innovation at Bayer. Prior to joining Bayer in 2018, Amy worked 14 years at the FDA's Center for Drug Evaluation and Research in various offices, including the Regulatory Affairs Team in the Office of New Drugs and the Special Projects Team in the Office of Executive Programs. Prior to working at the FDA, Amy worked 7 years at Pfizer in drug discovery and regulatory affairs, and 3 years at Roche in drug discovery.

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Speaker(s)

Jennifer L Mercier

Jennifer L Mercier

Director, Office of Regulatory Operations, OND, CDER

FDA, United States

Jennifer Mercier is the Director of the newly formed Office of Regulatory Operations (ORO) in CDER’s Office of New Drugs (OND). As Director, she is responsible for the oversight of OND’s regulatory review processes and regulatory project management (RPM) staff, who co-lead OND’s regulatory review activities. Jennifer has 25 years of regulatory project management experience, mostly in the Division of Urology, Obstetrics and Gynecology. Jennifer served as one of the leads on the development and implementation of the reorganization of OND and creation of ORO.

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John  Farley, MD, MPH

John Farley, MD, MPH

Director, Office of Infectious Diseases, OND, CDER

FDA, United States

Dr. John Farley is presently Director of the Office of Infectious Diseases in the Office of New Drugs at CDER, FDA. His office is responsible for the review of new antiviral and antibacterial drugs. In addition to new drug review work, Dr. Farley’s work at FDA has included implementation of the breakpoints provisions of the Cures Act, providing scientific leadership for establishment of the antimicrobial resistance focused regulatory science research program, and serving as a workstream lead for the Integrated Review as part of the Office of New Drugs Modernization. Prior to joining the FDA, Dr. Farley was on the faculty of the University of Maryland School of Medicine and focused care and research on perinatal HIV.

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Rhonda  Hearns-Stewart, MD

Rhonda Hearns-Stewart, MD

Associate Director, Implementation for the Integrated Assessment of Marketing Ap

FDA, United States

Rhonda Hearns-Stewart, MD, is the Associate Director of Implementation for the New Integrated Assessment of Marketing Applications. She is also on the staff at Walter Reed National Military Medical Center where she sees patients once a week. In 2013, Dr. Hearns joined the FDA as a Medical Officer in the Office of New Drugs (OND) within the Center for Drug Evaluation and Research (CDER). As a senior clinical reviewer in the Division of Bone, Reproductive, and Urologic Products (DBRUP), Dr. Hearns was responsible for reviewing the majority of ART and infertility products. In 2017, she joined the Drug Trials Snapshot Team in the Division of Professional Affairs and Stakeholder Engagement (PASE) within CDER’s Office of the Center Director.

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Janie  Parrino, MD

Janie Parrino, MD

Executive Director, Regulatory Affairs

Regeneron Pharmaceuticals, Inc, United States

Janie Parrino, MD, is Executive Director of Regulatory Affairs at Regeneron Pharmaceuticals, Inc. Dr. Parrino has 15 years of experience in government and pharmaceutical industry settings in drug and vaccine development. In her regulatory role at Regeneron, Dr. Parrino oversees activities across several therapeutic areas, with a special interest in Infectious Diseases. Dr. Parrino led the Regeneron regulatory activities related to approval of INMAZEB for the treatment of Zaire ebolavirus infection and most recently has been supporting Regeneron’s COVID-19 efforts, including emergency use authorization of casirivimab and imdevimab.

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