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Wednesday, June 27 • 10:30am - 11:45am
#342: Sex Considerations in the FDA Drug Review Pipeline: The Where, When, and How

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Component Type: Session
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-651-L04-P; CME 1.25; IACET 1.25; RN 1.25

There has been considerable progress in how sex differences are incorporated into both clinical trial development and how FDA reviews this data. The FDA has published several regulations and guidance in regard to women and sex and gender inclusion and incorporation into the review process. This forum will walk through the impact of these requirements and recommendations on the inclusion of women in clinical trials and comprehensive review of sex differences in clinical trials. It will dive further into the drug approval timeline focusing on the role of pharmacological and toxicology reviewers at the FDA. Participants will have the ability to test their knowledge on the drug approval process as well as walk through case study examples of drugs approved or rejected from the market. Presenters will begin with a brief overview of the regulatory history of the inclusion of women in research activities and clinical trials. In addition, presenters will discuss the evaluation of potential sex differences throughout the process of drug development including the pre-clinical and clinical phases.

Learning Objectives

Analyze the impact of regulatory requirements and policy on the inclusion of women in clinical trials; State the requirements for the use of male and female animals in preclinical toxicity studies; Recognize when and how sex is considered in the FDA drug review and approval process; Identify at least one method which FDA utilizes to communicate findings regarding sex differences to the public.


Erin South, PharmD, RPh


Gender Inclusion and Analysis of Sex Differences in Clinical Trials Supporting Drug Approvals
Erin South, PharmD, RPh

Sex Considerations in Drug Development: A Nonclinical Perspective
John H. Dubinion, PhD

Clinical Evaluation of a New Drug: Looking for Sex Differences
Milena M Lolic, MD, MS


John Dubinion

Pharmacologist, Office of Antimicrobial Products, OND, CDER, FDA
A nonclinical (Pharm/Tox) reviewer in the Division of Antiviral Products. A cardiovascular scientist by training ( Ph.D. in Pharmacology from University of Pittsburgh, Post-doctoral thru Junior Faculty at the Univ. of MS. Medical Center) with industry experience (Research Pharmacologist... Read More →

Milena Lolic

Lead Medical Officer, FDA
Dr. Lolic joined FDA in 2008. She is currently leading medical officer for Drug Trials Snapshot initiative aimed at increasing demographic transparency of clinical trials. Dr. Lolic received her medical degree from University of Belgrade, Yugoslavia. She completed research fellowship... Read More →

Erin South

Senior Pharmacist, Office of Women's Health, Office of the Commissioner, FDA
Erin South is a Senior Pharmacist in FDA's Office of Women’s Health. OWH is the principal advisor to the Commissioner on scientific, ethical, and policy issues relating to women’s health. She previously spent 3 years in FDA’s Division of Risk Management. Dr. South's experience... Read More →

Wednesday June 27, 2018 10:30am - 11:45am EDT
Room 205C Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  09: Regulatory, Session