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Panel 2: Women in Clinical Trials

Woman are notoriously underrepresented in numerous clinical trials, making gender based subset analysis difficult. As a result, the medical community cannot fully understand important differences in prevalence of disease and response to treatment as it relates to women population. This panel will provide context as to how and why this situation exists, elucidate current challenges and issues, and give participants ideas for how to address the issue within their organizations.

Moderator:

AnneAbreuphotoAnne Abreu, Founder/Principal, AMA Medical Device Consulting

Anne is currently the founder and principal of AMA Medical Device Consulting. Prior to consulting, she held numerous leadership positions at Sonitus Medical, Ventus Medical, Abbott Vascular, Guidant Corporation, among others.

Panel Members:

JoanneWeidhaasMDPhDMSMphotoJoanne Weidhaas, MD, PhD, MSM, Professor, Division Chief Translational Oncology

Dr. Weidhaas is a physician-scientist and a trained radiation oncologist. She is currently a professor and researcher at David Geffen School of Medicine at UCLA. She has spent over 15 years bringing together advances in scientific understanding and clinical cancer care. In 2007 she co-discovered a new class of genetic biomarkers that predict both increased cancer risk and unique responses to cancer therapy. Through extensive study she has now shown that there are significant differences in how these inherited differences impact men and women. These findings highlight the importance of including gender as a factor in all studies.

NoelBaireyMerzphotoNoel Bairey Merz, MD FACC, Director, Barbra Streisand Women’s Heart Center, Cedars-Sinai

Andréa C. Noel Bairey Merz, MD, holds the Women’s Guild Endowed Chair in Women’s Health, and is Director of the Barbra Streisand Women’s Heart Center, the Linda Joy Pollin Women’s Heart Health Program, and the Preventive Cardiac Center at the Cedars-Sinai Heart Institute. She also is Professor of Medicine at Cedars-Sinai Medical Center. Dr. Bairey Merz’s research interests include women and cardiovascular disease, mental stress and heart disease, the role of exercise and stress management in reversing disease, and the role of nutrition in heart disease.

KimTempletonMDphotoKim Templeton, MD, Professor of Orthopedics, University of Kentucky

Dr. Kim Templeton is Professor of Orthopedic Surgery and Health Policy and Management at the University of Kansas Medical Center in Kansas City.  She has been the orthopaedic residency program director since 2008.  She is past chair of the faculty council at the University of Kansas Medical Center and currently serves as the chair of the education council and is a member of the graduate medical education executive committee. Her research interests include women’s health, medical education, and treatment of osteosarcoma.

SallyLMaherphotoSally L Maher, V.P. Regulatory & Clinical Global Critical Care, Edwards Lifesciences

Sally L. Maher has been VP of Regulatory & Clinical Affairs for Edwards Lifesciences since May 2012. She has more than 25 years of medical device and combination product experience in regulatory, clinical, reimbursement, healthcare compliance and product development. Prior to joining Edwards, Maher held various Senior Vice President of roles at Smith & Nephew’s Advanced Surgical Products Division including, Regulatory & Clinical Affairs, Reimbursement & Healthcare Economics, Healthcare Compliance, Research & Development, and New Business Development.

NadaHanafiphotoNada Hanafi, Senior Science Health Advisor at Food and Drug Administration

Nada has been Senior Science Health Advisor, Center for Devices and Radiological Health (CDRH) for the Food and Drug Administration (FDA) since 2010, where she provides leadership on cross cutting initiatives that address key public heath issues and oversees the implementation of new legislative authorities to meet Congressional mandates. Prior to this role, she served as Network Leader of Plastic and Reconstructive Surgery, Breast Implants Network and as Staff Fellow /Lead Scientific Reviewer for the FDA.

Here’s the video of the panel discussion: