TherapeuticsMD announced the appointment of Sebastian Mirkin, M.D., a women's health product development executive with experience in the pharmaceutical industry and clinical research, as Chief Medical Officer, effective November 25.
Dr. Brian Bernick, TherapeuticsMD's current Chief Medical Officer, will then serve as Chief Clinical Officer.
According to a release, Dr. Mirkin joins TherapeuticsMD from Pfizer, Inc. where he served as the Global Lead of Women's Health Clinical Research and Development. Most recently, he oversaw the development and successful marketing authorization of Duavee (conjugated estrogens/bazedoxifene), a menopausal combination product approved by the U.S. Food and Drug Administration (FDA) earlier this month. Dr. Mirkin supervised and directed early- and late-stage clinical programs for Pfizer's small molecule and biologic product candidates to address menopausal symptoms, osteoporosis, contraception, uterine fibroids and endometriosis. He successfully executed phase 3 clinical trials for numerous other development programs and oversaw the filing of New Drug Applications and regulatory submissions worldwide for products addressing vasomotor symptoms associated with menopause, vulvar and vaginal atrophy, osteoporosis, and contraception, leading to marketing authorizations in the U.S., Europe and Japan.
"We are very pleased to welcome Dr. Mirkin to TherapeuticsMD. His strong and highly relevant experience overseeing successful clinical trial programs is the precise expertise we need for advancing the development of our bio-identical hormone franchise as we seek to introduce FDA-approved products that match the molecular structure of the estradiol and/or progesterone produced in a woman's body. More specifically, we believe his work on the first new combination hormone product to come to market in more than nine years could increase the likelihood of a positive outcome for our portfolio of products," said Robert G. Finizio, Co-Founder and Chief Executive Officer of TherapeuticsMD.
"We view his decision to join the company at this time to be a significant validation of our scientific and clinical platform, as well as the leadership role TherapeuticsMD is playing in advancing innovative treatments in the women's hormone and health market," concluded Finizio.
Prior to joining Pfizer, the Company said Dr. Mirkin spent three years at Wyeth Research at the Department of Women's Health and Bone Repair, Clinical Development. Previously, he was the Global Lead for Medical Services Female Health Care, Global Marketing Department, at Akzo Nobel/Organon International.
"Dr. Mirkin has extensive experience in the pharmaceutical industry and has been successful in obtaining regulatory approval for several products in Women's Health. His joining TherapeuticsMD signals the company's commitment to develop novel hormonal replacement therapy for women," said David F. Archer, M.D., Director of Intramural Clinical Research Center Force, CONRAD, Director of Clinical Research Center, Jones Institute for Reproductive Medicine, and an investigator in TherapeuticsMD's Replenish trial.
Dr. Mirkin began his post-doctoral career with a four-year Reproductive Endocrinology Fellowship in the Contraceptive Research and Development Program (CONRAD) at the Jones Institute for Reproductive Medicine at Eastern Virginia Medical School'sDepartment of Obstetrics and Gynecology under the mentorship of Dr. Archer. Dr. Mirkin did research on angiogenesis and endometrial gene expression during the window of implantation.
TherapeuticsMD is a women's healthcare company focusing on developing and commercializing products targeted exclusively for women.
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