Juniper Pharmaceuticals, a specialty pharmaceutical company focused on developing therapeutics that address unmet medical needs in women's health, has created a scientific advisory board (SAB) comprised of international physicians and scientists whose mission will be to provide scientific and clinical advice on the identification and advancement of product candidates for Juniper's women's health portfolio.
The SAB consists of: Ginger D. Constantine, M.D.; William F. Crowley Jr., M.D.; Martyn Davies, BSc, Ph.D., FRPharmS, CChem, FRSC; Robert S. Langer, Sc.D.; and, Daniel A. Shames, M.D., FACS.
During her ten year tenure within the Wyeth Pharmaceuticals and Wyeth Research organizations, Constantine held various management positions of increasing responsibility in the therapeutic areas of rheumatology, metabolism and bone repair. She ultimately was vice president of Women's Health & Bone Repair Medical Research at Wyeth Research until its acquisition by Pfizer in 2010, guiding her staff to the completion of numerous Investigational New Drug Applications and more than ten New Drug Applications and European dossiers in the areas of contraception, osteoporosis, menopausal symptoms, endometriosis and osteoarthritis.
Crowley is the Daniel K. Podolsky professor of medicine at Harvard Medical School, where he also is the chief of the Reproductive Endocrine Unit of the Department of Medicine at Massachusetts General Hospital (MGH). In addition, he is the director of the Harvard-wide Reproductive Endocrine Sciences Center.
Davies is professor of biomedical surface chemistry at the University of Nottingham School of Pharmacy, and has over 30 years' experience in the pharmaceutical, biopharmaceutical and drug delivery fields. Davies co-founded Juniper Pharma Services in 1997 as a spin-out company from his academic laboratory, and was its founder-chairman until its acquisition by Juniper Pharmaceuticals in September 2013, at which time he was appointed advisor to the company's board of directors.
Langer is the Massachusetts Institute of Technology department of chemical engineering David H. Koch Institute Professor. Langer was a member of the FDA SCIENCE Board from 1995 until 2002 and its chairman from 1999 to 2002.
Shames has extensive experience in pharmaceutical development and regulatory affairs. During his 12-year tenure at the FDA, he was deputy director, Office of Drug Evaluation III/Center for Drug Evaluation and Research (CDER) from 2006 to 2008, and was a member of the senior management team of the Office of New Drugs and the Drug Safety Oversight Board. From 2001 to 2006, he was Director of the FDA's Division of Reproductive and Urologic Products and reviewed therapeutic products for clinical areas including contraception, infertility, obstetrics, menopause and urinary incontinence.
The aggregate expertise of the SAB spans multiple areas of direct relevance to the company's proprietary product development strategy, including drug delivery and biomaterials, innovative engineering, women's health, including reproductive endocrinology and regulatory affairs.
The SAB will hold its inaugural meeting this week in Boston, and will meet on a regular basis as the company advances its proprietary product portfolio. Davies is chairman.
Juniper's drug development strategy is to advance novel formulations of previously approved products through proof-of-concept, and then look to partner for late-stage clinical trials and commercialization efforts. The company focuses on products for women where its novel technologies and in-house capabilities can improve performance and add value, that hold strong intellectual property and other potential barriers to entry, and which utilize the FDA's 505(b)(2) regulatory pathway when possible.
The company is poised to initiate a phase II clinical trial of COL-1077 in women undergoing transvaginal pipelle-directed endometrial biopsy this quarter. Formulated with Juniper's proprietary bioadhesive delivery system technology to achieve sustained-release of 10% lidocaine bioadhesive gel, COL-1077 is intended as an acute use anesthetic for minimally invasive gynecologic procedures.
Juniper's patent-protected drug delivery technologies include a segmented intra-vaginal ring (IVR) that was developed by SAB members Langer and Crowley. Langer and Crowley also are strategic advisors to the company to support the deployment of the IVR technology and guide development of future product candidates.
The IVR technology enables the delivery of one or more pharmaceuticals at different dosages and release rates in a single segmented ring. This patient administered-device will be utilized as a key drug delivery platform for Juniper's emerging proprietary product pipeline.