NIH Names Health Decisions to Leading Role in Quest for Next-Generation Contraceptives for Women and the First Male Hormonal Contraceptive

Durham, North Carolina—November 7, 2012. 
Health Decisions, Inc., the leading clinical research organization in women’s health, medical devices, diagnostics and other therapeutic areas, today announced receipt of an award to serve as Statistical and Clinical Coordinating Center (SCCC) for the Contraceptive Clinical Trials Network from 2013 through 2019. As SCCC in this period, Health Decisions will play a key role in clinical testing of multiple female and male contraceptives. Health Decisions received the award from The Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD), a unit of the National Institutes of Health. The award followed an independent review of competitive submissions by a panel of outside experts selected by NICHD.

“Recent research raises the hope of a safe and effective hormonal male contraceptive, a potentially revolutionary development,” stated James Higgins, PhD, Health Decisions’ Executive Vice President and Director of Biometrics, who will serve as Principal Investigator of the SCCC. “Epidemiological data also demonstrates a need for women’s contraceptives with improved safety and side-effect profiles, especially for women with risk factors such as advancing age and obesity. We are happy that NICHD has entrusted us with important responsibilities in research that will increase scientific understanding and advance promising female and male contraceptive products toward regulatory approval and public availability.”

Health Decisions’ CEO Michael Rosenberg, MD, MPH, commented, “Health Decisions has been honored to serve as Statistical and Clinical Coordinating Center for the past 15 years and we are honored that NICHD has chosen to continue this association for an additional seven years. NICHD is a catalyst for development of next-generation contraceptives. We appreciate the opportunity to do our part in providing a large and diverse population at risk with a wider range of acceptable and safe methods of preventing undesired pregnancies.” Dr. Rosenberg will serve as the SCCC’s Co-Principal Investigator.

Health Decisions has been involved in successful commercial and publicly funded development of a variety of contraceptive products, including the emergency contraceptive ella® and several additional products that are progressing toward marketing approval, including: Amphora®, a novel class of nonhormonal spermicidal gel, a contraceptive vaginal ring that is near filing, and the Woman’s Condom from the Program for Appropriate Technology in Health (PATH). Health Decisions is currently conducting a 2,800-patient global phase III clinical trial of Amphora® for privately held healthcare company Evofem, which plans to introduce Amphora® as “a low cost, hormone- and latex-free over-the-counter contraceptive option for women.”

Health Decisions has also been a driving force in clinical development of women’s health products besides contraceptives, including a novel treatment for breast cancer and an HPV diagnostic that has improved diagnosis of cervical cancer and prospects of survival for many women. In addition, Health Decisions has contributed to development of numerous products beyond women’s health, including treatments for chronic kidney disease, multiple sclerosis and renal cell carcinoma as well as new influenza vaccines and diagnostics for colon cancer.

About Health Decisions

Health Decisions is the leading clinical research organization (CRO) in Agile Clinical Trials, providing proactive trial management based on real-time actionable information, enabling decisions that reduce timelines and allow sponsors to seize market opportunities. Since 1989, Health Decisions has conducted a wide range of successful clinical trials, including Phase I – IV trials of drugs and biologics, global registration studies and 510(k) and Premarket Approval Application studies for medical devices. Founded in 1989, Health Decisions is headquartered in Durham, NC.

The projects described in this press release have been funded in whole, or in part, with Federal funds from the NICHD, National Institutes of Health, under Contract Number HHSN275201200002I. The content of this press release does not necessarily reflect the views or policies of the Department of Health and Human Services, nor does mention of trade names, commercial products, or organizations imply endorsement by the U. S. Government.

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