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MEDIA CENTER New Staff Members to Manage Clinical Trials for the NEW YORK (23 April 2003) — The Population Council announced the hiring of two researchers to manage the effectiveness testing of Carraguard™, the Council's lead candidate microbicide. Formulated as creams or gels, microbicides are being developed to substantially reduce the transmission of HIV and possibly other sexually transmitted infections. If proven effective, Carraguard would offer a powerful new prevention tool in the fight against AIDS. Pekka Lähteenmäki, a physician with a Ph.D. in reproductive physiology, will oversee the effectiveness testing. Stephanie Skoler, who holds an M.P.H. in epidemiology from Boston University, has the day-to-day responsibility for implementation of the clinical trial. Before joining the Council, Skoler conducted research for an international study on the effect of genetics and the environment on breast cancer. Lähteenmäki was previously vice president of research and development, specializing in contraceptive delivery technology, for the pharmaceutical firm Leiras Oy, a subsidiary of Schering AG, Germany. He also conducted research at the University of Helsinki. Lähteenmäki has written or co-authored more than 100 articles in peer-reviewed journals and 65 editorials and reviews in the areas of experimental endocrinology, gynecological endocrinology, and obstetrics and gynecology. Lähteenmäki's relationship with the Population Council began nearly fifteen years ago when he served as a consulting scientist—a post that he held until 1997. While at the University of Helsinki, he also ran the Council's core radioimmunoassay laboratory. Lähteenmäki said, "Carraguard's potential to help people in countries around the world drew me back to the Population Council." Skoler was on the staff of the Mount Sinai School of Medicine immediately before joining the Population Council. She has also worked on public health studies investigating eye disease, substance abuse, tobacco control, Lyme Disease, and Rocky Mountain Spotted Fever. As part of her master's degree program Skoler earned a certificate in economics and financing of health care in developing countries from Boston University. "Both researchers have the knowledge and ability to make a valuable contribution to the crucial next phase of testing," said Elof Johansson, the head of biomedical research at the Council. "Given the urgency and sheer numbers of people affected by the AIDS crisis, the Council needed professionals who have expertise in both science and management to move this project forward." The Population Council is working toward the creation of a safe, effective microbicide. Lähteenmäki and Skoler will oversee the Phase III clinical trial. To ensure acceptability, effectiveness, and safety, Carraguard is undergoing a four-stage testing process. The first three trials are done before the product is available to consumers. Phases I and II determine whether the drug is safe and acceptable to users. Testing during Phase III determines whether the product is effective in preventing the transmission of HIV and other sexually transmitted infections. Phase IV, or post-marketing surveillance, is done after the product is on the market, to study how the product works in real-world settings. Lähteenmäki will be based in the Population Council's office in Johannesburg, South Africa and Skoler in New York City at the Council's Center for Biomedical Research. Carraguard's Phase III trial will be conducted at three locations in southern Africa over a four-year period. For additional information see also: Frequently asked questions about the Population Council, Microbicides, and other Council HIV/AIDS research projects.
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