In the early 1990s, Hedy Teppler was treating AIDS patients with HIV/AIDS at a hospital in Philadelphia. She was also serving as a clinical trial investigator for Phase 1 and 2 Merck studies of a new class of anti-HIV drugs designed to block the HIV protease enzyme and thus prevent HIV replication. "The early results were exciting. In a short time, many patients responded to the investigational treatment," says Hedy.
Her positive experience during these and subsequent clinical trials was largely why she joined Merck in 1996. "I wanted to be more involved in drug development and clinical trial design, and Merck was doing some groundbreaking work in HIV," says Hedy, who now serves as executive director, Clinical Research, Infectious Diseases, at Merck Research Laboratories.
The year before Hedy arrived, another prominent HIV researcher and thought leader was keeping a close watch on Merck's work. Bach-Yen Nguyen, now retired-executive director, section head, HCV and HIV, decided to leave the National Institutes of Health to work on Merck's HIV research development team. Bach-Yen had spent years treating AIDS patients and working in HIV research and saw great potential in Merck's work. "We were faced with an opportunity to help patients infected with HIV."
For Bach-Yen, who also made vital contributions to the development of another one of Merck's medicines for the treatment of HIV, the drug's approval continues to be her most memorable moment at Merck. "We worked long hours. There were times when I couldn't attend school events with my son. When people asked him where I was, he would say, 'Mom is busy helping people with AIDS.' He was only 12, but he understood the importance of the work."
Within a few years, the team achieved additional success: In 2011, the FDA approved a chewable tablet form of this first agent in a new class of anti-HIV agents for children 2 years and older, and in 2013, approved granules for oral suspension for infants 4 weeks and older. "Our pediatrics program has been extremely satisfying as there is a tremendous need for new anti-HIV agents that can be used across the entire pediatric age range," says Hedy, who leads the Isentress pediatric development program.