Mihael H. Polymeropoulos, MD, president and CEO of Vanda Pharmaceuticals, marketers of HETLIOZ (tasimelteon, indicated for non-24-hour sleep-wake disorder) is the inaugural recipient of “The Trailblazer Award.”The Trailblazer Award is given by the Physicians Committee, a nonprofit with more than 12,000 doctor members. In a release, the committee indicated that it is awarding Polymeropoulos “for his unwavering commitment to prevent and replace animal tests and advance more human-relevant science.”
Vanda is currently suing the US Food and Drug Administration (FDA) for not allowing its drug to be studied in long-term clinical trials without a dog study.
“There is no evidence that long-term studies on dogs add any predictive value to human safety,” Polymeropoulos says in a release. “The FDA is ignoring a large body of published scientific evidence that concludes these dog studies are uninformative. It is time to demand that the pharmaceutical industry and government regulators abandon unscientific, low-resolution animal testing and adopt modern, human-based scientific methods to advance human drug safety.”
The Chad Sandusky Trailblazer Award is named for former Physicians Committee senior director of toxicology and research, Chad Sandusky, PhD. Sandusky’s strong belief that nonanimal testing was the way of the future led him to advocate for policies that ensured the Environmental Protection Agency and chemical companies adopted cellular and computational methods to assess chemicals.
“Patients need safe and effective drugs that are developed using modern approaches to assess safety and efficacy, instead of animal tests that are based on outdated science. Dr Polymeropoulos is pioneering a path for other pharmaceutical companies to provide what is best for human health. We are thrilled to present him with this trailblazer award, recognizing his work to move away from animal tests and advance safer, more accurate science,” says Kristie Sullivan, MPH, vice president of research policy for the Physicians Committee.