Robert Yocher, Genzyme's vice president of regulatory affairs, told attendees of IBC's Chips to Hits conference here today that the idea that a patient could go to a drugstore bearing a chip with his or her biological information on it and receive personalized treatment "is not going to happen in our lifetime or our kids' lifetimes." Yocher spoke during a joint US Food and Drug Administration and industry panel discussion at the conference.
Although he said his optimism about the future of PGx is "tremendous," Yocher said in an interview after his talk that bringing a test to market is a "tough, tough decision" for in vitro diagnostic developers, and that tests in development today would most likely take 10 to 15 years to reach the marketplace, rather than two or three. He noted that the timeline may be shorter for companies trying to bring oncology-focused tests to market.
Yocher placed much of the blame for the promise of a short time to market on "media hype" from "weekly news magazines like Newsweek, as well as trade magazines and newspapers" that create "unrealistic expectations" in the industry and cause, in his opinion, the FDA to "rush" guidance documents to the public. Yocher said he expects the FDA to release "dozens" of new guidance documents over the next decade and said that "what we think is valid now is probably going to change tomorrow."
Yocher also urged the pharmacogenomics community to police its message by writing letters to the editors of publications that "hype" the promise of personalized medicine and to collaborate more effectively to encourage progress in the industry.