Washington Editor

WASHINGTON The regulatory process is considered by many within the drug industry to be the most significant hurdle in the process of introducing a product to the market.

If today’s FDA standards were applied to the approval process generations ago, said William Haseltine, chairman and CEO of Rockville, Md.-based Human Genome Sciences Inc., aspirin probably never would have made it to the market.

Haseltine was among the panel members Thursday who opened the BioWindhover partnering conference held at the Ritz-Carlton in Washington.

Others, representing Millennium Pharmaceuticals Inc., of Cambridge, Mass.; Pharmacia Corp., of Peapack, N.J.; and Eli Lilly and Co., of Indianapolis, discussed the challenges and solutions that drug researchers and developers face when trying to get drugs to the market in the future.

It’s no secret that the FDA is slow, and sometimes picky when it reviews drug applications. But companies and researchers commonly fear publicly criticizing the agency that could hold the key to their financial success.

When Thursday’s panel discussion turned to the predictability or rather, unpredictability of research and development in terms of getting a product to the market, Haseltine said, “We are in a much more adverse regulatory environment than we were years ago. The focus used to be safety, then efficacy and then it became risk.”

Goran Ando, president, research and development of Pharmacia, agreed, saying oftentimes the benefit of a drug to a patient disappears in discussions of risk.

Seeing a drug through the FDA process is merely one industry challenge, but more pressing issues for a company likely are innovation and the drive to develop blockbuster drugs, panel member said.

“I would say large pharma in the future is going to have to be more inventive because the world wants invention, but I think this is good news for biotechnology,” Richard DiMarchi, group vice president, research technologies for Eli Lilly/Lilly Research Labs, said. “We are living through the Prozac patent at this time and we really don’t have a new and improved version of the drug.”

But Haseltine said he views the research proficiency in both pharmaceuticals and biotechnology as “tremendous.” He said the challenge companies face relates to transferring ideas into drugs and reaching the market. “Most biotechnology companies have a good idea, but they don’t have a market. The challenges we have are not in a generation of new ideas, but in the proper coupling of ideas to the market.”

Once the drug enters the market, whether it becomes a blockbuster or has the potential to reach blockbuster sales in many instances relates to how the clinical trials were designed and the label the product was given, Haseltine said.

Roger Longman, panel moderator and managing partner of Windhover Information in Norwalk, Conn., asked if companies pursue more blockbusters because of financial gaps caused by generic competition.

To that, Ando replied that pursuing only blockbusters would be too risky for most companies.

But the notion that biotechnology companies don’t have an eye on blockbusters is not true, Haseltine said. “When companies look at the possibility of partnering and the question is asked whether there’s a potential for a blockbuster, if there’s not, then you aren’t going to have a very large conversation.”

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