WASHINGTON - At the American Association of Cancer Research's annual meeting Sunday, a special session titled "Accelerating Cancer Therapeutic Development: The FDA Critical Path Initiative" investigated the reasons for the low success rate of cancer drugs.

The panelists - from the FDA, the National Cancer Institute and Biogen Idec Inc. - had a take-home message: Forget those turf wars and standardize.

Cancer therapeutics have even lower-than-average drug development success when it comes to attrition: The average chance that a given drug now in Phase I trials will enter the market is a dismal 8 percent; the average for cancer drugs, according to Janet Woodcock, deputy commissioner of operations at the FDA, is less than 5 percent.

And drugs are failing later, costing developers more money. Woodcock said that the failure rate of drugs in Phase III trials is now 50 percent, up from 20 percent 10 years ago.

All panelists acknowledged that the reasons are many, including the fact that genomics has clearly not reached its full potential and might be more of a distraction than an asset at this point. Also, escalating development costs might be causing risk aversion that in turn is leading to fewer viable drug candidates.

Lost In Translation

But the panel focused on one particular problem.

"We have been investing significantly and appropriately in basic research," Woodcock told the audience at the special session, "but scientific progress in product development has not kept pace."

Her comments were echoed by Anna Barker, deputy director for strategic scientific initiatives at the NIH's National Cancer Institute. "Drug development is, by definition, a process," she said, but added that the parts of the process are disconnected, and the tools to join them are not yet available.

Woodcock - who realized that her characterization of clinical trials as more or less willy-nilly might be unpopular in industry circles, and invited opinion from the audience - said that "most clinical oncology is empirical; that is, trial and error. You just give [a drug] to a bunch of people and see what happens." Barker agreed, but also pointed out that "we have the most sophisticated science to ensure that we don't have to work that way."

Woodcock got support from at least one industry source. David Parkinson, former vice president of oncology development and commercialization at Thousand Oaks-Calif.-based Amgen Inc., now working as senior vice president of oncology research and development at Biogen Idec, told the audience that "we don't have much excuse left anymore for the kinds of bad numbers" being discussed.

He added, "Before, we could say that we didn't understand the biology of cancer. This meeting is testament that while we're not there yet, we've made a lot of progress."

Left Hand, Meet Right Hand

All panelists agreed that progress in basic cancer understanding needs to be applied to the clinic. The main scientific advance in clinical research has been biomarkers. In one sense, NCI's Barker said, the industry has "more biomarkers than we know what to do with." But what is lacking is a deep understanding of their predictive value. As Woodcock put it, "Qualification of a biomarker means developing enough information to understand what a marker means in a given situation."

Woodcock gave the example of the FDG-PET method as a biomarker that needs such validation.

"You may say, 'Well, we already use FDG-PET to measure tumor response.' But my point is that we don't use it in a regulatory context because we don't know what it means," she said.

It will take a standardization of technologies to reach that understanding.

Parkinson said that industrial experts in other disciplines "are shocked at the lack of discipline in the biomedical community." Turf battles prevent researchers from looking at the processes of research and standardizing what can be standardized. That, in turn, leads to almost as many protocols, from the consent forms on up, as there are clinical trial sites.

"That is not value for anyone," Parkinson said.

One way to achieve standardization is through public-private consortia; Woodcock named the Critical Path Institute in Tucson, Ariz., and the Arlington, Va.- based Product Quality Research Institute as places in which government, academia and industry have worked together to generate scientific information to support policy.

Woodcock pointed out that collaborative standardization efforts were successful in HIV therapeutics, noting that "there was an industrial round-robin early in the epidemic to standardize the assays measuring CD4 count, and later, viral load," so that results from different sources would be comparable.

"It is possible, but it took a lot of effort," Woodcock said. In HIV treatment, though, that effort paid off; it is now easy to tell early on whether patients will respond to a given drug. Gone are the days of treating them "for years and see what happens."

The conference, with an attendance of roughly 16,000, runs through Wednesday.