Dr. H. "Kim" Lyerly is director of the Duke Comprehensive Cancer Center, and a member of NCI's Translational Research Working Group. He is one of the originators of the workshop "Accelerating Anticancer Agent Development and Validation" (see Spotlight).

Why was the workshop created?
There's a perception that it takes too long to get a drug to market and that the system is broken. You see people pointing fingers at the FDA, at NCI, at the big drug companies. But active attempts are being made. Nonetheless, when a patient asks me directly why he or she can't get access to some new anticancer treatment in the pipeline, I want to be able to say that we are working on tangible solutions as a team. With leadership and support from the FDA, NCI, American Association for Cancer Research, American Society for Clinical Oncology, and consumers, I hope the workshop has evolved into just that.

What is your own take on the problem?
The molecular era has spawned undreamed of advances in science, which the drug development process has not been able to keep up with. Ten years ago, the scientific community was aware of perhaps 500 "conceivable" drugs they might work on. In the wake of the Human Genome Project, that number has grown to more than 50,000. And yet the system that has evolved produces only 1 successful drug for every 20 that enter into clinical evaluation, often at a cost of more than a billion dollars. Hence, people working in every sector want to solve this problem.

Does the workshop provide a solution?
The workshop illustrates what we think is the most immediate solution by shining a light on a historically closed-door process. We provide lectures from experts in the drug development process and match younger scientists grappling with how to further develop their specific agent with some of the best minds in the country who are actively involved in drug development and approval, and with consumers, representing cancer patients. It's an open forum - no secrets, no cautious regulatory doublespeak, no self-interest. The FDA, in particular, has been a leading contributor and a crucial player, letting their best people provide guidance and insight into the approval process in a way they could not do when responding to an actual drug application. They've embraced the opportunity to deliver this practical but unofficial guidance.

What do you think should happen?
In order of importance, if not feasibility: Continued dialogue throughout the development process that allows more open and collaborative discussions about a drug's viability. Funded research focused on developing new endpoints, such as highly predictive markers of clinical efficacy and more realistic ways to define toxicity. Immediate and sustained action on the NCI working group recommendations to improve clinical trials and translational research. While the latter [TRWG] has yet to issue recommendations, clearly we need a team approach and a coordinated development context. Finally, national-level solutions to the imbalance between the cost of conducting clinical trials in this country and abroad.