Woosley aims to fix problems in the drug development process

Raymond Woosley, MD, helps industry and government work together more efficiently in the creation of new drugs.

Issue: December 2007

When it comes to the developmental process for new drugs, the FDA and drug manufacturers are not always on the same page. Raymond L. Woosley, MD, PhD, is working to change that.

Woosley has spent the better part of 35 years working in cardiovascular pharmacology, with a specific focus on arrhythmia drugs. As a public health advocate, renowned researcher and internationally recognized expert on drug interactions and internal medicine, he has recently directed his efforts to facilitating change in the drug and medical product development process.

The Critical Path Institute

Woosley said he reached a turning point in 2005 when he decided to leave his post as vice president of health sciences at the University of Arizona and found the nonprofit Critical Path Institute.

“The FDA came out with a White Paper a couple of years ago, and it really gave us all a lot of guidance,” Woosley told Cardiology Today. “It had some data that really shocked me and, in fact, shocked me into leaving my job and taking on a new one.”

Raymond Woosley, MD

CEO, The Critical Path Institute

Editor, Cardiovascular Pharmacology Section, Cardiology Today Editorial Board

Woosley noticed a significant decrease not only in the numbers of new products that had failed to meet FDA requirements but also in the numbers of new products and drugs being introduced to the FDA for approval. The large sums of public money spent to facilitate more drugs and treatments were disproportionate to the output of new products, Woosley said. It troubled him.

“During the last 10 years or so, we’ve spent about a half-trillion dollars on science and technology, and all that science was expected to turn into products, like drugs,” Woosley said. “We’ve doubled the NIH budget with a 250% increase in research and development. There clearly have been advances. We’ve sequenced the human genome, for example. However, in that same period, we’ve had 50% fewer products coming to the FDA for approval – not products sitting at the FDA but actually coming in the door for approval.”

With assistance from the FDA and the University of Arizona, Woosley founded The Critical Path Institute to facilitate the developmental process that new drugs and treatments go through to gain FDA approval and reach the market. He now serves as the CEO of the Institute.

“It’s a partnership with the FDA, and our sole purpose is to work on process improvement for drugs and new medical products,” Woosley said. “We don’t steer drugs into development. We work on the process for others to steer drugs. In a way, we’re like BASF. We don’t make the ski board; we make the ski board better.”

The Critical Path Institute does not accept any funding from drug companies, and is backed by federal, state, local and foundation funding. The reason for this, Woosley said, is so that the Institute can function as a conflict-free entity between the FDA and industry.

“When we identify a problem, we ask the FDA to work with the companies. If we were funded by the companies, the FDA wouldn’t be able to work with us the same way,” Woosley said. “So we’re a neutral third party that gets the FDA to work with industry on the process. It’s not to help the companies get their products approved but to help make the process better for everybody. We’re the catalyst in the process.”

Legislative initiatives

Woosley enjoys exploring his surroundings in the Arizona desert-scape during his leisure time.

Woosley has also been instrumental in setting up educational initiatives on therapeutics and getting supporting legislation for those initiatives passed in Congress. He ranks these as some of his most noteworthy achievements.

“One of the two things I’ve worked hardest on are ways to get therapeutics better employed,” Woosley said. “One of the initiatives is called the CERTS — the Centers for Education and for Research in Therapeutics. These are federally funded centers; there are 15 of them around the country. We set them up at academic institutions – Harvard, Penn, Duke, Vanderbilt and so on – so that leading institutions now are focusing on therapeutics with funding by the federal government. This was a concept that I championed and that I managed to get authorized into law in 1997.”

Woosley has had recent success getting more legislation passed through Congress securing funding and authorization for an initiative similar to CERTS, the second project he has worked hardest on.

“This year, we were able to get another concept pushed through, and these were public and private partnerships set up to work with the FDA,” Woosley said. “We were able to authorize $5 million from the FDA to form partnerships with universities and entities like ours.”

Academic, professional career

Following graduate school, Woosley was hired as the first scientist at Meyer Laboratories, which later became GlaxoSmithKline. He returned to school and earned his doctorate in pharmacology from the University of Louisville in 1967 and his medical degree from the University of Miami in 1971. After completing postdoctoral work in clinical pharmacology and internal medicine at Vanderbilt University, Woosley remained there on the faculty until 1988 as a professor of medicine and pharmacology.

Following his tenure as a professor, he served as the chairman and, later, associate dean of clinical research of the department of pharmacology at Georgetown University. In 2001, he was appointed vice president of health sciences at the University of Arizona.

Woosley has sat on numerous advisory committees for the National Institutes of Health, Veterans Administration, FDA Cardiorenal Advisory Committee, the Institute of Medicine for the National Academy of Sciences and the U.S. Pharmacopeial Convention. He served as the chairman of the Joint Committee on Cardiovascular Drugs for the American Heart Association and the American College of Cardiology. Woosley has been a special consultant for the FDA as well as ad hoc consultant to numerous FDA advisory committees. Woosley also served on the Director’s Advisory Committee on Clinical Research for the NIH’s National Center for Research Resources.

In his down time

Woosley enjoys exploring his surroundings in the Arizona desert-scape during his leisure time. He also has an affinity for tennis.

“I love hiking through the desert and looking for archeological findings,” Woosley said. “Living in the southwest, there are Indian villages all around, and some of them go back 1,200 years. I love looking for arrowheads and pottery shards and old Indian campsites and those kinds of things. I also love playing tennis with my son. Those are my two big adventures.” – by Eric Raible

For more information:

To learn more about The Critical Path Institute, visit www.c-path.org.