Four years ago, Arizona successfully recruited Dr. Ray Woosley, a nationally recognized clinical pharmacologist, to head the Arizona Health Sciences Center in Tucson. In doing so, the state gained more than a renowned researcher; it gained a vision of how to revolutionize the drug development process in America.
Last year, the means to achieve that vision became reality when, with the support of community and state leaders, Woosley founded C-Path, an organization dedicated to making drug development faster, safer, and less expensive.
C-Path, formally the Critical Path Institute, is a nonprofit organization whose mission is to “create innovative programs in education and research that enable the safe acceleration of the process for developing new medicines.”
It is an ambitious project, but, according to president and CEO Woosley, it is one that is desperately needed.
In the last ten years, pharmaceutical-industry research and development costs have risen 250 percent; at the same time, the number of new therapies submitted for U.S. Food and Drug Administration approval has declined by nearly 50 percent.
“During this time, scientists sequenced the human genome,” said Woosley. “As a nation, we doubled the amount of money for the National Institutes of Health research. All these advances and investments have occurred, but fewer and fewer products are being submitted to the FDA for approval.”
Woosley attributes the drop in FDA applications to the prohibitive timeframes and costs of developing a drug. According to the Pharmaceutical Research and Manufacturers of America, a trade association of leading pharmaceutical research and biotechnology companies, the average investment to take a drug to market is 15 years and more than $1 billion.
“For most people with serious illnesses, fifteen years is too long to wait for a new medicine,” Woosley said. “Also, if you’re going to spend a billion dollars to develop a new medicine, no one can afford it.”
Inspired to overcome these challenges, C-Path crafted its mission to meet three main goals: changing the drug development process to allow faster access to drugs; creating programs to ensure safer drugs and the safer use of drugs; and creating educational programs in advanced pharmaceutical development.
Although C-Path is still in its infancy, it has already forged ties with three founding partners: the FDA; University of Arizona, which is home to the pharmacy college ranked number four in the nation among graduate programs by US News and World Report; and SRI International, a leading research and development organization based in Menlo Park, Calif.
In addition, C-Path has raised $10 million in community support, including $400,000 from the state of Arizona, $1.87 million pledged by the City of Tucson, and an equal amount from Pima County government. The Flinn Foundation recently awarded C-Path a grant of $1.25 million. Private contributors, including the Thomas R. Brown Family Foundation and Tucson business leaders Jim Click and Don Diamond, have donated a total of $3.5 million. Finally, UA, SRI, and FDA have contributed substantial funding.
“I have been overwhelmed by how willing people are to help improve the process of drug development,” Woosley said, adding that most contributions were made because the person or a family member had previously needed a medication that was either not available or was not affordable.
Woosley refers to Arizona’s eagerness for collaboration on this project as “the cowboy/cowgirl spirit,” which is what initially attracted him to Arizona. “There is a general belief that anything is possible if we come together and work on it.”
This “cowboy” spirit of innovation has been the motivator for Woosley, who went on a family vacation to a ranch last week. It has brought him to where he is today, as the inspiration behind—and the vision guiding—C-Path, an organization that is the first of its kind in the nation.
Taking the reins
Woosley was supposed to be a chemist, but became a pharmacologist. Early on in his career while studying for a doctorate at the University of Louisville, he trained under a clinical pharmacology professor who encouraged him to attend medical school.
The thought of medical school stayed at the forefront of his mind when he moved to Florida in 1967 to become the first scientist hired by Meyer Laboratories, later Glaxo-Wellcome, now GlaxoSmithKline. After working in drug development for four years, he enrolled in the University of Miami School of Medicine because of an interest in testing the effectiveness of medicines in humans. In 1971 Woosley left Glaxo-Wellcome. In 1973 he graduated from the University of Miami and moved to train in internal medicine and clinical pharmacology at Vanderbilt University Medical School in Nashville.
Most of Woosley’s research was on cardiac drugs, and he worked with “a really great” team that included someone who would later become a key ally in Woosley’s mission to improve drug development—future Senate majority leader Bill Frist (then a transplant and arrhythmia surgeon).
At Vanderbilt Woosley had an experience that would change the course of his career. In 1987 he co-directed a team that began the Cardiac Arrhythmia Suppression Trial (CAST), funded by a grant from the National Institutes of Health. The trial, which began in 1987 tested whether the use of arrhythmia-suppressing drugs could prevent sudden death.
“[The trial] was a real eye-opener. Rather than finding [that the drugs] prevented death, we actually had to stop the study early because we found the drugs were causing sudden deaths,” Woosley said. “I think it really brought home to me how important it is that we do more studies to find the potential harm from medicines. So I spent the next fifteen years studying the side effects of medicines.”
While working on the CAST trial, Woosley was asked to serve as a consultant for a patient who had started blacking out after being prescribed Seldane, a popular antihistamine at the time. Wondering if Seldane was behind her medical problem, Woosley and his team began studying the drug and found that it was causing deaths. The FDA eventually pulled Seldane off the shelves.
Woosley’s work led him to discover fexofenadine—better known by the brand name Allegra—a safer version of Seldane that “lacked the toxicity on the heart.”
By 2001, Woosley was a wanted man. Then associate dean for clinical research at Georgetown University, he learned that then Secretary of Health and Human Services Tommy G. Thompson wanted to nominate him for the FDA commissioner position. Given his involvement in drug safety, particularly his push for FDA regulation of the herbal ephedra and dietary supplement industry, he would face formidable opponents.
It was about that time that the UA offered Woosley the position of vice-president of the Arizona Health Sciences Center. Ironically, the position in many ways offered greater opportunities to improve the national pharmaceutical process than the FDA commissioner position would have. Moreover, something in UA’s offer appealed to Woosley’s own sense of immediacy.
“[They] said ‘we need to know if you want to accept the position at the UA now.'”
Out of the Gate
Looking back on his decision to come to Arizona instead of waiting out the FDA commissioner confirmation process, Woosley believes he made the right choice: C-Path represents the opportunity to revolutionize the drug-development process from the outside.
“Working inside the FDA, you’re really constrained by the federal budget, and the Commissioner has to deal with a lot of other equally important problems like food safety,” Woosley said. “[With C-Path] we can focus on medicine and be advocates for more money into the FDA budget.”
Helping pave the way for C-Path was another drug-related organization that Woosley played a role in establishing: the Centers for Education and Research on Therapeutics (CERT). Working with Dr. Frist in the Senate, Woosley drafted the legislation and lobbied Congress to create the network of centers. He won a victory in 1997 when the legislation was passed authorizing the Agency for Healthcare and Research Quality for a CERT pilot program. The Healthcare Research and Quality Act of 1999 established the full CERT program, which now funds seven centers.
Woosley has run a premier CERT program focusing on heart arrhythmias ever since, bringing it from Georgetown University to Arizona when he moved to UA. Then, last year, Deputy Commissioner Janet Woodcock, a friend of his at the FDA who knew about CERT, sent him an early draft of a soon to be released white paper. It was a draft of the FDA’s Critical Path Initiative, a report that called attention to the serious problems in drug development and how the FDA proposed to work with partners to find solutions.
“The FDA recognized that drug developers need new and improved tools to develop and test new medicines.” Woosley said. “So we went to the FDA and said, ‘we would like to be a partner and help you develop these tools.'”
Woosley contacted Dr. Lester M. Crawford, FDA commissioner, and proposed the idea of a neutral organization that would serve as a meeting ground for the FDA, academic scientists, and the pharmaceutical industry.
Crawford, who had spent many years in the food safety part of the FDA, was enthusiastic about the idea, likening it to the National Center for Food Safety and Technology, a successful research consortium where FDA scientists, academia, and industry meet to address food safety issues.
With the FDA behind him, Woosley started work on his idea, and C-Path was born.
Making it to the bell
Now just a year old, C-Path has already generated a lot of excitement, locally, statewide, and nationally. So much so that in March, Woosley testified before Congress about drug safety, touting the new institute.
“A lot of people in those hearings went into them thinking we really need to revamp the FDA,” Woosley said. “And I think just the fact that we were talking about C-Path and the Critical Path Initiative made people realize there’s not a problem with drug safety—there’s a problem with drug development.”
C-Path’s mission to solve these problems includes a number of ambitious goals. Under each of its three main missions of faster drug development, safer drugs and drug use, and stronger education programs, are countless numbers of potential projects that are being explored. Those with the greatest potential for benefit and that can be funded will be developed, created, and implemented.
Under the umbrella of faster drug development, Woosley and his team are close to finalizing plans for a toxicogenomics cross-validation consortium with seven leading pharmaceutical companies. This consortium would serve as a neutral ground for drug companies to present their own internal safety-screening methods that have not been validated as approved testing methods by the FDA. Then companies would test each other’s methods, compare results, and, if favorable, would submit them to C-Path for an independent review. C-Path scientists would then submit the data to the FDA.
“At the end of the day the goal would be to have these tests validated, and any company using those methods could then submit data on their drugs using these methods and expedite their drug development,” Woosley said.
When it comes to safety, Woosley is very excited about the Community Pharmacy Safety Network, an effort to create a system of early, active surveillance that will identify potential serious side effects of drugs and trigger an early alert system. He believes that one of the greatest deterrents to efficient drug development is the lack of an early detection system for serious side effects of medicines. A network of trained pharmacists could serve this purpose.
Under education, C-Path promises a way for Arizona to be the home to another premier program: In partnership with C-Path, the UA is developing plans for master’s and Ph.D. programs in drug development.
“The pharmaceutical industry is a very established technology, but there is no academic home for it If a company wants to hire a really good pharmaceutical chemist, they have to hire a chemist and train them,” said Woosley, who hopes to help the UA create the first academic home for pharmaceutical development.
C-Path will also work with other organizations to set up a disease registry for rare diseases. The institute has already formed ties with the Ara Parseghian Medical Research Foundation, which focuses on Niemann-Pick disease, a genetic pediatric neurodegenerative disorder.
Although the expectations for C-Path are high, Woosley warns that change will not occur overnight; a sustained effort is needed, and Woosley is ready to put in the hours.
“We’re beginning to chip away at it,” he said.
Bringing it Home
When Ray Woosley made his decision to come to the UA, no one could have predicted the development of C-Path.
But the promise of innovation and opportunity, “the cowboy spirit” that put Woosley and his family on a plane to Tucson, is what has turned C-Path from a vision into a promising endeavor. And Woosley is thankful for that.
“On the East Coast the attitude is often ‘we’ve been here a long time, and we’ve tried everything’ people rarely work together as much as they do in the West,” he said. “For example, on the East Coast we could never have raised $100 million for genomics and TGen.”
Way out west, financial support is pouring into C-Path. Premier institutions from across the country are partnering with the young institute, and high-level community leaders are joining the nonprofit’s staff.
“[All these efforts] are already calling attention to the fact that Arizona is a very bio-friendly, collaborative state,” he said.
And Woosley is hopeful that, in the future, C-Path will attract “more and better science” to boost the Arizona bioscience industry even further.
The West is a place of transformation and invention. Here, the Hohokam turned desert into farmland; World War II brought the economic boom of aerospace; and the silicon revolution built microchip corridors. Now, C-Path is Arizona’s golden opportunity to transform drug development.
According to Woosley, there is no better place for it than Arizona.
“Here in the Southwest, anything is possible if you get together and work on it.”
For more Info:
Woosley testifies before Congress, touts C-Path, 03/16/2005
“Give FDA more tools to regulate drug development,” Arizona Daily Star, 12/30/2004