Pharmacy Dean James Dalton spoke at the Rackham Amphitheatre Friday, addressing the College of Pharmacy Graduate Student Organization on the process of taking a new drug from a research lab to a patient. The College of Pharmacy Graduate Student Organization was created this year to increase dialogue between departments of the college.

During his presentation, Dalton, who became dean of the college on Sept. 1, spoke of the hurdles he faced trying to take his drug from labs at the University of Tennessee and Ohio State University to the American patent offices and the FDA. He described his experiences with getting funding for research as well as the challenges in working with large corporations and regulators.

For more than 10 years, Dalton worked to put Enobosarm on the market, a drug that helps patients build back muscle lost from cancer treatments and other muscle wasting diseases. He said 50 to 80 percent of cancer patients have a degree of muscle wasting and because of age-related sarcopenia, muscle loss due to old age.

Another critical part of the process of creating new medicines is financing. Dalton’s company, GTx was taken public and partnered with two larger corporations, Johnson & Johnson and Merck. Dalton said that a University can help a scientist getting an initial patent, but financial support from an institution can run out quickly.

GTx raised $70 million on the stock market and received close to $1 million from its corporate partnerships. However, it had a massive research budget that was often over $40 million a year. Bringing a new drug to the market usually costs near $1 billion and Dalton stressed that outgoing Pharmacy students should look at the stability of any company they are may work for.

Dalton explained the regulatory challenges that he faced while developing Enobosarm. The drug initially failed two FDA trials and one by a European regulatory agency. Eventually, Dalton and his company discovered that the failed trials were not due to a lack of efficacy of the drug, but due to the fact that some patients in the trial were on harsher regimens of chemotherapy and were weaker because of it.

The talk was not only a case study in drug development, but also offered career advice session for young pharmacists. Dalton told students to keep their training broad early in their careers and to be ready to work for many companies. He added that it’s important for young pharmacists to take chances.

“It’s a high risk, high reward enterprise,” Dalton said.

Dalton was the inaugural speaker at the lecture, which the College of Pharmacy Graduate Student Organization plans on holding annually. The College of Pharmacy houses several departments which have been criticized for not always working together cohesively. One goal of the lecture is to unite the research focuses of the school with the more commercially-focused units.

“Some of the students in the research world don’t really understand pharmacy and drug development and the downstream patient population,” said Daniel Hertz, a faculty member at the College of Pharmacy.

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