Kathy Giacomini, PhD
Every year, the pharmaceutical industry invests billions of dollars in testing drugs that are eventually abandoned because they don’t work or cause side effects.
What if scientists could make better use of technology to predict which drugs will work and pinpoint the patients they’re most likely to help? UCSF scientists are doing just that as they pioneer a new field — quantitative pharmacology — aimed at improving the efficiency of the drug development process.
UCSF's new Center for Quantitative Pharmacology held its first symposium on Sept. 22 and 23, bringing together scientists from academia and industry. A joint department of the schools of pharmacy and medicine, the center brings together faculty for cross-disciplinary research as well as developing courses in this emergent discipline. The new center represents the latest step in UCSF’s significant and ongoing contributions to drug discovery.
Kathy Giacomini, PhD, co-chair of the new center and the symposium, answered questions about the burgeoning field of quantitative pharmacology in a recent interview. Giacomini is a professor of Bioengineering and Therapeutic Science in the UCSF School of Pharmacy. Q: The pharmaceutical and biotech industry is facing huge challenges. Last year, the US Food and Drug Administration (FDA) approved 21 new drugs, down from 25 in 2009 and 24 in 2008. A Pfizer Inc. executive at your symposium noted the cost of developing a new drug has reached $1.8 billion when the expense of all the drugs that fail to make it to market is included. Is the industry in crisis?
A: Yes, I think the industry has been in crisis for a period of time. They’re also responding to that crisis by changing the way they develop drugs, forming new partnerships with academia. Our partnership with Pfizer may represent a new model for drug discovery and development.
(Note: Pfizer, the world’s largest drug company, announced last year that it would provide up to $85 million in funding and milestone payments over the next five years to support research at UCSF that may lead to development of new drugs.)Q: Why do so many drugs fail to make it through the testing process and get abandoned or rejected?
A: The newest data suggest that they largely fail due to a lack of efficacy. They enter phase 2 and phase 3 clinical trials and the drug people thought would work doesn’t work. There’s also a failure rate of 15 to 20 percent because of safety issues. So you have to ask the question: Why didn’t it work? And why couldn’t they predict that it wasn’t going to work? One reason is they don’t know enough about the drug in humans. They don’t have enough information on the drug’s action and its effect on human biology. The second is there’s a need for integrative models that will help predict these things. That’s where quantitative pharmacology comes in.
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