The Long, Winding Road to Approval for New Drugs

CTSI is a partner adminstering PACT - the Partnership to Accelerate Clinical Trials.

By Stephanie M. Lee via SF Gate

A company that goes 24 years without ever selling a product may sound unusual. But in biotechnology, it's not that uncommon.

Take Geron Corp. in Menlo Park, which has struggled to develop a therapy - any therapy - since its founding in 1990. The company first focused on spinal cord injuries but later moved to various cancers. This month, the Food and Drug Administration halted clinical trials for its only drug.

The pharmaceutical industry has never been known for speed. All therapies must undergo years of clinical trials to meet the FDA's standards for safety and efficacy. Faced with 10- to 15-year timelines and uncertain regulatory outcomes, companies and investors might plow hundreds of millions of dollars into therapies that will never see the light of day.

While the FDA says the process ensures drugs are effective and safe, some doctors, scientists, companies and advocates see it as a bureaucratic slog that keeps promising treatments from dying patients. A dozen California academic medical centers and hospital systems recently teamed up to tweak a key part of trials: the ethics review board. This committee of independent experts monitors human subjects' rights during trials.

Under the new Partnership to Accelerate Clinical Trials, a single ethics board will serve multiple test sites that make up a clinical trial. Traditionally, each site has its own ethics committee: 15 sites, for example, have a total of 15 boards.

"That's a lot of delay, a lot of wasted time and energy, without much benefit," said Dr. Clay Johnston, who helped start the nonprofit as director of the Clinical and Translational Science Institute at UCSF. The partnership, which is under the banner of the Bay Area BioEconomy Initiative, includes Stanford University, UC Davis, Children's Hospital Oakland, Sutter Health and Dignity Health.

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