FDA, UCSF Partnership Helps Industry Identify Drug Interactions

UCSF's Kathleen Giacomini, PhD, a leader in the study of pharmacogenomics how an individuals genetics determine his or her response to medicines, is partnering with the Food and Drug Administration on a project to identify drug interactions before the medicines reach patients.

Drug interactions and drug side effects occur all-too-often in patients lives. Now theres a new online resource to help guide pharmaceutical developers as they endeavor to improve testing for potentially harmful drug interactions before new medicines reach consumers.

The UCSF-FDA TransPortal is the result of partnership spearheaded by UCSF and the U.S Food and Drug Administration (FDA). Its focus is on how drugs interact with gatekeeper proteins called membrane transporters.

Transporters play specific roles as hosts or bouncers to either boot out specific drugs or to escort them inside. They control whether drugs can gain access to cells and organs throughout the body, including the liver and kidneys big players in drug metabolism and elimination.

In recent years specific transporters have been found to play a role in drug side effects, such as the muscle pain and weakness sometimes caused by statins. Transporters influence the effectiveness of certain anti-cancer treatments.

An unanticipated drug interaction with a transporter associated with the blood-brain barrier determines how much of the anti-flu drug Tamiflu gets into the brain, and might help explain rare cases of suicide documented among young Tamiflu users.

Kathleen Giacomini, PhD, chair of the Department of Bioengineering and Therapeutic Sciences at UCSF, a joint program of the UCSF schools of pharmacy and medicine, is an international expert on transporters and leads the partnership. She is a leader in the study of pharmacogenomics how an individuals genetics determine his or her response to medicines. Giacomini's lab focuses on the roles of membrane transporters in drug absorption, disposition, targeting, and in clinical drug response.

Giacomini also is a leader within the International Transporter Consortium, a collaborative group of scientists from academia, industry and the FDA that explores the role of transporters in therapeutic and adverse drug responses. She has identified several genetic variants among these transporter proteins that can cause metabolism of certain drugs to vary among individuals.

Drugs rely on the smooth operation of specific membrane transporters, of which there are dozens, but some drugs can affect the functioning of a transporter that another drug relies upon.

In addition, researchers are discovering genetic variations among individuals in transporter genes that can affect drug effectiveness and safety.

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FDA, UCSF Partnership Helps Industry Identify Drug Interactions