Corporate Banner
Satellite Banner
Scientific Community
Become a Member | Sign in
Home>News>This Article

FDA, UCSF Partnership Helps Industry Identify Drug Interactions

Published: Wednesday, September 05, 2012
Last Updated: Wednesday, September 05, 2012
Bookmark and Share
Goal is to find risks before drugs reach patients.

Drug interactions and drug side effects occur all-too-often in patients’ lives. Now there’s 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.

Anticipating Drug Side Effects

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 individual’s 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.

The FDA already has issued guidelines strongly recommending that drug interactions with seven membrane transporters be tested, but there is information on the new site available on many more.

To better understand how drug concentrations rise and fall within the body after a particular dosage, one ought to know which transporters act on the drug, Giacomini said — but that is not all one needs to know.

Drugs taken at the same time might rely on the same transporters to get where they’re going. More dramatically, sometimes a co-administered drug can inhibit the workings of a transporter the other drug relies on.

“Transporter-mediated drug–drug interactions often affect clinical outcomes,” Giacomini said.

While much remains to be discovered about how drugs interact with transporters, drug developers can use the UCSF-FDA TransPortal to make better use of what is already known, she said.

Speeding Development of Improved Treatments

The project is one of many that the FDA has supported through its Critical Path Initiative, through which it aims to speed the development of improved treatments for patients by facilitating better use of scientific discoveries, technical tools and information technology in the evaluation of the safety, effectiveness and manufacturability of new medical products.

Through the initiative, the FDA strives to bring together federal agencies, patient groups, academic researchers, industry, health care practitioners, and others to collaborate on practical solutions to problems that slow the advancement of new treatments through the drug development pipeline.

During a May 2012 lecture on UCSF’s Mission Bay campus, Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research (CDER), said that evaluating the effectiveness of drugs remains a “huge challenge.” There is a need for better tools, techniques and strategies to identify winners, minimize costs and reduce failures during drug development, according to Woodcock.

The UCSF-FDA TransPortal helps further these aims, Giacomini said, not only by providing a compendium about what has been learned to date about drug-drug interactions at transporters, but also because it offers guidance about how to select and conduct pre-clinical studies to identify potential interactions with new drug candidates.

Further Information
Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 2,800+ scientific posters on ePosters
  • More than 4,000+ scientific videos on LabTube
  • 35 community eNewsletters

Sign In

Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Some 3-D Printed Objects Are Toxic
Researchers at the University of California, Riverside have found parts produced by some commercial 3-D printers are toxic to certain fish embryos.
Monday, November 09, 2015
Double Enzyme Hit May Explain Common Cancer Drug Side Effect
Mouse study suggests genomic screening before treatment may help prevent anemia.
Wednesday, October 14, 2015
Designing New Pain Relief Drugs
Researchers have identified the molecular interactions that allow capsaicin to activate the body’s primary receptor for sensing heat and pain, paving the way for the design of more selective and effective drugs to relieve pain.
Thursday, June 11, 2015
Powerful Anti-Cancer Compound Safely Delivered
Researchers have discovered a way to effectively deliver staurosporine (STS).
Tuesday, October 22, 2013
Mouse Models Point to Potential Therapy for Alzheimer's
Scientists demonstrate a new potential target in the fight against Alzheimer's and other neurodegenerative diseases.
Thursday, June 27, 2013
Blocking Inflammation can Prevent Heart Attack Damage
New research from UC Davis shows that blocking an enzyme that promotes inflammation can prevent the tissue damage following a heart attack that often leads to heart failure.
Tuesday, March 26, 2013
Computer Model Successfully Predicts Drug Side Effects
Research based on the similarity between a drugs chemical structures and those molecules known to cause side effects, according to a paper appearing online this week in the journal Nature.
Tuesday, June 12, 2012
UCLA Researcher Developing Lab to Help Manufacturer Testing
UCLA team has developed a testing method to assess the safety and health risks of engineered nanomaterials.
Wednesday, February 08, 2006
Scientific News
High Throughput Mass Spectrometry-Based Screening Assay Trends
Dr John Comley provides an insight into HT MS-based screening with a focus on future user requirements and preferences.
Personalized Drug Screening for Multiple Myeloma Patients
A personalized method for testing the effectiveness of drugs that treat multiple myeloma may predict quickly and more accurately the best treatments for individual patients with the bone marrow cancer.
Nanocarriers May Carry New Hope for Brain Cancer Therapy
Berkeley lab researchers develop nanoparticles that can carry therapeutics across the brain blood barrier.
Cancer-Fighting Tomato Component Traced
The metabolic pathway associated with lycopene, the bioactive red pigment found in tomatoes, has been traced by researchers at the University of Illinois.
Batten Disease may Benefit from Gene Therapy
NIH-funded animal study suggests one-shot approach to injecting genes.
Shedding Light on “Dark” Cellular Receptors
UNC and UCSF labs create a new research tool to find homes for two orphan cell-surface receptors, a crucial step toward finding better therapeutics and causes of drug side effects.
Molecule Proves Key to Brain Repair After Stroke
Scientists found that a molecule known as growth and differentiation factor 10 (GDF10) plays a key role in repair mechanisms following stroke.
Towards Patient-Specific Drug Screening
A new breakthrough by the 3D stem cell printing team at Heriot-Watt could pave the way to individually tailored drug testing regimes, both reducing the need for animal testing and ensuring that patients receive drugs which are most effective for their individual needs.
Antibody Targets Key Cancer Marker
University of Wisconsin-Madison researchers have created a molecular structure that attaches to a molecule on highly aggressive brain cancer and causes tumors to light up in a scanning machine.
Gut Bacteria Can Dramatically Amplify Cancer Immunotherapy
Manipulating microbes maximizes tumor immunity in mice.

Skyscraper Banner
Go to LabTube
Go to eposters
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
2,800+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,000+ scientific videos