Navigation Links
Drug Industry Seeks Tests to Spot Side Effect Risks
Date:9/27/2007

7 pharmaceutical giants are pooling resources to develop gene-based screens

THURSDAY, Sept. 27 (HealthDay News) -- Seven major pharmaceutical companies are banding together to develop genetic tests that predict which patients will have adverse side effects from drugs.

The group, a nonprofit organization dubbed the International Serious Adverse Events Consortium (SAEC), will conduct two studies, one to look at drug-related liver toxicity and the other aimed at a rare drug-related skin condition called Stevens-Johnson syndrome.

"SAEC's focus is to identify and to validate DNA variance or genetic markers that are useful in predicting a drug-induced serious adverse event," Arthur Holden, the chairman of the group, said during a midmorning teleconference Thursday.

The findings of the consortium could have an impact on improving the ability of patients to safely use existing drugs, Holden added. "We hope it will improve the productivity and effectiveness not only for those who develop drugs but for those who regulate drug development," he said.

"The immediate goal would be to develop a test that could identify who will have a problem with a drug before they get it," said Dr. Paul Watkins, director of the General Clinical Research Center at the University of North Carolina in Chapel Hill. "The ultimate goal is to look at the genes that are causing the susceptibility and work back to figure out how we can design drugs differently so that no one would have that problem," he added.

"The two drug reactions that are being studied, Stevens-Johnson and liver toxicity, are very common reasons for problems with drugs either being restricted, not being developed, not being approved or being pulled off the market," said Dr. Janet Woodcock, Deputy Commissioner and Chief Medical Officer at the U.S. Food and Drug Administration.

"This effort is part of personalized medicine -- personalized safety -- that will make treatments safer by understanding individual benefits and risks," she added. "This will help in the development of drugs both in avoiding these side effects in the future and maybe developing tests to help identify people at high risk," she said.

Findings from these studies could lead to the FDA requiring genetic tests to determine risk before the drug is prescribed, Woodcock added.

A recent survey found that most Americans are more concerned with drug safety than with speeding more medications to the marketplace.

Members of the consortium include Abbott, GlaxoSmithKline, Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Pfizer, Roche, Sanofi-Aventis and Wyeth. In addition, the FDA will consult on the design and conduct of SAEC studies.

The actual research will be done at academic centers in Europe and the United States.

The results of the studies will be made public domain, and none of the companies will have early access or be allowed to patent the findings. When the results are made public, any company can develop and sell the genetic tests that predict side effects.

SAEC is one of several consortiums formed by the pharmaceutical industry to conduct basic research. One of the first was started in 1999 and was headed by Holden. That consortium looked for DNA variations among people. Their data were also put into the public domain.

More information

For more on drug safety and side effects, visit the U.S. Food and Drug Administration.



SOURCES: Sept. 27, 2007, teleconference with Janet Woodcock, M.D., deputy commissioner and chief medical officer, U.S. Food and Drug Administration; Arthur Holden, chairman, International Serious Adverse Events Consortium; and Paul Watkins, M.D., Verne S. Caviness Distinguished Professor of Medicine and Professor of Pharmacotherapy, and Director, General Clinical Research Center, University of North Carolina, Chapel Hill; Sept. 27, 2007, International Serious Adverse Events Consortium, press statement


'/>"/>
Copyright©2007 ScoutNews,LLC.
All rights reserved

Related medicine news :

1. Healthcare sector is now a multi billion-dollar industry in India
2. Biotechnology industry expected to grow into a three billion dollar industry by 2002
3. Setting up a new pharmaceutical industry in India
4. Drugs control and industry departments to share a common e-platform
5. Indian pharma industry upbeat on WTO drug deal
6. Cancer risk among nuclear industry workers
7. Adding Credit To The Health Care Industry In India
8. Collaborations planned between British Organization and Indian health care industry
9. Jharkhand Gives Health industry status
10. Unregulated Fish Industry Harms Health Of Women
11. Tourism Industry Affected By Bird Flu
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/23/2017)... ... March 23, 2017 , ... Hakim ... based healthcare technology company California Healthcom Group (CHG). , The HUG investment ... arena. With headquarters in California, CHG is a growing, internationally recognized healthcare management, ...
(Date:3/23/2017)... ... March 23, 2017 , ... The TouchPoint Solution, home ... world to manage stress and anxiety. , “Buzzies change the way we interact ... co-founder of Buzzies. , Since its launch date in December 2016, The TouchPoint Solution ...
(Date:3/23/2017)... Toronto,ON (PRWEB) , ... March 23, 2017 , ... ... launch of a new solution that enables organizations to easily reprint customer invoices, ... ‘PRO Reprint Server’ automates all of the steps needed to retrieve and print ...
(Date:3/23/2017)... ... March 23, 2017 , ... Altec Products, Inc. ... Group as their 2016 Microsoft Dynamics Partner of the Year at DocLink ... The award recognizes The Resource Group for their outstanding relationship with Altec and ...
(Date:3/23/2017)... , ... March 23, 2017 , ... ... for seniors, today announced rapid completion of the strategic executive team expansion needed ... notable additions to the ChenMed executive team,” says Christopher Chen, MD, ChenMed Chief ...
Breaking Medicine News(10 mins):
(Date:3/23/2017)... 23, 2017  Digital Pharmacist Inc. ( ... rapidly growing digital health company, announced today that ... allows patients to manage their prescriptions. Over three ... Denver Health Pharmacy, USave Pharmacy and Owen,s Healthcare ... Pharmacist accelerate its product development schedule, the company ...
(Date:3/23/2017)... Mar 23, 2017 Research and Markets has ... report to their offering. ... The global capillary electrophoresis market to grow at ... The report, Global Capillary Electrophoresis Market 2017-2021, has been prepared based ... report covers the market landscape and its growth prospects over the ...
(Date:3/23/2017)... , March 23, 2017 Newborns ... optimally to most vaccines because their young immune ... at Boston Children,s Hospital report achieving strong vaccine ... final preclinical model before human trials — by ... immune response. In two simultaneous papers, they also ...
Breaking Medicine Technology: