MetaWorks® Bolsters Scientific Advisory Team with Addition of Risk Management Expert

MetaWorks® Bolsters Scientific Advisory Team with Addition of Risk Management Expert

This press release announces the addition of Dr. Stanley Edlavitch, one of the pharmaceutical industryÂ’s foremost risk management pioneers, to MetaWorks' Scientific Advisory team.

Medford, MA (PRWEB) March 21, 2005

Stanley A. Edlavitch, Ph. D., recognized as a pioneer and leader in the field of pharmacoepidemiology for his extensive experience in applying epidemiological principles to the risk/benefit assessment of drugs, as both a consultant to pharmaceutical companies and a major contract research organization, has joined the MetaWorks® Inc. Scientific Advisory Team as a Senior Advisor.

Dr. Edlavitch, who founded the International Society for Pharmacoepidemiology (ISPE) and served as its Executive Director for 15 years, will provide general and project-specific scientific oversight and direction to MetaWorks' scientific team on risk management and epidemiology projects while maintaining his position as Professor of Epidemiology and Director of Epidemiology Research at the University of Missouri School of Medicine, Kansas City. He is a former Director of Global Pharmacoepidemiology and Health Economics Research for a major pharmaceutical company and a former Director of the Epidemiology Development Branch, Bureau of Drugs, of the Food and Drug Administration (FDA).

“The addition of Dr. Edlavitch to our risk management advisory group reinforces our commitment to helping our customer base to respond and comply with increasing regulatory demands during the drug development process since we can provide support from phase II through post marketing (phase IV),” says Shubh L. Sethi, president and CEO of MetaWorks, Inc. “His extensive experience and expertise spanning both commercial and public sector clinical research will significantly enhance the value and productivity of our offerings.”

Recently, the FDA announced that it will enhance the independence of internal deliberations and decisions regarding risk/benefit analyses and consumer safety by creating an independent Drug Safety Oversight Board (DSB). The DSB will oversee the management of important drug safety issues within the Center for Drug Evaluation and Research (CDER). MetaWorks' Risk Management and Safety Services optimize Risk Management Programs for biopharmaceutical companies and support compliance with new FDA protocols by providing an evidence-based context to early safety event identification, response and planning, combining successful regulatory experience with strong epidemiological and meta-analytical capabilities for a variety of data sources.

In addition to serving as a lifetime board member of ISPE and Chair of its Global Development Committee, Dr. Edlavitch is a prolific author who has developed and managed over 30 international meetings and conferences focused upon risk management. Dr. Edlavitch holds an M. S. in Public Health and an M. A. in Mathematical Statistics from the University of Missouri, and a Ph. D. in Epidemiology from the University of California, Berkeley.

For more information on MetaWorksÂ’ risk management service offerings, visit www. metaworksinc. com.

About MetaWorks, Inc.

MetaWorks®, Inc. is a recognized healthcare consulting company focused in clinical drug development and commercialization within the pharmaceutical, biotechnology and healthcare industries. By combining its expertise and experience in systematic reviews and meta-analysis with diverse data sources including its proprietary clinical trial database, MetaHub™, MetaWorks delivers clinical evidence that drives sound decisions and supports key messages.

MetaWorks' clients utilize evidence derived from existing published medical information to support regulatory submissions, clinical trial planning and marketing claims. The companyÂ’s 1997 designation as an Evidence-based Practice Center by the Agency for Healthcare Research and Quality (AHRQ) established MetaWorks as a reliable and expert resource for evidence-based medical information. For more information, visit www. metaworksinc. com.

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