Working Group Session

"The Challenge For Biotech: Shaping The Future Of Clinical Trials"

WEDNESDAY, MAY 8, 2002

Moderated by Dr. C. Budd Colby, Colby Biomedical Consultants

Click here for the Summary on this Working Group Session in PDF format.
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Invitation-only. 3:00 - 5:30 p.m.

The objective of the Working Group session is to gather 8-10 thought leaders to exchange knowledge on the pain points (challenges) currently faced by biotech companies in structuring and processing clinical trials. The solutions biotech companies are using to meet these challenges will also be discussed as well as what critical technology solutions are still needed.

The pace of new drug development and rapid growth of biotech companies means a surge in clinical trials -- the expensive and time consuming process of testing medical drugs. Clinical trials, occurring in three overlapping phases and last several years each, are used not only to demonstrate the drug's efficacy, but also to determine its risks and side effects, measure effective doses, test various methods for delivering the drug, and even experiment with different manufacturing methods. The right strategic business decisions and compliance with the U.S. Food and Drug Administration's Center for Drug and Evaluation Research (CDER) are key to the success of clinical trials, inevitably getting new drugs to the U.S. market. With the rapid pace of new drug development and plethora of biotech companies, what is the impact on the structure and process of clinical trials?

The following questions, among others, will be discussed at this Working Group over wine and light hors d'oeuvres:

• What are the most felt pain points (challenges) faced by biotech companies with structuring and processing clinical trials in:
1) Patient acquisition and case management;
2) Data acquisition, storage, retrieval, and mining; and
3) Data analysis.
• What technology solutions are biotech companies using to address these pain points?
• What technology solutions are critically needed that to do not currently exist?

FOR FURTHER INFORMATION
This Working Group session is invitation-only. Individuals who are interested in possible participation and represent biotech companies that are involved in clinical trials, send your name, company, bio, email, and telephone number to:

Dr. Venilde Jeronimo
Senior Director, Client Services
Silicon Valley World Internet Center
mailto:venilde@worldinternetcenter.com
T: 650.462.9800

Or

Ms. Claire Kahrobaie
Manager, Client Services
Silicon Valley World Internet Center
mailto:kahrobaie@worldinternetcenter.com
T: 650.462.9800

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