Applied Clinical Trials-06-20-2006

Applied Clinical Trials

Keynote Address: Making Medicine Meaningful

June 19, 2006

Meeting Highlights

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Dr. Sanjay Gupta, senior medical correspondent for CNN, practicing neurosurgeon, and assistant professor of neurosurgery, delivered the Keynote Address at the 42nd DIA Annual Meeting on Monday morning.

Awards Ceremony

June 19, 2006

Meeting Highlights

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DIA President, Theresa Kane Musser, Executive Director, Development Operations, Rigel Pharmaceuticals, presented the awards

Fighting Fraud and Noncompliance

June 19, 2006

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In the afternoon, ACT columnist Ken Getz, MS, MBA, chaired the session: "Prevention of Fraud and Noncompliance in Clinical Research." Ken was joined by speakers David Cocchetto, PhD, RPh, of GlaxoSmithKline, and Dara Katcher, JD, of the Washington, DC law firm, Hyman, Phelps & McNamara.

Every Potential Patient Is Precious

June 19, 2006

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On Monday, Peter DiBiaso, MHA, director of clinical trial recruitment services for Pfizer, chaired the session: "Championing the Patient Perspective in Clinical Study Recruitment and Retention: The Role of Sponsor, CRO, and Vendor in Successful Strategy Development."

U.S., EU Officials Provide Update on Parallel Scientific Advice Pilot

June 19, 2006

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Representatives of FDA, EMEA and industry discussed their pilot program to provide parallel scientific advice to sponsors developing new drugs. The process aims to resolve critical clinical and safety issues early in the research process to avoid duplicative testing and regulatory delay.

Considering the Critical Path in Oncology Drug Development

June 19, 2006

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In an afternoon session examining innovations in the development of anticancer medicines, speakers from the research, therapeutic, regulatory and industry perspectives discussed "Changing the Paradigm: Innovative Oncology Drug Clinical Development Programs in the Age of the Critical Path and Personalized Medicine."

PROs and Drug Labeling Undergo Scrutiny

June 19, 2006

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In a Monday morning session entitled "Patient-Reported Outcome Instruments: Overview and Comments on the FDA Guidance," CDER officials stressed the importance of including PROs early in the clinical trial planning process, rather than at data analysis stages. Edwin P. Rock, MD, PhD, medical officer, division of drug oncology products, described the endpoint model/conceptual framework that organizes the amount/type of data for various uses.

INC Research Latest Organization to Partner with SAS in Life Science Industry

June 19, 2006

From The Pressroom

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Multiple partnerships formed over past year using SAS Drug Development, SAS Enterprise Intelligence Platform

SAS Drug Development Adds Genomic-Analysis Capabilities

June 19, 2006

From The Pressroom

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Solution addresses biomarkers, incorporates molecular information