News
KEY SFBC MIAMI ASSETS ACQUIRED BY ALLIED RESEARCH INTERNATIONAL
August 16th 2006Allied Research International (ARI), Canada's leading contract research organization (CRO), announced today that it has acquired key assets of South Florida Bioavailability Clinic International's (SFBC) Miami, Florida operations.
SHIRE ANNOUNCES FILING OF SPD465 FOR THE TREATMENT OF ADULT ADHD
July 27th 2006Shire plc announced today that it has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for SPD465, an investigational amphetamine compound for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in the adult population.
Fighting Fraud and Noncompliance
June 19th 2006In 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 19th 2006On 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 19th 2006Representatives 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 19th 2006In 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 19th 2006In 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.
