CenterWatch Monthly October 2008
Trio of Companies in Strategic Outsourcing Partnerships with Lilly
Eli Lilly’s recent agreement to sell an R&D facility to Covance is the largest and most comprehensive outsourcing deal in the CRO industry. Somewhat lost in the hoopla around the mega-Lilly-Covance deal, was that Lilly also cut similar agreements at the same time with Quintiles and i3 Statprobe.These agreements are indicative of major changes in the sponsor-CRO relationship as the pharmaceutical industry remains under pressure to cut drug development time and costs.
Replacing Declaration of Helsinki with GCP for Foreign Trials
The Good Clinical Practice (GCP) Guideline of the International Conference on Harmonisation is considered final guidance by FDA. Final guidance is considered a reflection of FDA’s current thinking on a subject.Up until October, FDA accepted non-IND foreign clinical studies, provided they were well-designed and well-conducted in accordance with ethical principles stated in the 1989 version of the Decleration of Helsinki or the laws and regulations of the country in which the research was conducted.
IMI and ECRIN Removing Bottlenecks of Drug Development in EU
The overall goal of the Innovative Medicine Initiative (IMI) and the European Clinical Research Infrastructure Network (ECRIN) is to remove the major bottlenecks in drug development where research is key. The European Commission (EC) has committed 1 billion euros to IMI, and the European Federation of Pharmaceutical Industries and Associations (EFPIA), a trade group representing the research-based pharmaceutical industry operating in Europe is committed to contributing resources that are at least equal to the EC’s. Both financial commitments are for the Seventh Framework Programme (FP7), which runs from 2007 to 2013, though IMI will run from 2008 to 2017.
Eye On: Breast Cancer
Breast cancer, which is the most common cancer among women worldwide, arises from breast tissues, typically from the ducts carrying milk to the nipple or the lobules that secrete milk. Although it occurs in both sexes, it is rare in men. Each year, more than 1 million new cases of breast cancer are diagnosed worldwide, and there are nearly 400,000 deaths from breast cancer. According to the National Cancer Institute, there will be 182,460 new cases of breast cancer in women and 1,990 in men in the United States in 2008, and 40,480 deaths in women and 450 in men.