Clinical Trials: Increasing the Potential for Developing Innovative, Breakthrough Medicines
Bristol-Myers Squibb has made a commitment to conduct clinical trials only in countries where it intends to later market and provide access to the compounds. In the process, we continue to help enable health care institutions in those countries strengthen their own capabilities to run advanced clinical trials that will meet both local and global registrational standards. Bristol-Myers Squibb has also committed to providing experimental drugs without charge to clinical trial study participants for as long as their physicians require them. We conduct clinical trials in about 50 countries around the world.
- Focus on Pediatric Formulations: Currently pediatric formulations for all existing Bristol-Myers Squibb anti-virals for HIV exist or are in development. Plans are also underway to develop pediatric formulations for investigational compounds for the treatment of hepatitis B and C. Oncology, cardiovascular and diabetes pediatric formulation activities are also ongoing.
- Sickle Cell Anemia: Bristol-Myers Squibb has provided data to the National Institutes of Health for an Investigational New Drug Application (IND) to be filed to develop a childhood formulation and pediatric indication of the company’s hydroxyurea compound for sickle cell anemia.
- Regional Clinical Operations (RCO) India: This center, which opened in 2006 with one researcher, now has 22 active R&D clinical personnel. It has organized 43 clinical trials in India enrolling some 4,400 patients. The majority of these studies are registrational trials for various oncology, diabetes, cardiovascular, hepatitis and immunoscience drugs addressing disease areas of concern within India.
- Clinical Trial Growth: Bristol-Myers Squibb invests in R&D in many developing countries to provide innovative, high-quality medicines that address the unmet medical needs of patients with serious diseases. For example, from 2008 through 2012 we had studies ongoing in the following countries.