-- Companies, acting alone and in consortia, will seek to improve drug discovery by examining pre-competitive data to identify and validate new targets. -- The high cost and low success rates of human studies will lead small/mid-tier pharma companies to adopt outsourcing and other clinical practices that big pharma increasingly uses to control costs and manage risk. -- Biotech firms will escalate biodefense and pandemic disease related R&D, emphasizing translational research and development of effective countermeasures. -- Instead of directly addressing off-label uses of existing prescription drugs, the U.S. Food and Drug Administration (FDA) will evaluate current studies and likely request new ones before deciding whether to further regulate off-label uses. -- Within two to three years, up to 65% of FDA-regulated clinical trials for top pharmaceutical companies will be conducted abroad. -- The European Medicines Agency (EMEA) will focus on implementing new legislation and integrating drug regulatory agencies of new European Union members into a comprehensive pan-European system. -- U.S. third party payers will move away from a binary coverage model in which prescription drugs are either covered or not covered. Instead, more than 90% of prescription drugs will be covered with a variety of limits.About the Tufts Center for the Study of Drug Development The Tufts Center for the Study of Drug Development (http://csdd.tufts.edu/) at Tufts University provides strategic information to help drug developers, regulators, and policy makers improve the quality and efficiency of pharmaceutical development, review, and utilization. Tufts CSDD, based in Boston, conducts a wide range of in-depth analyses on pharmaceutical issues and hosts symposia, workshops, and public forums on related topics, and publishes the Tufts CSDD Impact Report, a bi-monthly newsletter providing analysis and insight into critical drug development issues.
Contact Information: Contacts: Tufts Center for the Study of Drug Development Peg Hewitt 617-636-2185 Email Contact Business Communication Strategies Peter Lowy 781-326-9980 Email Contact