* Companies will continue to increase their investments in the development of personalized drugs and biologics, leading to an increased focus on diagnostic companies as potential partners and take-over targets. * The U.S. Food and Drug Administration (FDA) will be challenged to implement the FDA Amendments Act of 2007 in the wake of large staff turnovers, a new administration, as well as a vigilant and concerned public and Congress. * Drug sponsors will focus more attention on simplifying and streamlining study protocols to reduce study conduct delays and improve investigative site adherence and performance. * Interest in commercial cancer vaccine development will wane in the short term as more targeted cancer therapeutics, such as protein kinase inhibitors and monoclonal antibodies, reach the market. * U.S. policy makers will increasingly look to postmarketing studies that assess comparative clinical- and cost-effectiveness to make decisions on prescribing guidelines and drug reimbursement. * The European Medicines Agency and FDA will continue efforts to harmonize regulatory approaches in areas of common interest, such as pandemic vaccines, medicines for children, rare diseases, and cancer.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, and publishes the Tufts CSDD Impact Report, a bi-monthly newsletter providing analysis and insight into critical drug development issues.
Contact Information: Contact: Tufts Center for the Study of Drug Development Charlene Neu 617-636-2187