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Translational Research and the Evolving Landscape for Biomedical Innovation
  1. Kenneth I. Kaitin, PhD
  1. From the Tufts Center for the Study of Drug Development, Tufts University School of Medicine, Tufts University, Boston, MA.
  1. Received June 12, 2012, and in revised form June 29, 2012.
  2. Accepted for publication July 3, 2012.
  3. Reprints: Kenneth I. Kaitin, PhD, Tufts Center for the Study of Drug Development, Tufts University School of Medicine, Tufts University, 75 Kneeland St, Suite 1100, Boston, MA 02111. E-mail: kenneth.kaitin{at}tufts.edu.
  4. The following manuscript is adapted from Dr Kaitin’s presentation at the American Federation for Medical Research (AFMR) Translational Research Workshop in Washington DC, on April 9, 2011.
  5. Disclosures: The Tufts Center for the Study of Drug Development (CSDD) is a nonprofit, academic research center at Tufts University School of Medicine, Boston, MA. Tufts CSDD is funded in part by unrestricted grants from pharmaceutical and biotechnology firms, as well as companies that provide related services (eg, contract research, consulting, and technology firms) to the research-based industry. The author reports no potential conflicts of interest relevant to this report.

Abstract

This article addresses current challenges facing pharmaceutical and biopharmaceutical developers, including the expiration of patents on many high-revenue–generating products, increasing competition in the marketplace, low public support, high regulatory hurdles, and the increasing time, cost, and risk of new product development. To meet these challenges, drug developers are looking to new models of innovation to improve efficiency, lower risk, and increase output. These new models include codevelopment agreements with small companies, multicompany consortia, and strategic partnerships with academic research centers. In the United States and the European Union, the government is supporting these efforts by creating incentives for academic centers to foster translational research and become more “commercially minded”. The goal for all stakeholders is to reduce the barriers to product development and bring new medicines to market in a timely and cost-efficient manner.

Key Words
  • biomedical innovation
  • translational research
  • drug development
  • academic research centers
  • drug industry
  • current challenges
  • FDA
  • NIH

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