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New Report: Innovation in the Biopharmaceutical R&D Process – Adapting to a Changing Environment

Anne McDonald Pritchett, PhD   |     June 30, 2015   |   SHARE THIS

With the average cost of developing, testing and receiving approval for a new medicine at $2.6 billion and rising, biopharmaceutical companies are continuously looking at new ways to increase efficiencies in their research and development capabilities.Tufs_2

In a new report, “Profiles of New Approaches to Improving the Efficiency and Performance of Pharmaceutical Drug Development," the Tufts Center for the Study of Drug Development found that biopharmaceutical companies are using a variety of innovative approaches to improve the efficiency and productivity of their research efforts.

Key findings include:

  • New approaches to target validation to improve the ability to define the role of proteins, genes and other molecules involved in disease pathogenesis, which can increase the chances that medicines will act on these targets.
  • Innovative trial designs and methodologies which hold immense potential for improving success rates and creating greater efficiencies in conducting clinical trials.
  • New drug development tools, such as patient-reported outcomes or biomarkers, have the potential to improve efficiency at many points in the research and development process.
  • Improvements in IT structure to enhance data utilization can provide invaluable information on the benefits and risks of a medicine to help speed development.

New research from Boston Consulting Group (BCG) suggests these efforts may already be contributing to the record number of new drug approvals in 2014. In 2014 alone, the Food and Drug Administration (FDA) approved 51 new medicines, the highest number since 1996.

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Due to these and other innovations, including in the manufacturing process, biopharmaceutical companies continue to see increased productivity. Despite the challenges in the research and development landscape, there are currently more than 7,000 new medicines in development. To learn more about the exciting new innovations in biopharmaceutical research and development, read the full report

Anne McDonald Pritchett, PhD

Anne McDonald Pritchett, PhD Anne McDonald Pritchett, Ph.D., is Senior Vice President, Policy and Research, at the Pharmaceutical Research and Manufacturers of America (PhRMA). Her primary focus is overseeing the development of legislative and policy analysis and research studies on a range of issues impacting innovative biopharmaceutical companies including intellectual property issues, FDA policy issues, and other issue areas impacting the environment for innovation. In addition to her public policy work, she and her team lead the development of a range of educational and other materials focused on explaining the R&D process, the value of innovation, and the role and contributions of the innovative biopharmaceutical industry.

Topics: Drug Development, Clinical Trials, drug cost, clinical research, Research and Development

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