While many drug developers continue to improve clinical trial operational efficiency to increase the pace of new product introductions, their medium- and long-term success increasingly will depend on their ability to embrace more efficient R&D models, according to the Tufts Center for the Study of Drug Development.
“Pharmaceutical and biotech companies—large and small, established and early stage—are forging strategic alliances, collaborative partnerships and multi-company consortia,” said Kenneth I. Kaitin, Tufts CSDD director. “Early results indicate that sharing knowledge and leveraging resources is helping sponsors find new drugs to treat many of today’s most challenging and complex indications.”
Noting that the drug development model has not fundamentally changed in more than 50 years, when the Kefauver-Harris Amendments of 1962 established the current standard for the clinical testing of investigational drugs, Kaitin said, “Perhaps the greatest gain from clinical design improvements and new partnership models will be the development of industry best practices, which will enable companies to maximize their formidable R&D investment and help ensure future commercial success.”
Kaitin made his comments in connection with the release of the Tufts CSDD Outlook 2014 report on pharmaceutical and biopharmaceutical trends. Report highlights include: