Cancer Drugs and Biologics Among Top 2015 Trends in Tufts Annual Report

Drug sponsors are expected to expand their investments in developing new cancer therapies this year, spurred by a growing understanding of tumors’ molecular bases and immunotherapy techniques, according to a new report that projects pharma and biotech trends for 2015.

Roughly 40 percent of all orphan drug approvals over the next five years will target cancer indications, says Kenneth Kaitin, director of the Tufts Center for the Study of Drug Development and the author of the 2015 Outlook Report.

Continued development of biosimilars also will be a key focus this year in both the U.S. and Europe, Kaitin says. In the fourth quarter of 2014, for example, several hundred companies were testing biosimilars, with 30 to 40 molecules in late-stage trials in the U.S. and the European Union, he notes.

This movement will be aided by expected FDA biosimilar guidance in 2015 on topics such as labeling, demonstrating interchangeability and using statistical approaches to show biosimilarity.

In addition, sponsors this year will focus on improving clinical trial efficiency by working more closely with contract research organizations. Drug companies and CROs together will make greater use of adaptive trial designs and mining big data, Kaitin says. Access to large, comprehensive data sets will help sponsors perform better predictive analyses, refine research and protocol designs, engage volunteers, track metrics in real time and improve regulatory submissions.

A shift to more adaptive trial designs, such as sample size reestimation, early futility, dose-response and randomization ratios, will both increase data quality and clinical trial success rates, the report says. Congress and the FDA are expected to support drugmakers’ moves in this area through new legislation and regulations that create single pathways for testing multiple drugs at the same time.

Read the 2015 Outlook Report at http://csdd.tufts.edu/reports/outlook_reports. — Lena Freund