To meet the growing demand for innovation, drug developers need to significantly scale up their level of process improvements to reduce the time and cost associated with bringing new drugs to market, according to the Tufts Center for the Study of Drug Development.
"The core challenge is that developing new drugs has become more complex and more expensive than ever," said Tufts CSDD director Kenneth I Kaitin, “It takes an average of $2.6 billion and 15 years to develop and win approval for a new drug, and a typical Phase III protocol now entails an average of 167 procedures, 60% more than at the start of the millennium.
Improving the clinical trial process holds the most promise for enhancing R&D efficiency, he said, including reducing clinical trial complexity, engaging with new partners, and working more closely with regulators. In the longer term, Mr. Kaitin said policy changes, such as shifting some of the U.S. National Institutes of Health grant funding from translational research back to basic research, will improve prospects for developing new drugs to treat an expanding array of medical conditions.
"Just as the so-called War on Cancer in the United States in the 1970s saw significant levels of federal funding for research on the pathology of various cancers, government can stimulate basic research on neurological and psychiatric diseases, diabetes, and antibiotic resistance, among other disease areas -- for which there is a growing need for new therapies," said Mr. Kaitin.
The Tufts CSDD Outlook 2016 report on pharma and biopharma trends also notes that:
- Continued scientific achievements that increase understanding of the pathophysiology of oncological diseases will result in approvals of new cancer therapies, which will outpace new drug approvals in other therapeutic areas, as they have over the last 15 years.
- Sponsors and CROs will make greater use of electronic medical information and drug development management metrics to perform more robust, predictive analytics to drive operating efficiency, improve feasibility, inform portfolio strategy, and support more effective patient recruitment.
- Major regulatory agencies will emphasize harmonization of global activities to coordinate and facilitate pediatric studies, prompted by recent changes in policy that will increase the demand for pediatric patients to participate in clinical trials.
- U.S. payers and providers will quantify clinical benefits of new cancer and orphan products to align price with value by measuring safety, effectiveness, convenience of use, and other attributes in relation to cost.