October 20, 2015
Innovation in Drug Development Process Remains a Key Challenge
BOSTON – October 20, 2015 –Although pharmaceutical companies have long aspired to improve drug development efficiency, the drug development process remains highly inefficient and fraught with delays and rising costs, according to R&D leaders participating in a roundtable recently hosted by the Tufts Center for the Study of Drug Development.
“Drug development cycle times have not gotten faster, costs continue to increase, and drug development has become riskier than ever with only 11.8% of products that enter clinical testing receiving regulatory approval, about half the rate of the 1990s,” said Ken Getz, associate professor and director of sponsored research at Tufts CSDD.
He added, “The pay-off for companies that can reduce clinical time and cost is potentially large, as our research has found, for example, that a 10% improvement in cycle time and success rates can shave $634 million off the total capitalized cost of $2.6 billion required, on average, to bring a new drug to market.”
Roundtable participants noted that several factors are converging to alter traditional practices and processes to improve efficiency, performance, and success rates. They include the emergence of engaged and empowered stakeholders, including patients and advocacy organizations; new technologies and analytical techniques that capture and integrate real-time, patient-level data with life sciences data; and a push by payers, patients, clinicians, and health care delivery networks for more cost effective care.
Other points made at the Tufts CSDD Executive Forum, summarized in the October Tufts CSDD R&D Management Report, released today, included the following:
Mobile and wearable technologies are gaining ground as operational tools because they can be operationalized within existing trial frameworks with minimal disruption and used across multiple therapeutic areas and geographies.
Big data has great potential to deliver value, but key questions need answering, including: Who owns the data and who can use it? Who will pay to integrate it?
Although strategic partnerships between sponsors and CROs are projected to grow 11% between 2013 and 2020, many benefits of partnering have yet to be realized, as sponsor-CRO relationships still tend to be more transactional than strategic.
The next Executive Forum, on patient retention and recruitment, is set for Nov. 12 at Tufts CSDD in Boston.
To purchase a single report or subscription, please visit the reports page.
ABOUT THE TUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT
The Tufts Center for the Study of Drug Development at Tufts University provides strategic information to help drug developers, regulators, and policy makers improve the quality and efficiency of pharmaceutical development, review, and utilization. Tufts CSDD, based in Boston, conducts a wide range of in-depth analyses on pharmaceutical issues and hosts symposia, workshops, and public forums, and publishes Tufts CSDD Impact Reports, a bi-monthly newsletter providing analysis and insight into critical drug development issues.
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