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Does improving pre-clinical research reduce late-stage failures and improve R&D productivity?

Posted on January 12th, 2016 by in Pharma R&D

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It’s the turn of the year and if you’re like me, you’ve been immersed in reading all of the accompanying look back and look ahead articles and reports. 2015 was, indeed, a notable year — from the Martin Shkreli fiasco to the proposed Pfizer and Allergan merger — the industry was rocked. When the year-end dust settled, it was also a notable year in terms of new drug approvals in the U.S. with the total, 51 (based on FDA and CBER approvals), hitting a 66 year high (see Bernard Munos’ analysis on Forbes.com).

Yet amidst these banner results and all the analyses there’s still an undercurrent of challenges facing the industry, especially as it relates to R&D return on investment (ROI), as evidenced by the headline, “Drug Developers Are Working to Boost R&D Productivity, But Need to Do More to Achieve Large-Scale Improvements,” heralding the release of Tufts CSDD Outlook 2016 Report. Because of the considerable time and expense associated with the industry’s lengthy R&D process, reducing late stage failures remains a top priority in terms of improving ROI. Simply put – the industry can’t afford the development spend associated with drugs that never make it to market.

Among the ways in which experts believe productivity, and therefore ROI, can be increased are: performing more research in the pre-clinical process prior to Phase I, and improved collaboration between early stage researchers and disease experts involved in designing and conducting clinical trials.

One such example of this is a collaborative innovation model introduced by Dr. Ronald DePinho in his role as President at MD Anderson. As Greg Satell, a Forbes contributor, outlines in his January 4, 2016 post To Discover Better Drugs Faster, MD Anderson Is Innovating How It Innovates,” Dr. DePinho has assembled a multi-disciplinary team comprised of a former pharma industry executive, as well as other high caliber experts in genetic and drug discovery research to create the Institute for Applied Cancer Science (IACS). More than 70 scientists, approximately 75% of who were previously employed at leading biotech and pharmaceutical companies, are now working in cross-functional teams to advance discoveries, with the added benefit of access to the expertise of top biological researchers at the center’s home, The University of Texas, and top clinicians at the cancer center itself. Instead of working independently and handing off to the next team, at the next stage, the teams work in an integrated, cross-disciplinary manner “from hypothesis to proof of concept to development.”

The results? Thus far Dr. DePinho is quoted as saying the IACS integrated, cross-disciplinary approach has reduced his teams’ cost of getting to Phase I by “about two-thirds.” Equally important, the team has been successful at driving the “fast fail” approach by killing off candidates before they were subjected to greater scrutiny (and consumed resources/incurred more expense) in the pre-clinical phase.

This is but one example of the new models of innovation and collaboration that industry leaders are introducing to address perceived faults of the industry’s legacy discovery and development process. Here’s to a future where those year-end analyses and new year outlooks no longer dwell on the need for “large-scale improvements” in R&D productivity.

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