New Approaches to Assessing Drug Safety Will Help Reduce Development Time and Costs, According to Industry Panel Convened by the Tufts Center for the Study of Drug Development.

BOSTON -- Dramatic improvements in drug development efficiency --getting more new medicines to market and reducing the time it takes to get them there -- are possible, but require new approaches to assessing drug safety, according to a panel of industry leaders convened by the Tufts Center for the Study of Drug Development.

In addition, the panel suggested that more flexible approaches to clinical trials, which take advantage of real-time data collection and analysis, will help shorten the long and costly clinical development phase.

A summary of the panel discussion was released today as a Tufts CSDD R&D Management Report on transformational change in clinical development.

"The rate of R&D spending continues to rise rapidly, far exceeding the rate at which new products are winning market approval in the U.S. To halt and reverse this trend, drug developers need to lower late-stage attrition rates," said Tufts CSDD Director Kenneth I Kaitin, who chaired the panel.

"Lowering late-stage attrition requires developers to collect higher quality safety data and speed the communication of those data to the right people within the organization, so that a decision can be made as early as possible in the development program whether or not to terminate the project."

According to Tufts CSDD, average clinical phase time for new drugs receiving market approval in the United States in 2002-04 was 7.0 years. While slightly faster than the average of 7.2 years for the 1993-95 period, total development time, in general, has lengthened steadily since the mid-1990s.

In addition, average clinical period costs, which includes out-of-pocket and time costs, as well as the cost of products that fail in development, currently represent 58% of total development costs, compared to 32% for products developed in the 1980s, according to Tufts CSDD research.

The panel suggested that as the pharmaceutical industry evolves its R&D practices, the safety function will more likely resemble the way organizations address efficacy. Panelists suggested that, among other things, safety will need to have dedicated project management and informatics support that will develop statistics for deriving probability of toxicity on a real-time basis.

Instead of being a separate department within research organizations, as is frequently the case today, drug safety evaluation needs to be integrated seamlessly across all phases of drug development and commercialization, according to the panel.

Adaptive Clinical Trials Prove Useful for Optimizing Drug Development

One approach to improving the efficiency of drug development that the panel discussed is to use adaptive clinical trial design.

In contrast to a standard clinical trial, in which collected data are analyzed at the conclusion of the trial, adaptive clinical trials allow assessments of data at one or more points along the way. Adaptive clinical trials can reduce the timeline of clinical development by allowing sponsors to combine clinical phases, e.g. phases 1 and 2, phases 2 and 3, or sometimes phases 1 and 2 and 3.

Participating in the panel were the following:

--Kenneth I Kaitin (Meeting Chair), Director, Tufts Center for the Study of Drug Development

--Susan J. Ward (Session Chair), Executive Advisor to Biotechnology, their Suppliers, and Investors

--Maxine Gowen, Senior VP, Center of Excellence for External Drug Discovery, GlaxoSmithKline

--John Ferguson, VP, Drug Product Safety, Millennium

--Donald Johns, Head of Translational Medicine, Neuroscience and Ophthalmology Exploratory Clinical Development, Novartis

--William Pullman, Senior VP, Head Exploratory Development, TransForm Pharmaceuticals

--Jerald S. Schindler, President, Cytel Pharmaceutical Research

--Matthew L. Sherman, Chief Medical Officer, Senior VP, Synta Pharmaceuticals Corp

About the Tufts Center for the Study of Drug Development

The Tufts Center for the Study of Drug Development (http://csdd.tufts.edu) 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 on related topics, and publishes the Tufts CSDD Impact Report, a bi-monthly newsletter providing analysis and insight into critical drug development issues.