Regulatory Focus™ > News Articles > C-Path Obtains EMA, FDA Approval for Tool to Expedite Development of Alzheimer's Treatments

C-Path Obtains EMA, FDA Approval for Tool to Expedite Development of Alzheimer's Treatments

Posted 11 July 2013 | By Alexander Gaffney, RAC

The Critical Path Institute (C-Path), a public-private hybrid organization supported directly by the US Food and Drug Administration (FDA), has announced a "big step forward for Alzheimer's disease therapy development," saying that it has obtained the support of FDA and the European Medicines Agency (EMA) to launch a new disease simulation tool intended to improve clinical trial design for investigating Alzheimer's treatments.

C-Path, which was founded in 2005 under FDA's Critical Path Initiative, is behind a number of initiatives meant to expedite drug development by focusing on common bottlenecks in the development process. In September 2012, for example, it announced the launch of a new "breakthrough tool" intended to help combine data from multiple studies, standardizing the way companies report data from research on tuberculosis drugs. The collected data can be used to support the regulatory review process by developing new clinical trial simulation models and evaluation methods, C-Path wrote at the time.

The new Alzheimer's tool is very much in the same vein, C-Path wrote. "This new tool will make it possible to simulate clinical trials by integrating all relevant data so future studies will be more efficient and more likely to be successful."

The tool - essentially a statistical modeling system that simulates "what-if" scenarios - is "the first such instrument to ever receive this regulatory designation [from FDA]," C-Path explained. The tool obtained FDA approval on 12 June 2013, and a positive opinion from EMA's Committee on Human Medicinal Products (CHMP) on 27 June 2013.

The tool's development was reportedly supported by numerous pharmaceutical companies, which made de-identified patient-level data available to C-Path, which was then used to develop and calibrate the model. "This is a great example of a rising tide lifting all boats," wrote Richard Lalonde, global head of clinical pharmacology at Pfizer, in a statement.

The ultimate effect of the tool could be to expedite the drug approval process, C-Path explained. "The regulatory decisions on this tool exemplify how C-Path's efforts result in alignment between global regulatory agencies when based on consensus science and supporting data; an alignment that can result in greater efficiency in drug development," said Martha Brumfield, president and CEO of C-Path. And with greater efficiency should, if all goes according to plan, faster and more efficient trials that better support regulatory decisions by both FDA and EMA.


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