Thursday, November 12, 2009

Medanta, Duke Medicine to open translational research facility in India


Medanta–The Medicity and Duke Medicine signed a joint venture agreement to launch the
Medanta Duke Research Institute (MDRI), a early phase clinical research facility at Medanta.

The MDRI project will aim to transform the global framework for clinical development and evaluation of human biology, diseases, drugs & devices by leveraging cutting edge technologies and applying systems biology & molecular medicine to clinical research.

MDRI will collaborate with Duke affiliated early phase research units in the US & Singapore to develop a best-in-class global network for proof of concept clinical research. The collaboration will unlock the potential for undertaking simultaneous early phase clinical studies in three countries with diverse populations.

This network will enable globally relevant pharmacogenomic studies and also facilitate faster and more accurate early phase clinical trials.Industry statistics report that advancing a new compound through the clinical trials process is a long and expensive endeavor, with only about 11 percent of investigational compounds ultimately become drugs. Furthermore, one in four compounds fails even after completing registration trials, resulting in a loss of billions of dollars while also exposing patients to toxic agents. The objective of a typical early phase study is to provide information about the dosing, safety and toxicity of a drug by giving it to a relatively small number of healthy people and capturing pharmacokinetic, and other basic data, as well as patient reported adverse events.

The new paradigm being established with the launch of MDRI, and the associated global network of proof-of-concept facilities, will enable the elucidation of much more comprehensive insights at the front end of the clinical trials process by studying early compounds in small numbers of real patients – as opposed to healthy volunteers – utilizing proteomics, metabolomics, advanced imaging and other state-of-the-art research tools.

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