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Medanta -- The Medicity and Duke Medicine today finalized multiple agreements to establish the Medanta Duke Research Institute (MDRI) as a new joint venture company in India, fully realizing the vision for the creation of a world-class early phase clinical research facility at Medanta.

Medanta -- The Medicity is a conglomeration of multi-super specialty institutes led by medical practitioners who are leaders in their respective fields from all over the world with the vision to reach the highest levels of excellence in medical care, education, and research.

Duke Medicine is an internationally recognized Academic Health Sciences System based in Durham, North Carolina, USA. Duke Medicine combines one of the nation’s premier health care delivery systems and school of medicine, one of the largest biomedical research enterprises in the US, a leading school of nursing, and the innovative Duke-NUS Graduate Medical School in Singapore.

Representing Duke at today’s event were Robert M. Califf, MD, vice chancellor for clinical research and director of the Duke Translational Medicine Institute (DTMI); Robert Taber, PhD, Duke vice chancellor for corporate and venture development; John Sundy, MD, PhD, director of the Duke Clinical Research Unit (DCRU); and Krishna Udayakumar, MD, MBA, director of Duke Medicine Global.

The Medanta team was led by Dr. Naresh Trehan, founder, chairman, and managing director of Medanta -- The Medicity; Dr. Sanjay Mittal, director of clinical cardiology and research at Medanta; and Mr. Anil Virmani, chief financial officer of Medanta.

“This collaboration with Duke is a landmark event for India and Medanta in the direction of developing a center of excellence. Our shared goal is the safe and rapid development of therapies targeted at significant health problems. We hope that our partnership will produce research that will enable development of drugs and devices to improve health in India and around the globe,” said Trehan.

“These agreements create a significant opportunity to shift the paradigm for developing drugs and devices, and to collaborate for the achievement of a better understanding of human biology by using cutting-edge technologies and informatics,” Califf said. “A fundamental change in the way we study and develop drugs and devices is much needed and long overdue.”

“International collaboration is vital for both the future of medicine and for our economic well-being,” said Governor Beverly Perdue of North Carolina. “Today’s agreement is a giant step forward for the health of our people and it holds the promise of future economic benefits and jobs. I congratulate Duke and Medanta on their innovative partnership and their grand vision.”

“I am truly proud of the partnership Medanta -- The Medicity and Duke Medicine have created today,” said Victor J. Dzau, MD, chancellor for health affairs, Duke University, and CEO of Duke University Health System.

“Ours is a shared vision of pursuing innovative approaches for the translation of clinical research into outcomes that serve the delivery of health care around the world, and MDRI stands as a testament to our commitment to making that happen.”

The MDRI facility will occupy a 27,000-square-foot space at Medanta -- The Medicity comprising 60 beds and is expected to open in mid-April 2011. Tal Burt, MD previously associate professor for clinical research at Duke-National University of Singapore Graduate Medical School and director of the SingHealth Investigational Medicine Unit (IMU), serves as interim medical director for MDRI.

MDRI will leverage technologies and apply systems biology and molecular medicine to clinical research, with the goal of transforming the global framework for clinical development and evaluation of human biology, diseases, drugs, and devices. The MDRI will adhere strictly to highest global standards for research quality as well as human subject protection in clinical studies.

“This partnership between Medanta and Duke would enable cutting edge technology and knowledge transfer to India, which will catalyze the development of new therapies for a large number of diseases. By performing ‘proof of concept’ studies, the MDRI will provide opportunities for Indian physicians and patients to participate in the clinical research process in ways that have not been previously possible,” Mittal said.

“With our significant experience in early phase clinical trials, DCRU looks forward to working with MDRI as this important next chapter opens in Duke Medicine’s global vision of improving clinical research,” Sundy said.

He added, “In collaborating with the DCRU and with the IMU in Singapore, MDRI will be positioned to simultaneously conduct early phase clinical trials and to participate in the development of a globally relevant, best-in-class network for early phase clinical research in diverse populations.”

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, including patient-reported adverse events.

By studying early compounds in small numbers of patients with a specific disease, rather than in only healthy volunteers, using proteomics, metabolomics, advanced imaging, and hemodynamic monitoring, MDRI will enable the elucidation of comprehensive insights at an earlier point in the clinical trials process.

Under the terms of the agreement, Medanta, a 1,500-bed institute founded by Trehan, will fund the creation and operation of the facility, with Duke providing scientific, clinical research, and operational expertise. Medanta and Duke will share joint oversight over implementation and management of the unit, and ensure adherence to the highest ethical standards and transparency.

A six-member MDRI board will include Califf, Sundy and Mr. Michael Sledge, chief financial officer of DTMI, as well as Trehan, Mittal and Virmani.