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Expanded Role for NCI Needed to Hasten New Cancer Treatments

CARY, NCIncreased Public-Private Partnerships, Expanded Role for NCI Needed to Hasten New Cancer Treatments, Reports “The Oncologist”

CARY, N.C.--(BUSINESS WIRE)--Public-private partnerships — with cooperative roles for government, academic researchers, and industry — are a critical step toward faster development of "truly targeted therapies" for cancer, according to four articles published today by “The Oncologist” medical journal.

The articles reflect the recommendations of a recent conference of cancer experts held by the Engelberg Center for Health Care Reform at The Brookings Institution. Public-private collaborations among researchers in academia and the medical drug and device industries — along with an expanded role of the National Cancer Institute (NCI)— are at the heart of this "revolutionary new approach" to cancer research.

Advances in understanding of the genomics and molecular basis of cancer have opened the way to new therapies, targeted to the individual patient and cancer. However, the current system for drug discovery, development, and approval hinders rapid translation of scientific discoveries into new treatments for cancer patients.

In the first article, NCI Director Dr. John E. Niederhuber underscores the importance of federal coordination, noting that the proposals hinge on a central role for the NCI as a "safe harbor" in facilitating public-private partnerships. In this function, the NCI will help to bridge barriers to cooperative cancer research — issues related to intellectual property, etc. — while protecting and advocating for the public's interest in keeping cancer research moving forward.

The goal of the NCI safe harbor is to establish a pre-competitive pool of intellectual property for cancer drug development, according to Dr. Gregory A. Curt, Chairman of the Life Sciences Consortium (LSC) task force of the non-profit CEO Roundtable on Cancer. Together with changes in delivery of cancer clinical trials and streamlining of cancer drug approval, the NCI could bring about a "step change" in the way new cancer treatments are developed: "The research would be pre-competitive, the risks would be shared, and collaboration would replace competition," Dr. Curt writes. In a promising step forward, the NCI and the LSC task force have developed common language for contract clauses to speed the start of cooperative clinical trials.

Another priority is redesigning the Food and Drug Administration (FDA) to overcome delays in developing new cancer treatments, according to David Epstein, Member of the CEO Roundtable on Cancer and CEO of Novartis Oncology. He envisions the FDA as a "one-stop shop," providing integrated guidance on all new cancer treatments and tests.

Meanwhile, Drs. Mark B. McClellan and Joshua S. Benner of the Engelberg Center for Health Care Reform at The Brookings Institution outline steps the cancer research community can take now, without waiting for policy changes or additional funding. These include developing new standards for submitting cancer research data and new "auxiliary endpoints" to more quickly identify more- versus less-promising treatments. "These steps all amount to paying more attention to the science of demonstrating safety and effectiveness," they write.

“These insights clearly demonstrate the need for increased and expedited public-private collaboration in advanced cancer research, and point to the NCI's role as a valuable facilitator of these efforts," comments CEO Roundtable on Cancer Chairman William C. Weldon. "The NCI is a true catalyst for helping us realize important scientific advances. These advances have the opportunity to dramatically improve and perhaps save countless numbers of the more than 1.4 million Americans who are diagnosed with cancer each year."

"The calls for change in biomarker and regulatory science outlined by these papers would reduce the time needed to bring potentially lifesaving treatments to the public," says Dr. James H. Doroshow, Director of the NCI’s Division of Cancer Treatment and Diagnosis. "The NCI stands ready to support the regulatory process changes and the scientific underpinnings necessary to enhance delivery of novel cancer therapies to patients nationally."

The four commentaries have been published by “The Oncologist,” and are freely available online at: Gregory Curt, M.D. Chairman, Life Sciences Consortium of the CEO Roundtable on Cancer and US Medical Science Lead for Emerging Products, AstraZeneca Oncology Step Change in Safe Harbors: Public–Private Partnerships

John E. Niederhuber, M.D., Director, National Cancer Institute Facilitating Patient-Centered Cancer Research and a New Era of Drug Discovery

Mark B. McClellan, M.D., Ph.D., Director, Engleberg Center for Health Care Reform, Brookings Institution and Joshua S. Benner, PharmD, ScD, Research Director, Engleberg Center for Health Care Reform, Brookings Institution Four Important Steps Toward 21st Century Care for Patients with Cancer

David R. Epstein, President and CEO, Novartis Oncology & Novartis Molecular Diagnostics Vision and Will: The Future of the FDA

About the CEO Roundtable on Cancer

The CEO Roundtable on Cancer was founded in 2001, when former President George H.W. Bush challenged a group of executives to "do something bold and venturesome about cancer within your own corporate families." The CEOs responded with the CEO Cancer Gold Standard, a workplace accreditation program that calls for companies to evaluate their benefits and culture and take extensive, concrete actions in five key areas of health and wellness to fight cancer in the workplace. The CEO Roundtable on Cancer has since collaborated with the National Cancer Institute and other cancer fighting entities to find collaborative and innovative ways to eliminate cancer as a public health threat. For more information on the non-profit CEO Roundtable on Cancer and documents related to "common language" for clinical trial contracts, visit: www.CEORoundtableOnCancer.org.

About AlphaMed Press

AlphaMed Press publishes the internationally renowned journals, “Stem Cells” and “The Oncologist”. “Stem Cells”, now in its 27th year, is the oldest and one of the world's top-tier peer-reviewed monthly journals in the fast-paced area of stem cells and regenerative medicine. “The Oncologist,” in its 14th year, is a premier peer-reviewed monthly journal dedicated to physicians entrusted with the care of cancer patients. View AlphaMed Press journals at http://www.alphamedpress.org .

Contacts CEO Roundtable on Cancer Peggy Harrington, 919-531-0962 Peggy.Harrington@CEORoundtableOnCancer.org