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The Cancer Letter - Perspectives on Clinical Development of PD-1 Drugs

A conversation with The Cancer Letter and the experts listed below.

 

Jeff Abrams, NCI acting director for clinical research and associate director of the NCI Cancer Therapy Evaluation Program. Abrams wrote his responses with Elad Sharon.

 

Jeff Allen, president and CEO of Friends of Cancer Research,  an advocacy organization based in Washington, DC that drives collaboration among partners from every healthcare sector to power advances in science, policy, and regulation that speed life-saving treatments to patients.

 

Pink Sheet - Duke's McClellan: Changing Drug Development Policy From Outside FDA

Executive Summary

In an interview, Margolis Center for Health Policy's Mark McClellan and Gregory Daniel talk about their recent move from Brookings to Duke, the breadth and impact of their work with FDA on drug development issues, and opportunities for potential future collaborations under PDUFA VI.

 

 

ASCO Post - Jeff Allen, PhD, Named Friends’ First CEO

Friends of Cancer Research (Friends) has announced that its Executive Director, Jeff Allen, PhD, will assume the role of President and CEO of the organization. Friends’ founder, Ellen ­Sigal, PhD, will continue with the organization as Board Chair. Dr. Allen will become the day-to-day lead of Friends’ scientific and policy programs and organizational operations, in addition to directing strategic legislative initiatives.

 

OncLive - Dr. Gandara on How Lung-MAP Trial is Optimal for Patient Care

David R. Gandara, MD, director, Thoracic Oncology Program, professor, senior advisor to director, UC Davis Comprehensive Cancer Center, treasurer, International Association for the Study of Lung Cancer (IASLC), discusses the Lung Master Protocol (Lung-MAP) Trial and how it is an example of a rational clinical design that will impact patient care. Gandara shared this insight during an interview at the 2016 IASLC Multidisciplinary Symposium on Thoracic Oncology.

 

The Cancer Letter - No Moonshot Funds In House & Senate FY17 Appropriations Bills

The National Cancer Moonshot Initiative is not slated to receive funding in fiscal 2017—neither the House nor Senate appropriations bill includes the $680 million the White House proposed for Vice President Joe Biden’s project.

 

Despite great bipartisan breast-beating in support of boosting the NCI and NIH budgets, Congress has not dedicated funding for the moonshot, a broad scientific and public health effort focused on improving clinical trials, data sharing, and streamlining regulatory processes for oncology products at FDA.

 

Bloomberg - GOP Senator Blasts FDA’s Plans for Regulating Lab Tests

Clinical laboratories could face significant costs if the FDA moves forward with plans for lab-developed tests, the chairman of a Senate committee said Sept. 20.

 

Vanderbilt University’s lab in Nashville, Tenn., for example, could spend $30 million to $75 million to get Food and Drug Administration approval for a single high-risk laboratory-developed test (LDT) under the agency’s plan to regulate the tests, Health, Education, Labor and Pensions Committee Chairman Lamar Alexander (R-Tenn.) said during a hearing.

 

Inside Health Policy - Alexander Floats Separate Agency For LDT Oversight To Avoid Regulatory Duplication

Senate health committee Chairman Lamar Alexander (R-TN) floated creating a new regulatory agency to oversee lab-developed tests, which he told lawmakers would be preferable to the current duplicative regulation by CMS, FDA and state regulators. He also told reporters he hoped FDA would not release a final version of its controversial draft guidance bringing LDTs under the medical device regulatory scheme, given Senate and House efforts to address the issue.

Pink Sheet - Cancer 'Moonshot' Recommendations On R&D Have Strong Patient Focus

Executive Summary

Blue ribbon panel has plenty of industry-friendly recommendations on ways to accelerate oncology science, but with the clock ticking down on the Obama Administration, the question is whether the recommendations have any political traction.

 

Recommendations from Vice President Joe Biden’s Cancer “Moonshot” Blue Ribbon Panel have a specific emphasis on patient-focused research, new areas for oncology R&D and the establishment of a national clinical trial data network for “one-stop, free access” to patient data from studies across the country.

New York Daily News - How the cancer moonshot really could change everything: The key is aggregating anonymous patient data

Thirty years ago, I watched my sister Gale die of breast cancer. In those days, that meant seeing a strong and beautiful woman lose an excruciating battle against a disease that we had barely begun to understand. What few drugs we had were toxic; at best, they offered a poisonous pause in a patient’s painful decline. Limited therapies meant little hope. In too many cases, a cancer diagnosis was a death sentence.

 

Gale, a lifelong New Yorker, died on March 13, 1986. She was 40. Her daughter, Jillian, was 4 years old.

 

Bloomberg - Biden Gives a Peek at What’s to Come for Cancer Moonshot

A corporate-government partnership to improve U.S. veterans’ access to personalized cancer treatments will highlight a nationwide series of gatherings and events Wednesday detailing of Vice President Joe Biden’s “Cancer Moonshot” program.

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