20160610 - Jun 10, 2016
ISSUE 23 – June 10, 2016PDF



Biden Designates NCI’s Genomic Data Commons as Foundation of Moonshot 

CHICAGO—Vice President Joe Biden June 6 announced the NCI Genomic Data Commons as part of the National Cancer Moonshot Initiative.

The GDC, a $20 million portal that consolidates NCI’s diverse datasets, contains genomic sequences and analyses of tumors, as well as clinical data on enrollment and treatment.

Biden’s announcement—made hours before his address at the 2016 annual meeting of the American Society of Clinical Oncology—establishes NCI as the leader in a high-stakes debate over who gets to set standards for how health records data should be aggregated and organized.

• Related Coverage of the Cancer Moonshot

ASCO 2016

Biden: “I’d Like to Issue A Challenge to You”

Vice President Joe Biden challenged individual organizations and leading initiatives in oncology bioinformatics to interoperate and share data.

Speaking at the annual meeting of the American Society of Clinical Oncology in Chicago, Biden announced the NCI’s Genomic Data Commons as part of the National Cancer Moonshot Initiative, and urged others to collaborate with NCI.

Cancer Groups, Congress Push for
Dedicated Cancer Center at FDA

The FDA Oncology Center of Excellence—first proposed in the National Moonshot Cancer Initiative—is gaining support from oncology groups as well as in both chambers of Congress.

Earlier this week, 28 oncology professional societies and advocacy organizations sent a letter to FDA Commissioner Robert Califf, describing the organizational structure they’d like to see in the proposed center.

Capitol Hill

Senate Appropriators Propose $2 Billion
Increase for NIH

The Senate Committee on Appropriations marked up a bipartisan spending bill June 9 that gives NIH a $2 billion increase in the 2017 fiscal year.

NCI is to receive a $216 million increase over FY 2016.

Passed on a 29-1 vote, the measure boosts the NIH budget to $34 billion and now moves to consideration by full Senate. Funding for the Centers for Disease Control and Prevention will remain flat.

ASCO 2016

Vose: “Are We Ready To Care For These Patients?

Julie Vose, president of the American Society of Clinical Oncology, addressed the opening session of the society’s annual meeting in Chicago, discussing the themes of her year in office, the coming changes in federal cancer research and Medicare reimbursement, and the progress made over the society’s past 52 years.

Safety Bills on Morcellators,
Essure Introduced in House

Two House measures introduced earlier this week aim to strengthen federal requirements for reporting adverse outcomes caused by medical devices and to increase access to legal recourse for patients harmed by Class III high-risk devices.

• Related Coverage of Power Morcellation

In Brief
  • Former NCI Director Samuel Broder to retire from Intrexon Corp.
  • Yoshinori Ohsumi wins Janssen research prize from Johnson & Johnson

  • Five Pew-Stewart cancer research scholars announced

  • Susan G. Komen names 16 new Komen Scholars

  • American Hospital Dubai joins Mayo Clinic Care Network

  • University of Kentucky joins TriNetX

  • Roswell Park forms for-profit biotechnology company

  • CDC publishes Youth Risk Behavior Survey showing historic low smoking rates

 

20160606 - Jun 6, 2016
JUNE 6, 2016 

Biden Designates NCI’s Genomic Data Commons As “Foundational Element” of Cancer Moonshot

Vice President Joe Biden June 6 announced the NCI Genomic Data Commons as part of the National Cancer Moonshot Initiative.

The GDC, a $20 million portal that consolidates NCI’s diverse datasets, contains genomic sequences and analyses of tumors, as well as clinical data on enrollment and treatment.

Biden’s announcement—hours before his address at the 2016 annual meeting of the American Society of Clinical Oncology in Chicago—establishes NCI as the leader in a high-stakes debate over who gets to set standards for how health records data should be aggregated and organized.

• Related Coverage of the Cancer Moonshot

    20160603 - Jun 3, 2016
    ISSUE 22 – June 3, 2016PDF



    Obama and Congress Inadvertently
    Created Obstacles to Data Sharing, Biden Acknowledges—Now What?

    Seven years ago, when Congress sought to jumpstart the U.S. economy, few imagined that one aspect of the $800 billion stimulus program would turn electronic health records into the Tower of Babel.

    Speaking at Memorial Sloan Kettering Cancer Center last week, Vice President Joe Biden took full responsibility for the major bioinformatics snafu triggered by the American Reinvestment and Recovery Act of 2009.

    True, ARRA forced the U.S. medical establishment to digitize records in a hurry. Alas, today, fax machines and legions of data entry technicians are often required to transfer patient records from one hospital to another.

    Biden said the Obama administration didn’t foresee the consequences of mandating the switch to EHRs without developing a standard infrastructure for aggregating data.

    Biden: “You’re All Doing the Same Thing!”

    At a roundtable discussion at Memorial Sloan Kettering Cancer Center, Vice President Joe Biden urged greater efforts to aggregate cancer data.

    “I know MSK is part of Project GENIE and part of data sharing coalitions,” Biden said at the meeting May 26. “But I’ve met also with ORIEN, I’ve met with CancerLinQ.”

    “You’re all doing the same thing! I find it curious. I don’t know if that’s the only way it that can be done.”

    University of Maryland Cancer Center
    Earns NCI Comprehensive Designation

    The University of Maryland Marlene and Stewart Greenebaum Cancer Center has earned a designation as an NCI-designated Comprehensive Cancer Center. The center announced the NCI designation May 31.

    On Aug. 1, when the designation goes in effect, Maryland will become one of the 46 Comprehensive Cancer Centers in the U.S.

    ASCO Updates Value Framework

    The American Society of Clinical Oncology published an updated framework for assessing the relative value of cancer therapies that have been compared in clinical trials.

    The framework defines value as a combination of clinical benefit, side effects, and improvement in patient symptoms or quality of life in the context of cost. The updated framework will be the basis for a software tool that doctors can use to assist shared decision-making with their patients. The update was published in the Journal of Clinical Oncology.

    Study: 70 Cancer Treatments Launched Over 5 Years Pushes Oncology Market to $107 Billion

    A study reviewing trends in oncology found that more than 20 tumor types are being treated with one or more of the 70 cancer treatments that have been launched in the past five years.

    The surge in new therapies drove the global oncology market to $107 billion in 2015, an 11.5 percent increase over the previous year in constant dollars.

     

    Funding Opportunity

    CDMRP Taking Pre-Applications
    For Lung Cancer Concept Award

    Only 40 percent of Americans have a positive overall impression of clinical trials, according to a national survey conducted for Memorial Sloan Kettering Cancer Center.

    The survey, which polled over 2,100 people including nearly 600 physicians, found that 28 percent of doctors considered clinical trials as treatments of last resort.

    Letter to the Editor

    Progress Against Cancer:
    It Comes in Waves and Ripples

    By Silvia Paddock

    In 1916, Albert Einstein predicted the existence of gravitational waves. It took almost 100 years and the construction of the Laser Interferometer Gravitational-Wave Observatory (LIGO) to show that he was right. In 2015, a brilliant team of researchers detected gravitational ripples that had been generated by the collision of two black holes about 1.3 billion years ago.

    In Brief
    • Ralph De Vere White to step down as director of UC Davis Cancer Center
    • FDA publishes two guidances on compassionate use

    • ACCC launches Metastatic Breast Cancer Project

    Drugs and Targets
    • FDA approves cobas EGFR companion blood test for Tarceva

    • FDA approves NETSPOT for neuroendocrine tumors

    • European Commission approves Afinitor, Imbruvica
    • FDA grants orphan designations to Debio 1143 and SUBA-Itraconazole Capsules

    • Mylan launches generic version of Vidaza Injection

    • FDA grants Priority Review of telotristat etiprate in carcinoid syndrome