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The Cancer Letter Inc.
PO Box 9905
Washington
DC 20016
Tel: 202-362-1809
Fax: 202-379-1787
publication date: Jun 5, 2016

To the Moon

ISSUE 2 - JAN. 15, 2016 PDF



Obama Announces Moonshot to Cure Cancer

President Barack Obama announced a moonshot aimed at curing cancer, a project to be led by Vice President Joe Biden.

The United States can do “so much more,” Obama said in his seventh and final State of the Union address Jan. 12. “Last year, Vice President Biden said that with a new moonshot, America can cure cancer. Last month, he worked with this Congress to give scientists at the National Institutes of Health the strongest resources they’ve had over a decade.

“Tonight, I’m announcing a new national effort to get it done. And because he’s gone to the mat for all of us, on so many issues over the past 40 years, I’m putting Joe in charge of mission control. For the loved ones we’ve all lost, for the family we can still save—let’s make America the country that cures cancer once and for all.”

      When Moonshots Collide

    Did Patrick Soon-Shiong attempt to scoop President Barack Obama’s State of the Union address?

    Several days before Obama announced the federal government’s moonshot to cure cancer, Soon-Shiong put out a draft press release, claiming that the White House, NIH, FDA and pharmaceutical companies have united in “Cancer MoonShot 2020,” an immunotherapy clinical trials program he devised.

    Soon-Shiong, founder and CEO of NantWorks and the Chan Soon-Shiong Institute of Molecular Medicine, ultimately announced his moonshot on Jan. 11, a day before Obama announced his.

       

      Conversation with The Cancer Letter

      Soon-Shiong Says FDA & NCI are Onboard For His Moonshot; Feds Deny Involvement

      Government agencies said the biotechnology billionaire Patrick Soon-Shiong had overstated the extent of their involvement in “Cancer MoonShot 2020,” the immunotherapy clinical trials program he put together.

      In an in-depth conversation with Matthew Bin Han Ong, a reporter with The Cancer Letter, Soon-Shiong said that while his program doesn’t seek federal funds, it has the support of NCI and FDA officials.

      Soon-Shiong said he and Vice President Joe Biden met to discuss their interlocking missions and are now pursuing them.

       

      ISSUE 3 - JAN. 22, 2016 PDF



      Biden's Cancer Moonshot to Focus
      On Bioinformatics and Data Sharing

      The Obama administration will find the money to create a comprehensive oncology bioinformatics system, Vice President Joe Biden pledged Jan. 19 at a meeting of international cancer experts at the World Economic Forum in Davos-Klosters, Switzerland.

      Biden, whose son Beau died of brain cancer in May 2015 at age 46, is leading the White House “moonshot” program, which was announced by President Barack Obama during his final State of the Union address Jan. 12 (The Cancer Letter, Jan. 15).

      Obama is expected to announce the details of funding the moonshot in his budget proposal Feb. 9.

        Biden: Cancer Moonshot Seeks Quantum Leaps, Not Incremental Change

      The text of Vice President Joe Biden’s Jan. 19 remarks at a World Economic Forum meeting of international cancer experts in Davos-Klosters, Switzerland, follows:

      Almost everyone in the world, as you all know, has a family member who’s had cancer. Every year, around the world, 14 million people are diagnosed with cancer and 8 million people succumb to it, die, from cancer.

      And like many of you, I have experienced in my family the dreaded C-word that I think is the most frightening word that most people—as these docs and scientists can tell you—that anyone wants to hear walking out of a doctor’s office.

         

        Guest Editorial

        The False Allure of The Cancer Cure

        By Robert Cook-Deegan

        Over the past century, we have had many wars on cancer, and now we have a national “moonshot” to be spearheaded by Vice President Joe Biden, announced in President Barack Obama’s Jan. 12 State of the Union Address.

        In 1937, even as Congress was establishing the National Cancer Institute as the first of the National Institutes of Health, the American Committee to Combat Cancer was organizing the “Women’s Field Army” to mobilize against cancer, especially uterine, ovarian, and breast cancers. The main argument was that the nation was spending vastly more per person affected, and per death, on polio than it was on cancer. It was framed as a war.

         

        ISSUE 6 - FEB. 12, 2016 PDF



        Obama's $4.1 Trillion Budget Proposes Mandatory Funds for $1 Billion Moonshot

        President Barack Obama Feb. 8 unveiled his budget proposal for the 2017 fiscal year—a $4.1 trillion spending blueprint that is unlikely to be passed by a Republican-controlled Congress.

        The administration’s proposal appears to cut the NIH existing budget by $1 billion in discretionary funding and makes up the difference with mandatory funding.

        In a joint snub, the House and Senate budget committees declined to hold a hearing for Shaun Donovan, the director of the Office of Management and Budget. The move marks the first time in 41 years that Congress has refused to review a president’s budget.

        Conversation with The Cancer Letter

        Sigal: FDA Should Consolidate Cancer Portfolio

        President Barack Obama’s Feb. 8 budget request for fiscal year 2017 slates $75 million in additional funding for FDA for the creation of a virtual Oncology Center of Excellence.

        The proposal is arguably the most tangible component of Vice President Joe Biden’s National Cancer Moonshot program, which aims to double progress in cancer research and drug development over the next five years.

        White House Promises $1 Billion for Cancer Moonshot

        The White House announced a $1 billion initiative Feb. 1 to jumpstart the national cancer moonshot program—an ambitious proposal first announced by President Barack Obama during his final State of the Union address.

        Vice President Joe Biden, whose son Beau died of brain cancer in May 2015 at age 46, is leading the program, which aims to achieve a decade’s worth of progress within the next five years.

         

        ISSUE 8 - FEB. 26, 2016 PDF



        Capitol Hill Briefing Focuses on Moonshot's Provision to Integrate FDA Cancer Portfolio

        When the White House proposed a $1 billion startup fund for the National Cancer Moonshot, a largely unexpected directive to reform FDA raised many questions among oncology insiders.

        The agency will create a virtual Oncology Center of Excellence, the administration proposals and budget documents state.

        Alas, nobody can claim to understand what “virtual” means in this context, and how the $75 million in proposed fiscal 2017 mandatory funds would be used to “leverage the combined skills of regulatory scientists and reviewers with expertise in drugs, biologics, and devices.”

         

        ISSUE 13 - April 1, 2016 PDF



        NCI Makes Plans for Moonshot Dollars

        At a meeting of the NCI Board of Scientific Advisors March 29, NCI officials had good news to report:

        • The appropriations are increasing, with bipartisan support to boot.

        • The White House “moonshot” initiative on cancer is bringing new money and new urgency to the institute’s work.

        The cancer program has seen many aggressive mandates and has made many big promises, and it's worthwhile to remember this current initiative is being launched by an administration that is concluding its term.

         

        ISSUE 14 - April 8, 2016 PDF



        Jacks, Jaffee, Singer Named Co-Chairs of NCI’s Moonshot Blue Ribbon Panel

        NCI announced a panel of advisors to inform the scientific direction and goals of Vice President Joe Biden’s National Cancer Moonshot Initiative.

        The 28-member Blue Ribbon Panel, a committee of scientific experts, cancer leaders, and patient advocates, will serve as the working group of the National Cancer Advisory Board and provide scientific guidance from opinion leaders in the cancer community.

         

        ORIEN Partners with Pharma Companies to Develop Precision Medicines with Big Data

        The Oncology Research Information Exchange Network and M2Gen formed a bioinformatics collaboration with Celgene Corp.

        The partnership, announced April 7, is called the ORIEN Avatar Research Program. The initiative is managed by M2Gen and is designed to generate large amounts of genetic and clinical information on patients consenting to the Total Cancer Care Protocol, a standard operating protocol used by ORIEN member institutions.

         

        ISSUE 15 - April 15, 2016 PDF



        Parker Bets $250 Million on Immunotherapy

        A foundation established by Silicon Valley entrepreneur Sean Parker—founder of Napster and first president of Facebook—has committed $250 million to research in cancer immunotherapy.

        The newly founded Parker Institute for Cancer Immunotherapy brings together immunologists from Memorial Sloan Kettering Cancer Center, Stanford University, UCLA, UCSF, MD Anderson Cancer Center and the University of Pennsylvania.

         

        Conversation with The Cancer Letter

        Parker Mantra: Collaborate Like Hell

        The Cancer Letter invited Jedd Wolchok, associate attending physician and chief of the Melanoma and Immunotherapeutics Service at Memorial Sloan Kettering Cancer Center, to describe the workings of the just-announced Parker Institute for Cancer Immunotherapy.

        Agus: $200 Million Interdisciplinary Institute to Focus on Data Modeling

        A few years ago, at dinner with technology entrepreneur Larry Ellison, David Agus, director of the University of Southern California Center for Applied Molecular Medicine, mentioned his dream of opening an interdisciplinary cancer center.

        “I said, it really would be an amazing thing if we could start to get people in one place and have residences, so the greatest physicists, mathematicians, engineers can actually come in and live there and be engrossed in cancer,” said Agus, professor at the Keck School of Medicine of USC and USC Viterbi School of Engineering.

        ““Well, how much would it be to kind of put together such a building and program?” Ellison, Oracle Corporation’s chairman of the board and chief technology officer, said to Agus at the time.

        “You know, about $200 million,” Agus said.

        “Done,” Ellison responded.

         

        ISSUE 16 - April 22, 2016 PDF



        AACR 2016

        Biden Asks for Guidance in Leading Moonshot

        “There is more brain power in this room than exists in many countries,” said Vice President Joe Biden, addressing over 4,000 members of the American Association for Cancer Research, during a speech that turned personal at times, as he laid out several suggestions for accelerating progress.

        As head of the federal government’s cancer moonshot task force, the vice president listed recommendations he has received for reaching the initiative’s goal, not a cure, but completion of a decade’s worth of cancer research in five years. Recommendations include increasing research budgets across the federal government, making it easier to share data, removing paywalls around published research, and incentivizing verification of study results.

        “Toward that end, last year, the 2016 budget, and working with Congress, we were able to increase funding by $2 billion for the National Institutes of Health. The largest increase in a decade,” Biden said at the association’s annual meeting April 20 in New Orleans.

         

        ISSUE 17 - April 29, 2016 PDF



        Guest Editorial

        The Moonshot: A View from Europe

        By Peter Boyle

        “And I believe we need a moonshot in this country to cure cancer.”

        With these words, Vice-President Joe Biden gave the first public hint of a new specific, major program to be launched and funded by the U.S. government.

        President Barack Obama reiterated this development in his State of the Union address announcing a new national effort to get it done and placing Vice President Biden as leader of this initiative.

        The appointment of Vice President Biden to head the initiative is an inspired choice.

        Of course, let’s not forget that in 1971 President Richard Nixon launched a not dissimilar initiative and yet 45 years later, there still remains an on-going war against this feared group of diseases, despite progress in many aspects. Times change, knowledge advances, and there are many signs that this new initiative holds out a better chance of success.

         

        NCI's New Genomic Platform Seeks to Enable Data Sharing for Biden's Moonshot

        NCI is preparing to open the Genomic Data Commons, a $20 million big data endeavor aimed at making raw genomic data publicly available.

        The GDC, NCI’s largest bioinformatics effort since the ill-fated caBIG, will go live June 1. The database will be interoperable and publicly available to qualified researchers. Anyone will be able to submit data for consideration.

        While work on the GDC began over two years ago, the initiative is being launched at a time when leading oncology groups are positioning themselves to play a central role in the White House’s moonshot initiative.

            Conversation with The Cancer Letter

            NCI's Staudt and Kibbe: Data Commons Will Publish Annotated Raw Genomic Data

            The Genomic Data Commons, NCI’s latest big data project, is poised to become a major player in oncology bioinformatics when it opens June 1.

            The GDC aims to become oncology’s go-to database for comprehensive, raw genomics information. NCI officials said this sets the GDC apart from other bioinformatics projects, which are vying to play a role in the White House moonshot initiative.

            “When the other groups are sharing the data, what they are doing is sharing very derived data that is divorced from the actual data,” said Louis Staudt, director of NCI’s Center for Cancer Genomics. “The GDC is doing something different.

             

            ISSUE 18 - May 6, 2016 PDF



            Virtual is Not Enough

            FDA's Critics Call for Full Integration of Oncology Center Under Biden's Moonshot

            The White House moonshot to accelerate progress in cancer research directs FDA to consolidate its oncology portfolio.

            However, oncology insiders say the manner in which the presidential initiative will be implemented could make the difference between political balderdash and genuine improvement in FDA regulation of cancer therapies.

            The entire controversy boils down to the interpretation of one word: Virtual.

            Moonshot Director Addresses AAADV Workshop

            Greg Simon, executive director of the cancer moonshot task force, addressed the FDA-sponsored workshop for Accelerating Anticancer Agent Development and Validation in North Bethesda, Md., May 4.

            He discussed the goals for the moonshot initiative, how the program could fit into the next presidential administration, and how to take the project international.

             

            ISSUE 20 - May 20, 2016 PDF



            NCI Identifies Moonshot Priorities

            NCI is working to provide five to ten recommendations for Vice President Joe Biden’s cancer moonshot program, officials said at a recent advisory committee meeting.

            At a meeting of the Frederick National Laboratory Advisory Committee May 11, top NCI officials described the mechanisms that will be used to provide recommendations for spending new money that may be directed at cancer research.

            The institute’s Blue Ribbon Panel—consisting of 28 members representing academia, government, industry and patient advocates—has assembled seven working groups.

            Guest Editorial

            Nancy Davidson: Capturing the Moonshot's Momentum

            Vice President Joe Biden’s National Cancer Moonshot Initiative has touched off an unprecedented national and international dialogue about cancer.

            My presidential year at the American Association for Cancer Research brings the special opportunity to ensure that this momentum is captured and fully utilized to position cancer research as the key to saving more lives from cancer.

            The AACR has been and continues to be a trusted adviser to the vice president on this important initiative.

             

            ISSUE 22 - June 3, 2016 PDF



            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.”

             

            ISSUE 23 - June 10, 2016 PDF



            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.

            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.


            Copyright (c) 2016 The Cancer Letter Inc.

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