publication date: Jun. 5, 2016
To The Moon - Jun. 5, 2016

To the Moon

ISSUE 2 – JAN. 15, 2016PDF



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, 2016PDF



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, 2016PDF



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, 2016PDF



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, 2016PDF



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, 2016PDF



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, 2016PDF



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, 2016PDF



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, 2016PDF



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, 2016PDF

art 42-18 fda on the moon final

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, 2016PDF



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, 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.”

 

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.

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.

 

ISSUE 24 – JUNE 17, 2016PDF



Moonshot May Play Role in $400 Million Annual Contract to Run NCI’s Frederick Lab

The contract for operations and technical support at the Frederick National Laboratory for Cancer Research could be accepting proposals as early as next month—but NCI advisors said they are hoping to slow the recompetition process to reform the laboratory’s mission.

Moreover, NCI should consider how the laboratory could contribute to Vice President Joe Biden’s National Cancer Moonshot Initiative, members of the Frederick National Laboratory Advisory Committee said at a recent meeting.

ISSUE 25 – JUNE 24, 2016PDF



Stanford, Intermountain and Providence Use Syapse Platform to Integrate Their Data

Three health systems—Stanford Cancer Institute, Intermountain Healthcare and Providence Health and Services—have agreed to eliminate the electronic barriers between their medical records, tumor registries and genomics databases.

The three entities said they have started to use a common IT platform to achieve interoperability and guide clinical decision-making.

That platform is Syapse, a startup that is emerging as an important player in the ongoing conversation on bioinformatics and data sharing in oncology, led by Vice President Joe Biden and the National Cancer Moonshot Initiative.

Conversation with The Cancer Letter

Hirsch: I Dropped Out of Stanford to Start Syapse

Jonathan Hirsch was studying neuroscience at Stanford University when he wandered into two oncology classes and saw an opportunity to change the way health systems handle genomic data.

“I started getting really immersed in molecular oncology, and the challenges in implementing molecularly guided treatment started coming together with the challenges in utilizing complex data,” Hirsch said to The Cancer Letter.

Joint BSA-NCAB Meeting

The Moonshot’s Metric for Success: Avoiding a Single, Tangible Endpoint

How will the success of the moonshot be measured? NCI Acting Director Doug Lowy touched on the subject during the joint meeting of the institute’s Board of Scientific Advisors and the National Cancer Advisory Board June 21.

The moonshots of the 1960s were essentially engineering problems that had tangible goals. Cancer is an evolutionary problem, and the stated goal of the moonshot in cancer research, led by Vice President Joe Biden, is perhaps deliberately vague: to achieve a decade’s worth of progress in just five years.

 

ISSUE 26 – JULY 1, 2016PDF



News Analysis

Biden’s Moonshot Goals are Flexible Enough to be Realistic

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

After a year of trying to understand the biology and politics of cancer, Vice President Joe Biden admits that he has a stronger grasp on the nuts and bolts of Washington than the evolutionary mysteries known collectively as cancer.

Hosting the National Cancer Moonshot Summit at Howard University on June 29, Biden delivered a wide-ranging speech, even as his main initiatives remain what they have been from the start of his cancer odyssey:

 

Biden Announces FDA Center of Excellence

Vice President Joe Biden announced the formation of the FDA Oncology Center of Excellence, which is intended to consolidate the agency’s cancer portfolio and streamline regulatory pathways for cancer-related drugs, biologics, and devices.

Richard Pazdur, currently the director of the Office of Hematology and Oncology Products, will serve as acting director of the agency’s new cancer center.

Biden’s June 29 announcement at the National Cancer Moonshot Summit in Washington, D.C. follows months of lobbying by oncology professional societies, advocacy and patient groups.

Conversation with The Cancer Letter

Pazdur Named Acting Director of FDA’s New Cancer Center

Richard Pazdur, currently the director of the FDA Office of Hematology and Oncology Products, will serve as acting director of the newly formed FDA Oncology Center of Excellence.

The exact structure, budget and staffing for the program will be determined in an ongoing process, Pazdur said to The Cancer Letter.

“Because I will be working to develop the structure of the OCE with input across all centers, it would be premature to speculate about what the ultimate structure of the OCE will be,” Pazdur said. “The framework of the OCE will evolve over time, so as not to disrupt the ongoing work in each center.”

Biden: What I Learned About Cancer

A transcript of Biden’s speech at the National Cancer Moonshot Summit at Howard University.

 

ISSUE 28 – JULY 15, 2016PDF




New NCI Clinical Trials Program Will Automate Matching Through Third-Party Data Software

NCI is developing an open-source application intended to make it easier for patients and physicians to get information on clinical trials supported by the institute.

Vice President Joe Biden endorsed the initiative June 29 at the National Cancer Moonshot Summit in Washington, D.C., saying it will “strengthen participation in cancer research studies to help accelerate medical discoveries and treatments for cancer.”

When the institute’s application programming interface—a set of routine definitions, protocols, and tools for building software—is completed, data companies and programmers will be able to incorporate information on NCI-sponsored trials into their bioinformatics software. This enables physicians to search NCI’s clinical trials database via a more targeted and intuitive process eventually provided by any third-party software that uses the API.

Conversation with The Cancer Letter

Kibbe: Anyone Can Build Search Interface with Open-Source NCI Clinical Trials API

Vice President Joe Biden announced a new NCI application programming interface June 29 that will enable third-party developers to connect their bioinformatics software to NCI’s clinical trials database.

When completed, the API is expected to improve access to the data available from NCI on cancer clinical trials that are supported by the institute.

Capitol Hill

House Appropriators Propose $1.25 Billion Budget Increase for NIH in FY 2017

The House Appropriations Subcommittee on Labor-HHS marked up a bipartisan spending bill July 6 that gives NIH a $1.25 billion increase in the 2017 fiscal year.

NCI is to receive a $264 million increase over FY 2016.

The measure boosts the NIH budget to $33.3 billion and now moves to consideration by the full House appropriations committee.

The Senate Committee on Appropriations June 9 marked up a spending bill, which would provide a $2 billion funding increase for NIH and $216 million increase for NCI in FY 2017.

 

ISSUE 30 – JULY 29, 2016PDF




Foundation Medicine Contributes 18,000 Cases to NCI’s Genomic Data Commons

When the Genomic Data Commons opened June 6, the $20 million portal that consolidates NCI’s datasets contained genomic information from 14,500 patients.

Before the end of the month, that number jumped to 32,500, as a result of a contribution from Foundation Medicine Inc., a molecular information company founded in 2011.

The GDC was announced in June by Vice President Joe Biden as part of the National Cancer Moonshot Initiative.

“We’re adding 18,000 cases from Foundation,” said Louis Staudt, director of the NCI Center for Cancer Genomics. “Many important cancer genes, up to 287, have been sequenced by Foundation in these cases. We applaud their public spirit, and we are really glad that they anted up.”

Conversation with The Cancer Letter

Pellini: Data Sharing Central to Mission at Foundation Medicine

Making data broadly available to clinicians and researchers has always been a part of the mission for Foundation Medicine Inc., said Michael Pellini, the company’s CEO.

“We are proud to say the data that we contributed represents an important part of the GDC in terms of its sheer size,” said Pellini, discussing FMI’s decision to contribute 18,000 de-identified patient cases to NCI’s Genomic Data Commons.

Conversation with The Cancer Letter

Staudt: Foundation Medicine’s “Philanthropy of Data” More Than Doubles GDC Portfolio

Foundation Medicine approached NCI with the idea to make their data useful in the public domain.

“They had heard through a variety of mechanisms that we were doing the Genomic Data Commons, and they thought this was a good possible fit,” said Louis Staudt, director of the NCI Center for Cancer Genomics. “In the end, it did turn out to be good for both of us.”

Foundation donated the data from 18,000 de-identified cases, more than doubling the GDC’s total, up to 32,500.

 

ISSUE 26 – SEPT 6, 2016PDF




AACI, Biden’s Task Force Eye Matching Investors With Projects at Cancer Centers

The Association of American Cancer Institutes and the White House Cancer Moonshot Task Force are developing a new method for funding research at academic cancer centers through private investment and philanthropy.The move promises to establish a mechanism for matching investors with commercially viable research. It appears that this system would work separately from NCI.

 

ISSUE 33 – SEPT. 9, 2016PDF



NCI’s Moonshot Advisory Panel Identifies Ten Opportunities in Cancer Research

The Blue Ribbon Panel—a group of experts selected to identify scientific opportunities for the National Cancer Moonshot Initiative—has submitted 10 recommendations to the National Cancer Advisory Board.

The panel proposes creating tumor atlases and national networks for patient engagement, immunotherapy clinical trials, and data sharing. Recommendations also include supporting research on drug resistance, fusion oncoproteins, symptom management, and development of cancer technologies.

“The Blue Ribbon Panel recommendations outline a set of opportunities that, if implemented, will transform our understanding of cancer and result in new opportunities to more effectively prevent and treat the disease,” the authors write.

 

Conversation with The Cancer Letter

Lowy: Implementation Will Depend on NCI Funding in Fiscal Year 2017 and 2018

NCI will urge increased and sustained appropriations for carrying out ten recommendations put forward by the Blue Ribbon Panel, the institute’s scientific advisory panel to the National Cancer Moonshot Initiative.

On Sept. 7, NCI Acting Director Douglas Lowy accepted the recommendations of the Blue Ribbon Panel, which presented its report to the National Cancer Advisory Board.

“To the extent that NCI would be involved in making a case to Congress, we would be talking about the scientific validity of what is being recommended as a really important way of augmenting what NCI is already doing,” Lowy said.

White House: New Moonshot Initiatives On Clinical Trials Will Improve Speed, Access

Vice President Joe Biden Sept. 16 announced a series of initiatives to improve the safety, accessibility, and impact of clinical research—one of the central goals of the National Cancer Moonshot Initiative.

The programs, which span four federal entities—NCI, FDA, the Department of Health and Human Services, and NIH—would make existing clinical trial search sites more user-friendly, and ensure that results of clinical trials are shared in a timely fashion.

 

ISSUE 35 – SEPT. 23, 2016PDF



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 set aside 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.

 

ISSUE 36 – SEPT. 30, 2016PDF



Two Gigantic Health Systems Integrate Cancer Data to Bring Precision Medicine to Community Care

Two of the nation’s biggest nonprofit health systems—Dignity Health and Catholic Health Initiatives—launched a precision medicine program that has the potential to create the largest collection of clinical cancer data ever compiled by a single organization.

Together, Dignity and CHI, based in San Francisco and Englewood, Colo., respectively, operate nearly 150 hospitals and care centers across the U.S. Both rank in the top five largest nonprofit hospital systems.

NCI Suspends Frederick Lab Re-Competition Citing Moonshot, Zika and Ebola Research

NCI has suspended re-competition of the the $400 million-a-year operations and technical support contract for the Frederick National Laboratory for Cancer Research.

A brief notice of suspension was posted on the Federal Business Opportunities website at 4:06 p.m. Friday, Sept. 30, in the final business hours of the final day of the fiscal year.

Continuing Resolution Funds Zika, But Not Cancer or Biden’s Moonshot

A continuing resolution passed Congress passed Sept. 28 will avoid a government shutdown and fund federal agencies through Dec. 9.

This legislation comes two days before the government’s current funding was due to expire, at midnight Sept. 30. This would have closed all nonessential parts of the government, including NIH.

 

ISSUE 39 – OCT. 21, 2016PDF



Biden Delivers Task Force Report — Five Moonshot Goals in Cancer

Vice President Joe Biden and the National Cancer Moonshot Task Force published their final reports Oct. 17, summarizing the moonshot’s achievements, and outlining five strategic goals and action plans for the years to come.

The two reports conclude the 2016 National Cancer Moonshot Initiative, and the Obama administration’s efforts to develop a national conversation on cancer research.

Obama: The Moonshot, “Architecture and a Framework” for Cancer Research

President Barack Obama accepted Vice President Joe Biden and the National Cancer Moonshot Task Force’s reports—blueprints for how the federal government should focus on cancer research, oncology bioinformatics, and patient access and care over the next few years.

“This all comes down to, ‘How does it impact patients?’ And so Joe, I think, has done a great job in engaging people who are going through battling cancer right now, and finding ways that we’re not just coming up with cures, but we’re also making sure that these systems are set up so that they’re easier for people to access,’ Obama said at a press conference Oct. 17.

LLS Starts Beat AML Master Trial

After four decades of few improvements in the treatment for acute myeloid leukemia, the Leukemia and Lymphoma Society has launched a precision medicine trial to identify targeted treatments for patients with AML.

The society’s trial—called Beat AML Master Trial—was announced by Vice President Joe Biden Oct. 17 at a White House event rolling out Moonshot-related initiatives.

Where is the FY18 Bypass Budget? Cancer Groups Want to Know

The NCI Bypass Budget was expected to be made public on Oct. 6.

Alas, this didn’t happen; why didn’t it?

America’s top cancer groups would like to know, and theirs is not idle curiosity. The NCI Bypass Budget is an important, unique authority established by the National Cancer Act of 1971.

 

ISSUE 42 – NOV. 11, 2016PDF

Photo by Gage Skidmore


What the Trump Presidency Means for Cancer Care, the ACA, and the Moonshot

The House and Senate leadership postponed appropriations for fiscal 2017 in favor of a second continuing resolution that runs through March 31, 2017.

The move Nov. 17 is likely a signal that Congressional Republicans are hoping to start the budget process anew, tailoring it to the priorities of the administration of president-elect Donald Trump.

Cancer Moonshot Research Dollars Must Go to NCI—Not NIH—Groups Say

Nearly 50 cancer-related organizations urged Congressional leaders to ensure that funds slated for research in the National Cancer Moonshot Initiative go directly to NCI—as opposed to NIH or any other federal entity.

The letter, dated Nov. 3, was authored by One Voice Against Cancer, a broad coalition that convenes on national funding and policy issues in oncology.

“It is … imperative that funding provided for Cancer Moonshot research be specifically directed to NCI,” the letter states.

 

ISSUE 43 – NOV. 18, 2016PDF



Republicans Ditch 2017 Appropriations To Tailor Spending to Trump Priorities

President Barack Obama’s legacy health care programs—the Affordable Care Act, and the National Cancer Moonshot Initiative—have been thrown into uncertainty.

Hours after Republican Donald Trump became president-elect of the United States, Washington is left in a muddle: hopeful Democratic appointees who expected to join Hillary Clinton’s ranks ended up empty-handed. At stake is leadership at federal agencies, including the HHS, NIH, NCI, and FDA.

MD Anderson Sues Billionaire Over Using the Word “Moonshot”

Earlier this year, billionaire Patrick Soon-Shiong created considerable confusion by launching a cancer “moonshot” program at the same time that President Barack Obama announced an initiative that went by pretty much the same name.

On Jan. 11, a day before Obama announced his program during the State of the Union Address, Soon-Shiong, in a draft press release, claimed that the White House, NIH, FDA and pharmaceutical companies have united to launch the “Cancer MoonShot 2020,” an immunotherapy clinical trials program that Soon-Shiong had designed.

 

ISSUE 44 – DEC. 2, 2016PDF



House Passes 21st Century Cures Act, Slating $4.8 Billion for NIH, Moonshot

The House of Representatives has approved a revised version of the 21st Century Cures Act, a comprehensive $6.3 billion health care reform measure that would fund the National Cancer Moonshot Initiative and amend FDA standards for regulating drugs and devices.

Just as Feared: House Version of Cures Bill Gives Moonshot Money to NIH Director

In an unusual move, the National Cancer Advisory Board fired off a letter urging Congress to authorize additional “moonshot” funds, and—just as importantly—to place these new funds in the NCI budget.

The NCAB letter, dated Nov. 22, was likely motivated by insider accounts of a drive by top NIH officials to intercept these new dollars and place them under the purview of the NIH director (The Cancer Letter, Nov. 4).

 

ISSUE 45 – DEC. 9, 2016PDF

art 42-45 21st century cures

Senate Approves 21st Century Cures; CR Slates $300M for NCI and Moonshot

The Senate approved the 21st Century Cures Act, a wide-ranging bill that authorizes $1.8 billion over seven years for cancer research as well as $500 million over the next decade for FDA to streamline drug and device approval processes.

Being an Acting Director, NCI’s Lowy Isn’t Required to Submit Resignation

Doug Lowy will continue to lead NCI in his role as acting director in 2017 unless president-elect Donald Trump decides to appoint a different, new director.

 

ISSUE 46 – DEC. 16, 2016PDF

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Obama Signs Cures Act, Funding Biden’s Moonshot and Boosting NIH, NCI, FDA Budgets Over 10 Years

President Barack Obama Dec. 13 signed the 21st Century Cures Act, a bill that changes regulatory standards at FDA, slates additional research funds for NIH, and authorizes $1.8 million over seven years for Vice President Joe Biden’s National Cancer Moonshot Initiative.

Editorial

The Year of the Moonshot

The moonshot, The Cancer Letter’s biggest area of coverage of 2016, continues into 2017.

With the passage of the 21st Century Cures Act, the cancer moonshot initiative has been authorized at $1.8 billion over seven years. The Cures Act also authorizes $500 million over the next decade for FDA to streamline drug and device approval processes (The Cancer Letter, Dec. 10).

Copyright (c) 2017 The Cancer Letter Inc.