by Madison Arenchild, freelancer for Clinical Research Currents
“..we have examined where we are strong and where we are not, where we may succeed and where we may not. Now it is time to take longer strides–time for a great new American enterprise–time for this nation to take a clearly leading role.. which in many ways may hold the key to our future on earth.
I believe we possess all the resources and talents necessary. But the facts of the matter are that we have never made the national decisions or marshaled the national resources required for such leadership. We have never specified long-range goals on an urgent time schedule, or managed our resources and our time so as to ensure their fulfillment.” – John F. Kennedy, 1961
In May of 1961, John F. Kennedy famously declared that America would do the impossible: we would put a man on the moon within the decade. Eight years later, in the first mission to put humans on the Moon, NASA’s Apollo 11 put boots on the Moon in July of 1969.
Now, replace the context of sending a man to the moon with the mission of tackling the disease of cancer head on — and read that quote again. Relevant, right?
At the beginning of 2016, Vice President Joe Biden declared a new mission impossible for America, the Cancer Moonshot 2020 Initiative, that may perhaps prove to be even more difficult to conquer than it’s namesake. The goal? To pull down the barriers to cancer research that inhibit the progress in finding a cure. What cancer research anticipates it could accomplish in ten years, Moonshot 2020 aims to do in five.
Former Vice President Biden, whose own son, Beau, died of brain cancer in May 2015, was chosen by the president to head the ambitious initiative that will try to hasten a cure for cancer by “[breaking] down barriers in the medical world that hold back the progress of the disease.”
So what is the Cancer Moonshot 2020 Initiative? What progress did it make in its first year in 2016? And what can the clinical research sector and the American people anticipate for it in this new year under the Trump administration?
Quick facts – Here’s what you should know about the Cancer Moonshot 2020 Initiative:
● The Goal: To accelerate cancer research and accomplish ten years worth of cancer research in five years, in order to fundamentally change the life circumstances of millions of people around the world.
● But How? By eliminating the red tape that prevents drug therapies from getting FDA approval; By increasing funding, cooperation, sharing; And by significantly decreasing bureaucratic lag.
● The Players: On the federal side, the Task Force was convened by former President Obama and is made up of all of the federal agencies that have any involvement with cancer research. But the government is just one of eight players on this team. Moonshot 2020 is pulling together Pharmaceuticals, Research, Insurance, Physicians, Academia, Technology, NGO’s, and the Government, calling on all of these sectors to open their doors to information sharing and partnerships.
● What is QUILT?: (QUantum Immuno-oncology Lifelong Trial). It is the essence of Moonshot 2020. QUILT is a program designed to diagnose and sequence over 100,000 patients and based on those results, assign 20,000 of them to next generation immunocare for twenty different cancer types that would have otherwise been unavailable to them with the goal of achieving long-term, sustainable remission for patients.
● Watson for the Win: The power of the famous IBM supercomputer, Watson, has been donated to help the initiative with issues of scale. Able to process 40 million documents in 15 seconds, Watson is being used to overcome cancer institutes’ problem of the length of time it takes to interpret genetic data. The ability of Watson to aggregate vast amounts of information and process it into a usable format is now being applied to individual patient cases.
Joe’s Busy Season: Key Milestones for Cancer Moonshot in 2016:
January 2016: Pres. Obama announces the launch of Cancer Moonshot at the State of the Union address and assigns Vice Pres. Biden to head the initiative. February 1, 2016: Congress pledges 1 billion dollars into funding for the initiative. April 4, 2016: Blue Ribbon Panel announced as a working group of the National Cancer Advisory Board (NCAB) to act as consultants to the experts. April 18, 2016: NCI opens up platform for cancer researchers and the public to submit ideas for the Moonshot initiative. April 29, 2016: The Blue Ribbon Panel close to completion of the recommendations for how to speed up cancer research progress. May 9, 2016: NCI calls on data enthusiasts to help the initiative through data sharing, which is essential to the progress of the initiative. June 29, 2016: The National Cancer Moonshot Summit takes place at Johns Hopkins, bringing together patient advocates, healthcare providers, biomedical researchers, technological innovators, and industry leaders. June 29, 2016: NCI announces a partnership with Foundation Medicine Inc. to expand the cancer cases in the NCI Genomic Data Commons. September 7, 2016: The Blue Ribbon Panel formally announces its set of recommendations for the Moonshot initiative. September 16, 2016: New API to build online tool to help cancer patients find NCI-supported clinical trials. October 17, 2016: Cancer Moonshot releases their activities and implementation plan for achieving Moonshot goals. December 8, 2016: NantHealth, Inc. makes QUILT programs publically available for patients to enroll in trials.
So what has really been accomplished in 2016? A whole lot of planning.
2016 was all about encouraging data sharing and forming partnerships. Biden travelled around the country asking agencies, institutions, companies, and upwards of 200 universities – “Where is the federal government an impediment to your work? What is in your way?”
The two big buzzwords — cooperation and money. So, that’s where the work began. And Moonshot was wildly successful with this last year, producing partnerships such as between Amazon Web Services, Microsoft, and NCI, between the Department of Energy and the VA, between NASA and NCI, and between the National Endowment for the Arts and the NCI, to name a few.
San Diego Shows Up
Proud to live and/or work in one of the largest hubs for pharmaceutical and biotechnology research and development in the country? You’re about to be even more proud. San Diego’s companies and community have a history with Moonshot 2020 that goes back to at least February of 2016, when BIOCOM hosted Soon-Shiong, of NantHealth, at an event that brought together leaders from Celgene, Amgen, Altor Bioscience, other companies, major academic cancer centers and thousands of oncologists to form the National Immunotherapy Coalition. Soon-Shiong has become a powerful force behind the quest create next-generation cancer immunotherapies and NantHealth is now actively enrolling members of the public in the QUILT program clinical trials.
Nearly a year later, in December 2016, BIOCOM once again hosted – this time a local Moonshot Cancer Summit in honor of the passing of the 21st Century Care Act in November. The 21st Century Cures Act increased funding for NIH research for the Cancer Moonshot Initiative, along with the BRAIN Initiative, the Precision Medicine Initiative, and regenerative medicine. The summit featured discussions on oncology research, patient advocacy, and the biotech and pharma industries.
The oncology research panel featured moderator Scott M. Lippman, M.D., Director at the UC San Diego Moores Cancer Center, which is the only NCI-designated comprehensive cancer center in San Diego. It also included Dr. Razelle Kurzrock, Senior Deputy Director of UC San Diego’s Moores Cancer Center, Sonia Sharma, Ph.D., Director at the Center for Functional Genomics, La Jolla Institute for Allergy and Immunology and Dr. Garth Powis, Director at the Sanford Burnham Prebys Medical Discovery Institute’s Cancer Center. The group explained how the immune system is affected and the focus on studying the immune response to cancer.
The patient advocacy panel was moderated by Ujwala Rajgopal, MD, FACS, Surgical Oncologist, Scripps Health, Chair of the Board of Directors, American Cancer Society, California and was joined by Beth Anne Baber, Ph.D., MBA, CEO, Director and Co-Founder of the Nicholas Conor Institute, Rick Hazard, VP of Marketing at WAXIE, Tom Marsilje, Ph.D., Oncology Drug Discovery Scientist, Writer, and Colon Cancer Advocate and Peg Ford, Cancer Research Advocate and Co-Founder and President and of the Ovarian Cancer Alliance of San Diego. The discussion, in which the panelists shared their own experiences with cancer’s impact in their lives or their families’ lives, spoke to the need for a central location to house all the information coming in from clinical trials that is currently diffused throughout many locations.
Moderating the biotech and pharma industry panel, Joe Panetta, President of BIOCOM, was joined by Ho Cho, Vice President at Celgene, Jonathan Lim, Chairman, President and CEO of Ignyta, Dr. Neil Goodwin, Vice President of Corporate Research Development at Champions Oncology, and Dr. Bradley Messmer, Founder and CEO of Abreos Bio., to talk about partnering with research organizations in order to deliver products to patients faster.
Dick Woodruff, Senior Vice President for Federal Affairs Strategic Alliances at the American Cancer Society Cancer Action Network, presented a discussion on the political landscape surrounding and implications resulting from the 21st Century Cures Act and Affordable Care Act.
The summit wrapped up with accolades from Melissa Stafford Jones, Regional Director of Health and Human Services, Region IX, who commended the collective efforts of San Diego to grant increased access to clinical trials.
With the research and development institutions and companies in our backyards, we can expect our city to play a major role in how Moonshot 2020 plays out. But what can we expect this to look like as the head of the Moonshot initiative has just left office and the Trump administration is now in full control?
Moonshot Initiative in 2017: Don’t Expect Pence to Take Biden’s Place
The ushering in of a new administration will certainly impact the trajectory of Moonshot 2020. At the head of the discussion is who Trump will choose as his pick to direct the NIH. Additionally, while the congressional funding is set for year one of Moonshot 2020, the second year funding will be determined by a new congress. But, if the passing of the 21st Century Cures Act is any indication, the strong bipartisan support of the bill gives us good reason to believe that funding will, in fact, be continued. The 21st Century Cures Act passed in the House of Representatives with a 392-26 vote on November 30, 2016 and in the Senate by a 94-5 vote on December 7, 2016. If nothing else, all political parties share a common enemy in disease.
Greg Simon, Executive Director of the White House Task Force for Moonshot 2020, in a recent report said that these are things we know: both government and private programs will go forward, and scientific programs in the budget will continue. The programs are underway, they are funded and mission-oriented, and run by career people; Partnerships have been formed and good work has been started.
In January of this year, we’ve already seen the success of the initiative in giving rise to the NCI Formulary, a public-private partnership between the NCI and pharma and biotech companies. This is a hopeful outlook for collaboration as the partnership provides a channel for academic investigators to get fast access to agents for cancer clinical trial use that are comprised of the contributions and collaboration from multiple pharmaceutical companies.
As for Biden, on his way out of office he said that although the private sector, philanthropies, nonprofits, and academic institutions will perpetually push forward, he prays the Trump administration will play a contributing part in the efforts. The former Vice President himself will continue to pursue accelerated cancer research. Ten days before leaving the White House, Biden – who was recently awarded the Presidential Medal of Freedom – announced at the J.P. Morgan Healthcare Conference that he is to start an independent organization, the Biden Cancer Initiative to do just that.
The rest is all speculation for now
(For Biden’s hopes for Moonshot 2020 in the hands of Trump’s administration, see his recent talk at the World Economic Forum in Davos).