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advisory Blue Ribbon Panel to inform the scientific direction and goals of the National Cancer Moonshot Initiative and report back to the Task Force about the research areas with the greatest potential to drive significant advancement . 3
“ For example , immunotherapy is likely to be one of the areas that we will want to put a lot of attention into ,” Dr . Singer , who is one of three co-chairs of the panel , said . “ We know that some immunotherapies , including antibody-based immunotherapies and checkpoint inhibitors , are very promising , but we have a long way to go in understanding when and in which populations they are effective .”
While the Blue Ribbon Panel will be charged with addressing the cancer research issues of the Initiative , the Task Force will address the broader , non – research-based questions of the Initiative .
Formed in April , the Blue Ribbon Panel includes scientific experts from a variety of backgrounds , cancer leaders , and patient advocates . For instance , Deborah K . Mayer , PhD , RN , a professor at the school of nursing and director of cancer survivorship at the UNC Lineberger Comprehensive Care Center in Chapel Hill , North Carolina , brings 40 years of experience as an oncology nurse to the panel , which she said has given her a unique understanding of what it ’ s like to be on the front lines of cancer care .
“ All of the clinicians on this panel have an in-depth knowledge about what patients and families go through ,” Dr . Mayer said . “ We are also looking beyond treatmentfocused groups and toward survivorship and palliative care .”
The panel will have until late August to develop its recommendations before reporting its conclusions to the Task Force and the National Cancer Advisory Board .
To help the panel achieve its task , it has formed a series of workgroups , each comprised of just over a dozen subject matter experts , NCI staff members , and representatives from the private sector and advocacy groups . The panel created seven distinct workgroups ; each one is responsible for a different aspect of cancer research :
• Cancer immunology and prevention
• Precision , prevention , and early detection
• Tumor evolution and progression
• Expanding clinical trials
• Pediatric cancer
• Enhanced data sharing
• Implementation sciences
Each workgroup will create two to three recommendations within its subject area and present ideas to the Blue Ribbon
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Panel in mid-June . “ The Blue Ribbon Panel will then look at all those recommendations , synthesize them , refine them , and ultimately put them into its report ,” Dr . Singer explained .
The panel plans to include just five to 10 recommendations in its report to the Task Force and National Cancer Advisory Board . “ To truly galvanize people around an idea , to gather the resources we ’ ll need , and to develop the technology we ’ ll require , we have to focus on a few things ,” Dr . Singer said . Dr . Mayer added that she believes the Initiative will help address one of the biggest challenges facing cancer research : making sure all people have access to the latest research and treatments . “ Our goal is really to see what we can invest in to accelerate research even further , and then to ensure that what we find is available to those in need ,” she said .
The Initiative is also answering questions about how the research community can improve clinical trials – especially in adults with cancer , who are less likely to be enrolled in clinical trials than their pediatric counterparts . “ How much can we accelerate research if we were able to enroll many more adults in our studies ?” Dr . Mayer asked . “ How do we take advantage of the data that exist in electronic health records or databases in a way that will help us answer questions outside of clinical trials ?”
Follow the Funding
While it ’ s still unclear how the $ 1 billion allocated for the Initiative will be distributed , the White House has said the funding will go to support cutting-edge research opportunities in areas such as :
• Prevention and cancer vaccine development
• Early cancer detection
• Cancer immunotherapy and combination therapy
• Genomic analysis of tumor and surrounding cells
• Enhanced data sharing
• Pediatric cancer
The U . S . Food and Drug Administration ( FDA ) will also receive funding to establish a virtual Oncology Center of Excellence , that will , as the White House stated , “ leverage the combined skills of regulatory scientists and reviewers with expertise in drugs , biologics , and devices ” to speed the development of new oncology therapies , combination products , and diagnostic tests .
Few details are known about the center ’ s design , but FDA Commissioner Robert Califf , MD , suggested that reorganizing the agency ’ s oncology division could help expedite approvals . For example , combination product reviews can be slow because they
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require approval from the agency ’ s device and drug divisions ; pairing the relevant drug and device review staff together would hopefully alleviate delays .
Addressing a meeting of the Alliance for a Stronger FDA , Dr . Califf said , “ It ’ s not going to be purely virtual .” 4
In the fiscal year 2016 , the National Institutes of Health has been given $ 195 million for new cancer activities as part of the Moonshot Initiative , and the bulk of the funding will be included as part of the fiscal year 2017 budget . The Moonshot funding is in addition to the normal funding appropriations for cancer research and care ; for instance , the NCI will still have its normal appropriations budget of $ 5 billion . The Departments of Defense and the Veterans Affairs are also expected to increase their research investment as part of the Initiative . Ideally , the additional funding will give researchers incentive to study hardto-treat , more uncommon cancers – those that historically have received a smaller portion of the NIH ’ s budget than more common cancers . 5 The NIH ’ s funding has ebbed and flowed in the past , and , subsequently , so has the grant funding available to cancer researchers – making them more likely to focus on areas they know can yield publishable results to increase their odds of getting funded .
Only 16 percent of all grant applications are successfully funded , NIH Director Francis Collins , MD , PhD , noted at this year ’ s Milken Institute Global Conference . “ We ’ re not lacking for ideas , we ’ re not lacking for talent . We ’ re scaring away some of the talent .” 6
” We will continue to invest broadly in cancer research through our normal mechanisms of investigator-initiated research , our consortia network , and our clinical trials ,” Dr . Singer said , “ but this Initiative is an exceptional opportunity to do something really different that moves specific fields forward and makes a difference for patients .”
Homing in on the Target
The scope of the Initiative may seem overwhelming , but the sources who spoke with ASH Clinical News said that , as recommendations from the workgroups and the Blue Ribbon Panel come in , its focus will start to narrow and the steps to achieving these goals will become clearer .
Dr . Singer also acknowledged that the Initiative won ’ t touch on all aspects of cancer research and care . “ This is not going to be business as usual . We are looking for things that are exceptional .”
Regardless of which research areas and recommendations are selected as priorities , the announcement of the Moonshot Initiative has created a sense of enthusiasm and camaraderie among researchers .
“ There is huge excitement about the possibilities ,” Dr . Singer said . “ I think people are going to be energized by the amount of attention that is being given to cancer research , even if their own specific area isn ’ t
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identified as one that ’ s ripe for funding .”
The Blue Ribbon Panel hopes that enthusiasm extends to the American public . In addition to including voices from patient advocacy groups on its panel , they are also asking for the public ’ s input through the Cancer Research Ideas website ( cancer researchideas . cancer . gov ). People are encouraged to submit their ideas for research in the areas mentioned above ; from this information , NCI hopes to learn more about which issues matter most to the public and which areas the public views as those with the greatest needs and opportunities .
ASH has weighed in on the initiative as well , meeting with the White House in late April to offer its help and support . ( See the SIDEBAR for more on this visit .) “ ASH is poised to , on one hand , ensure that patients with hematologic malignancies are also benefitting from this Initiative in each of the selected topic areas and , on the other hand , to help assure that we do have realistic goals in each of these areas ,” Dr . Anderson said . “ We view this opportunity as a jumping-off point for a larger collaborative effort .”
Breaking Down Data Silos
Another hallmark of the Moonshot Initiative is its commitment to data sharing . While this has proven to be a divisive issue among the research community ( see last month ’ s feature story , “ Attack of the Data Suckers !” for some perspective ), those involved with the effort hope the emphasis on opening up data access will break down barriers between research institutions and enhance the collective knowledge of the research community .
Vice President Biden underscored the importance of collaboration in an address presented at the American Association of Cancer Research ’ s 2016 Annual Meeting in April . 7 “ I ask you a rhetorical question : Are we collaborating enough ? What can you do ? What can we do ?”
“ The way the system now is set up , researchers are not incentivized to share their data ,” he remarked . “ Together we can redesign a new system – or adjust to a new system that better supports your efforts and save lives sooner than otherwise would have been . … We have to work together . We have to give you the ability to take chances . We have to help you do what you want to do : Put patients first .”
Improved data sharing will be particularly relevant to those who treat patients with hematologic malignancies , due to the complexity and heterogeneity of cancer . “ A genomically profiled , clinically annotated database is essential for to improve the understanding and treatment of hematologic cancers ,” Dr . Anderson commented .
He added that , for real progress to take place , institutions , researchers , and private and public entities must collaborate . “ The complexity of our diseases requires that we pool data to have significant numbers of patients to reach conclusions and , ultimately , to deliver optimal treatments to
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