Building Blocks of Further Progress Against Cancer
Cancer Progress Report 2016: Contents
In this section you will learn:
Increasing federal support for biomedical research and cross-cutting research initiatives is crucial for furthering progress against cancer.
Regulatory science and policy play a key role in making continued progress against cancer.
Federal support is needed to develop and train the biomedical research workforce of tomorrow.
Precision prevention and early detection have the potential to reduce the burden of cancer.
It is a transformational time in cancer research. As we have delved deeper into the complexity of cancer, we have experienced an explosion in our understanding of the individual factors both inside and outside a cell that cause cancer initiation, development, and progression. This knowledge is beginning to unveil a clearer picture of how these factors work together and are influenced by each person’s unique biological characteristics.
Thanks to the efforts of countless researchers, physician-scientists, patient advocates, and other representatives from all sectors of the biomedical research community (see sidebar on
The Biomedical Research Community: Powering Progress Together), we are developing new methods for preventing, detecting, diagnosing, and treating cancer. More effective and less toxic interventions improve patient quality of life and ultimately, save more lives from cancer.
Between Aug. 1, 2015 and July 31, 2016, the FDA approved 18 new medical products for use in oncology—13 new anticancer therapeutics, one new cancer screening test, one new diagnostic test, two new diagnostic imaging agents, and a new medical device. During this same period, the FDA also approved new uses for 11 previously approved, anticancer therapeutics.
This progress would not have been possible without strong, bipartisan leadership and federal support for the NIH, NCI, and FDA and innovative programs, such as the Precision Medicine Initative (PMI). As the National Cancer Moonshot Initiative gets underway, it will be important that this promising effort receives support and robust funding as well (see sidebar on
Building Blocks of Further Progress Against Cancer).
Robust, Sustained, and Predictable Funding Increases for Biomedical Research
Federal funding through the NIH and NCI is the lifeblood of biomedical research and forms the foundation upon which the majority of scientific and medical discoveries are made. In the 45 years since President Nixon signed the National Cancer Act, investments in the NIH and NCI, in large part due to overwhelming bipartisan support from Congress, have resulted in extraordinary progress against cancer, as detailed in this report.
A strong federal investment in cancer research is good, both for our nation’s health and our economy. The impact of federal support for the NIH, NCI, and FDA reaches well beyond the laboratory and the clinic. More than 80 percent of the funds appropriated by Congress to the NIH are distributed to all 50 states and around the world to drive research, and it is estimated that every dollar invested in the NIH yields $2.21 in local economic growth. As a result, hundreds of thousands of jobs are created, and entirely new industries are established, such as the biotechnology industry.
As discussed by
Senator Roy Blunt, a decade of stagnant budgets at the NIH led to a more than 20 percent decline in purchasing power and threatened the United States’ position as the world leader in biomedical research. Recent funding increases signal an end to this troubling trend, but the budget must continue to grow at a level that outpaces inflation (see
Figure 17). This renewed investment in biomedical research will strengthen the position of the United States as the global leader in science and technology, and will ensure U.S. economic leadership in the 21st century.
Support for Cross-cutting Initiatives to Advance Progress Against Cancer
As highlighted in
Anticipating Future Progress, conquering a disease as complex as cancer requires a multidisciplinary approach, including collaborations with experts in areas of science, engineering, and technology that were not historically part of the cancer research ecosystem. Two examples of cross-cutting endeavors that are bringing many stakeholders together to advance progress against cancer are the National Cancer Moonshot Initiative and the Precision Medicine Initiative. These initiatives aim to bring various facets of the government, as well as the public and private sectors together to accelerate the pace of progress against disease, particularly cancer.
National Cancer Moonshot Initiative
During a speech in the White House Rose Garden on Oct. 21, 2015, where he was announcing that he would not run for President of the United States in 2016, Vice President Joe Biden referenced the tragic loss of his son to cancer and called for a “moonshot” to cure this terrible disease. The Vice President stated that we have a remarkable opportunity to advance many of the breakthroughs that are just on the horizon, provided that we join together to “make an absolute national commitment to end cancer, as we know it today.” In his final State of the Union address, President Obama followed Biden’s call with the announcement that he was tasking the Vice President with spearheading a national effort against cancer.
This extraordinary announcement was followed by the launch of the National Cancer Moonshot Initiative, which seeks to double the rate of progress toward a cure for cancer by achieving 10 years of progress in 5 years (see sidebar on
The National Cancer Moonshot Initiative). Since February 2016, the Vice President has created a federal interagency task force, bringing together every federal agency that has a role to play in addressing cancer. The Task Force is charged with producing recommendations before December 31, 2016, on how to accelerate the pace of progress across a number of areas—from cancer prevention and early detection, to patient access and care, to data and computational capabilities, to implementation science.
In April 2016, the Cancer Moonshot Blue Ribbon Panel was established to inform the scientific direction and goals at NCI of Vice President Biden’s National Cancer Moonshot initiative (see sidebar on
The National Cancer Moonshot Initiative). The 28-member panel, comprised of cancer researchers, physician-scientists, oncologists, patient advocates, and representatives from the private sector and government agencies, serves as a working group of the presidentially appointed National Cancer Advisory Board (NCAB). The Panel is co-chaired by Tyler Jacks, PhD, Chair, National Cancer Advisory Board Director, Koch Institute for Integrative Cancer Research, Massachusetts Institute of Technology ; Elizabeth Jaffee, MD, Professor and Deputy Director for Translational Research, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine; and Dinah Singer, PhD, Acting Deputy Director, National Cancer Institute, Director, Division of Cancer Biology, National Cancer Institute.
The FDA will also play an integral role in the implementation of the initiative. Towards this end, the FDA Oncology Center of Excellence (OCE) (see sidebar on
FDA Oncology Center of Excellence) was established. The OCE aims to expedite the development of novel combination products and support an integrated approach to tackling cancer.
The Precision Medicine Initiative
The Precision Medicine Initiative (PMI) was unveiled by President Barack Obama in January 2015. The goal of the PMI is to build on advances in precision oncology and extend precision medicine treatments to all forms of cancer and many other diseases.
Of the $300 million assigned to the PMI in the FY 2016 budget, $70 million were directed to the NCI to scale up efforts to identify genomic drivers of cancer and apply that knowledge in the development of more effective approaches to cancer treatment.
One area of particular focus is expanding precision medicine clinical trials, with an emphasis on supporting the NCI-Molecular Analysis for Therapy Choice (MATCH) clinical trial and planning and conducting a trial that will be known as NCI Pediatric MATCH. Other areas of focus include exploring fundamental aspects of cancer biology, and establishing a national “cancer knowledge network” to generate and share new knowledge to fuel scientific discovery and guide treatment decisions.
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Enhanced Support for Regulatory Science and Policy at the FDA
The FDA is an integral part of the biomedical research community, and the support of this critical agency through robust, annual appropriations from Congress is crucial if we are to continue to make progress against cancer through the delivery of safe, effective, and increasingly precise therapies to patients. The advancement of regulatory science, which is the study of developing new tools, standards, and approaches to assess the safety, efficacy, quality, validity, and performance of medical products, is especially important. The regulatory science initiatives of the FDA are aimed at promoting and developing evidence-based regulatory policies that balance innovation and the expedited approval of medical products with patient safety. These activities are not supported through user fees, but rather, depend on annual funding from Congress.
As research leads to more sophisticated and complex approaches to treatment, the process of approving those therapies must keep pace. Likewise, the FDA must keep abreast of the latest scientific and technological progress through discourse, cooperation, and collaboration with academia, industry, patient advocacy groups, and the government. Therefore, Congress must continue to equip the agency the resources it needs to support these regulatory processes, professional development of staff, and expand hiring authority.
Developing and Training the Workforce of Tomorrow
Many of the most innovative research questions and fresh ideas come from scientists early in their careers. Ensuring the pace of progress against cancer continues requires that the next generation of cancer researchers be recruited, supported and encouraged. A strong pipeline of talented researchers to whom current leaders in the field can pass the baton in the years to come will allow the work to continue in earnest to conquer this disease.
The current generation of early-career investigators has been privy to the exciting advancements that have been thus far described. At the same time, they have come of age in a decade when research funds were scarce, federal research budgets declined by more than 20 percent when adjusted for inflation, and the path forward was uncertain. Because of the difficult funding environment in recent years, many young investigators have opted for alternative career paths, thereby putting future generations of innovative research in jeopardy.
Our country must continue to invest in education and training of scientists at all career levels, but especially in the dawn of their careers. The cancer workforce of tomorrow also must reflect the increasing diversity in our country, including disciplinary, gender, racial, ethnic, and geographic diversity. Robust, sustained and predictable funding increases for the NIH, coupled with federal, state, and private sector-funded programs to assist early- career scientists, play an irreplaceable role in attracting and retaining tomorrow’s scientific leaders.
Precision Prevention and Early Detection
We know that more than half of global cancer cases are a result of preventable causes and that prevention is perhaps the most cost-effective strategy for controlling cancer in the long run. Thus, an increased focus on cancer prevention and early detection is required if we are to decrease cancer incidence, morbidity, mortality, and cost worldwide.
Thanks to the wealth of research demonstrating the health consequences of tobacco use, we have seen dramatic progress in the area of tobacco control through the implementation of policies and educational initiatives aimed at preventing use and facilitating cessation. As electronic nicotine delivery systems (ENDS), commonly called e-cigarettes, have proliferated in recent years, the need to understand and balance the potential cessation benefits and health risks associated with use of these products has grown (see sidebar on
E-cigarettes: What We Know and What We Need to Know). Recently, the FDA announced it would take the important step of regulating these tobacco- derived products and increase efforts to keep them out of the hands of youth (see sidebar on
Enhancing Tobacco Control Through FDA Regulation).
As discussed in
Protect Skin From UV Exposure, skin cancer prevention also remains a critical issue where significant, additional progress can be made. There is a growing body of scientific evidence that shows indoor tanning dramatically increases a person’s risk of skin cancer, including melanoma (65). In fact, one study found that individuals who have been exposed to UV radiation from indoor tanning before the age of 35 are 59 percent more likely to develop melanoma than those who have never tanned indoors (203). In an effort to strengthen policies in this area, the FDA issued a proposed rule in 2016 to prohibit the use of tanning beds by those under age 18 (see sidebar on
Indoor Tanning Legislation).
Increasingly, scientists are applying the principles of precision medicine to prevention, and this is a rapidly growing area of research (see
Anticipating Future Progress). Advances in genomic technologies can lead to improved prevention and early detection strategies. As we develop a better understanding of common genetic variants associated with a higher or lower risk of certain cancers, we may be able to use that knowledge to identify individuals who may or may not benefit from particular prevention strategies.
With respect to early detection, precision medicine applications can enable noninvasive screening for very early cancers. Liquid biopsies, noninvasive tests performed on biofluids to detect genetic alterations in tumors, are a recent revolution in the oncology field, and the technology is continuing to advance rapidly. In fact, the first liquid biopsy test was approved by the FDA in June 2016 to identify patients with metastatic NSCLC eligible for treatment with the EGFR-targeted therapeutic erlotinib (see
Helping Some Lung Cancer Patients Breathe Easier). When successfully integrated into clinics, liquid biopsies have the potential to improve all aspects of clinical cancer care, including early detection.
Although liquid biopsies offer manifold possibilities for improving cancer care, as with any emerging technology, there are many practical and logistical challenges in taking this technology to the next level and making it a standard of care for patients with cancer.
Strong support for cancer prevention research, coupled with support for a regulatory environment that will support the translation of this technology into improved patient care, is essential to move the needle toward prevention and early detection and ultimately, to saving more lives from cancer.
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Progress Report 2016 Contents