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​Cancer Policy Monitor - November 13, 2018

Appropriations Update: Congress Racing to Complete Remaining FY 2019 Spending Bills, Including FDA

By Dashiell Delan

Following the election, Congress will return to Washington for a “lame duck” session, and it faces a slew of remaining fiscal year (FY) 2019 appropriations bills, including the one that funds the Food and Drug Administration (FDA.) In September, Congress passed H.R. 6157, the fiscal year (FY) 2019 appropriations "minibus" bill comprised of the Labor, Health and Human Services (HHS), Education bill and the Department of Defense bill. The package, which includes $39.1 billion (a $2 billion increase) for the National Institutes of Health (NIH), also includes $6.14 billion for the National Cancer Institute. With the enactment of this bill, the NIH has now received its fourth consecutive and significant annual increase in funding, a boost of 30 percent ($9 billion) above the budget in FY 2015. 

While not itself controversial, the FY 2019 funding for FDA is caught in a package of bills that have not yet passed and are currently operating under a Continuing Resolution (CR) until Dec. 7. There is some post-election concern that there may not be political appetite to pass the remaining appropriations bills before current CR funding expires. If an agreement on the bills or passage of another CR cannot be accomplished by this deadline, a government shutdown remains a possibility. There is also potential gridlock looming in the next Congress because Democrats will control the House of Representatives, but Republicans will remain in control of the Senate. 

The split Congress resulting from the election could prove pivotal to both the fate of these appropriations bills and the likelihood of a partial government shutdown should no agreement on the bills be reached. The president continues to push for funding for the border wall, which is highly controversial, and could halt work to complete the bills. 

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Clinical Outcome Assessments: Nothing About Me Without Me

By Carrie Treadwell, MBA

Clinical Outcome Assessments (COAs) measure outcomes that describe or reflect how any individual feels, functions, or survives. COAs can be incorporated into clinical trials as primary efficacy endpoints, secondary endpoints, or as exploratory endpoints. Unlike biomarkers that rely on an automated process or algorithm, COAs depend on the implementation, interpretation, and reporting from a patient, a clinician, or an observer.

COA is an umbrella term that encompasses four measures:  patient-reported outcomes (PROs), clinician-reported outcomes (ClinROs), observer-reported outcomes (ObsROs), and performance outcomes (PerfOs). COAs may, or may not, be patient-centered outcomes which measure outcomes identified as important by the patient. 

The Food and Drug Administration (FDA) and Congress recognize the importance of incorporating patient perspectives in all areas of the biomedical research system. This is supported by the passage of 21st Century Cures Act of 2016 (Section 3002), the sixth authorization of the Prescription Drug User Fee Act (PDUFA VI), and initiation of Patient Focused Drug Development efforts.

Recently, the FDA embarked on a five-year effort to develop a series of guidance on the collection of patient experience data, and the use of this data in drug development. To gather input and insight from the community, FDA is hosting a series of public workshops delving into COAs and Real-World Evidence (RWE) to support regulatory decision making. Exogenous factors such as genomics, behavior, and social and environmental influences, play a critical role in delivering clinical outcomes and value to survivors. Technology is now capable of supporting the capture and analysis of this real-world data.

FDA defines real-world data (RWD) as health care information derived from multiple sources outside of typical clinical research settings, including electronic medical records (EMRs), claims and billing data, product and disease registries, and data gathered by personal devices and health applications. COAs are often integrated into EMRs, and there is an increase in use of personal devices to collect COA data.

RWE is the clinical evidence regarding the usage, and potential benefits or risks, of a medical product following analysis of RWD. The FDA acknowledges that these datasets can "effectively complement the knowledge gained from 'traditional' clinical trials, whose well-known limitations make it difficult to generalize findings to larger, more inclusive populations of patients..."

The most recent FDA public workshop was convened in October 2018 to obtain feedback on considerations for patient focused drug development documents Guidance 2 and Guidance 3.  These documents will replace the FDA's 2009 guidance document on patient reported outcomes. 

The deadline to submit comments through the public docket is Dec. 14, 2018.

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ODAC Unanimously Supports Biosimilar Candidate

By Trevan Locke, PhD

In October, the Oncologic Drugs Advisory Committee (ODAC) met to discuss the Celltrion biosimilar candidate, CT-P10, for rituximab (Rituxan), a treatment for non-Hodgkin's lymphoma (NHL). For a biosimilar to be approved, it must be highly similar to and have no clinically meaningful differences from its reference product- an already U.S. Food and Drug Administration (FDA) approved product to which the biosimilar is compared.

Celltrion presented the committee with data from assays that showed CT-P10 was highly similar to the rituximab reference product. Celltrion presented clinical data to demonstrate no clinically meaningful differences in pharmacology, efficacy, or safety between the two products. From the initial trials conducted, one raised safety questions based on higher rates of neutropenia in patients randomized to the CT-P10 arm of the trial. Another more robust study was conducted to answer these questions and showed no meaningful difference between the two products.

After presentations by Celltrion and the FDA, the committee voted on whether the totality of evidence supported licensure of CT-P10 as a biosimilar to rituximab. With a unanimous vote (16-yes, 0-no), the ODAC agreed that the evidence suggested CT-P10 be approved for three NHL indications of rituximab. Approval for other rituximab indications was not being pursued because of active exclusivities for the reference product.

Through the Biosimilar Action Plan released earlier this year, the FDA seeks to accelerate biosimilar development while maintaining agency standards for safety and efficacy. Increased competition from biosimilars is thought to lower cost and improve access to important therapies. Biosimilar development efforts are particularly relevant in the cancer space, where many new therapies are biologics. If approved, CT-P10 would be the third approved biosimilar for a cancer therapy in the U.S.

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FDA Intensifies Crackdown on Underage Vaping - E-Cigarette Manufacturers are on Notice

By Nicole Boschi, PhD

Electronic cigarettes (e-cigarettes) are the most commonly used tobacco product among U.S. youth. Many public health experts, including the Commissioner of the U.S. Food and Drug Administration (FDA), Scott Gottlieb, MD, believe that youth use of e-cigarettes has reached an epidemic proportion. In October 2018, Dr. Gottlieb announced that e-cigarette manufacturers were "on notice" and stated that the FDA would take swift action against those that the agency believes are skirting the law.

In July 2017, the FDA extended timelines to submit tobacco product applications for newly regulated tobacco products, such as e-cigarettes, that were on the market as of Aug. 8, 2016. This action was intended to allow time for the FDA to develop product standards to protect against known public health risks of e-cigarettes, study e-cigarette battery issues, and address concerns regarding children's exposure to liquid nicotine. The delay was also intended to provide manufacturers additional time to develop higher quality, more complete product applications. However, given the growing epidemic of youth e-cigarette use, there is evidence that manufacturers have taken advantage of the delayed enforcement to introduce products designed to attract children. In September 2018, Dr. Gottlieb announced that the FDA was launching massive enforcement actions against retailers for allegedly selling e-cigarettes to minors and warned manufacturers of a potential ban on flavored e-cigarette liquids.

Following through on the announced enforcement actions, the FDA conducted a surprise inspection of the San Francisco corporate headquarters of the e-cigarette manufacturer, Juul Labs. Juul manufactures sleek, flavored e-cigarette devices resembling UBS flash drives that are popular among youth. During the inspection, the agency seized more than 1,000 pages of documents related to Juul's marketing practices and product design. The FDA will inspect these documents to determine if Juul intentionally targeted minors in the design and marketing of their e-cigarette products. The inspection followed an earlier FDA request that Juul Labs submit information on the high rates of youth use of their product. In addition to this surprise inspection, the FDA has sent letters to 21 other e-cigarette companies seeking information on more than 40 products that are being illegally marketed under the agency's current policies. 

On Oct. 25, 2018, Altria, the parent company of Philip Morris USA, announced that it would discontinue most of its flavored e-cigarettes and stop selling some of its e-cigarette brands altogether. Additionally, the company announced that it would support federal legislation to raise the tobacco purchase age from 18 to 21 years old. Altria currently sells two types of vaping products but, relative to Juul, only occupies a small share of the vaping market.

In addition to regulatory action, the youth e-cigarette epidemic has garnered congressional interest as well. In July 2018, the AACR held a congressional briefing co-sponsored by Senator Dick Durbin (D-IL) and Representative Jackie Speier (D-CA) to update policymakers and the public on the latest scientific evidence related to e-cigarettes and to start a dialogue about challenges and potential solutions in preventing youth vaping. Shortly after this briefing, on Aug. 1, 2018, Senators Dick Durbin and Lisa Murkowski (R-AK) introduced the Stopping Appealing Flavors in E-Cigarettes for Kids Act (SAFE Act), which would immediately ban the use of flavorings in cigars and would give tobacco companies one year to prove that e-cigarette flavorings: (1) aid in adult smoking cessation; (2) do not attract children to tobacco products; (3) and do not harm the user.  On Oct. 2, 2018, Senators Durbin and Murkowski sent a letter to Dr. Gottlieb urging that the FDA act immediately to ban kid-friendly e-cigarette flavorings. Although the senators state that they were encouraged by recent FDA enforcement actions, they remain skeptical that tobacco manufacturers will adequately respond to public health concerns in a manner that goes beyond mere rhetoric. Following the Durbin Murkowski letter, on Oct. 29, 2018, 15 Democratic senators, led by Senators Wyden (D-OR), Durbin (D-IL), and Murray (D-WA), sent another letter to Dr. Gottlieb urging the FDA to require manufacturers to remove all kid-appealing flavored e-cigarette products from the market unless or until they can demonstrate that flavors have a public health benefit and that they do not attract children to using these addictive products. 

The AACR's Tobacco and Cancer Subcommittee, chaired by Roy S. Herbst, MD, PhD, will continue to advocate for new and novel research on e-cigarettes. This research should identify the toxicants in e-cigarette products, elucidate the short- and long-term effects on patients' health (especially cancer patients), and determine whether cancer patients should use these products to cease using combustible cigarettes. Finally, the AACR recommends that flavorings designed for these products undergo FDA review to determine their safety for inhalation, appropriateness for current smokers seeking to quit using tobacco products, and that the product is not designed to attract nor is marketed to children. The AACR recommends that children and non-tobacco users never use e-cigarette products.

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National and Global Efforts to Reduce the Incidence of and Mortality from HPV-Related Cancers

By Nicole Boschi, PhD

According to the U.S. Centers for Disease Control and Prevention (CDC), every year in the U.S., 33,700 women and men are diagnosed with a cancer caused by HPV infection. Although HPV infection is most commonly associated with cervical cancer in women, the virus can also cause cancers of the penis in men, cancers of the vagina and vulva in women, and cancers of the anus and back of the throat (oropharynx) in men and women. HPV vaccination could prevent more than 90 percent of these cancers, roughly 31,200 cases per year, from developing. This statistic underscores the public health importance of vaccination in reducing the incidence of and mortality from HPV-related cancers both in the U.S. and worldwide.

In the U.S., the Food and Drug Administration (FDA) recently approved the expanded use of the HPV 9-valent vaccine, Gardasil 9. Gardasil was initially approved by the FDA in 2006 to prevent cancers and diseases caused by four types of HPV. In 2014, the FDA approved Gardasil 9 which covered an additional five types of the virus, but the vaccine was only approved for use in males and females aged 9 - 26 years. On Oct. 5, 2018, the FDA announced the approval of expanded use of Gardasil 9 to include individuals 27 - 45 years old. Currently, the FDA recommends two doses of the vaccine for individuals under age 15 and a three-dose regimen for those 15 - 45 years old. An advisory panel at the CDC is currently discussing the data on using the vaccine in an older population and is expected to make a recommendation on its use in the expanded age group.

Internationally, Australia is celebrating the results of a study published in The Lancet Public Health that found that by 2028, fewer than four women in every 100,000 could be diagnosed with cervical cancer annually in the nation. This finding would make Australia the first country to essentially eliminate cervical cancer. This public health success was achieved through a combination of government action along with widespread public education and support. In 2007, the Australian government introduced a cost-free three-dose school-based vaccination program for teenage girls. In 2013, the program was expanded to school-aged boys. A cervical cancer screening program has been important for reducing rates of HPV in older adults who might have already been exposed to the virus.  

Although progress in HPV prevention is being celebrated, there have been challenges in implementing vaccination programs worldwide. In Japan, HPV vaccination rates were close to 70 percent, but recent fear campaigns that have spread misinformation regarding risks associated with vaccines have dropped that rate to nearly zero. In the U.S., data from the Kaiser Family Foundation has shown that in 2017, only half of those aged 13 - 17 were up-to-date with their HPV vaccinations. Additionally, HPV vaccination rates among teen boys are lower than for girls (44 percent vs. 53 percent), but they have been rapidly rising since 2011.

Eliminating HPV-related cancers will require researchers, health care providers, patients, community leaders, and government officials to work together to solve the impediments to implementation. The U.S. Department of Health and Human Services, through the Healthy People 2020 initiative, has introduced a goal of reaching a vaccination rate of 80 percent for both girls and boys by the year 2020. In order to help achieve this goal, the AACR has joined the National HPV Vaccination Roundtable whose goal is to reduce the number of HPV cancers and cervical precancerous lesions as well as non-cancer outcomes through: (1) increased frequency and strength of clinician recommendations for HPV vaccine; (2) decreased missed opportunities for HPV vaccine administration; and (3) increased HPV vaccination rates at national and states levels, with a focus on girls and boys ages 11 - 12.

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FDA Releases Minimal Residual Disease Draft Guidance

By Trevan Locke, PhD

In October, U.S Food and Drug Administration (FDA) released draft guidance titled, Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biologic Products for Treatment, which covers regulatory considerations for the use of minimal residual disease (MRD) in drug development. MRD positivity is the detection of low numbers of malignant cells that remain after treatment of blood cancer. A patient that is MRD positive is generally considered at a higher risk for relapse. This draft guidance describes potential uses of MRD as a biomarker in the context of clinical trials or to support marketing approval of products for the treatment of certain blood cancers.

The FDA issued the draft guidance to address inconsistencies in MRD data in marketing applications submitted to the agency. It provides direction on validating and using MRD status as a surrogate endpoint of drug efficacy. From a prognostic perspective, the guidance allows for the use of MRD status to improve risk classification and as a stratification factor for patient enrichment. Technical considerations for assays used to measure MRD level are also provided, including specific guidelines for cell-based and molecular-based assay platforms. While considerations vary for each test, the agency is agnostic to platform choice. However, developers must properly prespecify and analytically validate their chosen platform. The guidance also outlines specific regulatory considerations for the use of MRD status in leukemias and multiple myeloma.

Another important consideration for MRD status addressed in the draft guidance is the threshold for MRD positivity. The agency states, "the sensitivity of the MRD assay should be at least 10-fold below the clinical decision-making threshold." Under this recommendation, if MRD positive or negative is defined as detection of greater or less than one malignant cell per 100,000 cells, then the assay should be optimized and validated for detecting one malignant cell per 1,000,000 cells.

The release of this draft guidance follows the recent authorization of the ClonoSEQ next-generation sequencing test for measuring low levels of MRD. Data from a retrospective analysis of patients with acute lymphoblastic leukemia (ALL) or multiple myeloma showed that lower MRD level correlated to longer event-free survival for ALL patients and longer progression-free survival for multiple myeloma patients. The ClonoSEQ authorization created a new regulatory classification, which will allow subsequent devices to obtain marketing authorization via the 510(k) process by demonstrating substantial equivalence to the assay as a predicate device.

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MDIC Project to Develop NGS Reference Samples

By Trevan Locke, PhD, and Sarah K. Martin, MS, PhD      

Next generation sequencing (NGS)-based diagnostics are transforming the landscape of clinical oncology. However, a dearth of agreed-upon, well-characterized, and community-validated reference samples represents a challenge for development and understanding of NGS results. The Medical Device Innovation Consortium (MDIC) Somatic Reference Sample (SRS) project aims to develop properly-consented, widely-shareable somatic reference samples that can be made available to the public and produced in order to enable efficient development and improve the accuracy, reliability and transparency of NGS-based oncology tests.  

Already well-underway, the SRS project is set to occur in two phases. The Landscape Analysis Subgroup contributed to the first phase of the project by conducting a thorough review of existing NGS reference products to identify gaps in what is currently availableInterested NGS assay developers may contribute to ensuring the completeness of the landscape analysis by participating in a brief online survey here to share insights on reference samples currently used in their labs and any unmet needs they have observed 

Additionally, the Variants Subgroup contributed to phase 1 of the project by developing a prioritized list of genetic variants to be considered by the cancer research community for inclusion in the reference samples. On Nov. 8, MDIC hosted a webinar to discuss the list of variants, review their process and criteria for variant prioritization, and outline a process for gathering public input. Participating in the webinar were Stayce Beck, PhD, MPH, director of personalized medicine, U.S. Food and Drug Administration; J.D. Alvarez, MD, PhD, head oncology diagnostics, Janssen R&D; and Timothy McDaniel, PhD, SVP emerging opportunities, TGen and City of Hope. The Variants Subgroup welcomes feedback on the list, which can be submitted by emailing them directly at SRS-Variants@mdic.org  

The second phase of the project will work toward producing and characterizing the NGS reference samples containing the variants prioritized and agreed upon during phase 1. To learn more about the importance and regulatory implications of NGS-reference samples, watch the complimentary webcast of our 2018 AACR Annual Meeting session, “Cancer Genomic Reference Samples – Sequencing Consortium Results and Beyond.” 

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FDA Public Workshop: Partners in Progress 2018 - Cancer Patient Advocates and FDA

The FDA Oncology Center of Excellence will hold its second annual educational workshop for new cancer patient advocates, "Partners in Progress: Cancer Patient Advocates and FDA." The objectives are to provide basic training on the role of the FDA and cancer patient advocates in oncology product development. This broad introduction to FDA regulatory aspects of oncology product development is most relevant to attendees with limited knowledge and experience in cancer product development and patient advocacy.

Attendees will:

  • Learn more about cancer treatment development, diagnosis, devices, drugs, and beyond
  • Hear how patient advocates are crucial to supporting FDA's mission
  • Hear about recent approvals from CBER, CDER, and CDRH
  • Interact with FDA staff and leadership

Registration is available for both in-person attendance and remote webcast attendance.

In-person attendees will receive complimentary beverages and lunch courtesy of the supporting organizations (Cancer Support Community, Leukemia and Lymphoma Society, and Susan G. Komen Foundation).

Date: Nov. 27, 2018

Time: 9 a.m. to 4 p.m.

Location: FDA White Oak Campus
Building 31, Room 1503 - Great Room
10903 New Hampshire Avenue
Silver Spring, MD 20993

Click here for registration information.

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2019 AACR Early-Career Hill Day

The AACR will once again offer a limited number of Associate Members the opportunity to get involved in advocacy by engaging and educating key congressional leadership regarding the needs of cancer researchers, particularly those early in their careers. Submit an application to join us for 2019 AACR Early-Career Hill Day in Washington, D.C. on Feb. 27-28, 2019.

Click here to learn more.  Click here to apply

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The Science of Cancer Health Disparities

By Carrie Treadwell, MBA and Karen Russell, MA

Minority, immigrant, and disadvantaged populations continue to experience excessive cancer burden due to a number of factors including access to health care, cultural barriers, environmental factors, co-morbidities, and ancestry related risk factors. These factors are likely causes of the existing cancer health disparities in the US and globally. There is strong evidence from migration studies that the environment defines cancer risk, but there is also evidence that population differences in genetic ancestry can lead to population differences in cancer susceptibility. (Brid Ryan, 2018)

To improve understanding of cancer health disparities the National Cancer Institute hosted the Second Symposium on Cancer Health Disparities, Oct. 25-26 in Bethesda, Maryland.  Researchers presented advances in the causes of cancer health disparities in the US and globally, discussed disparities in cancer outcome and survivorship, and strategized how to reduce these disparities through novel approaches in prevention, the use of immunotherapy, and precision medicine.

Addressing cancer health disparities has been a priority for the American Association for Cancer Research (AACR) since 2006.  Last month, the AACR hosted its second think tank on Cancer Health Disparities in Washington, D.C., chaired by Dr. John D. Carpten, USC Keck School of Medicine and cochaired by Drs. Marcia R. Ruz-Correa from University of Puerto Rico, Brian M. Rivers from Morehouse School of Medicine, and Sanya A. Springfield from National Cancer Institute. The think tank convened seminal leaders to set an agenda to increase participation of underrepresented groups in clinical trials, accelerate research into the science of cancer health disparities, and train the next generation of cancer health disparities workforce.

Momentum continued at AACR's 11th Conference on The Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved, Nov. 2-5, organized in association with the AACR Minorities in Cancer Research Council. The goal of the conference was to advance the understanding of, and ultimately help to eliminate, the disparities along the cancer continuum.  Professionals from academia, industry, government, and the community came together to promote the exchange of novel ideas, discuss the latest findings in the field, and stimulate the development of new research on health disparities.

Dr. Norman E. Sharpless, director of the National Cancer Institute, presented the keynote lecture during the opening session, which also included patient advocates from AACR's Scientist<->Survivor Program (SSP). SSP is an educational program for both cancer survivors and researchers to fuel advances in the development of patient-centric cancer treatments. Advocates were an integral part of the conference, providing insights as panelists and lead presenters, in scientific and advocacy sessions.

More information can be found in the Cancer Research Catalyst blog, with links to the advocacy session "Addressing Advocacy at the Bench" and a conference recap "YouTube Live from New Orleans,", featuring patient advocate Sheila McGlowen and conference cochairs Ivis Febus-Sampayo, SHARE Cancer Support, Laura Fejerman, University of California San Francisco, Scarlet Lin Gomez, University of California San Francisco,  Augusto C. Ochoa, Louisiana State University Health Sciences, and Brian M. Rivers, Morehouse School of Medicine.

Congratulations to Chanita Hughes-Halbert, Medical University of South Carolina, for receiving the Ninth Annual AACR Distinguished Lectureship on the Science of Cancer Health Disparities, supported by a generous grant from Susan G. Komen. Dr. Hughes-Halbert's lecture was titled, "Towards understanding psychosocial and behavioral issues in cancer health disparities."

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Capitol Corner: AACR Interviews Members of Congress

Every month, the AACR will be interviewing members of Congress to get their personal story and views on cancer research. This month, we interviewed Senator Patty Murray (D-Washington).

Senator Murray is the Ranking Member on the Senate Health, Education, Labor, and Pensions (HELP) Committee and the Labor, Health and Human Services (HHS) Appropriations Subcommittee. Senator Murray is also a 2017 recipient of the AACR's Public Service Award.

Read our previous interviews with Congressman Ted Poe (R-TX), Congressman Mark DeSaulnier (D-CA), Congressman Bradley Byrne (R-AL), Congressman Markwayne Mullin (R-OK), Senator John Boozman (R-AR), Congressman Steve Stivers (R-OH), Senator Maggie Hassan (D-NH), Congresswoman Kristi Noem (R-SD), Senator Johnny Isakson (R-GA), Congressman Joseph Crowley (D-NY), Senator Jon Tester (D-MT), Congressman Dave Reichert (R-WA), Senator Gary Peters (D-MI), Congressman Charlie Crist (D-FL), Senator Susan Collins (R-ME), Congressman Dwight Evans (D-PA), Senator Chuck Grassley(R-IA), Senator Tammy Baldwin (D-WI), Congressman Brett Guthrie (R-KY) and Congresswoman Suzan DelBene (D-WA).

Senator Patty Murray (D-Washington)

Can you share with our readers, many of whom are cancer survivors, advocates, and researchers, your personal connection to cancer?

There is no community, no family, no person in this country who has not been impacted in some way by a loved one's cancer diagnosis. Two out of every five people in the country will face a cancer diagnosis in their lifetimes. I know so many people who have faced the tragedy of cancer, and heard the stories of many other families across Washington state and across the country.

How has the experience of dealing with cancer in your community, both personally and from stories you've heard from your constituents, shaped your views as a policymaker and a public official?

Hearing from families and communities across Washington state has made it clear just how heartbreaking the battle against cancer is for patients and their loved ones, and how important it is as we focus on policies to help support them. In Washington state, we have seen how breakthroughs in treatment can have a big impact for patients and families. It was medical research at Washington's Fred Hutchinson Cancer Research Center that helped pioneer bone marrow transplantation treatments that now save as many as 70,000 lives a year. And every year brings new stories of breakthroughs for science—and, more importantly, breakthroughs for patients and their families. 

When I visited the Ben Towne Center for Childhood Cancer Research at Seattle Children's Hospital, I heard about a beloved young patient there fighting cancer who had exhausted almost all of his treatment options—until they tried a new immunotherapy treatment. Ten days later he was in remission. That young man not only got better, he went on to get a job as a medical technician working at Seattle Children's Hospital himself. Stories like his show what a difference new discoveries can make, and why it's important we continue to increase our understanding of how to prevent cancer, how to reduce the risk of it, and how to treat it.

Speaking with families, it's clear we must not only fund research and new treatments, we also need to continue efforts to expand access to lifesaving care like screenings to catch cancer and different types of therapies to treat it. That means defending protections for people with pre-existing conditions so that insurance companies can't discriminate against cancer patients and make it harder for them to afford the care they need. This is especially important for cancer survivors, particularly childhood survivors who may face additional complications and need coordinated care throughout their lives.

As Ranking Member of both the U.S. Senate Appropriations Subcommittee on Labor, Health and Human Services (HHS) and the Senate HELP Committee, you are a strong and outspoken champion for medical research on Capitol Hill, and a leader in the effort to provide the National Institutes of Health (NIH) with the largest increases in funding in more than a decade. Why do you believe that robust funding increases for NIH are so important at this time? What would you say to your colleagues in the legislative branch who may not understand as you do how important federal investment in medical research is to our nation?

We've seen in the past how new research leads to life-changing, and lifesaving discoveries for patients, families, caregivers, researchers, and providers fighting cancer. We don't know what the next breakthrough will be, but we do know that sustained investments in research are critical to help us find it. Scientific discoveries aren't always predictable, but funding for scientific research needs to be, in order to allow our researchers to support long-term projects, build on past discoveries, and pursue new ones. We know the purchasing power of every dollar we invest in biomedical research declines each year, which makes increased funding for these efforts all the more important.

Continued investment is also critical to make sure we maintain the cutting-edge infrastructure we need to make cutting-edge discoveries. This is especially important when it comes to the biomedical research talent pipeline. We need to support our early stage investigators and make the investments necessary to bring in and keep the best and brightest minds in the field and build up the next generation of researchers.

I'd also encourage all of my colleagues to listen to the stories from their constituents about the families benefitting from new medical research and clinical trials in their own states who are making the most of federal investments to push forward our understanding of how to treat and prevent cancer and other conditions.

How can groups like the AACR and patient advocates best communicate the importance of medical research to the members of Congress? Do you think we have made progress in terms of raising awareness of the importance of National Institutes of Health (NIH) funding to saving lives and helping the American economy?

The most important thing AACR members and patient advocates can do is continue to use their voices and share their stories. Efforts from groups like AACR have been incredibly impactful in helping to win major increases in funding for the National Institutes of Health (NIH) in recent years. I know from my own experiences, and from working with other lawmakers, that hearing the personal stories of patients and families impacted by medical research helps make the stakes clear.

In the current political environment, it's also more important than ever that experts speak up to hold leaders accountable to decisions based in evidence and science, not ideology or partisanship. Advocates need to reach out to their colleagues as well about the importance of speaking up. We need the medical research community aware and engaged, which is why I've been so encouraged to see so many people in the scientific community across the country standing up and speaking out against proposals that would cut back investments and undermine medical research.

Can you tell us more about other efforts—legislation and otherwise—that you have worked on in support of better prevention, detection and treatment of cancer?

As Ranking Member of the Senate Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies (LHHS), I have continually pushed to increase our investments in medical research. I'm proud to say these efforts have been bipartisan, and that Chairman Blunt and I have been able to work together to increase funding for the NIH on multiple occasions, like the $3 billion dollar increase were able to include in the bipartisan spending deal earlier this year and the further $2 billion increase we included in the bill for [Fiscal Year 2019].

I've also fought for investments in medical research as Ranking Member of the Senate Health, Education, Labor and Pensions (HELP) Committee—like in the 21st Century Cures Act, which invests in a range of priorities, especially cancer research. The $4.8 billion dollars of new funding it provided to NIH, included $1.8 billion for the "Cancer Moonshot" launched by former Vice President Biden.

The Childhood Cancer STAR Act, which we passed through the HELP Committee earlier this year, also recently became law. This legislation supports efforts to enhance access to biospecimen repositories for researchers to address the challenges inherent in studying childhood cancers, identify best practices for health professionals to address the long-term health challenges survivors face, and reduce health disparities and cultural and linguistic barriers that can compromise care for patients.

The AACR is the world's first and largest organization dedicated to every aspect of high quality cancer research. The AACR has 40,000 members across all states, many of whom are in the state of Washington, as well as members in over 120 countries. Do you have anything you would like to say to the AACR and our scientists and physicians who have dedicated their careers to making progress against cancer?

Thank you for all the work you do for families in Washington state and across the country. I've had the honor and pleasure of visiting with researchers in Washington state at the Fred Hutch Center, University of Washington, Washington State University, Seattle Children's Hospital, the Allen Institute, and so many more organizations pushing forward our medical knowledge. I've been inspired by the dedication of the researchers I've met to making life better for families battling cancer—by the passion they have shown for their work and the compassion they have shown for those affected by it. I'm going to keeping fighting for you, and working to make sure my colleagues understand the importance of strong investments in medical research.

Is there anything we didn't discuss that you would like to add?

Unfortunately, we know from recent reports that we have a lot to do to end sexual assault and harassment in research settings, so I hope that everyone at AACR is committed to supporting a positive, inclusive, and safe setting for innovative biomedical research. The best research cannot be done in a hostile work environment.

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