​​Cancer Policy Monitor: March 7, 2017     

Regulatory Science and Policy at the AACR Annual Meeting     

The Regulatory Science and Policy track at the AACR Annual Meeting is your opportunity to interact with the U.S. Food and Drug Administration (FDA), National Cancer Institute, industry, and many in academia, including basic researchers and physician scientists. These informative sessions are designed to highlight recent regulatory developments and provide an open forum for the discussion of cutting-edge issues in cancer drug, biologic, and diagnostic regulation.

Among the exciting Regulatory Science and Policy track sessions this year, Dr. Richard Pazdur, newly-appointed director of the FDA Oncology Center for Excellence, will moderate “Tables Turned: A Conversation with the Press About the Future of Cancer Research and Treatment,” Sunday, April 2 at 1 p.m. (Room 143, Convention Center). Prominent journalists covering science and cancer will sit down with Dr. Pazdur to provide insight into how the news media reports on opportunities and challenges that exist today for advancing cancer research and developing cancer treatments.

Press panelists will include Adam Feuerstein from The Street, Matthew Herper from FORBES, Laurie McGinley from The Washington Post, and Meg Tirrell from CNBC. The session will likely explore the public’s perceptions of a wide range of topics, including: cancer research and innovative cancer treatments; the kinds of stories and issues that are deserving of “front page” news; and the future of the cancer moonshot initiative.

Back by popular demand, Dr. Amy McKee, deputy director of the Office of Hematology and Oncology Products at FDA, will chair “New Drugs –A Review of Recently Approved Breakthrough Therapies” Tuesday, April 4 at 3 p.m. (Room 143, Convention Center).  The FDA may designate a medical product as a Breakthrough Therapy if the therapy treats a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies.

This session will pair FDA reviewers discussing the approval of recent Breakthrough Therapy designated oncology products and leading academic researchers to explore the impact of accelerated drug access on patient treatment. Specifically, Olaratumab (LATRUVO) approved for treatment of soft tissue sarcoma will be discussed by Drs. Leslie Doros (FDA) and Katie Thornton (Dana-Farber Cancer Institute). Rucaparib (RUBRACA) approved for treatment of patients with deleterious BRCA mutation associated with ovarian cancer will be discussed by Drs. Sanjeeve Balasubramaniam (FDA) and Deborah Armstrong (Johns Hopkins Kimmel Cancer Center). Nivolumab (OPDIVO) and Atezolizumab (TECENTRIQ) approved for the treatment of urothelial carcinoma will be discussed by Drs. Daniel Suzman (FDA) and Dan Theodorescu (University of Colorado Cancer Center). Stay tuned to the online Itinerary Planner for additional Breakthrough Therapies to be featured in this session.

Learn more about the other Regulatory Science and Policytrack sessions at the AACR Annual Meeting 2017.

Learn more information about AACR Annual Meeting 2017 registration.

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Health and Science Policy at the AACR Annual Meeting      

The Science Policy track at the AACR Annual Meeting is your opportunity to learn more about health and science policy issues affecting cancer research, patients, survivors, and families. These informative sessions are designed to highlight recent developments in science policy as it affects cancer research and provide an open forum for the discussion of healthcare policies that impact cancer patients and families.

One Science Policy session, "The Potential Impact on Cancer Patients of a Repeal or Revision of the Affordable Care Act," takes place Tuesday, April 4 at 10:30 a.m. (Room 201, Convention Center). The session will discuss some of the specific provisions in the Affordable Care Act (ACA) that are benefiting cancer patients, such as ensuring that individuals are covered for pre-existing conditions; access is provided to preventive services; annual and lifetime coverage caps are prohibited; and access to clinical trials is encouraged.

The Trump administration and Republican lawmakers have said that dismantling the ACA is a top priority in 2017. The ACA, which was signed into law in 2010 and implemented over the subsequent four years, has provided major benefits for cancer patients. These include prohibiting denial of insurance coverage for those who have cancers (the “pre-existing conditions” stipulation); coverage of preventive services for colorectal, breast, cervical and lung cancer screenings and skin cancer counseling; removal of annual and lifetime dollar coverage caps; the mandate for insurance to cover participation in clinical trials.

The second Science Policy session, "E-cigarettes: Are they a Public Health Threat or a Useful Cessation Tool?," takes place Tuesday, April 4 at 1 p.m. (Room 201, Convention Center). This session will provide an opportunity to consider the different viewpoints on e-cigarettes, specifically whether they might act as a gateway to smoking for nonsmokers or be a useful public health tool to aid in smoking cessation. Additionally, there will be research updates on e-cigarettes related to their initiation, toxicity, and dependence, as well as possible use in tobacco treatment programs and second hand vaping associated risks. The session will also cover research on nicotine and nicotinic receptors and flavor related e-cigarette use and updates on new generation products (e.g., heat not burn tobacco devices).

In his latest report, the Surgeon General, Dr. Vivek Murthy, highlighted that e-cigarette use among U.S. youth and young adults has become a major public health concern due to a drastic increase in usage or “vaping” among high school students from 2011 to 2015. These products are now the most commonly used form of tobacco among youth in the United States. Since most e-cigarettes contain nicotine, the use of these products may lead to addiction and harm the developing adolescent brain.

Furthermore, when NIH Director Dr. Francis Collins was describing a recent study in his blog, he mentioned that e-cigarettes seem to be making the tobacco problem worse, not better. Contrast these viewpoints with that of Public Health England (PHE), a group made up of health specialists from more than 70 organizations in the U.K., which released an independent review of the evidence that evaluated e-cigarettes and health. The report from the summer of 2015 concluded that e-cigarettes were around 95 percent less harmful than combustible cigarettes and that there is, as yet, no evidence to suggest they are gateway products to smoking. In 2016, the U.S Food and Drug Administration (FDA) adopted the “deeming” regulation that gives FDA regulatory authority over several tobacco products, including e-cigarettes, cigars, and pipe tobacco, as amended by the Family Smoking Prevention and Tobacco Control Act. However, there are still many unanswered questions about e-cigarettes.

A special session, "Beau Biden Cancer Moonshot: Progress and Promise," takes place Monday, April 3 at 1 p.m. (Plenary Hall D/E, Convention Center). This session provides an opportunity for leaders from government, academia, industry, patient advocacy organizations, and Capitol Hill, to discuss how the "Beau Biden Cancer Moonshot" provision that was included in the 21st Century Cures Act is stimulating the acceleration of progress against cancer and how it will result in better outcomes for patients. In addition, panelists will discuss why it is vitally important for the Trump administration and the 115th Congress to continue the momentum and vital support for this transformative initiative that began on Vice President Biden’s watch.

During his State of the Union address in January 2016, President Obama announced his intention to launch the Cancer Moonshot Initiative and named Vice President Joe Biden as “Head of Mission Control.” Throughout 2016, Vice President Biden’s work on the Cancer Moonshot has been nothing short of spectacular, as he consistently delivered an extraordinary amount of personal commitment and dedication. Of course, he knows firsthand the devastating effects of cancer on a family because of the untimely loss of his beloved son, Beau.

During the past year, the vice president challenged all of us to “imagine what you could do in 10 years, and then do it in five” and in so doing lessen the burden of cancer for patients, their families, and generations to come. We all owe Vice President Biden and his staff a tremendous amount of gratitude for establishing an environment throughout 2016 that encouraged the cancer research community to provide thought leadership, including the opportunity to provide their recommendations for new approaches to spur major advances against the more than 200 diseases we call cancer.

Finally, the AACR will hold a special congressional briefing at the U.S. Capitol Visitors Center (Room 268) Tuesday, April 4 at noon. The briefing aims to bring the science and expertise from the AACR Annual Meeting to Capitol Hill by sharing the latest cancer research and developments with congressional staff. Leading this event will be Science Policy and Government Affairs Committee Chair Dr. George Demetri, and joining him on the panel will be Dr. Anna Barker, former deputy director of the National Cancer Institute, and patient advocate Jack Whelan. AACR Scientist Survivor ↔Survivor Program (SSP) participants will also attend the event as part of their program at this year’s meeting.

Learn more information about the Science Policy track.
Learn more information about AACR Annual Meeting 2017 registration.

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Early-career Scientists Spend a Day on Capitol Hill     

On Feb. 28 - March 1, 15 early-career scientists and a senior scientist mentor visited Washington D.C. to participate in face-to-face meetings with senators, representatives and their key staff members during the second annual AACR Early-career Hill Day. In conjunction, advocates from around the U.S. participated in the Early-career National Day of Action and urged Congress to provide robust, sustained and predictable funding increases for the National Institutes of Health (NIH) and National Cancer Institute (NCI).

While 95 percent of the NIH budget goes directly to research awards, programs and centers, including training programs, the average age at which researchers receive their first R01 independent research grant today is 42 and the chance of successfully receiving a research grant from NCI is less than 15 percent. In fact, in 2010, only 3 percent of independent R01-supported investigators were under the age of 36, compared to 18 percent in 1983.

“The AACR is very concerned about the future of the cancer research pipeline, and is most specifically focused on helping the early-career cancer scientist through numerous programs and initiatives, such as AACR NextGen Grants for Transformative Cancer Research, a funding initiative to stimulate highly innovative research from young investigators,” said Margaret Foti, PhD, MD (hc), chief executive officer of the AACR. “The AACR Early-Career Hill Day provided an opportunity for associate members to explain to policy makers how early-career scientists have been have been adversely affected by the funding environment over the past decade. We think their messages are powerful and underscore the importance of robust, sustained, and predictable budget increases for the NIH and NCI.” 

The participants had 39 meetings with 21 House and 18 Senate offices from 15 different states, an increase from the previous year. Meetings included those with congressional leadership offices, such as House Speaker Paul Ryan’s office, as well as members of House and Senate appropriations committees.

The early-career scientists discussed the positive impact that NIH and NCI funding has not only on their careers and on cancer research, but also on the U.S. economy. In 2015 alone, NIH funding directly and indirectly supported 352349 jobs nationwide, according to United for Medical Research. That same year, NIH funding and jobs generated by that funding produced $60.171 billion in new economic activities, with seventeen states seeing an economic gain of $1 billion or more.

Early-career investigators bring fresh ideas and technologies to existing biomedical research problems, and pioneering new areas of research. That is why entry of early-career investigators into the ranks of independent, NIH-funded researchers is essential to the health of this country’s biomedical research enterprise.

You can support early-career and all cancer researchers by contacting your members of Congress today to urge their support for increasing NIH and NCI funding. Visit our Take Action Page to send an email or make a phone call to your senators and representative. Graduate students, medical students and residents, and clinical and postdoctoral fellows who are enrolled in educational or training programs that could lead to careers in cancer research are also invited to join the AACR as Associate Members.

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CMS Administrator Nominee Seema Verma Advances in the Senate    

On March 2, the Senate Finance Committee approved the nomination of Seema Verma to be administrator of the Centers for Medicare and Medicaid Services (CMS), part of the Department of Health and Human Services, in a party-line 13-12 vote. Verma is the president and founder of Indiana-based SVC Inc., a national health policy consulting company. She’s credited as the architect the Healthy Indiana Plan (HIP), the first consumer directed Medicaid program in the U.S. that was developed under Governor Mitch Daniels, as well as of then-Governor Mike Pence's Medicaid expansion in Indiana.

While a major responsibility of CMS is to administers the Medicare program, along with Medicaid and the Children's Health Insurance Program (in partnership with state governments), CMS also has authority to regulate lab developed tests (LDTs) through the Clinical Laboratory ImprovementAmendments (CLIA) program.

There is little insight on Verma’s views on LDTs or CLIA. In her February hearing before the Senate Finance Committee, there were no mentions of or questions related to the subject of clinical laboratories or tests. Any effect of CMS policy on LDTs would likely be related to the Affordable Care Act (ACA) repeal and its impact on reimbursement and coverage for certain clinical laboratory tests.

The ACA, through its preventive health services requirements, mandated that non-grandfathered private health insurance plans cover at no cost certain recommended laboratory services. Currently, all republican ACA replacement plans include a repeal of that requirement. ACA replacement plans aim to shift cost-sharing to consumers, which may decrease the demand for LDTs from patients no longer able to afford them.

As far as any expected regulation of LDTs, that remains unlikely in the current political environment. Last year, the FDA delayed finalizing its draft guidance on regulating LDTs. Furthermore, the Trump administration’s stance on issuing new rules makes it highly unlikely that it will issue new rules to regulate LDTs.

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Register Today: Rally for Medical Research Hill Day    

The fifth annual Rally for Medical Research Hill Day will be held Sept. 14, 2017 in Washington, D.C., with a reception on the evening prior. Registration is now open and all interested advocates of biomedical research are invited to register. For those unable to travel to D.C., there will also be a National Day of Action, where advocates will be able to contact their Senators and Representative from anywhere in the United States to urge support for the National Institutes of Health.

Stay up-to-date on by visiting the Rally website, Facebook, and Twitter pages.

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Save the Date: AACR/AACI/ASCO May Hill Day    

On Thursday, May 4, 2017, AACR, Association of American Cancer Institutes (AACI), and American Society of Clinical Oncology (ASCO) will once again partner to bring researchers, oncologists, cancer survivors and other advocates to Capitol Hill to build congressional support for federal research by the National Institutes of Health (NIH) and the National Cancer Institute (NCI).

Participants will urge members of Congress to provide robust, predictable and sustained investments for NIH and NCI. Attendees will thank members of Congress for passing the 21st Century Cures Act in December 2016, which provided supplemental funding over seven years for the Beau Biden Cancer Moonshot Initiative, and for ensuring the initial $300 million in FY 2017 for the Moonshot was included in the continuing resolution (CR), passed in December.

With a new administration and Congress, including new members on key House and Senate committees, the May Hill Day is an important and opportune time to underscore the value of a bipartisan commitment to cancer research in saving and improving millions of lives touched by cancer.

You can register today at this link. A room block has also been reserved at the Hyatt Regency Washington on Capitol Hill. You can reserve your room today.

We look forward to seeing you in Washington, D.C. on May 4!

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The AACR Brings You Progress and Promise Against Cancer    

Join us at a community event bringing together renowned researchers, physician-scientists, and cancer advocates for an educational discussion about the latest advances in cancer science, treatment, and prevention. Progress and Promise Against Cancer,​ Saturday, April 1, at the Grand Hyatt in Washington, D.C., will explore themes such as cancer immunotherapy, precision cancer medicine, cancer prevention, and clinical trials. This is a free public event that will include a continental breakfast and lunch after the program.

Date: Saturday, April 1
Program Time: 8:30 a.m. to 12:15 p.m.
Location: Grand Hyatt, 1000 H Street, NW, Washington, D.C. 

Held in conjunction with the AACR Annual Meeting 2017, which brings together 20,000 cancer scientists, survivors, advocates, and others, this community event will showcase the progress we've made and promise of future advances against the many diseases we call cancer.

This year's event will feature an exhibit area with organizations dedicated to supporting the cancer patient community.

Register here today!

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