​​Cancer Policy Monitor: Feb. 7, 2017     

Science Policy and Government Affairs at the AACR Annual Meeting     

The American Association for Cancer Research’s Annual Meeting will take place in Washington, D.C., April 1 - 5, 2017. The AACR Annual Meeting, which highlights the best cancer science and medicine from institutions all over the world, attracts more than 19,500 scientists and other professionals from over 67 countries. This year’s theme, “Research Propelling Cancer Prevention and Cures,” reinforces the inextricable link between research and advances in patient care. 

Several science policy and government affairs events and sessions are being organized as a part of the Annual Meeting. These include nine sessions in the Regulatory Science and Policy Track, which feature presentations and discussions affecting the drug discovery and approval process, as well as sessions on health policy, tobacco and cancer, and the Beau Biden Cancer Moonshot.
The following is a list of currently planned Science Policy and Government Affairs sessions at the AACR Annual Meeting:

  • Understanding Mechanism-based, Cardiovascular Adverse Events Associated with Immune Checkpoint Blockade: Implications for Prevention and Management: Saturday, April 1, 2017, 1 p.m.    
  • Real World Data Policy: Saturday, April 1, 2017, 3 p.m.
  • Tables Turned: A Conversation with the Press about the Future of Cancer Research: Sunday, April 2, 2017, at 1 p.m.
  • Regulatory Considerations for Utilizing Liquid Biopsies in Drug and Diagnostic Development: Sunday, April 2, 2017, 3 p.m.   
  • Advancing Clinical Trial Design in Regulatory Science and Policy: Monday, April 3, 2017, 10:30 a.m.
  • Reference Materials for Next Generation Sequencing (NGS)-based Tests: Tuesday, April 4, 2017, 10:30 a.m.
  • Immuno-oncology Combinations: Tuesday, April 4, 2017, 1 p.m.
  • New Drugs – A Review of Recently Approved Breakthrough Therapies: Tuesday, April 4, 2017, 3 p.m.    
  • Recent Trends in Regulatory Science: Wednesday, April 5, 2017, 10:30 a.m.
  • The Beau Biden Cancer Moonshot: Progress and Promise: Monday, April 3, 2017, 1 p.m.
  • The Impact of Repealing the Affordable Care Act (ACA) on Cancer Patients, Tuesday, April 4, 2017, 10:30 a.m.
  • E-cigarettes: Are They a Public Health Threat or a Useful Cessation Tool?: Tuesday, April 4, 2017, 1 p.m.
  • AACR Congressional Briefing on Capitol Hill: Tuesday, April 4, 2017, noon, U.S. Capitol Visitor’s Center, Room 268

Learn more about the Annual Meeting, including registration and hotel and travel.

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The AACR's Statement on the Administration's Executive Order on Immigration      

In response to the Trump administration's Executive Order on Immigration, the American Association for Cancer Research, along with the American Society of Hematology (ASH), Association of American Cancer Institutes (AACI), American Society for Radiation Oncology (ASTRO), American Society of Pediatric Hematology/Oncology (ASPHO), and the LUNGevity Foundation released a joint statement expressing deep concern about the administration's executive. The full statement is included below. If you wish to send a letter to Congress or the administration regarding the executive order, you can do so here.

Statement from ASH, AACR, AACI, ASTRO, ASPHO, and LUNGevity Foundation on the Administration's Executive Order on Immigration 

(WASHINGTON) — As the world's leading organizations representing laboratory researchers, physician-scientists, clinicians, the nation's cancer centers, and patient advocates committed to improved care for patients with cancer and blood diseases, we express our deep concern about the administration's executive order that has denied U.S. entry to people who bring unique expertise to the practice of medicine and the conduct of cancer and biomedical research. Our nation depends on the contributions of the greatest minds from around the world to maintain the high quality of our biomedical research enterprise and health care services.

The benefits of scientific collaborations are amplified by our diversity. Limiting the exchange of ideas, practices, and data across cultures has the potential to significantly retard scientific progress and adversely affect public health. Any loss of researchers and physicians will render the United States less competitive over time, and our traditionally strong research institutions and the patients they serve will be negatively affected.

We remain deeply concerned that restricting travel will prohibit participation in scientific meetings, where cutting-edge science and treatment methods are often first introduced. These in-person meetings and other global exchanges are vitally important because they provide unparalleled opportunities for collaborations and information-sharing. Such scientific and medical meetings are absolutely essential to the conquest of cancer and blood diseases.

Much of the progress that has been achieved against cancer and blood diseases has been fueled by researchers from all corners of the world. For this progress to continue it is going to require an even greater commitment to collaborations among international organizations, governments, public and private institutions, and individuals dedicated to this cause.  

Therefore, we respectfully call on the administration to consider the negative impact of its executive order on our nation's ability to attract the world's best scientific and clinical talent to participate in the fight against cancer and blood diseases, irrespective of their country of origin. This includes those immigrants who are inspired by the opportunity to bring their scientific curiosity and intellect to our country.

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Recognizing the Cancer Research and Advocacy Community on World Cancer Day     

This article originally appeared as a guest post for World Cancer Day by AACR CEO Dr. Margaret Foti on Research!Ameria's blog.

On this World Cancer Day, the American Association for Cancer Research (AACR) would like to thank the thousands of laboratory researchers, physician-scientists, healthcare professionals and patient advocates around the globe and recognize their commitment to increasing the number of cancer survivors who are alive today. In the U.S., thanks to decades of federally funded cancer research supported by the National Institutes of Health (NIH) and National Cancer Institute (NCI), we have seen a steady rise in the number of Americans who survive a cancer diagnosis.  

Our continued commitment to preventing and curing cancer comes at a time when, despite all the incredible progress, one American continues to die every minute of every day from cancer, while in that same minute, five more Americans receive a cancer diagnosis. These are not just statistics. These are our loved ones, our friends, and our colleagues. Each of the 1,685,210 new cancer cases and 595,690 estimated cancer deaths this year in the U.S., out of 8.2 million worldwide, represents a real life that has been or may be lost. 

The AACR's sixth annual Cancer Progress Report highlights how advanced cancer treatments and diagnostics are finally making their way to market, due in large part to years of federally funded research. We're particularly encouraged by the increasing success of immunotherapeutics, which are treatments that supercharge the body's immune system to fight against cancer cells. Hundreds of other advanced therapies, however, remain in the pipeline, and without sustained, robust, and predictable annual federal funding increases for the NIH and NCI, safe and effective advanced cures will take longer to make their way from labs to patients.

With the passage of the Beau Biden Cancer Moonshot as a part of the 21st Century Cures Act (Cures), we now have an unprecedented opportunity to further reduce cancer incidence, morbidity, and mortality. This initiative, which aims to double our progress in half the time, received a commitment of funding in Cures totaling $1.8 billion over ​seven years. It will enable the NCI to jump-start research projects in specific focus areas recommended by the Cancer Moonshot Blue Ribbon Panel to accelerate progress in cancer prevention, detection, diagnosis, and treatment.  

The AACR is calling on Congress and the Trump administration to provide the NIH with a $2 billion increase for FY 2017 before the current continuing resolution that funds the federal government expires at the end of April. We are in an unprecedented era of scientific discovery that holds enormous promise for new advances in cancer treatment and prevention that could save lives around the world. Now is the time for policymakers worldwide to prioritize and invest in lifesaving cancer research. We remain committed to working with scientists and all stakeholders to ensure that the promise of cancer research is translated into lifesaving advances for patients around the world. We know that the science can and will bring us there.

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Richard Pazdur Appointed as Director of FDA Oncology Center of Excellence    

On Jan. 19, the U.S. Food and Drug Administration (FDA) made an announcement on behalf of outgoing FDA Commissioner Robert Califf, that Richard Pazdur had been appointed director of the Oncology Center of Excellence (OCE). Oncology is the first disease area at the FDA to have a coordinated clinical review of drugs, biologics and devices across the agency’s three medical product centers. The OCE will facilitate clinical review of oncology products by bringing together FDA’s experts to collaborate.

Pazdur, sometimes referred to as the “Cancer Drug Czar” by the media, has led the FDA’s Office of Hematology and Oncology Products (OHOP) since 2005. During this time, he and his colleagues have worked to speed the availability of therapies for cancer patients, especially when the drugs are the first available treatment or have advantages over existing therapies. On an annual basis, approximately 30 percent of all new drugs approved by the FDA are oncology products, and under his leadership, the office has approved many novel, innovative treatments for patients, such as the recent approvals of immune checkpoint inhibitors, immune modulators and many of the targeted therapies that have not only extended patient lives but which have also improved the quality of their lives.

​On behalf of the American Association for Cancer Research (AACR), Chief Executive Officer Margaret Foti, PhD, MD (hc) and AACR President Nancy Davidson, MD, extended congratulations to Dr. Pazdur on his appointment as director of the FDA OCE. “This is a great time for the entire cancer research and patient care community. It is hard to imagine anyone more qualified than Dr. Pazdur for this important new position,” said Dr. Foti. “During his tenure at the FDA, Dr. Pazdur has provided extraordinary, steadfast leadership to improving cancer treatment via the approval of safe and effective drugs for cancer patients. He has also embraced regulatory science to truly inform and improve the way in which new cancer medicines are evaluated for their safety and efficacy.”

“The AACR looks forward to working with Pazdur and his staff in the months and years to come, as they have worked for years to build collaborative partnerships with academia, industry, other government agencies, scientific societies, and patient advocacy organizations to improve both the pace and the quality of new cancer drugs reaching patients,” said Dr.  Davidson, who is also the executive director of the Fred Hutch/University of Washington Cancer Consortium. “We are indeed at an inflection point in cancer research and in how we are preventing and treating cancer. This is the result of decades of dedicated efforts to increase our knowledge and understanding of the more than 200 diseases called cancer, as well as because of the extraordinary commitment from individuals like Pazdur and his colleagues to effectively employ a variety of regulatory tools such as master clinical trial protocols, expedited approval pathways, including the agency’s new breakthrough therapy designation and clinical trial enrichment strategies for approving targeted therapies in oncology.”

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Revisions to the Common Rule Released    

Every year, thousands of individuals, including cancer patients and survivors, make the selfless choice to participate in federally funded cancer research so that effective preventive strategies and treatments continue to make a difference in the lives of those affected by cancer.

Because the samples and data provided by these research participants have the potential to positively impact the lives of millions of patients long after they have been collected, research and patient advocacy groups and organizations, including the American Association for Cancer Research, have long worked to reconcile the need to protect the safety and privacy of research participants with the needs of researchers in a rapidly changing scientific landscape.

Current protections based on basic ethical principles for federally funded research involving human subjects stem from the Federal Policy for the Protection of Human Subjects, known as the “Common Rule,” published in 1991.

Since then, the field of biomedical research has evolved dramatically. The Common Rule had not been updated to reflect those changes until this month. On Jan. 18, the U.S. Department of Health and Human Services (HHS) and 15 other federal agencies issued a final rule intended to safeguard individuals who participate in cancer and other biomedical research, while making it easier for scientists to conduct lifesaving research on samples provided by these individuals.

In developing the new regulations, HHS and other Common Rule agencies issued a Notice of Proposed Rulemaking and invited comments from the public. In January 2016, the AACR together with the Association of American Cancer Institutes (AACI), American Society of Clinical Oncology (ASCO), and American Society of Radiation Oncology (ASTRO) sent a letter voicing support for many of the proposed revisions, while expressing concern about certain elements.  In all, HHS received more than 2,100 comments about the proposed rule.

One of the provisions of the proposed rule that concerned the AACR referred to the use of biospecimens (blood, cancerous tissue, urine, etc.) that become available from clinical care or research. Under current regulations, if identifiable information had been removed from these samples so that they could not be traced back to the individuals who donated them, then researchers could have used these samples for future studies without having to obtain new consent forms from the donors.

Earlier drafts of the proposed changes would have required additional consent for future use of de-identified samples, which would have placed a large administrative and financial burden on scientists and research institutions.

The AACR’s January 2016 letter suggested removing that requirement, and we were pleased to see that the final rule signed on Jan. 18 removed that requirement.

While not all our concerns are addressed, such as the lack of harmonized guidelines for reporting adverse reactions, we are confident that the final rule, which will come into effect in 2018, represents a positive step in the right direction. Here’s a look at several other changes to the way research is conducted on human subjects.

Meanwhile, we look forward to continuing our work with HHS and other Common Rule agencies on behalf of researchers, patients, and advocates to further strengthen protections for the privacy and safety of research participants and reduce administrative burdens on researchers.

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Highlights of Tobacco and Cancer Subcommittee's Activities    

Nearly eight years after the signing of Family Smoking Prevention and Tobacco Control Act, 54 Americans still die every hour of every day from smoking-related illnesses. The American Association for Cancer Research (AACR), through its Tobacco and Cancer Subcommittee, is determined to significantly decrease that number by fostering scientific and policy initiatives that reduce the burden of tobacco smoking on health, quality of life, and mortality.

With tobacco use being the leading cause of preventable deaths and causally associated with 18 different cancers, the Tobacco and Cancer Subcommittee remains actively involved in policy initiatives aimed at tackling tobacco-related health risks, including cessation programs for youths and adults and regulation of e-cigarettes.

E-cigarettes updates

At the end of 2016, the surgeon general released a report on e-cigarettes highlighting public health concerns of e-cigarettes use among youths and young adults.

Of particular concern in the report was the fact that "about one in six high school students used an e-cigarette in the past 30 days in 2015," which may potentially lead to use of other tobacco products. To address these concerns, the report recommends several actions, including enforcement of minimum-age-laws, implementation of e-cigarette smoke-free policies, regulation of advertising and media education campaigns, as well as increased research into the effects of e-cigarettes on health.

This report strengthens the AACR Tobacco and Cancer Subcommittee's past and current efforts to raise awareness about the increasing use of electronic nicotine delivery systems (ENDS), especially by underage youth. The report also reinforces the subcommittee's work in providing up-to-date information on the safety and efficacy of ENDS with the goal of guiding policymakers in how to best minimize the potential negative consequences of ENDS without undermining their potential use as a smoking cessation tool.

In May 2016, the AACR together with the American Society of Clinical Oncology (ASCO) and the International Association for the Study of Lung Cancer (IASLC), sent a letter to President Obama urging the administration to finalize the US Food and Drug Administration (FDA) "deeming" regulation. This regulation, which became effective Aug. 8, 2016, makes additional tobacco products, including electronic cigarettes, cigars and pipe tobacco, subject to the FDA's federal regulatory authority as amended by the Family Smoking Prevention and Tobacco Control Act. This in effect bans the sale of e-cigarettes to underage youth.

In recognition of the ban, the Tobacco and Cancer Subcommittee released a webinar, "E-cigarettes: Research, Public Health Concerns and Opportunities, and Regulations," with discussions of current research on and the public health impact of e-cigarettes.

The use of tobacco in cancer patients

In another initiative of the AACR Tobacco and Caner Subcommittee, members of the subcommittee together with representatives from the National Cancer Institute's (NCI) Division of Cancer Control and Population Sciences, Coordinating Center for Clinical Trials, and Cancer Therapy Evaluation Program and other experts from the academia, formed the NCI-AACR Cancer Patient Tobacco Use Assessment Task Force to provide recommendations for tobacco use measurement in clinical cancer research and to outline research priority areas.

The Task Force has developed a standardized tobacco use assessment protocol and outlined research priorities to improve the understanding of the effects of tobacco use on cancer treatment efficacy and toxicity. These efforts will have great implications for the collection and analysis of data from different studies in order to better inform the treatment decisions of cancer patients who use tobacco products.

Moving forward in this new year, the AACR remains committed to working with the FDA and all other policymakers on improving our understanding of the public health impact of tobacco use and to reduce global burden associated with tobacco use.

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AACR Early Career National Day of Action    

Following the recent election cycle in the United States, the new Congress presents a great opportunity to engage and educate key congressional leadership regarding the needs of cancer researchers, particularly those early in their careers. As such, 15 Associate Members in good standing will participate in the second annual AACR Early-career Hill Day, Feb. 28-Mar. 1, 2017 in Washington, D.C.

In conjunction with the AACR Early Career Hill Day on March 1, we invite early career scientists to participate in a National Day of Action by contacting their congressional representative and senators and urge them to support robust, sustained and predictable funding increases for the National Institutes of Health.

Learn more about the AACR Early Career Hill Day and then take action on March 1 from anywhere in the U.S.

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Making Sense of Cancer Screening Guidelines    

Learn more Thursday, Feb. 16 at 1 p.m. ET in our first Progress and Promise Against Cancer webinar, a new series by the AACR and Cancer Today.

Conflicting cancer screening recommendations can confuse even the most health-conscious consumer. Should you start getting mammograms at age 40, 45, or 50? Is prostate-specific antigen testing a good measure for prostate cancer? What method of colorectal cancer screening should you choose?

Register for this American Association for Cancer Research (AACR) and Cancer Today webinar starting at 1 p.m. to hear from top experts in breast, prostate, and colorectal cancer screening. Panelists will summarize the various guidelines and provide perspective on determining the best course of action so you can make an individualized decision with your doctor.

Date:  Thursday, Feb. 16

Time:  1 to 2 p.m. ET

Meet the Experts

Moderator, Prostate Cancer Screening

William G. Nelson, MD, PhD, editor-in-chief of Cancer Today, is the Marion I. Knott professor of oncology and director of The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins in Baltimore. A trained medical oncologist, Dr. Nelson directs a research laboratory focused on discovering new strategies for prostate cancer treatment and prevention. He is also a recognized leader in translational cancer research.

Breast Cancer Screening

Dr. Elaine Schattner will consider breast cancer screening from a multitude of perspectives. A former oncologist and hematologist, she is a breast cancer survivor and patient-advocate whose experiences inform her current role as a medical commentator. Dr. Schattner is a frequent contributor to Forbes, and her work has been published in high-profile publications including The New York Times, The Atlantic, and Scientific American. She is working on a book about public perception of cancer.

Colorectal Cancer Screening

Ernest Hawk, MD, MPH, is vice president and division head for Cancer Prevention and Population Sciences at The University of Texas MD Anderson Cancer Center and holds the T. Boone Pickens distinguished chair for early prevention of cancer. He serves on the Editorial Advisory Board of Cancer Today.

You can register here in advance to join us  Thursday, Feb. 16, at 1 p.m. ET.

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