​​Cancer Policy Monitor: June 6, 2017     

Trump Administration Proposes Largest Single Year Cut in NIH’s History     

The AACR stands firmly against the Trump administration’s outrageous $7.1 billion proposed cut from the National Institutes of Health (NIH) budget in fiscal year (FY) 2018. When accounting for medical inflation, the proposed cuts would set the NIH budget back to funding levels last seen in the 1990s, and as a result, they would severely jeopardize the progress we are making in preventing, treating, and curing cancer.

These proposed cuts, if enacted, would represent the largest single annual decrease in NIH funding in the entire history of the agency going back to 1938. A drastic cut of this scale is not only horrifying, but also would irreversibly harm our nation’s ability to understand complex diseases such as cancer and develop lifesaving therapies for patients.

“Over the past couple of years, we have seen a groundswell of bipartisan support for the NIH on Capitol Hill, and this commitment is essential to ensure that we have the resources available to make further strides toward defeating cancer and the many other human diseases that afflict so many Americans,” said AACR President Michael A. Caligiuri, MD, director of the Ohio State University Comprehensive Cancer Center and chief executive officer of the Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, located in Columbus. “Therefore, we are appalled that the Trump administration would include in its budget a proposal that would risk irreversibly harming our nation’s ability to further understand the complexity of cancer and postpone the development of lifesaving therapies for patients.”  

Aside from derailing advancements in lifesaving research, the proposed cuts to the NIH budget would cause irreparable harm to the U.S. economy and jobs, threatening a drop in economic activity of more than $15 billion and a loss of 89,500 jobs across the United States (learn more about how the proposed NIH cuts can impact your state). Annual robust, sustained, and predictable funding increases for the NIH are essential if the United States is to maintain its global leadership in scientific research, especially at a time when countries like China are drastically increasing their investments.

“We are at an inflection point in cancer research. We are making major strides in preventing and treating cancer, which is the result of decades of dedicated efforts on the part of policymakers, laboratory and translational cancer researchers, physician-scientists, and patient advocates to address the ravages of cancer in all of its forms,” said Margaret Foti, PhD, MD (hc), chief executive officer of the AACR. “The budget proposal by the Trump administration would jeopardize the pace of progress we are making to save the lives of cancer patients and also extend and improve the quality of their lives. Therefore, we call on Congress to reject the Trump administration’s FY 2018 budget proposal for the NIH.”

Take a minute today to call on members of Congress to strongly reject this budget proposal and urge them to stay on the present course by providing an additional $2 billion for the NIH in FY 2018. Robust, sustained, and predictable annual funding increases for the NIH are absolutely required if we are to conquer the devastating collection of diseases we call cancer.

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NAS to Study Return of Individual-specific Research Results Generated in Research Laboratories      

The National Institutes of Health (NIH), in collaboration with the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) are announcing the launch of a study by the National Academies of Sciences, Engineering, and Medicine that will convene a committee to review and evaluate the return of individual-specific research results from research laboratories, which are required to be returned in accordance with the Clinical Laboratory Improvement Amendments of 1988 (CLIA).  This committee will:

  • Review and assess the current evidence concerning the benefits and harm to individuals and society regarding the return of individual-specific research results generated in research laboratories;
  • Review the current regulatory environment, including CLIA and any other applicable laws, for conducting tests and returning individual-specific research results; and
  • Make recommendations on the issue of returning individual-specific research results generated in research laboratories that are regulated by CLIA.

To learn more about the importance of this study, please read the latest Under the Poliscope post by Dr. Carrie D. Wolinetz, NIH associate director for science policy.

Additional information on the study can also be found on the NAS website.

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NIH Proposes to Limit the Amount of Grant Money a Scientist Can Receive     

On May 2, the NIH announced a policy proposal designed to expand the amount of funding available to early- and mid-career scientists by limiting the amount of money that scientists with multiple grants can receive. The proposed policy would assign points to various types of grants and give individual investigators a total score called a Grant Support Index (GSI). NIH would aim to limit a person’s GSI to 21 points, or the equivalent of three standard R01 grants. This would in effect free up more grant money that can be made available to early- and mid-career scientists who may otherwise face difficulties competing for grants with more experienced investigators due to limited funds.

“While implementation of a GSI limit is estimated to affect only about 6 percent of NIH-funded investigators, we expect that, depending on the details of the implementation, it would free up about 1,600 new awards to broaden the pool of investigators conducting NIH research and improve the stability of the enterprise,” said NIH Director Francis Collins, MD, PhD in a statement. According to the NIH, 40 percent of NIH extramural funding goes to 10 percent of the investigators that receive NIH funding.

Congress has also expressed concerns about how early- and mid-career investigators are a shrinking part of the NIH principal investigator (PI) pool. In the recently passed 21st Century Cures Act, Congress pressed NIH to develop and promote policies that will attract and sustain support for diverse groups of outstanding young and new investigators.

The NIH has received a mixture of support and concern regarding this proposed policy, which promoted the agency to plan on making some significant revisions to the proposal when it presents an “updated proposal” to the NIH Advisory Committee to the Director (ACD) June 8 and 9. 

Leaders at the NIH understand that this proposal could negatively affect support for “team science” and the important collaborations that are taking place across the research community. Additionally, many of the NIH Institutes and Centers (IC), such as the NCI, have a varying mixture of grant mechanisms and overall grant portfolios than that of the NIH National Institute of General Medical Sciences (NIGMS), which provided much of the data that was used to develop the proposed policy. Some of the grants funded by certain ICs, such as grants with multiple PIs and ones that involve sophisticated networks, as well as center grants, modular grants, and training grants, need to be viewed differently from the standard R01, which is something that the NIH is beginning to consider for the revised proposal. 

Ultimately, the NIH is committed to ensuring that the proposed mechanisms will fit the intended goals of the policy: to attract and sustain support for diverse groups of outstanding young and new investigators.

Once NIH officials unveil and discuss this revised policy June 8 and 9, NIH leaders plan to make the rounds to the various IC advisory councils to explain the policy and seek additional feedback. The agency hopes to incorporate this feedback into a final policy that can be implemented in time for the September 2017 grants review cycle. 

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Scott Gottlieb Confirmed as Commissioner of the Food and Drug Administration    

The AACR applauds the U.S. Senate for its confirmation of Scott Gottlieb, MD, as the new commissioner of the U.S. Food and Drug Administration (FDA) and offers its congratulations to Dr. Gottlieb on his new role. Dr. Gottlieb has shown a commitment to science-based policies and is extremely qualified for the position of FDA commissioner.

Dr. Gottlieb, a survivor of Hodgkin’s lymphoma, served as FDA deputy commissioner during the George W. Bush administration. He also served as a senior adviser to the administration at the Centers for Medicare and Medicaid Services and was a member of the Federal Health IT Policy Committee. As a cancer survivor, he understands the challenges that patients face every day, and also knows firsthand the importance of utilizing scientific-based evidence to evaluate the safety and efficacy of new therapies and devices. At a time when the patient’s perspective is becoming a central component of drug development and approval, having a cancer survivor who deeply understands both the patient’s journey and the regulatory ecosystem at the helm of the FDA is a positive and welcomed development.

Dr. Gottlieb appreciates and supports innovative regulatory approaches at the FDA, such as the breakthrough therapy designation and creation of the Oncology Center of Excellence. Such regulatory innovations ensure that effective and safe treatments reach patients efficiently. As the FDA continues to advance world-renowned regulatory policy, the AACR stands ready to work with Dr. Gottlieb and his staff on behalf of cancer patients, healthcare professionals, and researchers.

Through its synergistic partnership with the FDA, the AACR has provided thought leadership, scientific guidance, and feedback to the FDA on a number of important scientific topics and initiatives. The AACR looks forward to continuing this strong partnership under Commissioner Gottlieb, starting with two upcoming joint FDA-AACR Regulatory Science and Policy Workshops. The first workshop will examine immuno-oncology combination therapies and will take place July 20, 2017, while the second, focused on applications for liquid biopsies in breast cancer, is scheduled for Oct. 10, 2017. For more information on these and other upcoming events, visit

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Scientist↔Survivor Program at the Science of Cancer Health Disparities Conference    

The 10th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved brings together physicians, scientists, health professionals, advocates, and health care leaders. Scientist↔Survivor Program participants are accepted by competitive application and expenses for those accepted are paid. The application deadline is June 26.

The goals of this conference are:

  • To bring together physicians, scientists, health professionals, and health care leaders working in a variety of disciplines to discuss the latest findings in their fields;
  • To foster collaborative interdisciplinary interactions and partnerships; and
  • To stimulate the development of new research in cancer health disparities.

Patient advocates who participate in the Scientist↔Survivor Program at the Science of Cancer Health Disparities Conference will:

  • Discuss relevant and timely cancer topics with scientific mentors during small group meetings and roundtable discussions;
  • Attend scientific talks at the Cancer Health Disparities Conference on their own or with their scientific mentors and other advocates;
  • Create and participate in the poster session;
  • Communicate to scientists the key issues, questions, and concerns of the survivor and patient advocacy communities; and
  • Network with scientists and fellow advocates from local, national, and international cancer organizations.

The AACR will cover the cost of approved travel and lodging for accepted participants of the Scientist↔Survivor Program during the conference. Some meals will be provided as part of the program. However, participants are responsible for any incidental expenses, including tips, meals, phone charges, poster fees, laundry fees, and baggage fees. Participants are also responsible for any rental car charges if they choose to rent a car. Car rentals or gas will not be reimbursed.

Scientist↔Survivor Program participants are accepted by competitive application. Patient advocates are encouraged to apply to the Scientist↔Survivor Program at the Science of Cancer Health Disparities Conference if they:

  • Actively support cancer research through policy advocacy, research advocacy and/or community outreach;
  • Have a constituency with which to share the knowledge they gain through the program;
  • Are in a position to communicate the knowledge gained from the program to colleagues and/or constituents and have access to avenues for disseminating this information; and
  • Are able to participate in all components of the four-day program in Atlanta.

If you have never participated in a Scientist↔Survivor Program, please complete the new applicant application.

If you have participated in a Scientist↔Survivor Program, please complete the past participant application.

The application deadline is Monday, June 26, 2017. Please complete this application in its entirety. Applicants will be notified of their status by mid-July. 

Please note, you cannot save your application online. Applications must be completed in one sitting.

Please review the PDF application to become familiar with the application questions. Applications must be completed online. Incomplete applications will not be considered. Advocate mentors are not required for this program.

Current cancer clinicians and researchers (including post-docs) cannot apply to participate for the program.

If interested in attending the Science in Cancer Health Disparities as an advocate, outside of the Scientist↔Survivor Program, you may register at the advocate rate. Please visit the Opportunities for Survivor Advocates page for additional information. 

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Scientist↔Survivor Program Participants Spend a Memorable Day on Capitol Hill    

This article first appeared on the AACR's official blog, the CANCER RESEARCH Catalyst.

May was National Cancer Research Month, and for the past 10 years, leaders and members from the American Association for Cancer Research (AACR), the Association of American Cancer Institutes (AACI), and the American Society of Clinical Oncology (ASCO) have converged on Capitol Hill during this month to share how cancer research is saving lives and transforming patient care.

This year, as the U.S. Senate was getting ready to vote on a government spending bill that included a $2 billion increase for the National Institutes of Health (NIH) in fiscal year 2017, cancer researchers, physicians, survivors, patient advocates, and cancer center directors were making their way through the halls of congressional office buildings to thank members for their support and urge them to keep the momentum going next year. With the White House now proposing deep cuts of nearly 22 percent to the NIH budget in fiscal year 2018, it is more important than ever that Congress continues to make medical research a national priority.

Included among those were members of the AACR Scientist↔Survivor Program (SSP), a program launched in 1999 to foster mutually beneficial and enduring partnerships among the leaders of the scientific and cancer survivor and patient advocacy communities through the exchange of information on key aspects of cancer research, survivorship, advocacy, and public policy.

“This Hill Day was particularly meaningful attending as a part of the Scientist↔Survivor Program and demonstrating a unified partnership between multiple groups with the common goal of improving patient outcomes and curing cancer,” said Aime T. Franco, PhD, an assistant professor in the Department of Physiology and Biophysics at the University of Arkansas for Medical Sciences. “The alliance of the AACR, ASCO, and AACI for this event demonstrates the effective cooperation of patients, caregivers, physicians, and researchers. It is critical that we are able to demonstrate our unity in the battle against cancer when advocating for funding and support for research.”

Gerald Green, a mechanical engineer, three-time cancer survivor, and SSP advocate from California, shared his survivorship journey with members of Congress and their staffs. He was first diagnosed with tongue cancer in 1995, then with neck cancer in 1997 and prostate cancer in 2008.

“When I was diagnosed with tongue cancer, my son was a year old, and the first milestone that I wanted to reach was being able to see him graduate kindergarten,” Green told staffers, adding that his son has now graduated high school. “Through it all, Monica, my wife and my north star, supported me through cancer’s uncertainties.”

William (Bill) Rosvold, a pancreatic cancer survivor from New York who serves as the Advocacy Chair for PanCAN NYC, was part of an eight-person delegation from New York that included physicians and researchers from top cancer institutions, such as Memorial Sloan Kettering and Columbia University.

“It was good to speak out, and better to be heard,” said Rosvold. “We met with senior health aides for two senators and six representatives. Though in the moment you never know about the long-term impact of these meetings, I think we were heard. In particular, I think we have a friend in Senator Chuck Schumer and in Representative Peter King.”

The day before Hill Day, the House of Representatives had approved the 2017 omnibus appropriations bill by a vote of 309-118. On Hill Day, the Senate approved the bill by a 79-18 vote. While the SSP participants celebrated the increase in NIH funding that was included in the bill, they also recognized the work left to be done.

“Everyone is touched by cancer, whether through their own diagnosis or the diagnosis of a loved one, yet we are still fighting to make research a national funding priority,” said Franco, who shared her story with the AACR in a previous blog post.

“I am honored to have the opportunity to represent cancer patients, researchers, and clinicians and to work collaboratively to raise awareness about the importance of cancer research and sustained, predictable funding,” she added. “But every time I’m in D.C., I do secretly hope that this will be the last trip that I have to make, because I’m hopeful for a future without cancer where we will no longer need to make it a national priority.”

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Share Your Cancer Research or Advocacy Story for National Cancer Survivors Day    

June 4 was National Cancer Survivors Day, which celebrates life and raises awareness of the challenges faced by cancer survivors. If you are or work with cancer survivors, we’re looking for your inspiring stories about survivorship research or advocacy. Submit your story to be featured on our Take Action website.

You can be as creative as you are inspirational. Write your story in your own words, make an online mini-site, create a video, or submit a digital collage. Any way you think would best tell your story is acceptable. You can submit your story and/or links here. There is no deadline to submit your story. We will be accepting stories throughout the year.

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FDA-AACR: Oncology Dose Finding Workshop Part III    

Given the recent history of approvals based on the results of early phase trials driven by extraordinary efficacy data, the incentive for conducting rigorous dose-finding trials may not be overtly apparent. However, the increasing need for the development of combination therapy due to resistance to monotherapy and poor tolerance of approved dosing regimens underscores the need for a more efficient process of dose selection in the early stages of study design.

FDA and AACR have successfully held Oncology Dose Finding Workshops in 2015 and 2016. Patient and dose selection of oncology drugs will be of critical importance, as recent approvals of immune checkpoint inhibitors (ICIs) and early, promising readouts from studies combining ICIs with chemotherapy, targeted therapy, and other immuno-oncology agents will put enormous pressures on the current clinical trial infrastructure of the U.S. and the international community. A recent article in The Cancer Letter reported that 803 clinical trials currently testing PD-1 and PD-L1 drugs had over 160,000 slots for adult patients. As more ICIs enter the market, additional trials will seek to combine these products with standard of care therapies, novel small molecules, targeted antibodies, and other biologic therapies such as vaccines and engineered T-cells. This year’s workshop will focus on approaches to combination therapy and best practices regarding patient and dose selection, biomarkers to aid in selection, and novel endpoints that can define patient benefit.

SESSION I:    Immuno-Oncology (IO) Overview – Scope of the problem

SESSION II:    Key Translational and Design Questions for IO Agents

SESSION III:    Considerations for Dose Selection of IO Combination Products

Workshop Co-chairs:

Amy E. McKee, MD

Deputy Director (Acting), Office of Hematology and Oncology, Center for Drug Evaluation and Research, FDA

Elizabeth M. Jaffee, MD

AACR President-elect 2017-2018; The Dana and Albert "Cubby" Broccoli Professor of Oncology; Deputy Director, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; Co-Director, Gastrointestinal Cancer Program The Johns Hopkins University School of Medicine

Registration is now available at this link.

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Register Today: Rally for Medical Research   

In May, we were shocked to learn that the Trump administration is proposing to cut $7.2 billion from the National Institutes of Health (NIH) budget in fiscal year (FY) 2018, a nearly 21 percent cut. These draconian proposed cuts make this year’s Rally for Medical Research more important than ever for protecting funding for lifesaving cancer research. 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. Save the date!

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

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