Washington Update: Friends Testifies, Holds Hill Briefing | Friends of Cancer Research

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Washington Update: Friends Testifies, Holds Hill Briefing

Friends of Cancer Research Newsletter

Friends of Cancer Research Testifies Before Congress On Tuesday, March 23, 2010, Friends of Cancer Research (Friends) Executive Director, Dr. Jeff Allen, testified at a Congressional hearing held by the Committee on Energy and Commerce, Subcommittee on Health, "NCI Cancer Research: Today's Progress; Tomorrow's Challenges" held in the Rayburn House Office Building. The hearing examined the National Cancer Institute's (NCI)  research efforts and provided recommendations to the path forward for continued progress. Testimony sought to educate members about cancer research conducted and supported by NCI, and to help all, better understand the current state of programs at the NCI as well as the direction that the institute, along with the entire cancer community, is headed.  The hearing, held by Subcommittee Chairman Frank Pallone Jr. (D-NJ),opened with statements by all members in attendance including Committee Chair, Henry Waxman (D-CA)  who gave opening remarks stating that; "Cancer is a complex disease. We know that genetic, environmental, and other factors all contribute to an individual's risk for developing cancer. Discovering cures and developing effective treatments are complex, difficult, and expensive endeavors as well." Deputy Director of NCI, Dr. Anna Barker                           Friends Executive Director, Dr. Jeff AllenDr. Anna Barker, Deputy Director of NCI, was the first to testify (Full Text Available [HERE]). Dr. Barker opened her testimony by expressing the challenges that cancer research faces, the advances in research, and how increased knowledge of cancer is allowing us to move from a "one size fits all" approach to fighting the disease. Dr. Barker articulated what challenges are currently being addressed, saying; "NCI's key challenge is to understand the changes in the genome and associated biology that ultimately cause cancer in order to enable the development of more effective diagnostics, therapies, and prevention strategies that can be delivered to cancer patients." Dr. Barker emphasized the importance of how projects like The Cancer Genome Atlas (TCGA), a comprehensive and coordinated effort aimed to accelerate our understanding of the molecular basis of cancer through the application of genomic analysis technologies, will "re-define cancer targets and provide a rational basis for the development of new targeted diagnostics and therapeutics." Dr. Barker also said that the American Recovery and Reinvestment Act funds that NCI received helped to significantly expedite this project, which was started in 2005.  For more information on the Cancer Genome Atlas click [HERE] Friends of Cancer Research Executive Director, Dr. Jeff Allen, gave oral testimony on the second panel, and also submitted a more detailed written testimony for the congressional record (Full Text Available [HERE]). Dr. Allen's statement gave perspective on the vital need for NCI to be in direct collaboration with other federal health agencies, the important role that public-private partnerships, such as the Foundation for the NIH and The Reagan-Udall Foundation, can play in spurring innovation, and the need to tear down the silos that currently exist within the biomedical research community.  He emphasized not only the need for sustained federal funding of research at NCI and NIH, but also the importance of supporting scientific capacity at the Food and Drug Administration, which he said "serves as the nexus between the progression of laboratory research and the clinical use of new therapies." In written testimony submitted to the subcommittee, Friends asked that Congress support the President's FY11 budget for FDA, which includes $25 million for Regulatory Science programs at the FDA. Dr. Allen concluded his testimony by asking Congress to continue their commitment to ending cancer and the need for a unified front in this fight.  "The advocacy community, and entire research community, must embrace our common goal and support science and collaboration that will enhance the battle against cancer on all fronts," said Dr. Jeff Allen. "It is our responsibility to represent patient's needs, and what is needed to end the burden of all diseases." The second panel to testify also included: Dr. Robert DiPaola, Director, Cancer Institute of New Jersey, and Member of the Science Policy and Legislative Affairs Committee, American Association of Cancer Research (AACR); Megan Gordon, Director of Government Affairs, Pancreatic Cancer Action Network; and Kristin Fitzgerald, a former congressional staffer who lost her husband to cancer.
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Friends and FasterCures Host Hill Briefing: "Science and Progress at the FDA: Realizing the Return on Investment from Biomedical Research" Speakers at a congressional briefing on March 24, 2010, said that in order to realize the full return on investment from biomedical research, the U.S. Food and Drug Administration (FDA) needs to be in a position to take the baton of innovation from the research community and turn it into medical products that are safe, effective, and accessible for patients who need it most. The briefing, "Science and Progress at the FDA," was convened by Friends of Cancer Research and FasterCures/The Center for Accelerating Medical Solutions.In her opening remarks, Rep. Rosa L. DeLauro (D-CT) said that the FDA must work in new ways to enhance science at the agency, recruit more top minds to formulate regulatory regimens to promote safety without stifling innovation, and adapt a multidisciplinary approach.  She noted that for FDA to be the thriving center of scientific knowledge, it requires more than resources alone, its culture must change from within.Rep. Rosa DeLauro (D-CT) addresses audience.                           (L-R) John Marshall, Margaret Anderson, Ellen Sigal, Jesse                                                                                Goodman, Max WallaceJesse L. Goodman, MD, MPH, Chief Scientist and Deputy Commissioner for Science and Public Health (Acting) at FDA defined the premise of FDA's focus on regulatory science. He said that the science done by academia - often supported by NIH - gives us tremendous insight into basic mechanisms of disease while the work done by the biopharmaceutical industry focuses on getting products on the market. Regulatory science is applied science that aims to develop, assess and provide new, validated tools and approaches to better evaluate the utility of new medical products.   "At our very best, FDA can join with partners to develop tools that make the evaluation process sounder," Goodman said. "The model of going it alone doesn't work. The world of science and amount of information out there is just too huge. What we need to do is collaborate and engage with the scientific community." Echoing DeLauro's point, he said that some of it is about resources, but some of it is about doing things in a more innovative way. He noted the need to reduce risk while maintaining patient benefit. "Along with medical and scientific risks, we need to consider financial risk as well," said Max Wallace, JD, CEO of Accelerated Brain Cancer Cure. Wallace, who has also founded a number of biotechnology companies, said that capital is the rocket fuel that propels the process from discovery to product.  "Capital is rocket fuel without soul - it hates risk. If risk is doubled by time delays or failure to understand science or opaque noncollaborative environment, the capital will seek its level in other places," he noted. "So, how do these discussions about regulatory science translate into patient benefit?" asked briefing moderator Margaret Anderson, Executive Director of FasterCures. John D. Marshall, M.D., Clinical Director of Oncology for Georgetown-Lombardi Comprehensive Cancer Center and principal investigator of over 150 clinical trials provided real-world context. He said that the FDA sets the goal, the rules, the parameters that we are to aim for in clinical research: safety and efficacy.  Marshall said that by having the scientific capacity to determine the best models to measure safety and work and collaborate with researchers to design appropriate trials, the FDA can make the process more effective, and efficient. He noted that having the ability to tailor trials to a subset of patients that are known to respond to specific medical products paves the way to a better development system and realizes the promise of personalized medicine. Ellen Sigal, PhD, Chair and Founder of Friends of Cancer Research said that patients have different risks and profiles. But consistent with all patients is the need for more information. Sigal said that "we can evaluate risk with the right data. We want to be able to make choices based on the data."  Marshall later noted the importance of "building a system that allows buy-in from the patients." Regulatory science is the backbone that supports all other FDA activities. Improvements in regulatory science will support better assessment of drug and device safety, and create efficiencies in the development process.
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Groundbreaking Public-Private Collaboration Combines Personalized Medicine and Novel Trial Design to Develop Potentially Life Saving New Breast Cancer Drugs On March 17, 2010, leaders from the academic research community, members of congress, including Senator Arlen Specter (D-PA), and leaders from government agencies, including Dr. Janet Woodcock from the Food and Drug Administration (FDA) and Anna Barker from the National Cancer Institute (NCI), joined the Biomarker Consortium* at the National Press Club to announce the launch of "The I-SPY 2 Trial," a highly anticipated clinical trial to help screen promising new drugs being developed for women with newly diagnosed, fast-growing breast cancers.
"This is an excellent example of a new and innovative model to truly help patients," said Dr. Ellen Sigal, Chair & Founder of Friends of Cancer Research, and Chair of the Public-Private Partnerships Committee for the Foundation for the NIH (FNIH). "This type of public-private partnership, with collaboration between government agencies, patient groups, industry and multiple academic institutions, is vital to the process, and is the direction science needs to be heading."

This collaboration comes on the heels of an announcement, on February 23rd, of a joint FDA-NIH Leadership Council to spearhead collaborative work on important public health issues. More information on the announcement last month can be found [HERE].

  • "The I-SPY 2 trial" will employ a groundbreaking clinical trial model that uses biomarkers from individual patients' tumors to screen promising new treatments and identify which treatments are most effective in specific types of patients.
  • The innovative adaptive trial design will enable researchers to use early data from one set of patients to guide decisions about which treatments might be more useful for patients later in the trial, and eliminate ineffective treatments more quickly.

"I-SPY 2 promises to leverage convergence of progress on a number of research fronts to speed the evaluation of promising new breast cancer drugs using molecular cancer biomarkers to identify those agents that are effective in specific subpopulations of breast cancer patients," said Dr. Anna D. Barker, Deputy Director, NCI, and....To Continue Reading Click [HERE]

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Focus on the National Cancer Institute (NCI): 10logoARRA Funds Support Comparative Effectiveness Research in Cancer NCI has announced that, to date, ARRA funds have enabled NCI to support approximately $70 million in comparative effectiveness research, including $50 million in Grand Opportunities and $13 million in Challenge Grants. Grantees/Researchers are examining a broad spectrum of cancer-related issues, including smoking cessation trials, cancer screening methods, risk behavior interventions, surgery and treatment options, community cancer surveillance and genomic medicine. Remaining NIH ARRA funds for CER will be used to support a variety of initiatives, including training the next generation of CER researchers and improving CER methods.To Read About the CER-Related Projects NCI Has Funded [Click Here]To Read More About CER and Keep Up To Date on Current Actions [Click Here]
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