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July 2010 CER and Kansas Town Hall

July 2010 CER and Kansas Town Hall

Friends of Cancer Research Newsletter

Secretary Sebelius (HHS), Dr. Francis Collins (NIH) and Dr. Margaret Hamburg (FDA) join leadership from Academia, Government and Industry to discuss “The New Role of Academia in Drug Discovery and Development”


                                                      Sec. Kathleen Sebelius Delivers Keynote Address

On July 6th, Friends of Cancer Research and The University of Kansas Cancer Center, in conjunction with the Kauffman Foundation, Kansas Bioscience Authority and the Council for American Medical Innovation, convened a symposium on “The New Role of Academia in Drug Discovery and Development: New Thinking, New Competencies, New Results and New Paradigms in Cancer Research.” The symposium was held at the Kauffman Foundation Conference Center in Kansas City, Missouri and attended by members of Congress, experts from federal and state health agencies, individuals from
industry as well as the academic, advocacy and research communities.  The conference was convened to foster collaboration between academia, industry, government and patients to accelerate drug discovery and development in cancer research. 


                                                 Audience listens to Sec. Sebelius at the Kaufman Foundation Conference Center

US Secretary of Health and Human Services Kathleen Sebelius delivered the keynote speech and stated, “we have no better partners than our academic centers” in research. She reiterated the Obama administration’s commitment to science and emphasized that increasing research budgets alone is not enough; new partnerships are essential in order to achieve success with research dollars. Examples of recently established collaborations within the federal government to cultivate partnerships in drug discovery are the new FDA/NIH Leadership Council announced earlier this year, and the Cures Acceleration Network established as a part of the health-care reform legislation.

To View the Secretary’s Speech Click Here

(L-R) Tom Thorton, Judy Baker, Cong. Richard Gephardt, Dr. Ellen Sigal, Cong. Dennis Moore, Dr. Margaret
Hamburg, Sec. Kathleen Sebelius, Dr. Francis Collins, Dr. Barbara Atkinson, Chancellor Bernadette Gray-Little

During a special panel discussion moderated by former House Majority Leader Richard Gephardt, FDA Commissioner Dr. Margaret Hamburg, and NIH Director Dr. Francis Collins, discussed programs they are implementing to capitalize on the strengths of each agency in advancing medical research. Dr. Collins stated that government collaboration is just one vehicle, but it will require collaboration with academia and industry to develop new innovations. Dr. Hamburg said that there is a need to step back and evaluate the FDA’s role in advancing biomedical research. She discussed the need for an emphasis on regulatory science, which has the ability to bring a cutting-edge scientific approach to safety and efficacy evaluations of new products. Dr. Hamburg told the audience that President Obama included money in the 2011 budget specifically targeted to advance regulatory science.

To View Dr. Collins and Dr. Hamburg’s Discussion Click Here

The conference consisted of four panel discussions moderated by Reuters National Health Correspondent Lisa Richwine.  The first panel focused on a new way of thinking about how industry and academia can better collaborate to successfully and efficiently translate scientific discoveries into new therapies. The panelists emphasized that moving an idea from basic research into clinical study is becoming increasingly difficult. New ideas often languish due to scarce resources for early stage investment or a lack of expertise. The panelists agreed that a new model requires multi-disciplinary interaction at each step of the process to encourage the translation from basic science to clinical application.
The second panel focused on how new collaborations can aid in the development of new tools to evaluate medical products and establish best practices for commercial agents. Increased collaboration between academic centers and FDA could help support regulatory science programs and develop core competencies for product development.  Institutions with a specific area…

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Leaders on from NIH, AHRQ, FDA, CMS, NCI, House, Senate, and Academia Discuss the Future of Comparative Effectiveness Research at Friends Forum Supported by Oracle Health Sciences

On June 18, Friends of Cancer Research hosted a forum on the future of comparative effectiveness research (CER). The meeting featured leaders from all sectors discussing priorities for expanding the conduct of CER in the U.S. 
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 (L-R) Ramsey Baghdadi, Dr. Clancy, Dr. Collins field questions from the audience; Dr. Sigal delivers opening remarks

Discussion with Dr. Collins and Dr. Clancy
The forum began with a discussion between Dr. Francis Collins (Director, NIH) and Dr. Carolyn Clancy (Director, AHRQ) moderated by Ramsey Baghdadi of The RPM Report. Dr. Collins and Dr. Clancy are the first designated members of the seventeen-member Board of Governors of the Patient Centered Outcomes Research Institute (PCORI). This institute, established as a part of health care reform legislation, will play a pioneering role in the future of CER.

  • Patient-Centered Outcomes Research Institute Structural Chart [Click Here]

  • Patient-Centered Outcomes Research Institute Funding Chart [Click Here]

During the discussion it was noted that the PCORI Board needs to promote transparency, credibility and inclusiveness in the processes of identifying the best choices for patients.Dr. Clancy conveyed her optimism about the opportunity to focus research on a longitudinal basis, as well as the legislation’s recognition of the need for additional methods of development. Both agreed that achieving meaningful use out of today’s wealth of data is a major priority.  This included the importance of establishing a robust infrastructure to support ongoing CER. Specifically, Dr. Collins suggested tapping into patient data gathered in HMOs.

 Audience Listens to Panel Discussion

The discussion concluded with a conversation regarding the compatibility of CER and personalized medicine. Both agency directors suggested that the two are complimentary and voiced that CER and personalized medicine ought to be considered “hand in glove.”

Panel 1: Coordination and Use of CER Studies by Federal Health Agencies
The first discussion panel provided the perspective of several key agencies and representatives from Capitol Hill about with the future direction for CER. The panel included the following members:
·      Richard Hodes- Director of the National Institute on Aging, (NIH)
·      Jesse Goodman- Chief Scientist & Deputy Comm. for Science & Public Health (Acting), (FDA)
·      Louis Jacques- Director, Coverage & Analysis Group(CMS)
·      Jean Slutsky- Director, Center for Outcomes and Evidence, (AHRQ)
·      Stephen Cha- Professional Staff, House Committee on Energy & Commerce
·      Andrew Hu- Professional Staff, Senate Committee on Finance

(L-R) Dr. Stephen Cha, Dr. Jesse Goodman, Dr. Richard Hodes, Andrew Hu

The panel opened with enthusiasm for CER and the new Institute, as well as the inter-agency collaborations that are already taking take place.  Dr. Hodes noted those recently established partnerships between the FDA and NIH. The panelists discussed the need for public literacy and transparency in terms of CER, and the importance of filtering CER information through decision makers to improve patient outcomes.
Congressional staff members were asked to discuss the approach they took in developing the health care reform legislation. The two panelists acknowledged that the House and Senate had different visions of the role of CER, although both felt that the language in the bill was structured appropriately. Both panelists made clear that separating CER and coverage decisions was a priority. The staffers also agreed that the makeup of advisory committees would be one of the most important factors determining the Board’s success, as well as patient input and participation.
The panelists continued their discussion by suggesting hypothetical CER projects they would like to see undertaken. Dr. Jacques suggested addressing elderly care, and whether particular interventions were as effective if they were administered in-home. Dr. Slutsky spoke of the importance of the CER community to keep an open mind about factors such as different populations, interventions, and the spectrum of care. The panelists also discussed clinical trials in terms of CER, and the challenge of encouraging patients to participate when they frequently would prefer existing treatment options, or in some cases experimental treatment.
The panelists all agreed that research priorities and questions should determine how studies are funded. Dr. Goodman suggested that the range from patient intervention to outcomes, and where breakdowns occur in that range, ought to be considered in this context.
Panel 2: Development of a Linked Health Data Network
The final panel discussed the research potential of health data networks and the processes of effectively capturing productive health data. The panel included the following members:
·      Jeff Allen- Executive Director, Friends of Cancer Research
·      Bob Croyle- Director, Division of Cancer Control & Population Sciences (NCI)
·      Bill Dalton- Director, Moffitt Cancer Center
·      Brett Davis- Senior Director, Oracle Health Sciences
·      Kim Lyerly- Director, Duke Cancer Center
·      Amol Navathe- Medical Officer, U.S. Department of Health and Human Services

(L-R) Brett Davis, Dr. Kim Lyerly, Dr. Jeff. Allen, Dr. Bill Dalton

The panel began by discussing the importance of current data aggregation efforts. Dr. Croyle spoke of the need for balance among several important elements of the aggregation process: infrastructure development, standards development, and grow-your-own development. One of the biggest challenges facing health data aggregation is the amount of unclear evidence that often faces patients.

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 *A complete conference report will be prepared in the coming weeks. 


*Click below to view a recent Article in Journal of Clinical Oncology describing the need for a learning health-care system.
“Rapid-Learning System for Cancer Care”
Amy P. Abernethy, Lynn M. Etheredge, Patricia A. Ganz, Paul Wallace, Robert R. German, Chalapathy Neti, Peter B. Bach, and Sharon B. Murphy


10logoFocus on the National Cancer Institute (NCI)
       Harold Varmus Sworn in as National Cancer Institute’s 14th Director

Nobel Prize winner Harold E. Varmus, M.D., yesterday took the oath of office to become the National Cancer Institute’s (NCI) 14th director. NCI is one of the 27 Institutes and Centers that comprise the National Institutes of Health (NIH).

“It’s very exciting to have you back,” said Health and Human Services Secretary Kathleen Sebelius during the swearing-in ceremony. “Today is the opening of a new chapter for NCI.”
Varmus was director of NIH from 1993 until the end of 1999.

In his opening remarks to a town hall meeting that reintroduced Varmus to the NIH community, NIH Director Francis Collins, M.D., Ph.D., called him “the best person on the planet to take the reins of the National Cancer Institute at this propitious moment.”

Varmus was co-recipient of the Nobel Prize in Physiology or Medicine in 1989 for studies of the genetic basis of cancer. He most recently served as president of Memorial Sloan-Kettering Cancer Center in New York City.

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