It was announced Friday, November 16, that Friends of Cancer Research chairperson, Dr. Ellen Sigal, was elected as a member of the inaugural board of directors for the U.S. Food and Drug Administration (FDA) Reagan-Udall Foundation. The purpose of the foundation is to establish public-private partnerships and facilitate research projects designed to modernize medical product development, accelerate innovation, and enhance product safety.

The foundation was established as a part of the Food and Drug Administration Amendments Act of 2007 (FDAAA), which was signed into law at the end of September. The bill called for nominations from the National Academies of Science, as well as public nominations provided by advocacy groups, professional and medical societies, and trade organizations. After receiving several hundred nominations, the final board was unanimously determined by the directors of the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), the Agency for Healthcare Research and Quality (AHRQ), and the Commissioner of the FDA.

Also serving on the 14-member board of directors are representatives from the private industry sector, academic research organizations, healthcare providers and consumer advocacy groups.

The establishment of the Reagan-Udall Foundation will take important steps to further integrate science into the regulatory process, provide training opportunities for FDA employees and fellows, and create a valuable public-private partnership for the advancement of the Critical Path Initiative.

Official announcement from the FDA

As a part of the 2007 Association of American Cancer Institutes (AACI) annual meeting, clinical and administrative leaders from the nation's top cancer research institutes gathered in Washington, DC on October 28-30. Nearly 300 attendees came together to discuss the challenges and opportunities that are facing their individual centers as well as the nation's efforts to advance cancer research.

As a part of a session entitled, "The Role of Congress in Shaping Cancer Policy," Dr. Ellen Sigal shared her perspective as a Washington cancer research advocate. Dr. Sigal charged those in the audience to "be active and be often" when engaging their members of Congress in the exciting work that is being done at their cancer center: "We all must be better at informing our nation's leaders of the immediate opportunities and innovative discoveries that come from their investment in biomedical research. These discoveries improve the lives of the millions of people facing this terrible disease each year."

PBS News Health Correspondent Susan Dentzer leads panel discussion.

Joining Dr. Sigal on the panel was Carolyn Gluck, Senior Policy Advisor for Senate Majority Leader Harry Reid (D-NV), and Dr. Sudip Parikh, Professional Staff Member for the Senate Committee on Appropriations. Their insight came at a key time in the Fiscal Year (FY) 2008 budget cycle as final funding decisions are still in negotiation.


FDA Examines Benefit-Risk Models

On November 6-7, a working conference entitled, "Assessing Drug Benefits-Risk in Regulatory Decisions," was held at the U.S. Food and Drug Administration (FDA), and Dr. Ellen Sigal spoke on behalf of the patient and research advocacy community. The meeting was convened as a starting point for on-going discussions about new methods of modeling and quantifying benefits and risks associated with therapeutic regimens. Dr. Sigal spoke of potential benefits that can be gained through the use of mathematical modeling in helping to shape patients' and doctors' treatment decisions. She also discussed the need for such models to be fluid: "Patients are not monolithic. Cancer itself spans a continuum from prevention to late-stage illness. While calculating benefits and risks numerically can provide great guidance, we must also remain focused on the underlying science of disease mechanisms for improved treatment options."

Also presenting at the meeting were national leaders from academia, industry, and patient advocacy organizations. As a part of the Food and Drug Administration Amendments Act of 2007 (FDAAA), the FDA is required to report to Congress in one year about steps the agency has taken to improve the communication of benefits and risks to patients and healthcare providers.


The Future of Innovation

On November 16, Dr. Sigal presented the role advocates play in fostering innovation at a conference entitled, "Transforming Health: Fulfilling the Promise of Research." The conference was co-sponsored by Research!America and the Pharmaceutical Research and Manufacturers of America.

Dr. Sigal reminded the audience of the current opportunities in science and described a future of collaborative research involving diverse stakeholders, "No one sector can do this on its own. We must all be relentless in our pursuit of innovation because at the end of the day it is personal to each of us."

The conference was hosted by Mary Wooley (President and CEO, R!A) and Billy Tauzin, (President and CEO, PhRMA). Featured speakers also included Dr. Elias Zerhouni (Director, NIH), Dr. Doug Throckmorton (Deputy Director CDER, FDA), and Meryl Comer (CEO, Geoffrey Beene Foundation, Alzheimer’s Initiative).

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