Confronting Cancer Today

Cancer Symposium a Huge Success
On November, 12 2003, Friends of Cancer Research in conjunction with the Division of U.S. Studies at the Woodrow Wilson International Center for Scholars hosted a forum entitled, "Confronting Cancer Now." Our speakers and panelists raised a number of important topics including the exciting gains in our understanding of cancer's genetic mechanisms and the consequent medical advancements in terms of treatment and prevention, particularly in the fields of genomics, proteomics, metabolomics, and molecular imaging.

As many speakers noted, numerous options exist for expediting the advancement of cancer research, such as increased NIH and FDA funding and a more efficient, predictable federal review process for oncology products. This important dialogue about the promise of future discoveries reached an important cross section of scientists, cancer advocacy groups, and policy makers. CSPAN will rebroadcast the event during the month of December.

Dr. Andrew von Eschenbach, Director of the National Cancer Institutue (NCI), delivered the first keynote address. He reiterated the NCI's goal to eliminate the suffering and death associated with Cancer by 2015 and praised the exponential expansion in cancer research and technology. To help perpetuate this growth, the NCI will pursue several important initiatives this year in such fields as early screening and prevention, Molecular Epidemiology, and Integrative Biology.

Dr. Mark McClellan, FDA Commissioner, delivered the second keynote address. He noted that the shift toward truly individualized cancer treatment based on a patient’s genetic profile will require new paradigms in clinical trial design and implementation. Prevention, especially in the area of nutrition, must continue to play a preeminent role in the war on cancer. Dr. McClellan also discussed the need to decrease drug development costs by shortening the total review time.

The keynote speakers also made a joint news announcement regarding two new collaborative efforts between the FDA and the NCI: an oncology fellowship training program and an electronic submission program from new drug applications.

Moderating the two panels was Dr. Charles Balch, Vice President and CEO of ASCO, who noted that the challenge will be to secure approval for clinical trial efficiently and to apply new knowledge to the care of patients. The first panel focused on the emerging science and highlighted current barriers to translating these advances from the laboratory to the bedside. Panelists included Dr. Nancy Davidson (Professor of Oncology and Breast Cancer Research and Chair in Oncology at Johns Hopkins University), Dr. Mel Sorenson (Vice President of Clinical Development & Medical Affairs at GlaxoSmithKline), and The Honorable Ralph M. Burnett (prostate cancer survivor and an Associate Judge for the District Court of Maryland).

Dr. Davidson described how multiple reviews by multiple agencies has significantly and unnecessarily delayed the development a new treatment for patients with advanced breast cancer using low dose chemotherapy and a new vaccine. Dr. Sorensen identified several steps for accelerating the advancement of new breakthroughs such as the development of surrogate markers and closer regulatory collaboration between drug applicants and the FDA. Offering a cancer survivors perspective on the clinical trial process, Judge Burnett described the difficulties many patients face when trying to access timely, accurate, and pertinent information about such trials.

The second panel focused on issues surrounding cancer drug approval within the FDA. Panelists included Dr. Susan Desmond-Hellman (MPH, Chief Medical Officer & Executive VP of Development and Product Operation, Genentech, Inc.), Dr. Herbert Kim Lyerly (Director, Duke Comprehensive Cancer Center), Dr. Gerard Kennealey (VP Clinical Research, Oncology, AstraZeneca LP), and Charlene G. Wallace (American Catholic University student and breast cancer survivor).

Dr.Desmond-Hellmann discussed the future hurdles to cancer research including patient recruitment, tissue acquisition, trusted surrogates, novel-novel combinations, and the transparency, efficiency, and predictability of the FDA and it regulatory decision-making. According to Dr. Kennealey, the FDA’s working relationship in recent years with drug manufacturers has improved, especially with the Oncology Division. However, he noted that major problems remain including the lack of a single “port of call” for oncology products, which leads to different agencies applying different standards for product reviews in similar therapeutic areas. Dr. Lyerly highlighted the importance of cancer centers to the translation of scientific discoveries into clinical trials. In a very moving and passionate speech, Charlene Wallace shared with the audience her experience with the Phase III clinical trials for Taxol.

Three Senators also spoke at different points during the event. Senator Edward M. Kennedy (D-MA) spoke of the importance of continued and significant increases in NCI funding. He warned that a return to small funding increases, such as the 2.5% being discussed by some in Congress, would sideline important research and unnecessarily postpone progress. Senator Stevens (R-AK) emphasized the need for increased NIH funding. He also highlighted the importance of nanotechnology and molecular imaging to the important, multi-disciplinary work being undertaken at the NIH and the NCI. Senator Specter (R-PA) felt that NIH funding and facilitating stem cell research should remain high legislative priorities. Both Senators Stevens and Specter called for renewed pressure on lawmakers who recently voted against a larger appropriation package than the one passed by both houses of Congress.