The conference, held September 26 at the Hotel Palomar in Washington DC, convened key stakeholders to address critical questions regarding the future of clinical cancer research.
(Panel Four: L-R Dr. Mark McClellan, Dr. Ann Barker, Dr.Robert Young, Dr. David Kessler, David Epstein, Dr. Ellen Sigal)
The conference, held September 26 at the Hotel Palomar in Washington DC, convened key stakeholders to address critical questions regarding the future of clinical cancer research. Panelists included; Dr. Mark McClellan (Brookings), Dr. David Kessler (Former FDA Commissioner), Dr. Ellen Sigal (Chair and Founder Friends), Dr. Janet Woodcock (FDA), Dr.Richard Pazdur (FDA) and others representing the most influential minds of industry, advocacy, regulatory, academic and government research communities. NCI Director Dr. John Niederhuber made opening remarks, and FDA Commissioner Dr. Andrew von Eschenbach delivered the luncheon keynote address.
(Panel One: L-R Dr. Gwen Fyfe, Dr. Richard Schilsky, Dr. Jeffrey Abrams, Robert Erwin, Dr. Janet Woodcock)
Throughout the day long conference, panelists addressed pressing scientific and regulatory challenges and opportunities for progress in innovations in cancer therapy. The first three panels discussed options for clinical data standards, alternative methods for demonstrating the efficacy of promising therapies, and approaches to the joint development of cancer drugs and diagnostic tests respectively.
(Panel Two: L-R Dr. Jim Doroshow, Dr. Debasish Roychowdhury, Dr. Raymond DuBois, Dr. Richard Pazdur, Dr. Donald Berry, Nancy Roach)
The final panel, moderated by Dr. Robert Young, Chancellor of Fox Chase Cancer Center, explored a vision for the future of FDA – looking at how FDA can guide innovation and respond to the challenges of a quickly advancing field.
Dr. Ellen Sigal, Chair and Founder of Friends, closed the panel by calling for the establishment of a clear FDA oncology program, the need for transparency and consistency to regulatory procedures, and the necessity for a clear path forward, emphasizing the importance of keeping the momentum of the conference going “toward action rather than rhetoric.”
Prior to the conference, panelists developed white papers on these issues that are available here:
- Panel 1 Issue Brief: Data Submission Standards and Evidence Requirements
- Panel 2 Issue Brief: Improved Insights into Effects of Cancer Therapies
- Panel 3 Issue Brief: Co-Development of Diagnostics and Therapeutic
Download the full White Paper [here]