Steve Jones - Comment

July 28, 2012 Re: Docket No. FDA-2012-D-0432 Dear Dr. Powell, On behalf of more than 1,000 community oncologists in The US Oncology Network and the physicians and other researchers affiliated with US Oncology Research, thank you for the opportunity to comment in support of the Draft Guidance for Industry on Pathologic Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint To Support Accelerated Approval. The US Oncology Network is one of the nation’s largest networks of community-based oncology physicians dedicated to advancing cancer care in America. Like-minded physicians are united through The Network around a common vision of expanding patient access to high-quality, integrated cancer care in communities throughout the nation. Leveraging healthcare information technology, shared best practices, refined evidence-based medicine guidelines, and quality measurements, physicians affiliated with The US Oncology Network are committed to advancing the quality, safety, and science of cancer care to improve patient care. US Oncology Research draws from a network of experienced investigators and dedicated clinical staff who specialize in Phase I through Phase IV oncology clinical trials. US Oncology Research serves more than 85 practices in more than 245 locations managing more than 200 active trials at any given time. Physicians in the research network have enrolled more than 52,000 patients in over 1,200 trials since inception in 1992 and have contributed to the development of 43 cancer therapies approved by the FDA. We believe the guidance will have the effect of speeding new, promising therapies to patients fighting breast cancer and we commend the FDA for taking this significant step toward accelerating the clinical use of scientific advances. We look forward to continuing our work to advance the science of cancer care. Sincerely, Steve Jones, MD Medical Director US Oncology Research