Translation of new cancer treatments from canine to human cancer patients.

Meeting Scope and Purpose: The integration of studies that include pet dogs with cancer into the development path of new cancer drugs is becoming more common and is expected to increase as a part of a creative drug development mechanism. The guidelines for regulatory oversight of non-clinical trials that include pet dogs with cancer, intended to support the development of a human drug or treatment delivery device, require input and discussion from several interested communities.

Towards this goal we propose an open meeting of regulatory and federal agencies, the pharmaceutical/biotechnology community, and others involved in the field of cancer drug development. This meeting will generate an agenda that will prioritize the use of canine disease models in the assessment of potential biological activity and efficacy of agents and devices in the cancer treatment development path.

References (attached):

• Paoloni et al. The Dog as a Cancer Model. Nature Reviews Cancer 8, 147-156 (2008)
• Khanna, C. et al. The Dog as a Cancer Model. Nature Biotechnology 24, 1065-166 (2006)
• Mack, G. Clinical Trials Going to the Dogs: Canine Program to Study Tumor Treatment, Biology. Journal of the National Cancer Institute 98, 161-162 (2006)

Format: The value, opportunities, risks and rewards of an integrated and comparative drug development path for cancer will be presented through specific examples of cancer therapeutics at various points in the development process. These examples will provide breadth to the discussion of the value of a comparative approach to cancer drug development and will outline specific considerations that should be discussed in defining a regulatory agenda for the conduct of these studies. Each presentation will highlight important issues that require discussion of the important intermediary position (between conventional animal models and human clinical trials) for studies of new cancer therapies in pet dogs with naturally occurring cancer. The focus of these presentations will center on the types of questions that can and should be asked and answered within these comparative studies and how these data may be successfully integrated into the development path. Presentations will include all perspectives of the drug and device development community including the pharmaceutical industry, cooperative groups, academic institutions, regulatory bodies, and the National Cancer Institute.

Intended Outcome: This meeting will generate discussion on the use of canine disease models in the assessment of potential biological activity of agents and devices in the cancer treatment development path. We hope that this agenda will include a discussion of questions best answered by this approach, options for trial designs, what if any regulatory oversight is needed, and methods of presentation and reporting of data.