Walker Downey & Associates, Inc.

Pathology Consulting

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One of the important steps in the medical devices, biologics and drug development process is the demonstration that it is safe to administer the product to humans for the first time (Phase I). The process is especially difficult because this demonstration of safety is most often limited to the use of preclinical in vitro and in vivo studies, including animal toxicology studies. In order to carry out this task, consideration must be given to the FDA regulatory process, the appropriate FDA and ICH guidances, general principles related to proper toxicology study design, specific safety considerations related to the biological product or drug class, additional safety concerns obtained from a careful scientific review of the pharmacodynamics and mechanism of action of the product, and an analysis of the risk-benefit issues associated with the product. The product development cannot proceed until preclinical toxicology study results that support safe administration of the product to humans are submitted to the FDA in a 510(k) or an IND. It is recommended this process involve continuous communication with the FDA, including a pre-IND meeting. Clinical and anatomic pathology are important components of the toxicology study.

The services Walker Downey & Associates provides are diverse and vary from one individual consultant to another based on the consultant’s expertise and experience. For the majority of our clients, we provide written reports on the adverse health/environmental effects of chemicals or assist them by developing a toxicity testing strategy for a new product that complies with regional or international regulatory requirements. Walker Downey & Associates can also prepare protocols for non-clinical drug/device/biologic safety studies and work with laboratories to ensure that they are being conducted properly. We can also interpret the pathology results of toxicology studies to help prepare the regulatory submissions. Our Associates have many years of experience in their fields including:

• Effects of exposure as may be reported through risk assessments or expert opinions
• New product development and existing product defense
• International and domestic pharmaceutical and medical device development
• Resolution of US and international regulatory compliance issues
• Cosmetics and consumer product development
• Preparation of regulatory submissions
• GLP study auditing
• Monitoring of contracted studies
• Serving on Expert Panels
• Pathology peer review