Walker Downey & Associates, Inc.

Toxicology 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.

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 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
• Labeling, Material Safety Data Sheets, etc.
• 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
• Environmental pollutants in soil, water and air
• Preparation of regulatory submissions
• GLP study auditing
• Monitoring of contracted studies
• Serving on Expert Panels

Case Study 1 (2005) – A newly formed venture capital-funded company with intellectual property rights to a novel technology conceived >20-years ago was now working expeditiously toward treatment of a new disease indication and sought Walker Downey & Associates guidance in the completion of IND-enabling studies. The company had strong research and development skills, but lacked the internal experience to complete the pivotal studies of their product. More specifically, the company required preclinical expertise in a porcine animal model in addition to a facility capable of conducting polymerase chain reaction (PCR) biodistribution studies. Walker Downey & Associates, Inc. was able to facilitate this testing.

Walker Downey & Associates first designed the needed studies (two separate studies were run concurrently) by “concept protocol” for discussion at the client’s Type-B pre-IND meeting with the FDA. After receiving FDA concurrence (no changes were required in the concept protocols by FDA) Walker Downey & Associates then called on the expertise of their staff to evaluate and review all requirements of the studies, including protocol design, personnel qualification evaluation, review of financials and pricing schedules. The team from Walker Downey & Associates recommended several qualified CROs with comparators for decision-making. Once the facility was selected by the client, Walker Downey & Associates was asked to oversee the studies. Walker Downey & Associates in conjunction with the selected CRO was able to complete the required studies on time and on budget. The client’s IND was subsequently approved and they were able to proceed to Phase I clinical testing. They are currently designing Phase II and III clinical trials with their product.