Walker Downey & Associates, Inc.

Toxicology Services

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Once a company has a viable product (one that has shown the potential for benefit through preclinical pharmacodynamics or proof-of-concept studies and can be manufactured with reasonable consistency), the next step in development is to provide evidence in an IND (Investigational New Drug) Application that it is safe to administer the product to humans for the first time (Phase I clinical trial). This evidence is gathered from a well-designed program of appropriate preclinical/nonclinical studies. It is at this IND stage that the preclinical toxicology studies play perhaps their most important role. More specifically, the planning of an appropriate toxicology program to support a Phase I clinical trial and the interpretation of the resulting data in terms of safety requires careful consideration of an entire array of different factors, including the FDA regulatory process, the relevant FDA and ICH guidance/points-to-consider documents, general principles related to the design of an appropriate toxicology program, safety issues specific to a product class, a scientific evaluation of any risk inherent in a specific product, risk assessment issues, and differences in regulatory philosophy between the CBER, CDER and CDRH, and the international agencies.

Walker Downey & Associates prides itself in its product-specific preclinical concept protocols prepared with justification for the type-B pre-IND meeting with the appropriate agency. Following concept protocol approval by the agency we, acting as your Authorized Representative, will solicit bids from our list of reputable Contract Research Organizations (CRO) and function as the Study Monitor to assure the satisfactory completion and reporting of all testing. After “doing the right test right” we will summarize the testing for your Investigators Brochure (IB), 510(k) or IND (Section 8).

Oftentimes, an evidence-based risk assessment or expert opinion will satisfy the requirements for regulatory toxicology, thereby potentially reducing costs to the client and sparing experimental animals. Since preclinical testing is a time-consuming process that requires careful planning and evaluation early on and throughout development, Walker Downey & Associates makes every effort to promote this formal risk assessment approach. A summary of our Toxicology Services is provided below. Click on any learn more for additional discussions.

	Walker Downey & Associates will serve as a product safety and development consultancy for your project team from discovery and proof-of-concept through clinical testing. We will develop strategies for product classification and approval. We have provided evidence-based risk assessments, expert opinions, and strategic sourcing for decades. Our staff has extensive hands-on experience monitoring and auditing safety studies and we work closely with clients to ensure protocol consistency and compliance with Good Laboratory Practice (GLP). Learn more
	The hazard presented by a substance or device (i.e. the agent) is its potential to do harm and risk is the likelihood that it will cause harm in the circumstances of actual use or that the hazard will be realized. The aim of making a risk assessment is to identify the hazards associated with the agent, to assess the seriousness of these hazards and to formulate strategies to reduce the associated risks to a minimum or at least to an acceptable level. The staff at Walker Downey & Associates is considered academically and experientially competent in risk assessment by their peers and by the regulatory authorities. Learn more
	The staff at Walker Downey & Associates is widely recognized as experts in their respective fields owing to their many years of professional work experience, extensive academic training, board certifications, and professional affiliations. Dr. McLain, for example, in his capacity as a decades-long practicing toxicologist and as the current convener of ISO 10993-11 (Biological Evaluation of Medical Devices – Systemic Toxicity Evaluation), has helped numerous medical device clients navigate the hurdles of product development within their specific regulatory framework. His authoritative, evidence-based Expert Opinions, or White Papers, have been viewed by numerous international regulatory agencies in support of his client’s submissions. Expert Opinions can be useful at any stage of the product development cycle. Learn more
	Walker Downey & Associates has an in-depth knowledge of the preclinical marketplace, thus access to this critical information means improved CRO selection. This means a reduction in risk, expense, and a faster time to market. Walker Downey & Associates, Inc. will help to identify a CRO suitable for your experiments and protocol requirements, provide service comparisons, audit facilities and capabilities, conduct price comparisons that reflect specification and risk parameters, and will provide management of the CRO from contract details through study reporting. We have many repeat clients for this aspect of our service offerings. Learn more
	Proof-of-concept testing is the initial stage of product commercialization. The development in this stage involves taking an idea and conducting enough research to prove that the idea is feasible and can work. Walker Downey & Associates will collaborate with you early in product development to provide critical proof-of-concept data. Using our dedicated porcine isolation facility we can serve as an incubator for successful medical device and biotechnology companies and support fundraising efforts by generating proof-of-concept data, assisting with presentations to investors and serving as a subcontractor on grant proposals. Learn more
	Walker Downey & Associates can either assess initial medical device functionality or facilitate the collection of traditional bioavailability data from our proof-of-concept service offerings in the domestic pig (sp. Sus scrofa). Learn more
	Before entering into a major commercial agreement such as a license, joint venture or other collaboration a company will want to carry out a certain amount of due diligence. Due diligence is the detailed investigation of the affairs of a business, with the aim to identify problems within the business, particularly any issues which may give rise to unexpected liabilities in the future. Walker Downey & Associates specializes in product safety and development activities, thus our team of selected scientists can provide the due diligence that an in-licensed product “is what it is said to be”. Learn more
	The process of peer review is considered critical to establishing a reliable body of research and knowledge. Regulatory agents charged with acting upon a submission can only be expert in a limited area; thus they welcome and rely to some degree on the third-party peer-review process to lend additional credibility to the research. Walker Downey & Associates will facilitate a peer review of preclinical study reports, or other written documents by our internal scientists who are experts in the field. Learn more
	Walker Downey & Associates has worked in the regulated healthcare industry for decades and can provide a thorough assessment of your company’s compliance to pertinent standards and regulations. Our certified scientific and quality assurance auditors have been used internationally to assure that, for example, GLP testing facilities being considered by the client are appropriately accredited and qualified. We can also extend this quality assurance for compliance to your manufacturing process (cGMP). Learn more
	In preclinical research, SOPs are typically defined as "detailed, written instructions to achieve uniformity of the performance of a specific function". Walker Downey & Associates recognizes the importance for your staff to train on SOPs so that they are actually aware of why and how SOPs can play an important role in fulfilling the FDA and other regulatory requirements. We can provide that training or develop your internal program to facilitate it. Where SOPs may be lacking we can help you to write them, or we can review your existing documents. Learn more
	Walker Downey & Associates is committed to sharing our decades of combined knowledge with you. Although we specialize in GLP training for regulatory compliance our expert staff can provide introductory or advanced training in toxicology, pathology, statistics, auditing, formulations and development, project management, histology, animal husbandry, and plasmid vector design. Learn more
	The most effective and accurate manuscripts of research projects are written as close as possible to the completion of the project. All too often, however, that important research project is followed too closely by another, such that the first oftentimes becomes buried in the stack of “things I must do”, and many important projects are never published. The experienced writing staff at Walker Downey & Associates can help to alleviate your manuscript backlog. Learn more
	The Science of Toxicology Learn more