Additional Program Expertise:
Dr. Wolfe is qualified to provide additional professional expertise that includes audits of reports and facilities for regulatory compliance, due diligence for compound acquisition, gap analysis for program completeness, litigation support and expert witness services, assistance with animal use documents, and reviews for conduct of animal studies.
Auditing of Nonclinical Studies – Dr. Wolfe has extensive experience provides a wide range of quality assurance services to confirm that published nonclinical reports meet the standards prescribed by GLP.
Animal Facilities – Dr. Wolfe has extensive experience ensuring that animal facilities are in compliance with GLP and other regulatory guidelines. Dr. Wolfe is able to assess and monitor the quality of animal facilities in studies placed by clients. In addition, for contract research organizations, Dr. Wolfe is able to offer a wide range of recommendations and expertise to improve the operation of animal facilities and bring them into regulatory compliance.
Due Diligence – Dr. Wolfe is experienced in reviewing entire nonclincal programs on behalf of clients interested in the acquisition of specific compounds.
Gap Analysis – Dr. Wolfe is able to review client nonclinical programs in search of missing elements that are required by the FDA to facilitate the drug development process. In addition, Dr. Wolfe’s services can be used to make compounds more marketable to potential acquirers.
Litigation Support and Expert Witness Services – As a board certified toxicologist with over 30 years of experience, Dr. Wolfe is qualified to be an expert in litigation and arbitration proceedings. As such, Dr. Wolfe is able to submit expert reports in accordance with Rule 26 of the Federal Rules of Civil Procedure and testify at deposition and trial.
Animal Use Documentation – Dr. Wolfe has filed documents and received approval from the following regulatory or accrediting bodies: AAALAC International, USDA, and NIH OLAW. Dr. Wolfe is able to assist animal laboratories in obtaining such accreditations or approvals.
IACUC Advisor – Dr. Wolfe’s experience as a study director at contract research laboratory, including chair of multiple animal care and use committees at multiple contract research organizations, qualifies him to fulfill an advisor role in the Institutional Animal Care and Use Committee (IACUC).