Nonclinical Study Design and Management
Dr. Gary Wolfe is an expert in formulating drug development plans for small molecules and biologics for FDA submissions. He is able to identify, design, and implement nonclinical study programs in multiple species that are recommended for the IND or NDA submissions to the FDA. Dr. Wolfe’s 30+ years experience in industry and consulting has provided him unique insight and ability to identify the most appropriate contract research laboratories that suit client needs and his scientific expertise is applied in monitoring study conduct and reporting to ensure the highest quality standards are maintained from study inception through the submission of the final GLP-compliant report.
Study Identification and Design – Dr. Wolfe provides comprehensive services for pharmaceutical and biotech companies with small molecules and biologics with potential for FDA approval. Dr. Wolfe has expertise in identifying and implementing required drug development programs for a broad range of therapeutics, including: oncologics, vaccines, gene-therapy drugs, anti-hypertensives, anti-microbials, anti-inflammatories, and antibiotics. Dr. Wolfe’s methodology in designing studies ensures that studies are designed to effectively meet the requirements for regulatory approval while maintaining cost efficiency.
- Acute, Subchronic, Chronic Toxicology – single and multiple dose studies to 52 weeks in small and large animals examine adverse effects with organ involvement, reversibility, and toxicokinetics.
- Genetic Toxicology – in vitro and in vivo studies designed to evaluate point mutations and/or clastogenic damage/chromosomal alterations.
- Safety Pharmacology – studies to examine undesirable pharmacologic effects in the CNS, cardiovascular, and respiratory systems.
- Carcinogenicity – 104-week studies in rats and mice designed to identify tumorigenic potential of small molecules.
- Developmental and Reproductive Toxicology – studies generally conducted in rats, rabbits, or mice but also in pigs, dogs, and nonhuman primates to evaluate the developmental and reproductive effects on gametes and progeny.
Study Placement and Contract Negotiation – Dr Wolfe has 30+ years of experience at contract research organizations offering a full suite of preclinical services to a diverse network of clients. In these positions, Dr. Wolfe served as a GLP study director but was also responsible for technical scientific leadership as well as the management of day-to-day operations. Over the past five years, Dr. Wolfe has been placing studies designed to suit various client needs at major contract labs across the United States and internationally. Dr. Wolfe’s experience working inside of contract research organizations, in addition to his experience working on behalf of clients doing business with contract research organizations, makes him uniquely qualified to manage the overall contracting process, including negotiations of price, timeline, and quality.
Study Monitoring – Upon execution of a contract, Dr. Wolfe is able to provide monitoring services that ensure all studies meet the two important aspects of quality: (1) compliance with all Good Laboratory Practices Regulations (GLP) as promulgated by the FDA, and that (2) scientific integrity is maintained at all times to meet the objectives of the study as specified in the study protocol.
Study Data Interpretation – Upon conclusion of the data collection phase of a study, Dr. Wolfe is able to summarize findings as presented in the data, compare findings to scientific literature, and formulate conclusions to determine the next phase of drug development.
Study Reporting and Auditing – Dr. Wolfe is able to provide comprehensive reviews of reports published by contract research organizations to guarantee scientific validity and compliance with the reporting standards of GLP studies. As part of the auditing process, Dr. Wolfe will verify that the data provided by the study are appropriately reflected in the report and that its collection was in accordance with the GLPs. In addition, if a report is not provided by a contract research organization, Dr. Wolfe is qualified to compile data and draft GLP-compliant reports.
Peer Review – Dr. Wolfe is qualified to critically analyze published reports. His analysis will both identify potential deficiencies in scientific validity and/or GLP compliance and provide recommendations to resolve such issues.
Quality Assurance/Quality Control – Dr. Wolfe has extensive experience and is able to offer a wide range of quality assurance (QA) services to confirm that published reports meet the standards prescribed by GLP. In addition to QA services, Dr. Wolfe is able to reinforce the validity of reports by offering quality control (QC) review of the data underlying reports.