Identification and Coordination of Professional Experts:
Dr. Wolfe’s wide network of professional contacts in industry and government allows him to put clients in contact with leading experts in fields including pathology, clinical pathology, pharmacokinetics, and analytical and bioanalytical chemistry. Dr. Wolfe identifies and manages these diverse teams of professionals for standard or specialized study needs.
Pathology – Dr. Wolfe is able to identify qualified histology laboratories and pathologists to meet client needs for additional pathology or peer review. Dr. Wolfe is able to manage pathologists’ preparation of microscopic slides and review of tissues, and in addition, coordinate responses to specific pathologic requests or issues.
Clinical Pathology – Dr. Wolfe is able to identify and manage specific clinical pathology laboratories or clinical pathologists to conduct clinical pathology analysis or address specific requests or issues.
Pharmacokinetics/Toxicokinetics – The analysis of drug levels in biological fluids can be coordinated by Dr. Wolfe utilizing qualified expert pharmacokineticists. Such services include WinNonlin® modeling and analysis for multiple timepoints.
Statistics – Dr. Wolfe is able to identify statisticians that will evaluate additional statistical analysis and/or conduct further analysis of data that may be required or recommended by the FDA.
Analytical Chemistry – Dr. Wolfe is experienced in identifying GLP-compliant analytical laboratories that analyze dosing formulations for concentration, homogeneity and stability using a variety of analytical methods including HPLC, GC, AA, and UV-VIS spectrophotometry. Dr. Wolfe is also experienced in coordinating the analysis of these samples between the client and contract laboratory.
Bioanalytical Chemistry – Dr. Wolfe is experienced in identifying GLP-compliant bioanalytical laboratories that analyze biological samples for drug levels in a GLP- compliant manner using a variety of methods including HPLC UV, LC/MS/MS, LC/MS and ELISA. Dr. Wolfe is also experienced in coordinating the analysis of these samples between the client, contract laboratory, and pharmacokineticist.
CMC – Dr. Wolfe is able to identify CMC experts and manufacturing facilities that review or prepare CMC documents and manufacturing facilities that provide GMP material.
Clinicians – Dr. Wolfe is able to identify clinicians experienced in clinical trials that can develop the clinical protocols and programs for your drugs.