Shirley A. Aguirre DVM, PhD, DACVP
Independent Consultant, Virchow Toxpath LLC
As the founder of Virchow Toxpath LLC in 2018, Dr. Aguirre provides veterinary anatomic pathology and risk/safety assessment expertise to pharmaceutical and contract research organizations..
Dr. Aguirre is board-certified by the American College of Veterinary Pathologists and a PhD scientist. Dr. Aguirre's experience in drug development and nonclinical safety assessment began at Schering Plough (now Merck) in Lafayette, NJ in 2003. As a study pathologist, Dr. Aguirre conducted necropsies, interpreted and integrated nonclinical GLP study findings in nonhuman primates, dogs and rats administered small molecules in the allergy and cardiovascular therapeutic areas. She gained peer review experience with in-house and CRO GLP studies to support Phase I and II clinical trials and on a carcinogenicity study to support long term drug dosing in humans.
From 2004 to 2017, Dr. Aguirre worked at Pfizer in San Diego, CA in the role of study and/or peer review pathologist and as a drug safety team leader in the oncology and cardiovascular vaccine therapeutic areas. As a study pathologist, Dr. Aguirre interpreted and integrated macroscopic, microscopic, novel biomarkers, organ weight and clinical pathology findings and wrote pathology reports for non-GLP and GLP studies conducted in mice, rats, rabbits, dogs and nonhuman primates administered novel compounds in the multiple therapeutic areas (oncology, cardiovascular, metabolic, ophthalmic) using multiple routes of administration. She is well versed in moving novel drug entities including small molecules, antisense RNA and DNA, biologics, antibody drug conjugates from discovery to development. Dr. Aguirre provided pathology expertise to issues management teams to study mechanisms of disease and toxicity and was coauthor on several peer reviewed scientific publications.
Dr. Aguirre thrived in the matrixed multi-disciplinary collaborative and/or independent environment as a drug development team leader and was coauthor on regulatory documents (investigator brochures, investigative new drug application, nonclinical output and Canadian clinical trials application). Dr. Aguirre led the team that investigated and substantiated the use of novel plasma retinal biomarkers and use of electroretinography (ERG) in early discovery de-risking strategies and collaborated with senior, peer and subordinate colleagues across multiple disciplines. She mentored subordinate colleagues on her team and the team was awarded for the scientific achievements. Dr. Aguirre participated on ophthalmic excipient and formulations safety screening and optimization projects using intravitreal injections in rabbits and was coauthor on several peer reviewed scientific publications. Dr. Aguirre took the initiative to work successfully under aggressive timelines to provide timely, high quality anatomic and clinical pathology study findings in an integrated pathology study report for accelerated candidate selection, regulatory document submissions and clinical trial study starts. Dr. Aguirre focused on excellence in customer service and has effective verbal, written and interpersonal skills.
Dr. Aguirre was a postdoctoral scientist at Stanford University in Palo Alto, CA in the laboratory of Dr. Edward S. Mocarski. She wrote an NIH grant to fund her research on herpesvirus pathogenesis. Dr. Aguirre received a mentored clinical scientist award (NIH K08 A101638-03, $309,312.00) to investigate virally encoded chemokines in herpesvirus pathogenesis and published the work in Blood 2006 107(1) 30-38. Dr. Aguirre received her PhD and anatomic pathology training in a combined training program at Washington State University in Pullman, WA and her doctorate in veterinary medicine at the University of Florida in Gainesville, FL. She holds a baccalaureate in chemistry and biology from the University of Miami in Coral Gables, FL. Dr. Aguirre holds a veterinary license in the state of Florida and is an active member of the Society of Toxicologic Pathology, American College of Veterinary Pathologists and American College of Toxicology. She is an active editorial board member for Toxicologic Pathology.