Veterinary Clinical Trials Office and Biospecimen Repository Veterinary

Veterinary Clinical Trials Office and Biospecimen Repository Veterinary Clinical Research Services Shared Resource October 2020

Veterinary Clinical Trials Office and Biospecimen Repository WHO WE ARE Veterinary Clinical Trials Office • • One of the largest in the country. Overseeing 30 to 50 clinical trials/year in client-owned animals with naturally occurring diseases. Biospecimen Repository (BR) • • • Collects and stores samples from client-owned animals affected by a variety of illnesses. Very valuable to propel ground-breaking advances. Dogs and cats are exposed to the same environmental risk factors as humans. Similarities between companion animal and human diseases, make them an excellent research model for human disease. Used by clinicians, molecular biologists, geneticists, and epidemiologists to conduct research that will improve the lives of both animals and humans.

Veterinary Clinical Trials Office and Biospecimen Repository WHAT WE DO Examples of clinical trials we perform are: • • • Pharmaceutical Medical Devices Prevention and Treatment Multicenter Cohort Studies Pilot and Feasibility Studies We can assist investigators in numerous areas to ensure a successful clinical trial including: • • Protocol design Budget review Regulatory compliance Execution and oversight of clinical trials Technical support Electronic databases (REDCap™ support) Collection of tissues/body fluids Marketing WHO WE SERVE • • • Academic institutions Ohio State faculty Government entities Pharmaceutical companies Research organizations and more

Veterinary Clinical Trials Office and Biospecimen Repository Investigational drug in dogs with cancer (Lymphoma)* • • Investigational drug (RV 1001) Evaluate safety and efficacy in dogs with Non. Hodgkin lymphoma (NHL) Conclusions and relevance: • • • RV 1001 exhibits good oral bioavailability Showed acceptable safety profile Data from this study can be leveraged to help inform the design of future studies in humans ü The Veterinary clinical trials office provided administrative, financial management, technical support, and marketing. * Heather L. Gardner, Sarah B. Rippy, Misty D. Bear, Kim L. Cronin, et al. Phase I/II evaluation of RV 1001, a novel PI 3 Kδ inhibitor, in spontaneous canine lymphoma. PLo. S One. 2018; 13(4):

Veterinary Clinical Trials Office and Biospecimen Repository Identification of genetic mutations in dogs with lung cancer * • • • Lung cancers are increasingly common in pet dogs Dog lung cancer resembles human lung cancer in never-smokers Understanding and developing new models in dogs will fuel translational research in never-smoker lung cancer Conclusions and relevance: • • • This trial described for the first time the detailed genomic foundations of lung cancer It offered immediate diagnostic and therapeutic opportunities for dogs with lung cancer Comparative understanding of never-smoker and HER 2 -mutant lung cancer across species ü The Veterinary Biospecimen Repository provided tumor samples and cell lines. * Lorch G, Sivaprakasam K, Zismann V, Perdigones et all. Identification of recurrent activating HER 2 mutations in primary canine pulmonary adenocarcinoma. Clin Cancer Res. 2019 Oct 1. 25 (19) 5866 -5877.

Veterinary Clinical Trials Office and Biospecimen Repository Future Plans • Continue to expand industry-sponsored efforts • Pursue investigator-initiated opportunities • Greater involvement in extramural funding applications • Recruitment of research-clinician scientists Request BBVCTO Services • To request BBVCTO services visit go. osu. edu/bbvctoservicerequest • BR Services through e. Ramp at eramp. osumc. edu/welcome Phone number: 614 -247 -8706 CVM-Clinical. Trials@osu. edu