Considerations for Immunology and Immunotoxicology Endpoints in Early Drug Development

James Munday, PhD, EU Lead, Immunology & Immunotoxicology, Covance by Labcorp

James Munday completed his doctorate at the University of Oxford in the field of Molecular and Cellular immunology. The work he carried out during this time lead to several publications on a family of cell adhesion molecules known as Siglecs (Sialic acid binding immunoglobulin like lectins). After completion of his doctorate, he continued his academic career as a postdoctoral scientist at the Mount Sinai School of Medicine in New York. This work focused on early haematopoiesis and vasculogenesis in embryonic stem cells.

After successful completion of this position, he gained his first position in the pharmaceutical Industry as a Senior Scientist at Celltech/UCB in the Assay Technologies group. This role supported the development and implementation of assays that assess biomarkers for PK/PD relationships to predict potency and efficacy of compounds in-vivo for a variety of immunology based disease endpoints.

He then moved to Quotient Bioresearch, where he worked on a diverse range of bioanalytical based projects and biomedical testing for external pharmaceutical clients. This led to his first role at Covance as a Study Director in the Immunochemistry Department. After over 12 years of employment at Covance he has risen to the position of European Lead for Immunology and Immunotoxicology with responsibilities for teams based in Harrogate, Huntingdon and Muenster.

Chris Cooper, Subject Matter Expert, Manager, Covance by Labcorp

Christopher Cooper has worked in the pharmaceutical industry within Covance Clinical Pathology and the Immunology & Immunotoxicology (I&I) departments for the past 14 years. Over his early career Christopher has developed expertise in a diverse range of critical Immunology techniques including flow cytometry, Immunoassays & complex tissue culture previously as a subject matter expert. Over time, Christopher has played an integral role is developing & specializing in cell bases assay capabilities with a primary focus human/preclinical in vitro alternatives, ex vivo functional cell based assays including ELISpot & Flourospot.

Christopher has also over the past ~9 years gained expertise in supporting pre-clinical & clinical gene therapy programmes. His current role within the organization is now as a subject matter expert (SME) manager within the Immunology & Immunotoxicology group.