Stephen Kirk,
Non-Clinical Immunotoxicologist,
Covance Laboratories Ltd
Immunology graduate from University of Glasgow. Spent over 3 years in academic research predominantly in the areas of mucosal immunity and lymphocyte trafficking. Since then spent >18 years working in the CRO industry, mostly as a study director, within the field of immunotoxicology. During those years was responsible for the validation and establishment of many immunological assays and techniques as well as the production of numerous presentations. Initially worked at IRI (Edinburgh), before spending 5 years at CTBR (Montreal), returned to the UK in 2005 to take up a position within the toxicology group at Aptuit (Edinburgh), before moving to Covance in 2009. Currently hold the position of pre-clinical immunotoxicology specialist and biologics subject matter expert within the non-clinical safety assessment group at Harrogate. Main responsibilities include designing studies intended to assess preclinical safety of novel biotechnology derived therapies, as well as interpretation of the data generated from such work.
Safety Evaluation of Biotechnology-derived Immuno-Oncology Therapies, Considerations in Species Selection for Pre-Clinical Testing
Wednesday, 2 November 2016 at 14:30
Add to Calendar ▼2016-11-02 14:30:002016-11-02 15:30:00Europe/LondonSafety Evaluation of Biotechnology-derived Immuno-Oncology Therapies, Considerations in Species Selection for Pre-Clinical TestingCancer Immunotherapy and Biofluid Biopsies 2016 in Boston, USABoston, USASELECTBIOenquiries@selectbiosciences.com
Regulatory guidance requires pre-clinical evaluation of immuno-oncology therapies prior to first in human (FIH) trials. Evaluation of such drug candidates can pose many challenges when the compound is a biotechnology based product. Often biotech products are highly specific for human targets and bind the equivalent target in pre-clinical species with much lower affinity or the presence of the target in healthy pre-clinical toxicology species is expressed at much lower levels, or is absent, when compared to the disease state in humans. The intended pharmacological activity of the therapy, such as immuno-stimulation for check-point inhibitors, is only observed when the target is present above certain levels, making exaggerated pharmacology difficult to evaluate in the pre-clinical space. This presentation looks at the challenges of selecting suitable species for pre-clinical evaluation, covering topics such as the use of transgenic mouse models, homologues versus the human drug candidate, overcoming anti-drug antibody challenges and supplementation of in vivo work with in vitro / ex vivo cell based assays.
Add to Calendar ▼2016-11-01 00:00:002016-11-02 00:00:00Europe/LondonCancer Immunotherapy and Biofluid Biopsies 2016Cancer Immunotherapy and Biofluid Biopsies 2016 in Boston, USABoston, USASELECTBIOenquiries@selectbiosciences.com
Add to Calendar ▼2016-11-02 14:30:002016-11-02 15:30:00Europe/LondonSafety Evaluation of Biotechnology-derived Immuno-Oncology Therapies, Considerations in Species Selection for Pre-Clinical TestingCancer Immunotherapy and Biofluid Biopsies 2016 in Boston, USABoston, USASELECTBIOenquiries@selectbiosciences.com
