Recommended Short Courses*

(SC1) TRANSLATIONAL STRATEGIES FOR DEVELOPMENT OF MONOCLONAL ANTIBODIES FROM DISCOVERY TO THE CLINIC – PART 1(Click on the title to view the full description)

Successful strategies for development of monoclonal antibodies require integration of relevant knowledge with respect to target antigen properties, antibody design criteria such as affinity, isotype selection, PK and PD propertie, and antibody cross-reactivity across species from the early stages of antibody development.  Biophysical measurements are one of the critical components necessary for the design of effective translational strategies for lead selection and evaluation of the relevant animal species for preclinical safety and efficacy studies.  This short course is divided into a morning and afternoon session.  Topics to be covered in morning session: Considerations for target selection, antibody screening and preclinical development of mAbs Antibody affinity and biophysical characterization: Biacore, Kinexa, and FACS Introduction to surrogate approaches in development of monoclonal antibodies Course Instructors: Mohammad Tabrizi, Ph.D., Director,Global PK-PD & Bioanalysis, MedImmune Gadi Bornstein, Ph.D., Principle Scientist, AstraZeneca Scott Klakamp, Ph.D., Research Fellow, Biophysical Chemistry and Bioinformatics, Takeda Andrew Drake, Ph.D., Principal Scientist, Biophysical Chemistry, Takeda

(SC2) TRANSLATIONAL STRATEGIES FOR DEVELOPMENT OF MONOCLONAL ANTIBODIES FROM DISCOVERY TO THE CLINIC – PART 2 (Click on the title to view the full description)

Topics to be covered in afternoon session: Considerations for immunoassay development in support of pharmacokinetic & immunogenicity & biomarker evaluation Preclinical and clinical safety of monoclonal antibodies Translation of exposure-response data from discovery into the clinic in support of FIH dosing Course Instructors: Cheryl Funelas, B.S., Manager, Global PK-PD & Bioanalysis, MedImmune Mohammad Tabrizi, Ph.D., Director, Global PK-PD & Bioanalysis, MedImmune