Dr. Mayer joined Certara in June 2018 as Associate Director of Clinical Pharmacology in the Integrated Drug Development. Christina provides expertise in translational and early to mid-stage clinical development of oncology biologics, including traditional monoclonal antibodies as well as novel platforms/approaches such as engineered antibodies, bi-specifics, gene therapies, cell therapies, and combination therapies.
Dr. Mayer’s experience includes NME to IND strategy, pre-IND NME risk assessment, non-clinical PK/PD and TK study design and analysis, justification of first-in-human dose, regimen, escalation strategy, maximum dose, flat dosing, and Phase 2 dose justification. She also has experience in NCA, sampling schemes, bioanalytical considerations, and analysis plans for PK, PD, receptor occupancy, and target engagement, Phase 1 in-stream evaluation of PK relationships with safety, efficacy, and PD, and multi drug combination study dose selection and trial design
Dr. Mayer earned a BS degree from Boston College and PharmD with Honors from the University of North Carolina, Chapel Hill. She completed a postdoctoral fellowship in Clinical PK/PD at the University of North Carolina, Chapel Hill and GlaxoSmithKline. Prior to Certara, she worked as a Clinical Pharmacology Lead at Janssen Biotherapeutics (Johnson & Johnson). Dr. Mayer is also a practicing pharmacist and an active lecturer in clinical pharmacology globally.