Goals and Objectives
This workshop will provide the current best practices in Clinical Pharmacology of Biotherapeutic proteins by experts from industry, academia and regulatory colleagues and discuss challenges we are facing. The emphasis will be on monoclonal antibodies and antibody-drug conjugates and cover topics such as FIH study design, QT assessment, pharmacokinetic characterization, bioanalytical assays, therapeutic protein-drug interactions, QT risk assessment and immunogenicity testing. Additionally, traditional clinical pharmacology aspects including special populations (Paediatrics, Hepatic and renal impairment) and ADME characterization will be reviewed, as well as regulatory expectations in this area.
- Learn about the current best practices and regulatory expectations in the area of clinical pharmacology of biotherapeutic proteins
- Learn how to implement these best practices in drug development
- Learn how disease, target and non-clinical testing impact FIH study design
- Understand the utility of immunogenicity testing and how to develop a testing plan during various stages of development
- Understand when and how to implement clinical pharmacology studies in special populations
- Learn how the outcomes of clinical pharmacology studies impact regulatory decision making
Who should attend?
Clinical pharmacologists, scientists and regulators involved in early clinical development, clinicians and clinical pharmacologists involved in putting together a clinical pharmacology package for biotherapeutics.
Cosponsored by
