IIR’s Inaugural Event:
BioAnalytical Method Development
From Basic Principles to Practical Solutions
Intercontinental, San Francisco, CA • www.iirusa.com/bamd
Strengthen your comprehension of molecular interactions. Bring back new applications to incorporate immediately. Advance your candidates ahead with fewer unknowns.
Aid Drug Discovery & Development with Molecular Interaction Information
- Understanding molecular interactions and their applications in drug discovery & development
- Practical strategies for obtaining meaningful data on biomolecular interactions
- Linking in vitro affinity and kinetics to in vivo activity
- Alternative technologies for evaluating molecular interactions
Develop Analytical Tools for Measuring Monoclonal Antibody Therapeutics - PK Assay strategies to support non-clinical and clinical studies
- Pharmacological and toxicological perspectives about which drug species should be measured
- Choosing a PK assay format: circulating target considerations
- Methods to measure unbound therapeutic and “total” drug
New Emerging Strategies for Antibody-Drug Conjugates (ADCs) - ADCs in preclinical and clinical development
- Unique challenges for ADC development
- Tools and current bioanalytical strategies
- Novel bioanalytical strategies
Regulatory Perspectives on BioAssays for Anti-Drug Conjugates Jun T. Park, PhD,
Division of Monoclonal Antibodies, OBP/CDER/FDA Gain New Insights of Fc Functionality - Methods for in vitro assessment of Fc effector functionality
- Relate in vitro analyses to in vivo efficacy and toxicity
- Current state of Fc biology and Interaction of human IgG-Fc with FcyR
- Regulatory perspectives Conference Chairpersons
Conference Chairpersons:
Eric Wakshull, PhD, Senior Scientist/Group Leader, Bioanalytical Research & Development, GENENTECH
Valerie Quarmby, Principal Scientist/Associate Director, Bioanalytical Research & Development, GENENTECH