Selected Presentations on Bioanalysis and Immunogenicity of Biotherapeutics
Challenges and opportunities in developing a sound bioanalytical strategy for PK assessment of antibody drug conjugate therapeutics. JBC 2019, Yokohama
Analytical Run. ICH M10. AAPS – FDA joint workshop 2019. Washington DC
ICH M10 and FDA BMV 2018. EBF 2019 meeting, Barcelona
Evolution of WRIB recommendations on Gene Therapy Bioanalysis. WRIB 2019, New Orleans
Anti-Drug Antibody assay validation. Industry perspective. AAPS – FDA Guidance Forum 2018
ICH M10 representation at the ICH M10 -- EFPIA FG
Bioanalysis of Viral Vector-based Gene Therapy: Regulatory Expectations and Industry Experiences. WRIB 2018
Regulatory Expectations for Immunogenicity Assessment of Viral Vector-Based Gene Therapy Modality. PEGS 2018
Pre-existing antibody, impact and mitigation. Coral Gables Immunogenicity conference 2016
Bioanalysis of Multi Domain Biologics. Focus on PK. WRIB 2016
ADA characterization for Multi Domain Biologics. Open Forum. NBC 2014.
Antibody Drug Conjugates Open Forum, NBC 2013
Evaluation of ADA / NAB responses to Multi Domain Biologics Case Studies. PEGs 2012
Detection and evaluation of pre-existing anti-drug antibody reactivity. Informa Immunogenicity forum Berlin 2011
Pharmacokinetics of an Antibody-Drug Conjugate AAPS 2011
Correctly Interpreting The Reporting Data Within Pre-Clinical Development To Ensure Clinical Relevance. Immunogenicity: Prediction, Detection and Effective Assay Development. 2010, Maritim, Munich, Germany
Impact of administration routes in non-clinical anti-drug antibody development to a biotherapeutic Bioanalytical R&D. Wyeth. AAPS NBC 2009, Seattle
Anti-drug antibody (ADA) assay validation: Industry survey results and data analysis. Informa Immunogenicity for Biologics 2009, Berlin 2009
Strategies for the Determination of Anti-Drug Antibodies in the Presence of Circulating Drug, AAPS Annual Meeting, October – November 2006, San Antonio, TX
Compare and Contrast Ligand Binding Assays with Chromatographic Assays. AAPS Third Bioanalytical Workshop. Crystal City, Arlington VA, 2006
Protein-toxin Biopharmaceuticals: Bioanalytical Considerations, AAPS Annual Meeting, October 2005, San Francisco, CA.
Computer System Validation of BiaCore 3000 in Wyeth Research, PharmaIQ, IQPC Compliance and Analytical Equipment Qualification conference, 2005, June 28 - 29th in Philadelphia, PA.
Problem Solving in Development of a Neutralizing Antibody Assay for a novel Biopharmaceutical – A Case Study, Immunogenicity Testing for Therapeutics, Barnett International, September 30 – October 1, 2004, Brussels, Belgium
Development and Validation of a Cell Based Neutralizing Antibody Assay – A Case Study, AAPS Annual Meeting, October 2004, Baltimore, MD.