AGENDA - Main Workshop DAY 1 - Tuesday Sep. 28, 2021: 8am - 5:30pm

"Ligand-binding, Flow Cytometry and qPCR Assays Day"

Session 1: Immunogenicity Assays

Chair: Dr. Swati Gupta, Executive Director, AbbVie
08:00am-08:20am: Dr. George Gunn, Head Immunogenicity/Senior Scientific Director, GlaxoSmithKline
"New Insights on Drug and Target Interference in Nab Assays"
08:20am-08:40am: Mr. Daniel Baltrukonis, Senior Director Biologics, Pfizer
"ADA Cut Point Appropriateness: Moving Beyond False Positives"
08:40am-09:00am: Dr. Roland Staack, Head Large Molecule Bioanalytical Sciences, Roche
"Developments on Circulating Immune Complexes (CIC) - Size-specific PK Analysis of ADA-drug complexes and influence of Fc-variants on PK"
09:00am-09:20am: Dr. George Gunn, Head Immunogenicity/Senior Scientific Director, GlaxoSmithKline
Mr. Daniel Baltrukonis, Senior Director Biologics, Pfizer
Dr. Roland Staack, Head Large Molecule Bioanalytical Sciences, Roche
"Panel Discussions on Immunogenicity Assays"
09:20am-09:40am: Short Break

Session 2: Gene Therapy, Cell Therapy and Vaccine Assays

Chair: Dr. Meena, Vice President Bioanalytical, DMPK and Biomarker Development, Stoke
09:40am-10:00am: Dr. Vibha Jawa, Executive Director Biotherapeutics Bioanalysis, Bristol Myers Squibb
"TAb Assays vs. NAb Assays in Gene Therapy: Do we need both or which one?"
10:00am-10:20am: Dr. Michele Fiscella, Vice President Preclin. Dev. and Bioanalytical Sciences, Regenxbio
"Monitoring of rAAV Shedding in Gene Therapy Studies"
10:20am-10:40am: Dr. Yanmei Lu, Vice President Biomarker and BioAnalytical Sciences, Sangamo
"RT-qPCR to Quantify Transgene mRNA Copy Numbers and Relative Expression of Target Gene as Target Engagement PD Biomarkers for Gene Therapy"
10:40am-11:00am: Dr. Ivo Sonderegger, Director / Clinical Serology Strategy Lead, Takeda
"Analyte stability for Ligand-Binding and Functional Assays Examples from Vaccine Serology Assays"
11:00am-11:30am: Dr. Vibha Jawa, Executive Director Biotherapeutics Bioanalysis, Bristol Myers Squibb
Dr. Michele Fiscella, Vice President Preclin. Dev. and Bioanalytical Sciences, Regenxbio
Dr. Yanmei Lu, Vice President Biomarker and BioAnalytical Sciences, Sangamo
Dr. Ivo Sonderegger, Director / Clinical Serology Strategy Lead, Takeda
"Panel Discussions on Gene Therapy, Cell Therapy and Vaccine Assays"
11:30am-11:50am: Short Break

Session 3: Biomarker Assays

Chair: Dr. Sarah Hersey, Vice President, Translational Sciences & Diagnostics, Bristol Myers Squibb
11:50am-12:10pm: Dr. Lindsay King, Senior Director Clinical Biomarker Assay, Pfizer
"ISR for Biomarker Assays?"
12:10pm-12:30pm: Dr. Jean-Claude Marshall, Vice President Clinical Biomarkers, Moderna
"Clinical Biomarkers as Surrogate Endpoints"
12:30pm-12:50pm: Dr. Priscila Teixeira, Scientific Leader Clinical Biomarker, Roche
"Extracellular Vesicles (EV) as Biomarker Approach in Clinical Trials"
12:50pm-01:10pm: Dr. Alessandra Vitaliti, Executive Director Molecular and Cellular Biomarker, Novartis
"From dust to novel biomarker modality: analytical validation and clinical feasibility of extracellular vesicles (EVs)"
01:10pm-01:40pm: Dr. Lindsay King, Senior Director Clinical Biomarker Assay, Pfizer
Dr. Jean-Claude Marshall, Vice President Clinical Biomarkers, Moderna
Dr. Priscila Teixeira, Scientific Leader Clinical Biomarker, Roche
Dr. Alessandra Vitaliti, Executive Director Molecular and Cellular Biomarker, Novartis
"Panel Discussions on Biomarker Assays"
01:40pm-02:00am: Short Break

Session 4: PK Assays & Biodistribution

Chair: Dr. Carrie Hendricks, Scientific Director Biomarkers and Clinical Bioanalysis, Sanofi
02:00pm-02:20pm: Dr. Meina Liang, Executive Director, Global Head Integrated Bioanalysis, AstraZeneca
"Bioanalytical Challenges and Approaches for Inhalation and Oral Delivery of Biologics"
02:20pm-02:40pm: Mr. Jad Zoghbi, Associate Director Biomarkers and Clinical Bioanalysis, Sanofi
"Current Bioanalytical Trends and Technologies for Free, Bound, Total, Active, Monoactive, Biactive, Multiactive PK Assays"
02:40pm-03:00pm: Dr. Tong-Yuan Yang, Senior Scientific Director Bioanalytical Sciences, Janssen
"Biodistribution Studies of Biotherapeutics"
03:00pm-03:20pm: Dr. Meina Liang, Executive Director, Global Head Integrated Bioanalysis, AstraZeneca
Mr. Jad Zoghbi, Associate Director Biomarkers and Clinical Bioanalysis, Sanofi
Dr. Tong-Yuan Yang, Senior Scientific Director Bioanalytical Sciences, Janssen
"Panel Discussions on PK Assays & Biodistribution"
03:20pm-03:40am: Short Break

Session 5: 2021 White Paper in Bioanalysis

03:40pm-04:00pm: Dr. Swati Gupta, Executive Director, AbbVie
"Recommendations on Immunogenicity Assays"
04:00pm-04:20pm: Dr. Meena, Vice President Bioanalytical, DMPK and Biomarker Development, Stoke
"Recommendations on Gene Therapy, Cell Therapy and Vaccine Assays"
04:20pm-04:40pm: Dr. Sarah Hersey, Vice President Translational Sciences & Diagnostics, Bristol Myers Squibb
"Recommendations on Biomarker Assays"
04:40pm-05:00pm: Dr. Carrie Hendricks, Scientific Director Biomarkers and Clinical Bioanalysis, Sanofi
"Recommendations on PK Assays & Biodistribution"
05:00pm-05:30pm: Dr. Swati Gupta, Executive Director, AbbVie
Dr. Meena, Vice President Bioanalytical, DMPK and Biomarker Development, Stoke
Dr. Sarah Hersey, Vice President Translational Sciences & Diagnostics, Bristol Myers Squibb
Dr. Carrie Hendricks, Scientific Director Biomarkers and Clinical Bioanalysis, Sanofi
"Panel Discussions on 2021 White Paper in Bioanalysis draft Recommendations"
05:30pm-05:45am: Short Break
05:45pm-06:45am: Poster Spotlight Sessions with open access to all attendees
Note: Recommendations related to Specialized Workshops M1, Th1, Th2, F1 and F2 are shared during M1, Th1, Th2, F1 and F2 Specialized Workshops




Agenda at a Glance Agenda at a Glance