AGENDA - Main Workshop DAY 3
June 24, 2020, 11am to 5pm ET: Part 1
June 25, 2020, 11am to 5pm ET: Part 2

LBA, Flow Cytometry, qPCR and Emerging Technologies - Part 1: June 24, 2020 (EDT time listed)

11:00am-11:10am: Dr. Roland Staack, Head Large Molecule Bioanalytical Sciences, Roche
"Introduction of LBA, Flow Cytometry, qPCR and Emerging Technologies DAY - Part 1"

Immunogenicity Assays

Chair: Dr. Roland Staack, Head Large Molecule Bioanalytical Sciences, Roche
11:10am-11:25am: Dr. Yuanxin Xu, Vice President of Bioanalytical Sciences, Intellia Therapeutics
"Future Strategy on Immunogenicity Assessment: “What we have learned from late stage clinical studies?"
11:25am-11:40am: Dr. Becky Schweighardt, Executive Director Immunogenicity Assessment and Clinical Pharmacology, BioMarin
"Future Strategy on Immunogenicity Assessment: What we have Learned from Late Stage Clinical Studies?"
11:40am-11:55am: Dr. Meiyu Shen, Expert Mathematical Statistician and Team Leader, US FDA
"Statistical Methods of Cut Point Determination in Immunogenicity Studies - US FDA Perspective on Statistical Evaluation of CP"
11:55am-12:10pm: Dr. Akiko Ishii-Watabe, Director Division of Biological Chemistry and Biologicals, Japan MHLW
"Statistical Methods Used for Cut Point Determination in Immunogenicity Assays - Japan MHLW Perspective on Statistical Evaluation of CP"
12:10pm-12:30pm: Dr. Roland Staack, Head Large Molecule Bioanalytical Sciences, Roche
"Bioanalysis of Circulating Immune Complexes (CIC)"
12:30pm-01:00pm: Social Networking - Time to "Visit" Exhibitors and Posters
01:00pm-01:30pm: Dr. Yuanxin Xu, Vice President of Bioanalytical Sciences, Intellia Therapeutics
Dr. Becky Schweighardt, Assoc. Director DMPK, Incyte Corporation
Dr. Meiyu Shen, Expert Mathematical Statistician and Team Leader, US FDA
Dr. Akiko Ishii-Watabe, Director Division of Biological Chemistry and Biologicals, Japan MHLW
Dr. Roland Staack, Head Large Molecule Bioanalytical Sciences, Roche
"Panel Discussion on Statistical Evaluation of CP, Immunogenicity Assessment, and CIC"

2020 White Paper on Immunogenicity Assays

01:30pm-01:50pm: Dr. Roland Staack, Head Large Molecule Bioanalytical Sciences, Roche
"Consensus & Recommendations on Immunogenicity Assays"
01:50pm-02:20pm: Immunogenicity Assays White Paper Working Experts Group
"Panel Discussion on Immunogenicity Assays"

PK Assays & Immunogenicity Assays

Chair: Dr. Christine Grimaldi, Director Biotherapeutics Bioanalysis, Boehringer Ingelheim
02:20pm-02:40pm: Dr. Meina Liang, Director and US Head of Clinical Immunology & Bioanalysis, AstraZeneca
"Novel Immunogenicity Assay Strategy for Multi-Domain Biotherapeutics (MDB)"
02:40pm-03:00pm: Mr. Daniel Baltrukonis, Director and Group Lead Clinical Assay Group, Pfizer
"Bispecific T-cell Redirectors: PK and Immunogenicity Method Development Strategies and Challenges"
03:00pm-03:20pm: Dr. Kate Peng, Assoc. Director Department BioAnalytical Sciences, Genentech
"Bioanalysis of Bispecific Monoclonal Antibodies: Unique Challenges in PK Assays"
03:20pm-03:50pm: Social Networking - Time to "Visit" Exhibitors and Posters
03:50pm-04:20pm: Dr. Meina Liang, Director and US Head of Clinical Immunology & Bioanalysis, AstraZeneca
Mr. Daniel Baltrukonis, Director and Group Lead Clinical Assay Group, Pfizer
Dr. Kate Peng, Assoc. Director Department BioAnalytical Sciences, Genentech
Dr. Christine Grimaldi, Director Biotherapeutics Bioanalysis, Boehringer Ingelheim
"Panel Discussion on MDB and Bispecific"

2020 White Paper on PK Assays

04:20pm-04:40pm: Dr. Christine Grimaldi, Director Biotherapeutics Bioanalysis, Boehringer Ingelheim
"Consensus & Recommendations on Biotherapeutics Regulated Bioanalysis, Biotherapeutics Stability and BMV for PK Assays"
04:40pm-05:10pm: PK Assays White Paper Working Experts Group
"Panel Discussion on Biotherapeutics Regulated Bioanalysis, Biotherapeutics Stability and BMV for PK Assays"


LBA, Flow Cytometry, qPCR and Emerging Technologies - Part 2: June 25, 2020 (EDT time listed)

11:00am-11:10am: Dr. Tong-yuan Yang, Sr. Scientific Director Biotherapeutics, Janssen
"Introduction of LBA, Flow Cytometry, qPCR and Emerging Technologies DAY - Part 2"

Cell Therapy and Vaccine Assays

Chair: Dr. Tong-yuan Yang, Sr. Scientific Director Biotherapeutics, Janssen
11:10am-11:30am: Dr. Tong-yuan Yang, Sr. Scientific Director Biotherapeutics, Janssen
"Considerations in Immunogenicity Strategy for Autologous CAR-T Products"
11:30am-11:50am: Dr. Bart Corsaro, Lab Head Preclinical Group, GlaxoSmithKline
"Clinical Vaccine Assays from a Fit-for-Purpose to a Fully Validated Assay"
11:50am-12:10pm: Dr. Tong-yuan Yang, Sr. Scientific Director Biotherapeutics, Janssen
Dr. Bart Corsaro, Lab Head Preclinical Group, GlaxoSmithKline
"Panel Discussion on Cell Therapy and Vaccine Assays"
12:10pm-12:40pm: Social Networking - Time to "Visit" Exhibitors and Posters

2020 White Paper on Vaccine Assays and Cell Therapy

12:40pm-01:00pm: Dr. Rocio Murphy, Senior Principal Scientist Bioanalytical, Merck
Dr. Tong-yuan Yang, Sr. Scientific Director Biotherapeutics, Janssen
"Consensus & Recommendations on Vaccine Assays and Cell Therapy"
01:00pm-01:30pm: Gene/Cell Therapy and Vaccine Assays White Paper Working Experts Group
"Panel Discussion on Vaccine Assays and Cell Therapy"

Biomarker Assays

Chair: Dr. Yan Zhang, Group Director in Translational Sciences, Bristol-Myers Squibb
01:30pm-01:40pm: Dr. Susan Spitz, Sr. Director Clinical Research Translational Sciences, Incyte
"Challenges in Translational Sciences: Discovering, Developing and Validating Biomarkers - '…from Omics to CDx'"
01:40pm-02:00pm: Dr. W. Rodney Mathews, Assoc. Director OMNI Biomarker Development, Genentech
"Proteomic Approaches to Biomarker Discovery"
02:00pm-02:20pm: Dr. Kristina McGuire, Sr. Director of Precision Medicine, Regeneron
"Evaluation of Quality Systems for Biomarker Analysis and Patent Selection/Stratification"
02:20pm-02:40pm: Ms. Cherie Green, Sr. Scientific Manager Flow Cytometry Group, Genentech
"Is CLSI H62 Guideline also good for Bioanalysis or not? Building on WRIB recommendations, practical consideration for the validation of assays performed by Flow Cytometry in Pharmaceutical Bioanalytical Labs"
02:40pm-03:00pm: Dr. Steven Eck, Sr. Scientist Clinical Pharmacology, AstraZeneca
"Acceptance Criteria for Pharmacodynamic Biomarker Assays in a Fit-For-Purpose World"
03:00pm-03:30pm: Dr. Susan Spitz, Sr. Director Clinical Research Translational Sciences, Incyte
Dr. W. Rodney Mathews, Assoc. Director OMNI Biomarker Development, Genentech
Dr. Kristina McGuire, Sr. Director of Precision Medicine, Regeneron
Ms. Cherie Green, Sr. Scientific Manager Flow Cytometry Group, Genentech
Dr. Steven Eck, Sr. Scientist Clinical Pharmacology, AstraZeneca
Dr. Yan Zhang, Group Director in Translational Sciences, Bristol-Myers Squibb
"Panel Discussion on Biomarker Assays"
03:30pm-04:00pm: Social Networking - Time to "Visit" Exhibitors and Posters

2020 White Paper on Biomarker Assays and Flow Cytometry

04:00pm-04:20pm: Dr. Alessandra Vitaliti, Executive DirectorMolecular and Cellular Biomarker, Novartis
"Consensus & Recommendations on Cytometry Validation"
04:20pm-04:40pm: Dr. Yan Zhang, Group Director in Translational Sciences, Bristol-Myers Squibb
Dr. Susan Spitz, Sr. Director Clinical Research Translational Sciences, Incyte
"Consensus & Recommendations on Biomarker Assays"
04:40pm-05:10pm: Biomarkers and Flow Cytometry White Paper Working Experts Group
"Panel Discussion on Biomarkers and Flow Cytometry"




Final Agenda Agenda at a Glance