AGENDA - Training Session M1
June 15, 2020, 11am to 4pm ET: Part 1
June 16, 2020, 11am to 4:30pm ET: Part 2

"Advanced Biomarkers Development & Troubleshooting by LBA & Flow Cytometry: Challenges from Exploratory to Clinical/Confirmatory Biomarkers, Fit-for-Purpose, Context of Use and New Platforms"

From Discovery/Exploratory Biomarkers to Clinical/Confirmatory Biomarkers, actual challenges in developing and implementing biomarkers assays in different phases of drug discovery/development by embedding the Fit-for-Purpose (FFP), Context of Use (COU) and new platforms in real-life situations

Advanced Biomarkers Development Part 1: June 15, 2020 (EDT time listed)

11:00am-11:10am: Dr. Sally Fischer, Assoc. Director BioAnalytical Sciences, Genentech
"Introduction of Advanced Biomarkers Development Part 1"

Biomarkers Assays Development & Troubleshooting (Part A)

Chair: Dr. Sally Fischer, Assoc. Director BioAnalytical Sciences, Genentech
11:10am-11:30am: Dr. Linda Terry, Group Lead Biomarker Assay Development, GlaxoSmithKline
"Insights on Parallelism Assessment in Biomarker Assays: Challenges and Solutions based on COU & FFP"
11:30am-11:50am: Mr. John Allinson, Vice President Biomarker Sciences, Immunologix
"Biomarker Advanced Method Development Strategies Endogenous Quality Controls"
11:50am-12:10pm: Mr. David Lanham, Scientific Director Bioanalytical Group, Eurofins
"Practical Strategies for Commercial Kit Optimization in Biomarker Method Development"
12:10pm-12:40pm: Social Networking - Time to "Visit" Exhibitors and Posters
12:40pm-01:10pm: Live Quiz on Biomarkers Assays Development & Troubleshooting
01:10pm-01:40pm: Dr. Linda Terry, Group Lead Biomarker Assay Development, GlaxoSmithKline
Mr. John Allinson, Vice President Biomarker Sciences, Immunologix
Mr. David Lanham, Scientific Director Bioanalytical Group, Eurofins
Dr. Sally Fischer, Assoc. Director BioAnalytical Sciences, Genentech
"Panel Discussion on Biomarkers Assays Development & Troubleshooting"

Moving Forward an Internationally Harmonized BAV Guidance and Regulatory Perspectives

Chair: Dr. Susan Spitz, Sr. Director Clinical Research Translational Sciences, Incyte
01:40pm-02:00pm: Dr. Lakshmi Amaravadi, VP and Head Translational Medicine, Boston Pharmaceuticals
"Summary of 2019 Recommendations on COU & FFP Biomarker Assay Development & Validation: Agreement on Need for a Harmonized Guidance"
02:00pm-02:20pm: Dr. Susan Spitz, Sr. Director Clinical Research Translational Sciences, Incyte
"Is the newly released Industry/FDA C-Path White Paper helping perform Biomarker Assay Development & Validation and moving towards a BAV Guidance?"
02:20pm-02:40pm: Dr. Yoshiro Saito, Director Division of Medicinal Safety Science, Japan MHLW
"Development of points to consider document on biomarker assay validation in Japan"
02:40pm-03:10pm: Live Quiz on BAV Guidance, C-Path & Parallelism
03:10pm-03:40pm: Social Networking - Time to "Visit" Exhibitors and Posters
03:40pm-04:10pm: Dr. Lakshmi Amaravadi, VP and Head Translational Medicine, Boston Pharmaceuticals
Dr. Susan Spitz, Sr. Director Clinical Research Translational Sciences, Incyte
Dr. Yoshiro Saito, Director Division of Medicinal Safety Science, Japan MHLW
"Panel Discussion on BAV Guidance, C-Path & Parallelism "


Advanced Biomarkers Development - Part 2: June 16, 2020 (EDT time listed)

11:00am-11:10am: Dr. Susan Spitz, Sr. Director Clinical Research Translational Sciences, Incyte
"Introduction of Advanced Biomarkers Development Part 2"

Target Engagement (TE) & Receptor Occupancy (RO)

Chair: Dr. Susan Spitz, Sr. Director Clinical Research Translational Sciences, Incyte
11:10am-11:30am: Mr. Gregor Jordan, Lab Head, Roche
"Target Engagement Biomarker Assay Development Strategies"
11:30am-11:50am: Ms. Lisa Patti-Diaz, Principal Scientist Clinical Flow Cytometry, Bristol-Myers Squibb
"Target Engagement by Flow Cytometry"
11:50am-12:10pm: Dr.Christèle Gonneau, Lead Scientist Flow Cytometry, Covance
"Flow Cytometry Receptor Occupancy (RO) Assays: Challenges and Lessons Learnt from Method Development and Validation"
12:10pm-12:30pm: Dr. Fabian Junker, Senior Scientist Pharmaceutical Sciences Division, Roche
"Receptor Occupancy (RO) by Flow Cytometry: Strategies for Developing Robust PD Biomarker assays"
12:30pm-01:00pm: Social Networking - Time to "Visit" Exhibitors and Posters
01:00pm-01:40pm: Live Quiz on Target Engagement (TE) & Receptor Occupancy (RO)
01:40pm-02:10pm: Mr. Gregor Jordan, Lab Head, Roche
Ms. Lisa Patti-Diaz, Principal Scientist Clinical Flow Cytometry, Bristol-Myers Squibb
Dr.Christèle Gonneau, Lead Scientist Flow Cytometry, Covance
Dr. Fabian Junker, Senior Scientist Pharmaceutical Sciences Division, Roche
Dr. Susan Spitz, Sr. Director Clinical Research Translational Sciences, Incyte
"Panel Discussion on Target Engagement (TE) & Receptor Occupancy (RO)"

Biomarkers Assays Development & Troubleshooting (Part B)

Chair: Dr. Sally Fischer, Assoc. Director BioAnalytical Sciences, Genentech
02:10pm-02:30pm: Dr. Giane Sumner, Sr. Director Assay Development, Regeneron
"Measuring VEGF in the Presence of anti-VEGF Therapeutics: Lessons Learned with a Commercially Available Kit"
02:30pm-02:50pm: Mr. Rafiq Islam, Executive Director Bioanalytical Services, Celerion
"Challenges & Solutions in VEGF Quantification by LBA: Overcoming Method Development Obstacles and Interferences"
02:50pm-03:10pm: Dr. Sally Fischer, Assoc. Director BioAnalytical Sciences, Genentech
"Challenges in Developing Ultrasensitive Biomarkers Assays"
03:10pm-03:40pm: Social Networking - Time to "Visit" Exhibitors and Posters
03:40pm-04:10pm: Live Quiz on Free Target & Ultrasensitive Assay
04:10pm-04:40pm: Dr. Giane Sumner, Sr. Director Assay Development, Regeneron
Mr. Rafiq Islam, Executive Director Bioanalytical Services, Celerion
Dr. Sally Fischer, Assoc. Director BioAnalytical Sciences, Genentech
"Panel Discussion on Free Target & Ultrasensitive Assay"




Final Agenda Agenda at a Glance