AGENDA - Specialized Workshop M2 - Monday September 27, 2021: 8am - 5pm

"BMV Guidance Day: Recent Issues in Bioanalytical Method Validation Guidance/Guidelines and Regulated Bioanalysis for Small and Large Molecules"

Industry/Regulators focused and interactive discussions on Audits/Inspections/Submissions outcome, gap analysis on new Controversial Issues, interpretation and training on BMV Guidance/Guideline by Chromatographic and Ligand Binding Assays. In depth discussions on Evolving Regulated Bioanalysis Standards and Regulated Bioanalysis of Complex PK Assays. Special focus on Patient-centric Approaches in Regulated Bioanalysis

Session 1: Current Regulatory Standards in Bioanalysis

Chair: Dr. Jian Wang, Associate Director Bioanalysis, Crinetics
08:00am–08:20am: Dr. Eric Woolf , Executive Director Regulated PK Bioanalytics Group, Merck
"Bioanalytical Support for Studies in China"
08:20am–08:40am: Dr. Kathrin Heermeier , Head of Biomarkers & Clinical Bioanalyses Germany, Sanofi
"How do bioanalytical laboratories deal with GLP, GCP and GcLP Recommendations/Framework?"
08:40am–09:00am: Dr. Eric Woolf , Executive Director Regulated PK Bioanalytics Group, Merck
Dr. Kathrin Heermeier, Head of Biomarkers & Clinical Bioanalyses Germany, Sanofi
"Panel Discussions on Current Regulatory Standards in Bioanalysis"
09:00am-09:30am: Short Break

Session 2: Regulations & Science Evolution to Solve Bioanalytical Issue

Chair: Dr. Jian Wang, Associate Director Bioanalysis, Crinetics
09:30am–09:50am: Mr. Sune Hove Sporring , Manager LCMS Group Development Bioanalysis, Novo Nordisk
"Challenges when Changing Assay Platform from Immunoassay to LCMS"
09:50am–10:10am: Dr. Chris James , Director Bioanalytical Sciences, Amgen
"Bioanalytical Complexity of Polypharmacy and Combination Therapies in Oncology"
10:10am–10:30am: Mr. Sune Hove Sporring , Manager LCMS Group Development Bioanalysis, Novo Nordisk
Dr. Chris James, Director Bioanalytical, Amgen
"Panel Discussions on Regulations & Science Evolution to Solve Bioanalytical Issue"
10:30am-11:00am: Short Break

Session 3: Regulated Bioanalysis of Complex PK Assays

Chair: Dr. Carrie Hendricks, Scientific Director Biomarkers and Clinical Bioanalysis, Sanofi
11:00am–11:20pm: Dr. John Kamerud , Director Bioanalytical BioMedicine Design Dept., Pfizer
"Challenges Developing and Implementing Free/Total PK assays"
11:20am–11:40pm: Dr. Seema Kumar , Director & Head of Clinical Bioanalytical Sciences, EMD Serono
"Bioanalytical Support for Multi-Domain Biotherapeutics"
11:40am–12:00pm: Dr. John Kamerud , Director Bioanalytical BioMedicine Design Dept., Pfizer
Dr. Seema Kumar , Director & Head of Clinical Bioanalytical Sciences, EMD Serono
"Panel Discussions on Regulated Bioanalysis of Complex PK Assays "
12:00pm-12:30pm: Short Break

Session 4: Recent Regulatory Findings

Chair: Dr. Anna Edmison, Senior Clinical Assessment Officer, Health Canada
Chair: Drs. Jan Welink, Senior Clinical Assessor, EU EMA
12:30pm–12:40pm: Dr. Diaa Shakleya , Pharmacologist and Bioanalytical Scientist, US FDA
"Bioanalytical Regulatory Requirements for Diverse Complex Matrices"
12:40pm–12:50pm: Mr. Stephen Vinter , Operations Manager, GLP Monitoring Authority and Laboratories Group, UK MHRA
"UK MHRA Bioanalytical Observations and Findings"
12:50pm–01:00pm: Dr. Mohsen Rajabiabhari , Pharmacologist, Office of Study Integrity and Surveillance, US FDA
"Recent FDA Observations of Biologics PK Assays"
01:00pm–01:10pm: Drs. Jan Welink , Senior Clinical Assessor, EU EMA
"Regulatory Findings & Observations: EU Applications"

ASK THE REGULATORS! Interactive Panel Discussion with All the Regulators

Chair: Dr. Anna Edmison, Senior Clinical Assessment Officer, Health Canada
Chair: Drs. Jan Welink, Senior Clinical Assessor, EU EMA
01:10pm–02:00pm: Regulators Panel Discussion for Chromatographic and Ligand-Binding Assays
  • Dr. Seongeun Julia Cho (US FDA)
  • Dr. Arindam Dasgupta (US FDA)
  • Dr. Sam Haidar (US FDA)
  • Dr. Mohsen Rajabiabhari (US FDA)
  • Dr. Nilufer Tampal (US FDA)
  • Dr. Diaa Shakleya (US FDA)
  • Dr. Jinhui Zhang (US FDA)
  • Drs. Jan Welink (EU EMA)
  • Mr. Stephen Vinter (UK MHRA)
  • Dr. Sandra Prior (UK MHRA)
  • Dr. Anna Edmison (Health Canada)
  • Dr. Catherine Soo (Health Canada)
  • Mr. Gustavo Santos (Brazil ANVISA)
  • Dr. Elham Kossary (WHO)
02:00pm-02:30pm: Short Break

Session 5: Patient-centric Approaches in Regulated Bioanalysis

Chair: Dr. Carrie Hendricks, Scientific Director Biomarkers and Clinical Bioanalysis, Sanofi
02:30pm–02:50pm: Ms. Daniela Fraier , Head of Regulated Small Molecules Bioanalysis, F. Hoffmann-La Roche
"The role of Regulated Bioanalysis in Patient-centric Approaches"
02:50pm–03:10pm: Dr. Sally Fischer , Senior Director BioAnalytical Sciences, Genentech
"Next Generation Bioanalytics and Impact on Drug Discovery/Development: Microsampling & POC "
03:10pm–03:30pm: Ms. Daniela Fraier , Head of Regulated Small Molecules Bioanalysis, F. Hoffmann-La Roche
Dr. Sally Fischer , Senior Director BioAnalytical Sciences, Genentech
"Panel Discussions on Patient-centric Approaches in Regulated Bioanalysis"
03:30pm-04:00pm: Short Break

Session 6: Evolving Regulated Bioanalysis Standards

Chair: Dr. Jian Wang, Associate Director Bioanalysis, Crinetics
04:00pm–04:20pm: Dr. Katty Wan , Director Small Molecule Group Lead Clinical Assay Group, Pfizer
"Importance of Incurred Sample Stability (ISS) in Regulated Bioanalysis: Strategies, Investigations, and Lessons Learned"
04:20pm–04:40pm: Dr. Allena Ji , Director Clinical Mass Spectrometry Laboratory Biomarkers and Clinical Bioanalyses, Sanofi
"Application of the ICH M10 Section 7.1 Endogenous Compounds Quantification by LC/MS/MS When Authentic Biological Matrix Contains High Endogenous Level"
04:40pm–05:00pm: Dr. Katty Wan , Director Small Molecule Group Lead Clinical Assay Group, Pfizer
Dr. Allena Ji , Director Clinical Mass Spectrometry Laboratory Biomarkers and Clinical Bioanalyses, Sanofi
"Panel Discussions on Evolving Regulated Bioanalysis Standards "
05:00pm-05:20pm: Short Break
05:20pm-06:20pm: Poster Spotlight Sessions with open access to all attendees




Agenda at a Glance Agenda at a Glance