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-09:20am: Short Break

Session 2: Regulations & Science Evolution to Solve Bioanalytical Issue

Chair: Dr. Jian Wang, Associate Director Bioanalysis, Crinetics
09:20am–09:40am: Mr. Sune Hove Sporring , Manager LCMS Group Development Bioanalysis, Novo Nordisk
"Challenges when Changing Assay Platform from Immunoassay to LCMS"
09:40am–10:00am: Dr. Chris James , Director Bioanalytical Sciences, Amgen
"Bioanalytical Complexity of Polypharmacy and Combination Therapies in Oncology"
10:00am–10:20am: 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"
10:20am-10:40am: Short Break

Session 3: Regulated Bioanalysis of Complex PK Assays

Chair: Dr. Carrie Hendricks, Scientific Director Biomarkers and Clinical Bioanalysis, Sanofi
10:40am–11:00pm: Dr. John Kamerud , Director Bioanalytical BioMedicine Design Dept., Pfizer
"Challenges Developing and Implementing Free/Total PK assays"
11:00am–11:20pm: Dr. Seema Kumar , Director & Head of Clinical Bioanalytical Sciences, EMD Serono
"Bioanalytical Support for Multi-Domain Biotherapeutics"
11:20am–11:40am: 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 "
11:40am-12:00pm: Short Break

ASK THE REGULATORS! Interactive Panel Discussion with All the Regulators

Chair: Drs. Jan Welink, Senior Clinical Assessor, EU EMA
12:00pm–01:00pm: 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)
01:00pm-01:20pm: Short Break

Session 4: Evolving Regulated Bioanalysis Standards

Chair: Dr. Jian Wang, Associate Director Bioanalysis, Crinetics
01:20pm–01:40pm: 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"
01:40pm–02:00pm: 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"
02:00pm–02:20pm: 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 "
02:20pm-02:40pm: Short Break

Session 5: Patient-centric Approaches in Regulated Bioanalysis

Chair: Dr. Carrie Hendricks, Scientific Director Biomarkers and Clinical Bioanalysis, Sanofi
02:40pm–03:00pm: Ms. Daniela Fraier , Head of Regulated Small Molecules Bioanalysis, F. Hoffmann-La Roche
"The role of Regulated Bioanalysis in Patient-centric Approaches"
03:00pm–03:20pm: Dr. Sally Fischer , Senior Director BioAnalytical Sciences, Genentech
"Next Generation Bioanalytics and Impact on Drug Discovery/Development: Microsampling & POC "
03:20pm–03:40pm: 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"
03:40pm-04:00pm: Short Break

Session 6: Recent Regulatory Findings

Chair: Drs. Jan Welink, Senior Clinical Assessor, EU EMA
04:00pm–04:10pm: Dr. Diaa Shakleya , Pharmacologist and Bioanalytical Scientist, US FDA
"Bioanalytical Regulatory Requirements for Diverse Complex Matrices"
04:10pm–04:20pm: Mr. Stephen Vinter , Operations Manager, GLP Monitoring Authority and Laboratories Group, UK MHRA
"UK MHRA Bioanalytical Observations and Findings"
04:20pm–04:30pm: Dr. Mohsen Rajabiabhari , Pharmacologist, Office of Study Integrity and Surveillance, US FDA
"Recent FDA Observations of Biologics PK Assays"
04:30pm–04:40pm: Drs. Jan Welink , Senior Clinical Assessor, EU EMA
"Regulatory Findings & Observations: EU Applications"
04:40pm–05:00pm: Dr. Diaa Shakleya , Pharmacologist and Bioanalytical Scientist, US FDA
Mr. Stephen Vinter, Operations Manager, GLP Monitoring Authority and Laboratories Group,UK MHRA
Dr. Mohsen Rajabiabhari, Pharmacologist, Office of Study Integrity and Surveillance, CDER, US FDA
Drs. Jan Welink, Senior Clinical Assessor, EU EMA
"Panel Discussions on Recent Regulatory Findings"
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