AGENDA - Specialized Workshop F1 - Friday October 1, 2021: 7am - 5pm

"Biomarkers Development & Translational Science: Recent Issues from Discovery to Regulatory BAV Guidance"

Innovation in Biomarkers Assays Development in Discovery & Development. Harmonized Biomarker Assay Validation (BAV) Guidance and regulatory approval questions, advanced method development from Discovery multiplex/OMICs to Clinical primary/secondary endpoints & patients stratification, Ultra-sensitivity platforms pros/cons, best time to initiate CDx, complex assay Parallelism assessment, insights on when CLIA /ISO/GLP, challenges in Sample Collection. Focus on advancements in Exploratory Biomarkers & Target Engagement (TE) Biomarkers Assays

Session 1: Innovation in Biomarkers Assays Discovery & Development

Chair: Dr. Steve Keller, Senior Director Global Head Biomarker Bioanalysis, AbbVie
08:00am-08:20am: Ms. Mary Birchler, Group Leader Exploratory Biomarkers, GlaxoSmithKline
"High Sensitivity Immunoassay Platforms for the Measurement of Endogenous Analytes"
08:20am-08:40am: Dr. Imelda Schuhmann, Head of Laboratory Biomarker, Novartis
"Breath Bioanalysis as Non-invasive Matrix for Disease Biomarkers Determination"
08:40am-09:00am: Dr. Gizette Sperinde, Senior Scientist BioAnalytical Science, Genentech
"Biomarker Quantitation in Airway Matrix"
09:00am-09:20am: Ms. Mary Birchler, Group Leader Exploratory Biomarkers, GlaxoSmithKline
Dr. Imelda Schuhmann, Head of Laboratory Biomarker, Novartis
Dr. Gizette Sperinde, Senior Scientist BioAnalytical Science, Genentech
"Panel Discussions on Innovation in Biomarkers Assays Discovery & Development"
09:20am-09:40am: Short Break

Session 2: Advancements in Exploratory Biomarkers & Target Engagement (TE) Biomarkers Assays

Chair: Dr. Joel Mathews, Director Biomarker Assay Research and Assay Development, Ionis
09:40am-10:00am: Dr. Joseph Bower, Senior Vice President, Lab Services, Precision for Medicine
"Exploratory Biomarker Assays a Back-to-basic in Bioanalytical Method Development & Validation"
10:00am-10:20am: Dr. Richard Wnek, Director Translational Molecular Biomarkers, Merck
"Bioanalysis of Pharmacodynamic Biomarkers in Solid Tissue: End-to-End Considerations from Concept to Execution of Sample Analyses"
10:20am-10:40am: Mr. Michael Naughton, Investigator Senior Analyst Exploratory Biomarkers, GlaxoSmithKline
"Recent Developments in Target Engagement (TE) Assays at GSK"
10:40am-11:00am: Dr. Joseph Bower, Senior Vice President, Lab Services, Precision for Medicine
Dr. Richard Wnek, Director Translational Molecular Biomarkers, Merck
Mr. Michael Naughton, Investigator Senior Analyst Exploratory Biomarkers, GlaxoSmithKline
"Panel Discussions on Advancements in Exploratory Biomarkers & Target Engagement (TE) Biomarkers Assays"
11:00am-11:15am: Short Break

Session Finale: ASK THE REGULATORS! Interactive Panel Discussion with All the Regulators

Chair: Dr. Steve Keller, Senior Director Global Head Biomarker Bioanalysis, AbbVie
Chair: Dr. Joel Mathews, Director Biomarker Assay Research and Assay Development, Ionis
11:15am–11:45pm: Regulatory Feedbacks on Biomarker Assay Validation (BAV):
  • Dr. Soma Ghosh (US FDA CDRH)
  • Dr. Kevin Maher (US FDA CDRH)
  • Dr. Yow-Ming Wang (US FDA CDER)
  • Mr. Abbas Bandukwala (US FDA CDER)
  • Dr. Shirley Hopper (UK MHRA)
  • Dr. Yoshiro Saito (Japan MHLW)
11:45am-12:00pm: Short Break

Session 3: Part 1 - Challenges with Regulatory Biomarker Assay Validation (BAV) as Primary End Points: BMV, CLIA and CDx

Chair: Dr. Steve Keller, Senior Director Global Head Biomarker Bioanalysis, AbbVie
12:00pm-12:20pm: Dr. Omar Mabrouk, Principal Scientist Biomarkers, Biogen
"Biomarker Development using Mass Spectrometry: Current Challenges with Regulatory Biomarker Assay Validation (BAV) to Enable Treatment Decisions in Clinical Studies"
12:20pm-12:40pm: Mr. Mike Baratta, Scientific Director/Chief of Staff, Clinical Biomarker Development Innovation and Development, Takeda
"Characterizing Expression Levels of Mechanism-Based Oncology Biomarkers by Mass Spec: From Concept to Proteomic Screen and CLIA Assay Validation"
12:40pm-01:00pm: Dr. Valerie Clausen, Director Bioanalytical Sciences, Alnylam
"Challenges and Opportunities in the Use of Small Molecule Biomarkers in Clinical Studies: Validation for the Context of Use"
01:00pm-01:20pm: Dr. Omar Mabrouk, Principal Scientist Biomarkers, Biogen
Mr. Mike Baratta, Scientific Director/Chief of Staff, Clinical Biomarker Development Innovation and Development, Takeda
Dr. Valerie Clausen, Director Bioanalytical Sciences, Alnylam
"Panel Discussions on Part 1 - Challenges with Regulatory Biomarker Assay Validation (BAV) as Primary End Points: BMV, CLIA and CDx"
01:20pm-01:40pm: Short Break

Session 4: Part 2 - Challenges with Regulatory Biomarker Assay Validation (BAV) as Primary End Points: BMV, CLIA and CDx

Chair: Dr. Joel Mathews, Director Biomarker Assay Research and Assay Development, Ionis
01:40pm-02:00pm: Dr. Erin Stevens, Associate Research Fellow / Lab Head - Early Clinical Development, Pfizer
"Clinical Biomarkers Development, Validation and Interpretation"
02:00pm-02:20pm: Ms. Flora Berisha, Scientific Director Head of Dx Strategic Partnering Oncology, Janssen
"Why do we need Companion Diagnostics?"
02:20pm-02:40pm: Dr. Kristina McGuire, Senior Director, Precision Medicine Companion Diagnostics and Biomarker Operations, Regeneron
"Considerations for Quality Oversight of CLIA Laboratory Testing for Companion Diagnostic (CDx) Tests for Routine Patient Care"
02:40pm-03:00pm: Dr. Erin Stevens, Associate Research Fellow / Lab Head - Early Clinical Development, Pfizer
Ms. Flora Berisha, Scientific Director Head of Dx Strategic Partnering Oncology, Janssen
Dr. Kistina McGuire, Senior Director, Precision Medicine Companion Diagnostics and Biomarker Operations, Regeneron
"Panel Discussions on Part 2 - Challenges with Regulatory Biomarker Assay Validation (BAV) as Primary End Points: BMV, CLIA and CDx "
03:00pm-03:20pm: Short Break

Session 5: Ongoing Issues in Biomarker Discovery & Development

Chair: Dr. Steve Keller, Senior Director Global Head Biomarker Bioanalysis, AbbVie
03:20pm-03:40pm: Dr. Yan Zhang, Scientific Senior Director, Translational Sciences, Bristol Myers Squibb
"When Lack of Parallelism is Expected"
03:40pm-04:00pm: Mr. José Duarte, Scientist Clinical Protein Biomarker Development, Roche
"Challenges in PBMC Sample Collection for PD Biomarkers Involving Functional Assays in Multicenter Clinical Trials "
04:00pm-04:20pm: Dr. Yan Zhang, Scientific Senior Director, Translational Sciences, Bristol Myers Squibb
Mr. José Duarte, Scientist Clinical Protein Biomarker Development, Roche
"Panel Discussions on Ongoing Issues in Biomarker Discovery & Development "

Session 6: 2021 White Paper in Bioanalysis

04:20pm-04:40pm: Dr. Steve Keller, Senior Director Global Head Biomarker Bioanalysis, AbbVie
Dr. Joel Mathews, Director Biomarker Assay Research and Assay Development, Ionis
"Recommendations on Biomarkers Development & Translational Science: Recent Issues from Discovery to Regulatory BAV Guidance "
04:40pm-05:00pm: "Panel Discussions on 2021 White Paper in Bioanalysis draft Recommendations"
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