AGENDA - Main Workshop DAY 3 - Thursday Sep. 30, 2021: 8am - 5pm

"Mass Spectrometry Day"

Session 1: Advanced / Innovative Applications of Mass Spec in Bioanalysis

Chair: Dr. Matthew Szapacs, Scientific Director Precision Medicine – Neuroscience, AbbVie
08:00am–08:20am: Ms. Amanda Wilson, Director Discovery Bioanalysis Biomarkers, AstraZeneca
"Bioanalytical Strategies for Quantification of CRISPR Therapeutic Genome Editors"
08:20am–08:40am: Dr. Jianing Zeng, Scientific Director Translation Medicine, Bristol Myers Squibb
"Extracellular Vesicles (EV) Bioanalysis by Mass Spec"
08:40am–09:00am: Dr. Neil Henderson, Associate Principal Scientist Discovery Bioanalysis, AstraZeneca
"Nanomedicines Bioanalysis by Mass Spec in support of both Preclinical and Clinical studies: Advanced / Innovative Applications of Mass Spec in Bioanalysis"
09:00am–09:20am: Ms. Amanda Wilson, Director Discovery Bioanalysis & Biomarkers, AstraZeneca
Dr. Jianing Zeng, Scientific Director Translation Medicine, Bristol Myers Squibb
Dr. Neil Henderson, Associate Principal Scientist Discovery Bioanalysis, AstraZeneca
"Panel Discussions on Advanced / Innovative Applications of Mass Spec in Bioanalysis"
09:20am-09:40am: Short Break

Session 2: Bioanalysis of Biotherapeutics by Mass Spectrometry from Discovery to Regulatory Submissions

Chair: Dr. Matthew Szapacs, Scientific Director Precision Medicine – Neuroscience, AbbVie
09:40am-10:00am: Dr. John Mehl, Director & Group Leader, GlaxoSmithKline
"Immunocapture platform considerations for the quantitative and qualitative bioanalysis of biotherapeutics using intact mass LC-MS approaches"
10:00am-10:20am: Dr. Surinder Kaur, Senior Director Bioanalytical Sciences, Genentech
"Bioanalytical Method Validation (BMV) of Biotherapeutics by Mass Spectrometry in Regulated Bioanalysis"
10:20am-10:40am: Dr. Stephen Alley, Executive Director Scientific Integration and Strategy, Seattle Genetic
"Internal Standard (IS) selection in Hybrid Assays, Impact to acceptance Criteria & Recommendation for a Regulatory Guidance"
10:40am-11:00am: Dr. John Mehl, Director & Group Leader, GlaxoSmithKline
Dr. Surinder Kaur, Senior Director Bioanalytical Sciences, Genentech
Dr. Stephen Alley, Executive Director Scientific Integration and Strategy, Seattle Genetic
"Panel Discussions on Bioanalysis of Biotherapeutics by Mass Spectrometry from Discovery to Regulatory Submissions"
11:00am-11:20am: Short Break

Session 3: Challenging Bioanalytical Methods in Mass Spec

Chair: Dr. Ragu Ramanathan, Director Drug Metabolism and Pharmacokinetics, Vertex
11:20am-11:40am: Dr. Sekhar Surapaneni, Vice President Nonclin. Disp. and Bioanalysis, Bristol Myers Squibb
"Chiral Methods for Bioanalytical and DMPK Applications: BMS/Celgene Experience in Development & Validation"
11:40am-12:00pm: Dr. Luca Ferrari, Head Small Molecules Bioanalytical Sciences, Roche
"Selectivity & Sensitivity (S&S) Challenges in the Bioanalysis of Oligonucleotides"
12:00pm-12:20pm: Dr. Lieve Dillen, Lead Assay Development Bioanalytical Dept, Janssen
"Challenges in the Investigation and Quantitation of Intracellular Disposition of Oligonucleotides"
12:20pm-12:40pm: Dr. Sekhar Surapaneni, Vice President Nonclin. Disp. and Bioanalysis, Bristol Myers Squibb
Dr. Luca Ferrari, Head Small Molecules Bioanalytical Sciences, Roche
Dr. Lieve Dillen, Lead Assay Development Bioanalytical Dept, Janssen
"Panel Discussions on Challenging Bioanalytical Methods in Mass Spec"
12:40pm-12:50pm: Short Break
12:50pm-01:50pm: 15th WRIB AWARDS presentation: Outstanding Contribution Award and Best Poster Award
01:50pm-02:00pm: Short Break

Session 4: Rare Matrices, Tissues Analysis and Endogenous Compounds by Mass Spec

Chair: Dr. Ragu Ramanathan, Director Drug Metabolism and Pharmacokinetics, Vertex
02:00pm–02:20pm: Dr. Scott Summerfield, Head of Bioanalysis and Soluble Biomarkers UK, GlaxoSmithKline
"Challenging Bioanalytical Methods in Mass Spec: Very Small Volumes, Rare Matrices, and Tissues"
02:20pm–02:40pm: Dr. Anton Rosenbaum, Head of Regulated Bioanalysis and OMICS by LC-MS, AstraZeneca
"Fit-for-Purpose Validation/Qualification of Highly Multiplex / Metabolomic-style Methods for Small Molecules Biomarkers"
02:40pm–03:00pm: Ms. Lina Luo, Team Lead Bioanalytical, Pfizer
"Novel Urinary Biomarker Development and Implementation in Clinical Trials to Facilitate Assessment and De-Risking of Drug Interactions"
03:00pm–03:20pm: Dr. Scott Summerfield, Head of Bioanalysis and Soluble Biomarkers UK, GlaxoSmithKline
Dr. Anton Rosenbaum, Head of Regulated Bioanalysis and OMICS by LC-MS, AstraZeneca
Ms. Lina Luo, Team Lead Bioanalytical, Pfizer
"Panel Discussions on Rare Matrices, Tissues Analysis and Endogenous Compounds by Mass Spec"
03:20pm-03:40pm: Short Break

Session 5: 2021 White Paper in Bioanalysis

03:40pm–04:00pm: Dr. Matthew Szapacs, Scientific Director Precision Medicine – Neuroscience, AbbVie
"Recommendations on Bioanalysis of Biotherapeutics and Innovative Applications of Mass Spec in Bioanalysis"
04:00pm–04:20pm: Dr. Ragu Ramanathan, Director Drug Metabolism and Pharmacokinetics, Vertex
"Recommendations on Challenging Bioanalytical Methods and Endogenous Compounds by Mass Spec"
04:20pm–04:40pm: Dr. Jian Wang, Associate Director Bioanalysis, Crinetics
"Recommendations on Evolving Regulated Bioanalysis Standards and Patient-centric Approaches in Regulated Bioanalysis"
04:40pm–05:00pm: Dr. Matthew Szapacs, Scientific Director Precision Medicine – Neuroscience, AbbVie
Dr. Ragu Ramanathan, Director Drug Metabolism and Pharmacokinetics, Vertex
Dr. Jian Wang, Associate Director Bioanalysis, Crinetics
And ALL Participating Panelists...
"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
Note: Recommendations related to the Specialized Workshop T1 were shared during the T1 Specialized Workshop




Agenda at a Glance Agenda at a Glance