AGENDA - Training Session Th1
June 24, 2020, 11am to 4:30pm ET: Part 1
June 25, 2020, 11am to 4:30pm ET: Part 2

"Mass Spec Advanced Method Development - Peptides, Oligos, SM and Biomarkers: Solving Complex Challenges with Innovative Approaches on Sensitivity & Selectivity, Unstable/Sticky Compounds; Column Chemistry, Orthogonal Separations, Tissue Bioanalysis"

New level of Sensitivity & Selectivity (S&S); “Very” Unstable Metabolites/Pro-drugs how to catch them; Back to basic with adsorption of very “sticky” Compounds; Novel column chemistry and orthogonal separations. Novel strategies for tissue bioanalysis

Mass Spec Method Development Part 1: June 24, 2020 (EDT time listed)

11:00am-11:10am: Dr Scott Summerfield, Sr. Director and UK Head of Bioanalysis and Biomarkers,GlaxoSmithKline
"Introduction of Mass Spec Method Development Part 1"

Method Development & Metabolites Quantification Challenges - Part A

Chair: Dr Scott Summerfield, Sr. Director and UK Head of Bioanalysis and Biomarkers,GlaxoSmithKline
Co-Chair: Dr. Lieve Dillen, Lead Assay Development Bioanalytical Dept, Janssen
11:10am-11:30am: Dr Scott Summerfield, Sr. Director and UK Head of Bioanalysis and Biomarkers,GlaxoSmithKline
"Advanced Method Development Strategies to Avoid Pitfalls in Small Molecules Bioanalysis: Building on WRIB recommendations, evaluating the chemical structures and evolving trends"
11:30am-11:50am: Dr. Sune Sporring, Manager LCMS Group Development Bioanalysis, Novo Nordisk
"Importance of Step by Step Investigations and Troubleshooting of Unexpected Bioanalytical Result: Lesson learnt from multiple complex case studies in small molecule bioanalysis"
11:50am-12:10pm: Dr. Lieve Dillen, Lead Assay Development Bioanalytical Dept, Janssen
"State-of-the-Art Method Development Strategies in HRMS for Small Molecules: Building on WRIB recommendations, challenges with extraction windows, effect of different processing software, balancing quality/quantity, evolving trends"
12:10pm-12:40pm: Live Quiz on Method Development Challenges
12:40pm-01:10pm: Dr Scott Summerfield, Director and UK Head of Bioanalysis and Biomarkers,GlaxoSmithKline
Dr. Sune Sporring, Manager LCMS Group Development Bioanalysis, Novo Nordisk
Dr. Lieve Dillen, Lead Assay Development Bioanalytical Dept, Janssen
"Panel Discussion on Method Development Challenges"
01:10pm-02:10pm: Social Networking - Time to "Visit" Exhibitors and Posters

Biomarker Methods for new levels of Sensitivity & Selectivity (S&S)

Chair: Dr. Hongbin Yu, Director Bioanalytical Mass Spectrometry, Boehringer Ingelheim
Co-Chair: Ms. Anita Lee, Principal Scientist Translational Biomarkers Group, Merck
02:10pm-02:30pm: Ms. Anita Lee, Principal Scientist Translational Biomarkers Group, Merck
"Novel Method Development Approaches for Tissue Bioanalysis of Biomarkers"
02:30pm-02:50pm: Ms. Lina Luo, Team Lead Global Bioanalytical Laboratories, Pfizer
"Novel Multiplex HRMS Approaches in the Quantification of Clinical Small Molecule Biomarkers of Transporter Mediated in DDI: Building on WRIB recommendations, new case studies, evolving trends"
02:50pm-03:10pm: Dr. Jenny Zhang, Assoc. Director Precision Medicine Early Clinical Development, Pfizer
"Method Development Challenges and Solutions in Small Molecules Biomarkers: Importance of thoroughly Optimized Chromatography and Column Chemistry"
03:10pm-03:30pm: Dr. Allena Ji, Director Clinical Mass Spectrometry Laboratory Biomarkers and Clinical Bioanalyses, Sanofi
"Challenges with Small Molecules Biomarkers Quantification in Rare Matrices: How to conduct method development for successful FFP BAV and sample analysis?"
03:30pm-04:10pm: Live Quiz on Biomarkers Methods
04:10pm-04:40pm: Ms. Anita Lee, Principal Scientist Translational Biomarkers Group, Merck
Ms. Lina Luo, Team Lead Global Bioanalytical Laboratories, Pfizer
Dr. Jenny Zhang, Assoc. Director Precision Medicine Early Clinical Development, Pfizer
Dr. Allena Ji, Director Clinical Mass Spectrometry Laboratory Biomarkers and Clinical Bioanalyses, Sanofi
"Panel Discussion on Biomarkers Methods"


Mass Spec Method Development - Part 2: June 25, 2020 (EDT time listed)

11:00am-11:10am: Dr Scott Summerfield, Sr. Director and UK Head of Bioanalysis and Biomarkers,GlaxoSmithKline
"Introduction of Mass Spec Method Development Part 2"

Peptides & Oligos - Solving Challenges with Innovative Approaches

Chair: Dr Scott Summerfield, Sr. Director and UK Head of Bioanalysis and Biomarkers,GlaxoSmithKline
Co-Chair: Dr. Luca Ferrari, Head Small Molecule Bioanalytical Sciences, Roche
11:10am-11:30am: Dr. Daniel Spellman, Director Discovery Bioanalytics, Merck
"Challenges and Advances in the Modern Discovery Bioanalytical Lab: Modality Independent Analytical Support, a Focus on Unique Method Development Challenges for Therapeutic Peptides"
11:30am-11:50am: Dr. Troy Voelker, Assoc. Director Bioanalytical, Covance
"Adsorption & Internal Standards Contribution Impact on Inaccurate Peptides Quantification: Innovative Approaches in Method Development, Use of HRMS & Novel Column Chemistry for Peptides, and Lesson Learnt"
11:50am-12:10pm: Dr. Luca Ferrari, Head Small Molecule Bioanalytical Sciences, Roche
"LCMS Bioanalysis of Oligonucleotides: Building on WRIB recommendations, overcoming analytical challenges during method development, technology consideration and new case studies"
12:10pm-12:30pm: Mr. Noah Post, Assis. Director Bioanalytical Group, Ionis
"Advanced Strategies in LCMS for Oligonucleotide and Chain-Shorted Metabolites Quantitation: How to develop a sensitive & selective by overcoming traditional oligonucleotide bioanalytical challenges"
12:30pm-01:10pm: Live Quiz on Peptides & Oligos
01:10pm-01:40pm: Dr. Daniel Spellman, Director Discovery Bioanalytics, Merck
Dr. Troy Voelker, Assoc. Director Bioanalytical, Covance
Dr. Luca Ferrari, Head Small Molecule Bioanalytical Sciences, Roche
Mr. Noah Post, Assis. Director Bioanalytical Group, Ionis
"Panel Discussion on Peptides & Oligos"
01:40pm-02:40pm: Social Networking - Time to "Visit" Exhibitors and Posters

Method Development & Metabolites Quantification Challenges Part B

Chair: Dr. Hongbin Yu, Director Bioanalytical Mass Spectrometry, Boehringer Ingelheim
Co-Chair: Dr. Jian Wang, Sr. Principal Scientist Bioanalytical Sciences, Bristol-Myers Squibb
02:40pm-03:00pm: Dr. Jinhui Zhang, Chemist Division of Product Quality Research, US FDA
"Specificity Issue Caused by Metabolite Interference in Regulated Bioanalysis Using LC-MS/MS"
03:00pm-03:20pm: Dr. Jian Wang, Sr. Principal Scientist Bioanalytical Sciences, Bristol-Myers Squibb
"Rising of a Novel Paradigm in Metabolite Quantification: Building on WRIB recommendations, pharma experience on evolving trends on what metabolite to quantify at what stage"
03:20pm-03:40pm: Dr. Nicki Hughes, Vice President Laboratory Operations BioPharma Services
"Free Drug Quantification: Building on WRIB recommendations, what’s new & new case studies, strategies on how to ensure no impact from very unstable metabolites"
03:40pm-04:10pm: Live Quiz on Method Development & Metabolites
04:10pm-04:40pm: Dr. Jinhui Zhang, Chemist Division of Product Quality Research, US FDA
Dr. Jian Wang, Sr. Principal Scientist Bioanalytical Sciences, Bristol-Myers Squibb
Dr. Nicki Hughes, Vice President Laboratory Operations BioPharma Services
"Panel Discussion on Method Development & Metabolites"




Final Agenda Agenda at a Glance