AGENDA - Specialized Workshop Th1 - Thursday Sep. 30, 2021: 8am - 5pm

"Conventional & Novel Critical Reagents: Recent Issues in Development and Management for Established/Emerging Technologies/Modalities"

New tools to support Robust Immunoassays, Bridging Highly Variable Critical Reagents lots, Critical Reagents from Phage-Display Technology vs conventional Animal-Based Critical Reagents, dealing with Critical Reagents Discontinued by Vendors, Critical Reagent for New Modalities and new Assays Platforms, High Affinity Critical Reagents and Relation to Assay Function, Aptamers/Affimers/Novel Non-Antibody Critical Reagents, Vaccine advanced experience in Critical Reagent Life Cycle Management/Bridging, Selection of Clinically-Relevant Positive Control for ADA assays

Session 1: Advanced Approaches in Critical Reagents Selection

Chair: Dr. Mark Ma, Executive Director Head of Bioanalytical and Biomarker Development, Alexion
08:00am-08:20am: Ms. Kelly Coble, Director Bioanalytical Sciences, Boehringer Ingelheim
"Advanced Approaches in Selection of Critical Reagents for Sensitive Clinical PK Assays"
08:20am-08:40am: Dr. Ellen O’Connor, Associate Director Biopharmaceutical Development, AstraZeneca
"Critical Reagents for Ligand-Binding Assays: Process Development to Enable High Quality Reagents "
08:40am-09:00am: Ms. Terri Caiazzo, Senior Principal Scientist BioMedicine Design Group, Pfizer
"Importance of Affinity Determination in Critical Reagent Development: Pfizer Experience Based on Multiple Case Studies "
09:00am-09:20am: Dr. Shannon Chilewski, Principal Scientist, Bristol-Myers Squibb
"The Effect of Degree of Labeling and Aggregation on Pharmacokinetic Ligand Binding Assays"
09:20am-10:00am: Ms. Kelly Coble, Director Bioanalytical Sciences, Boehringer Ingelheim
Dr. Ellen O’Connor, Associate Director Biopharmaceutical Development, AstraZeneca
Ms. Terri Caiazzo, Senior Principal Scientist BioMedicine Design Group, Pfizer
Dr. Shannon Chilewski, Principal Scientist, Bristol-Myers Squibb
"Panel Discussions on Advanced Approaches in Critical Reagents Selection"
10:00am-10:30am: Short Break

Session 2: Novel Critical Reagent Modalities: "Thinking out of the Box"

Chair: Dr. Shannon Harris, Head of Clinical Serology, Seqirus
10:30am-10:50am: Dr. Boris Gorovits, Vice President Biomarker Discovery and Bioanalysis, Sana Biotechnologies
"Impact of Restrictions on Animal-Derived Antibodies on Critical Reagents: Current Regulatory Status and Industry’ Thinking out of the Box"
10:50am-11:10am: Ms. Beth Leary, Principal Scientist BioMedicine Design Group, Pfizer
"Novel Critical Reagent Modalities: Pfizer’s Positive/Negative Experience with Aptamers, Virus-Like Particles, and other Non-antibody Reagents"
11:10am-11:30am: Dr. Andrew Mayer, Group Leader Bioanalysis, GlaxoSmithKline
"Recent Issues in Conventional & Novel Critical Reagents"
11:30am-12:00pm: Dr. Boris Gorovits, Vice President Biomarker Discovery and Bioanalysis, Sana Biotechnologies
Ms. Beth Leary, Principal Scientist BioMedicine Design Group, Pfizer
Dr. Andrew Mayer, Group Leader Bioanalysis, GlaxoSmithKline
"Panel Discussions on Novel Critical Reagent Modalities: Thinking out of the Box"
12:00pm-12:30pm: Short Break

Session 3: Challenges in Critical Reagent & Positive Control Generation for ADA Assays

Chair: Dr. Mark Ma, Executive Director Head of Bioanalytical and Biomarker Development, Alexion
12:30pm-12:50pm: Dr. Christine Grimaldi, Distinguished Research Fellow, Boehringer Ingelheim
"Selection and Application of “Clinically Relevant” Positive Control (PC) Antibodies for ADA Assays"
12:50pm-01:10pm: Dr. Yang Xu, Senior Principal Scientist, Merck
"Positive Control as Critical Reagent for ADA Assays"
01:10pm-01:30pm: Dr. Hanjo Lim, Scientific Manager BioAnalytical Sciences, Genentech
"Management and Characterization of Critical LBA Reagents during Drug Development"
01:30pm-02:00pm: Dr. Christine Grimaldi, Distinguished Research Fellow, Boehringer Ingelheim
Dr. Yang Xu, Senior Principal Scientist, Merck
Dr. Hanjo Lim, Scientific Manager BioAnalytical Sciences, Genentech
"Panel Discussions on Challenges in Critical Reagent & Positive Control Generation for ADA Assays"
02:00pm-02:30pm: Short Break

Session 4: Critical Reagent Management for Lot-to-Lot Bridging and Assay Comparability

Chair: Dr. Shannon Harris, Head of Clinical Serology, Seqirus
02:30pm-02:50pm: Mr. Francis Dessy, Clinical Assays Science Advisor, GlaxoSmithKline
"Bridging of Critical Reagents and Vaccine Immuno-Assay Stability"
02:50pm-03:10pm: Dr. Mark Ware, Scientific Director, Janssen
"Critical Reagent Management for Lot-to-Lot Bridging and Assay Comparability: Janssen’s Experience & Perspective"
03:10pm-03:30pm: Mr. Francis Dessy, Clinical Assays Science Advisor, GlaxoSmithKline
Dr. Mark Ware, Scientific Director, Janssen
"Panel Discussions on Critical Reagent Management for Lot-to-Lot Bridging and Assay Comparability "
03:30pm-04:00pm: Short Break

Session 5: 2021 White Paper in Bioanalysis

04:00pm-04:30pm: Dr. Mark Ma, Executive Director Head of Bioanalytical and Biomarker Development, Alexion
Dr. Shannon Harris, Head of Clinical Serology, Seqirus
"Recommendations on Conventional & Novel Critical Reagents: Recent Issues in Development and Management for Established/Emerging Technologies/Modalities"
04:30pm-05:00pm: Dr. Mark Ma, Executive Director Head of Bioanalytical and Biomarker Development, Alexion
Dr. Shannon Harris, Head of Clinical Serology, Seqirus
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




Agenda at a Glance Agenda at a Glance