Register for the Conference HERE
BEBPA’s 5th Annual
US Bioassay Conference Best Practices for the Best Potency
Assays
March 22-25, 2021
3 Ways to Register: Online at BEBPA.org – Phone: 206-651-4542 –
Email: [email protected]
Day 1: Monday, March 22, 2021 Regulatory Insights and Potency
Method Development
Day 2: Tuesday, March 23, 2021 Method Development Tools
Day 3: Wednesday, March 24, 2021 Reference Standards for Potency
Assays
Day 4: Thursday, March 25, 2021 Potency Assay Development for
Complex Products
*All Times are in US PACIFIC DAYLIGHT TIME*
Session Chair: Laureen Little, President, BEBPA 7:30-7:35:
Welcome Comments by BEBPA’s President
7:35-7:45: Session Introduction & Audience Survey
7:45-8:15: Switching from In-Vivo to In-Vitro Assays: A
Reviewer’s Perspective Leslie Wagner, Chemist, FDA 8:15-8:30: Q
& A Session
8:30-9:00: A Reviewer’s Perspective on Bioassay Development in
2021
Gerald Feldman, Office of Biotechnology Products, FDA
9:00-9:15: Q & A Session
9:15 - 9:30 Break 9:30-10:00: Design of Experiments for the
Validation of Potency
Assays Perceval Sondag, Director of Data Science, Merck
10:00-10:15: Q&A Session
10:15-10:45: Implementation of Acoustic Droplet Ejection
Technology in Quality Control Potency Testing
Jill Crouse-Zeineddini, Scientific Director, Amgen Inc.
10:45-11:15: Panel Discussion
11:20-12:00: Round Table - Discussion Topics:
• Rapid Fire Talks: Complex Product Bioassays (Kristin Clement)
Potency Assay Cell Therapy talk (Katherine
Matsuda) Promega (Jey Cheng)
• Potency Assays for mAb (Mike Merges) • Bioassays for Vaccine
Products (Bassam Hallis) • Rapid Fire Talks: Solutions for Potency
Assays (Mike Sadick)
Brendan Bioanalytics (John Dunn) ImmunXperts (Sofie Pattyn) Svar
(Michael Tovey)
12:00 Conference Adjourns
Session Chair: Nancy Niemuth, Research Leader, Battelle
7:30-7:45: Session Introduction & Audience Survey
7:45-8:15: Statistical Model Selection Using USP Steven Walfish,
Principal Liaison, USP
8:15-8:30: Q & A Session 8:30-9:00: Mixed Model Bioassay
Analysis: How & Why David Lansky, President, Precision
Bioassay
9:00-9:15: Q & A Session
9:15 - 9:30 Break 9:30-10:00: Why We Like the 15PL Stan Deming,
President, Statistical Designs
10:00-10:15: Q & A Session
10:15-10:45: Potency Assays for Phase I/II Cell and Gene Therapy
Products: Experiences for a Small “CMO” Within an Academic
Institution
Scott Witting, Director, Translational Trials Support and
Developmental Laboratory (TTSDL) Cincinnati Children’s Hospital
Medical Center
10:45-11:00: Q & A Session
11:00-11:45: Panel Discussion
11:45 Conference Adjourns
Session Chair: Sian Estdale, Head of Scientific Affairs,
Covance
7:30-7:45: Session Introduction & Audience Survey
7:45-8:15: Handling Product References for Potency Assays: A
Review of the BEBPA White Paper
Laureen Little, President, BEBPA 8:15-8:30: Q & A
Session
8:30-9:00: Why the Reference Standard is so Important to Potency
Assays
Mena Odocayen, Senior Research Associate, Genentech
9:00-9:15: Q & A Session
9:15 - 9:30 Break 9:30-10:00: A Lesson from Monitoring
Reference
Standard Stability Gareth Rees, Senior QA Biological Specialist,
Porton
Biopharma Limited
10:00-10:15: Q & A Session
10:15-10:45: CEPI Centralized Laboratory Network for Measurement
of Immune Responses Elicited by SARS-CoV-2 Vaccines
Valentina Bernasconi, Scientist, CEPI 10:45-11:15: Panel
Discussion 11:20-12:00: Round Tables - Discussion Topics:
• Reference Material: Continued (Seth Foltz) • Replacing a
Potency Assay (Sian Estdale) • Validation Strategies (David Lansky)
• Advance Analysis for Potency, LBA and IMG Assays (John Dunn)
12:00 Conference Adjourns
Session Chair: Kristin Clement, Principal Consultant, Bio-Val
Consulting
7:30-7:45: Session Introduction & Audience Survey
7:45-8:15: Translating the USP for Cell-Based Gene Therapy
Methods
Catherine Liloia, Director, PPD
8:15-8:30: Q & A Session
8:30-9:00: Evaluation of a Cell-Based Potency Assay to Support
Clinical Development of an Amniotic-Derived Biologic for the
Treatment of Osteoarthritis
Miranda Burnette, Senior Scientist, Organogenesis
9:00-9:15: Q & A Session
9:15 - 9:30 Break 9:30-10:00: Potency Bioassay Strategies for
Gene Therapy
Programs Savita Sankar, Principal Scientist, Pfizer
10:00-10:15: Q & A Session
10:15-10:45: Assessing Stability-Indicating Methods of a CAR T
Cellular Therapy
Mel Davis-Pickett, Senior Associate Scientist, Bristol Myers
Squibb
10:45-11:00: Q & A Session
11:00-11:45: Panel Discussion
11:45 Conference Adjourns
Thank You Conference Sponsors!
*Slides not available for distribution are highlighted in
RED*
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