Register for the Conference HERE BEBPA’s 5 th Annual US Bioassay Conference Best Pracces 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 Lile, President, BEBPA 7:30-7:35: Welcome Comments by BEBPA’s President 7:35-7:45: Session Introducon & Audience Survey 7:45-8:15: Switching from In-Vivo to In-Vitro Assays: A Reviewer’s Perspecve Leslie Wagner, Chemist, FDA 8:15-8:30: Q & A Session 8:30-9:00: A Reviewer’s Perspecve 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 Validaon of Potency Assays Perceval Sondag, Director of Data Science, Merck 10:00-10:15: Q&A Session 10:15-10:45: Implementaon of Acousc Droplet Ejecon Technology in Quality Control Potency Tesng Jill Crouse-Zeineddini, Scienfic Director, Amgen Inc. 10:45-11:15: Panel Discussion 11:20-12:00: Round Table - Discussion Topics: • Rapid Fire Talks: Complex Product Bioassays (Krisn 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: Soluons for Potency Assays (Mike Sadick) Brendan Bioanalycs (John Dunn) ImmunXperts (Sofie Payn) Svar (Michael Tovey) 12:00 Conference Adjourns Session Chair: Nancy Niemuth, Research Leader, Baelle 7:30-7:45: Session Introducon & Audience Survey 7:45-8:15: Stascal Model Selecon Using USP <1034> 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, Stascal 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 Instuon Sco Wing, Director, Translaonal Trials Support and Developmental Laboratory (TTSDL) Cincinna 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 Scienfic Affairs, Covance 7:30-7:45: Session Introducon & Audience Survey 7:45-8:15: Handling Product References for Potency Assays: A Review of the BEBPA White Paper Laureen Lile, 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 Valenna Bernasconi, Scienst, CEPI 10:45-11:15: Panel Discussion 11:20-12:00: Round Tables - Discussion Topics: • Reference Material: Connued (Seth Foltz) • Replacing a Potency Assay (Sian Estdale) • Validaon Strategies (David Lansky) • Advance Analysis for Potency, LBA and IMG Assays (John Dunn) 12:00 Conference Adjourns Session Chair: Krisn Clement, Principal Consultant, Bio-Val Consulng 7:30-7:45: Session Introducon & Audience Survey 7:45-8:15: Translang the USP for Cell-Based Gene Therapy Methods Catherine Liloia, Director, PPD 8:15-8:30: Q & A Session 8:30-9:00: Evaluaon of a Cell-Based Potency Assay to Support Clinical Development of an Amnioc-Derived Biologic for the Treatment of Osteoarthris Miranda Burnee, Senior Scienst, 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 Scienst, Pfizer 10:00-10:15: Q & A Session 10:15-10:45: Assessing Stability-Indicang Methods of a CAR T Cellular Therapy Mel Davis-Picke, Senior Associate Scienst, 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 distribuon are highlighted in RED* PDT SGT CDT EDT GMT CET KST
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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*
PDT
SGT
CDT
EDT
GMT
CET
KST
https://www.bebpa.org/conferences/registration/https://www.bebpa.org/conferences/registration/https://www.bebpa.org/2021-us-bioassay-abstracts/#wagnerhttps://www.bebpa.org/2021-us-bioassay-abstracts/#wagnerhttps://www.bebpa.org/2021-us-bioassay-abstracts/#feldmanhttps://www.bebpa.org/2021-us-bioassay-abstracts/#feldmanhttps://www.bebpa.org/2021-us-bioassay-abstracts/#sondaghttps://www.bebpa.org/2021-us-bioassay-abstracts/#sondaghttps://www.bebpa.org/2021-us-bioassay-abstracts/#crousehttps://www.bebpa.org/2021-us-bioassay-abstracts/#crousehttps://www.bebpa.org/conferences/2021-usb-roundtables/#rt-1-1https://www.bebpa.org/2021-us-bioassay-abstracts/#matsudahttps://www.bebpa.org/2021-us-bioassay-abstracts/#matsudahttps://www.bebpa.org/2021-us-bioassay-abstracts/#chenghttps://www.bebpa.org/conferences/2021-usb-roundtables/#rt-1-2https://www.bebpa.org/conferences/2021-usb-roundtables/#rt-1-3https://www.bebpa.org/conferences/2021-usb-roundtables/#rt-1-4https://www.bebpa.org/2021-us-bioassay-abstracts/#dunnhttps://www.bebpa.org/2021-us-bioassay-abstracts/#pattynhttps://www.bebpa.org/2021-us-bioassay-abstracts/#toveyhttps://www.bebpa.org/2021-us-bioassay-abstracts/#walfishhttps://www.bebpa.org/2021-us-bioassay-abstracts/#lanskyhttps://www.bebpa.org/2021-us-bioassay-abstracts/#deminghttps://www.bebpa.org/2021-us-bioassay-abstracts/#wittinghttps://www.bebpa.org/2021-us-bioassay-abstracts/#wittinghttps://www.bebpa.org/2021-us-bioassay-abstracts/#wittinghttps://www.bebpa.org/2021-us-bioassay-abstracts/#bebpahttps://www.bebpa.org/2021-us-bioassay-abstracts/#bebpahttps://www.bebpa.org/2021-us-bioassay-abstracts/#odocayenhttps://www.bebpa.org/2021-us-bioassay-abstracts/#odocayenhttps://www.bebpa.org/2021-us-bioassay-abstracts/#reeshttps://www.bebpa.org/2021-us-bioassay-abstracts/#reeshttps://www.bebpa.org/2021-us-bioassay-abstracts/#bernasconihttps://www.bebpa.org/2021-us-bioassay-abstracts/#bernasconihttps://www.bebpa.org/2021-us-bioassay-abstracts/#bernasconihttps://www.bebpa.org/conferences/2021-usb-roundtables/#rt-3-1https://www.bebpa.org/conferences/2021-usb-roundtables/#rt-3-2https://www.bebpa.org/conferences/2021-usb-roundtables/#rt-3-3https://www.bebpa.org/conferences/2021-usb-roundtables/#rt-3-4https://www.bebpa.org/2021-us-bioassay-abstracts/#liloiahttps://www.bebpa.org/2021-us-bioassay-abstracts/#liloiahttps://www.bebpa.org/2021-us-bioassay-abstracts/#burnettehttps://www.bebpa.org/2021-us-bioassay-abstracts/#burnettehttps://www.bebpa.org/2021-us-bioassay-abstracts/#burnettehttps://www.bebpa.org/2021-us-bioassay-abstracts/#sankarhttps://www.bebpa.org/2021-us-bioassay-abstracts/#sankarhttps://www.bebpa.org/2021-us-bioassay-abstracts/#davishttps://www.bebpa.org/2021-us-bioassay-abstracts/#davishttps://www.bebpa.org/2021-us-bioassay-abstracts/#davishttps://www.stegmannsystems.com/?utm_source=signatur&utm_medium=email&utm_campaign=E-Mail-Signaturhttps://biologics.catalent.com/https://www.brendan.com/https://www.promega.com/https://www.bebpa.org/brochures/2021-USB-Current.pdfhttps://www.bebpa.org/brochures/2021/USB-TZ/2021-USB-SGT.pdfhttps://www.bebpa.org/brochures/2021/USB-TZ/2021-USB-CDT.pdfhttps://www.bebpa.org/brochures/2021/USB-TZ/2021-USB-EDT.pdfhttps://www.bebpa.org/brochures/2021/USB-TZ/2021-USB-GMT.pdfhttps://www.bebpa.org/brochures/2021/USB-TZ/2021-USB-CET.pdfhttps://www.bebpa.org/brochures/2021/USB-TZ/2021-USB-KST.pdf
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