October 25-28, 2021
Delivered in a 100% Digital FormatKey Sessions
Nadine Ritter, Ph.D.
Accelerated CMC Strategies for Biological/Biosimilar Products
Global Biotech Experts, LLC
Janet Lathey, Ph.D.
KEYNOTE: Standardizing Assays Using ZIKV as an Example
DMID/NIAID/NIH
Wei Zhang, Ph.D.
Featured Presentation: Bioassay Strategies for AAV Gene Therapy Products
Biogen
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Main Conference - Day One
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Main Conference - Day One
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9:00am - 9:05am5 mins
PLENARY SESSION
Opening Remarks
9:10am - 9:35am25 mins
PLENARY SESSION
Accelerated CMC Strategies for Biological/Biosimilar Products
- Nadine Ritter, Ph.D. - President and Analytical Advisor, Global Biotech Experts, LLC
9:40am - 10:05am25 mins
PLENARY SESSION
KEYNOTE: Standardizing Assays Using ZIKV as an Example
- Janet Lathey, Ph.D. - Health Science Specialist, DMID/NIAID/NIH
10:05am - 10:30am25 mins
PLENARY SESSION
Live Q&A with Nadine Ritter and Janet Lathey
- Nadine Ritter, Ph.D. - President and Analytical Advisor, Global Biotech Experts, LLC
- Janet Lathey, Ph.D. - Health Science Specialist, DMID/NIAID/NIH
10:30am - 10:50am20 mins
WELL CHARACTERIZED BIOLOGICS TRACK
Quantify Viral Vector Attributes with Light Scattering
- Andrew Meyer, Ph.D. - Southeast Regional Manager & Senior Applications Scientist, Wyatt Technology
10:30am - 10:50am20 mins
BIOLOGICAL ASSAYS TRACK
Measuring Protein Concentration by Diffusion-filtered Quantitative Nuclear Magnetic Resonance Spectroscopy
- Scott Bradley - Principal Research Scientist, Eli Lilly
10:50am - 11:20am30 mins
Networking Break: View Exhibit Booths & Poster Rooms, Schedule Some Meetings
11:20am - 11:40am20 mins
WELL CHARACTERIZED BIOLOGICS TRACK: Analytical and Biophysical Characterization Requirements for Novel Modalities
High-Resolution Mass Spectrometry as a Tool for Characterization of Post-Translational Modifications (PTMs) and Sequence Extensions in Fc-Fusion Proteins
- Chris Spahr - Senior Scientist, Discovery Attribute Sciences, Amgen
11:20am - 11:40am20 mins
BIOLOGICAL ASSAYS TRACK: Bioassay Development for Non-mAbs
Development of a Robust Functional Cell-based Assay for Replacing the Rabbit Blood Sugar Bioidentity Test of Insulin Analog
- Junming Yie - Principal Scientist, Cell Based Assays, Merck
11:45am - 12:05pm20 mins
WELL CHARACTERIZED BIOLOGICS TRACK: Analytical and Biophysical Characterization Requirements for Novel Modalities
International Regulatory Landscape for Cell and Gene Therapy Products (CGTP)
- Chenghong Wei, Ph.D. - Associate Director, Global Regulatory Affairs CMC, AstraZeneca
11:45am - 12:05pm20 mins
BIOLOGICAL ASSAYS TRACK: Bioassay Development for Non-mAbs
Bioassays for use in measuring the expression and biological activity of therapeutic transgenes within recombinant oncolytic virus genomes
- Dylan Weil - R & D Associate II, Astrazeneca
12:10pm - 12:30pm20 mins
WELL CHARACTERIZED BIOLOGICS TRACK: Analytical and Biophysical Characterization Requirements for Novel Modalities
Accelerating Assay Execution and Data Analysis with Antha® Auto-programming Software
- Luke Cach - Scientific Solutions Lead, Synthace
12:10pm - 12:30pm20 mins
BIOLOGICAL ASSAYS TRACK: Bioassay Development for Non-mAbs
Bioassay To Assess Knockdown Efficiency Using mRNA Knockdown rAAV Technology
- Esteban Carrillo - Research Scientist (Technical Project Manager), PPD Laboratories
12:30pm - 1:00pm30 mins
WELL CHARACTERIZED BIOLOGICS TRACK: Analytical and Biophysical Characterization Requirements for Novel Modalities
Live Q & A Panelists: Andrew Meyer, Chris Spahr, ChengHong Wei, Luke Cach Moderator: Ranjini Ramachander
- Luke Cach - Scientific Solutions Lead, Synthace
- Andrew Meyer, Ph.D. - Southeast Regional Manager & Senior Applications Scientist, Wyatt Technology
- Chris Spahr - Senior Scientist, Discovery Attribute Sciences, Amgen
- Chenghong Wei, Ph.D. - Associate Director, Global Regulatory Affairs CMC, AstraZeneca
- Ranjini Ramachander, Ph.D. - President and CEO, NuBioVista LLC Consulting
12:30pm - 1:00pm30 mins
BIOLOGICAL ASSAYS TRACK: Bioassay Development for Non-mAbs
Live Q & A Panellists: Scott Bradley Junming Yie, Dylan Weil, Esteban Carrillo Moderator: Gaurav Agrawal
- Scott Bradley - Principal Research Scientist, Eli Lilly
- Esteban Carrillo - Research Scientist (Technical Project Manager), PPD Laboratories
- Dylan Weil - R & D Associate II, Astrazeneca
- Junming Yie - Principal Scientist, Cell Based Assays, Merck
- Gaurav Agrawal, Ph.D. - Scientific Development Manager, Eurofins DiscoverX
1:00pm - 1:30pm30 mins
Luncheon Roundtable A
Analytical and Biophysical Characterization of Novel Modalities – Experiences and Lessons Learned
- Chris Spahr - Senior Scientist, Discovery Attribute Sciences, Amgen
- Chenghong Wei, Ph.D. - Associate Director, Global Regulatory Affairs CMC, AstraZeneca
1:00pm - 1:30pm30 mins
Luncheon Roundtable B
Conducting Biological Assays for Cell & Gene Therapies
- Wei Zhang, Ph.D. - Associate Director, Biogen
- Rajeev Boregowda - Senior Manager, Sangamo Therapeutics Inc.
1:30pm - 2:00pm30 mins
Luncheon Roundtable C
Novel Approaches to Accelerating Characterization – Successes and Failures
- Nadine Ritter, Ph.D. - President and Analytical Advisor, Global Biotech Experts, LLC
1:30pm - 2:00pm30 mins
Luncheon Roundtable D
Optimizing Bioassay Workflows & Methods To Achieve Better Product Quality
- David Lansky, Ph.D. - President and Principal Statistician, Precision Bioassay, Inc.
- Nathan Oien, Ph.D. - Senior Scientist, Zoetis Inc.
- Luke Cach - Scientific Solutions Lead, Synthace
2:00pm - 2:20pm20 mins
WELL CHARACTERIZED BIOLOGICS TRACK: Analytical and Biophysical Characterization Requirements for Biosimilars
Physicochemical Characterization of Antibodies in Undiluted High-Concentrated Drug Product Solutions and in Concentrations Used in the Clinic – Comparison of the Originator Bevacizumab with a Biosimilar Candidate
- Tudor Arvinte, Ph.D. - Professor / CEO, University of Geneva Switzerland / Therapeomic Inc.
2:00pm - 2:20pm20 mins
BIOLOGICAL ASSAYS TRACK: Bioassay Development for Non-mAbs
Considerations for Gene Therapy Potency Assay Development
- Rajeev Boregowda - Senior Manager, Sangamo Therapeutics Inc.
2:25pm - 2:45pm20 mins
WELL CHARACTERIZED BIOLOGICS TRACK: Strategies for Accelerated Method Development & Phase Appropriate GMP Work
Accelerated Analytical Development for Biopharmaceuticals in the 21st Century
- Drew Kelner, Ph.D. - President, Colorado Biotechnology Consultants
2:25pm - 2:45pm20 mins
BIOLOGICAL ASSAYS TRACK: Bioassay Development for Non-mAbs
Featured Presentation: Bioassay Strategies for AAV Gene Therapy Products
- Wei Zhang, Ph.D. - Associate Director, Biogen
2:50pm - 3:10pm20 mins
WELL CHARACTERIZED BIOLOGICS TRACK: Strategies for Accelerated Method Development & Phase Appropriate GMP Work
Lean CMC Strategies and Phase Appropriate Stability
- Ranjini Ramachander, Ph.D. - President and CEO, NuBioVista LLC Consulting
2:50pm - 3:10pm20 mins
BIOLOGICAL ASSAYS TRACK: Bioassay Development for Non-mAbs
Building Quality into a Cell-Based Assay for a Potent Receptor Agonist; a DOE approach
- Nathan Oien, Ph.D. - Senior Scientist, Zoetis Inc.
3:10pm - 3:30pm20 mins
WELL CHARACTERIZED BIOLOGICS TRACK: Strategies for Accelerated Method Development & Phase Appropriate GMP Work
Live Q&A with Tudor Arvinte, Drew Kelner. Ranjini Ramachande
- Tudor Arvinte, Ph.D. - Professor / CEO, University of Geneva Switzerland / Therapeomic Inc.
- Drew Kelner, Ph.D. - President, Colorado Biotechnology Consultants
- Ranjini Ramachander, Ph.D. - President and CEO, NuBioVista LLC Consulting
3:10pm - 3:30pm20 mins
BIOLOGICAL ASSAYS TRACK: Bioassay Development for Non-mAbs
Live Q & A with Rajeev Boregowda, Wei Zhang, and Nathan Oien
- Rajeev Boregowda - Senior Manager, Sangamo Therapeutics Inc.
- Wei Zhang, Ph.D. - Associate Director, Biogen
- Nathan Oien, Ph.D. - Senior Scientist, Zoetis Inc.
- David Lansky, Ph.D. - President and Principal Statistician, Precision Bioassay, Inc.
3:30pm - 4:25pm55 mins
Networking Break: View Exhibit Booths & Poster Rooms, Schedule Some Meetings
4:25pm - 4:45pm20 mins
Next Generation Characterization Approaches
Structure Characterization of Protein Therapeutics
- Frank Delaglio, Ph.D. - Principal Investigator, IBBR, National Institute of Standards and Technology and the University of Maryland
4:45pm - 5:00pm15 mins
Next Generation Characterization Approaches
Live Q & A Panellists: Frank Delaglio
- Frank Delaglio, Ph.D. - Principal Investigator, IBBR, National Institute of Standards and Technology and the University of Maryland
5:00pm - 6:00pm60 mins
Networking Activity - More details to come!
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