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Day 1 - EST/EDT (Eastern Daylight, GMT-4)
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Day 1 - EST/EDT (Eastern Daylight, GMT-4)
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Streams
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8:00am - 9:00am60 mins
Coffee and Registration
9:00am - 11:00am120 mins
Principles and Practices of CMC Analytics for Cell and Gene Therapy
Principles and Practices of CMC Analytics for Cell and Gene Therapy
- Nadine Ritter - President and Analytical Advisor, Global Biotech Experts, LLC.
9:00am - 11:00am120 mins
CDMO Partnerships- Selection, Negotiation, Tech Transfer, Life Cycle Management
CDMO Partnerships- Selection, Negotiation, Tech Transfer, Life Cycle Management
- James Blackwell - President and Principal Consultant, The Windshire Group, LLC
9:00am - 11:00am120 mins
Data Management and Predictive Analytics for Sound Pharma 4.0 Process Understanding
Data Management and Predictive Analytics for Sound Pharma 4.0 Process Understanding
- Christoph Herwig - Head Biochemical Engineering, Institute of Chemical Engineering, TU Wien, Austria
9:00am - 11:00am120 mins
Analytical Technologies and CMC Comparability of Biotechnology Products
Analytical Technologies and CMC Comparability of Biotechnology Products
- Kevin Zen, PhD - Executive Director, Chemistry Manufacturing and Control, AnaptysBio, AnaptysBio
9:00am - 9:30am30 mins
Pre-Conference Symposia: Cell Line Development & Engineering
Cell Line Case Study: Amgen
- Geneva Alok - Postdoctoral Fellow, Amgen
9:00am - 11:00am120 mins
Pre-Conference Symposia Drug Product Formulation & Fill/Finish
Drug Product Formulations & Fill-finish
- Marc Taraban - Assistant Professor, University of Maryland
- Sisi Zhang, Msc. - Lead Research Specialist, Analytical Chemistry, Regeneron
9:30am - 10:00am30 mins
Pre-Conference Symposia: Cell Line Development & Engineering
Cell Bank Characterization and Retrospective Assessment of Clonality
- Benson Li - Associate Principal Scientist, Merck
10:00am - 10:30am30 mins
Pre-Conference Symposia: Cell Line Development & Engineering
Use of Transposase-Mediated Integration to Reduce Screening and Shorten Cell Line Development Timelines
- Hillary Warrington - Scientist, Janssen
10:30am - 11:00am30 mins
Pre-Conference Symposia: Cell Line Development & Engineering
Perkin Elmer Presentation
11:00am - 11:30am30 mins
Networking Break
11:30am - 1:00pm90 mins
Principles and Practices of CMC Analytics for Cell and Gene Therapy
Principles and Practices of CMC Analytics for Cell and Gene Therapy
- Nadine Ritter - President and Analytical Advisor, Global Biotech Experts, LLC.
11:30am - 1:00pm90 mins
CDMO Partnerships- Selection, Negotiation, Tech Transfer, Life Cycle Management
CDMO Partnerships- Selection, Negotiation, Tech Transfer, Life Cycle Management
- James Blackwell - President and Principal Consultant, The Windshire Group, LLC
11:30am - 1:00pm90 mins
Data Management and Predictive Analytics for Sound Pharma 4.0 Process Understanding
Data Management and Predictive Analytics for Sound Pharma 4.0 Process Understanding
- Christoph Herwig - Head Biochemical Engineering, Institute of Chemical Engineering, TU Wien, Austria
11:30am - 1:00pm90 mins
Analytical Technologies and CMC Comparability of Biotechnology Products
Analytical Technologies and CMC Comparability of Biotechnology Products
- Kevin Zen, PhD - Executive Director, Chemistry Manufacturing and Control, AnaptysBio, AnaptysBio
11:30am - 12:00pm30 mins
Pre-Conference Symposia: Cell Line Development & Engineering
Growing Pains: The Ups and Downs of Building a CLD Platform Process from Scratch
- Allyn Spear - Principal Research Scientist, Elanco Animal Health
11:30am - 1:00pm90 mins
Pre-Conference Symposia Drug Product Formulation & Fill/Finish
Drug Product Formulations & Fill-finish
- Marc Taraban - Assistant Professor, University of Maryland
- Sisi Zhang, Msc. - Lead Research Specialist, Analytical Chemistry, Regeneron
12:00pm - 12:30pm30 mins
Pre-Conference Symposia: Cell Line Development & Engineering
Accelerating Cell Line Development Process Through Automation Platform Integration
- Woo Chi - Principal Scientist, Just Evotec Biologics
12:30pm - 1:00pm30 mins
Pre-Conference Symposia: Cell Line Development & Engineering
Spotlight Session
1:00pm - 2:00pm60 mins
Networking Luncheon
2:00pm - 3:30pm90 mins
Principles and Practices of CMC Analytics for Cell and Gene Therapy
Principles and Practices of CMC Analytics for Cell and Gene Therapy
- Nadine Ritter - President and Analytical Advisor, Global Biotech Experts, LLC.
2:00pm - 3:30pm90 mins
CDMO Partnerships- Selection, Negotiation, Tech Transfer, Life Cycle Management
CDMO Partnerships- Selection, Negotiation, Tech Transfer, Life Cycle Management
- James Blackwell - President and Principal Consultant, The Windshire Group, LLC
2:00pm - 3:30pm90 mins
Data Management and Predictive Analytics for Sound Pharma 4.0 Process Understanding
Data Management and Predictive Analytics for Sound Pharma 4.0 Process Understanding
- Christoph Herwig - Head Biochemical Engineering, Institute of Chemical Engineering, TU Wien, Austria
2:00pm - 3:30pm90 mins
Analytical Technologies and CMC Comparability of Biotechnology Products
Analytical Technologies and CMC Comparability of Biotechnology Products
- Kevin Zen, PhD - Executive Director, Chemistry Manufacturing and Control, AnaptysBio, AnaptysBio
2:00pm - 2:30pm30 mins
Pre-Conference Symposia: Cell Line Development & Engineering
Evaluation of Transposase Technology to Generate Highly Productive CHO Cell Lines
- Eric Lee - Senior Associate Scientist, Biogen
2:00pm - 3:30pm90 mins
Pre-Conference Symposia Drug Product Formulation & Fill/Finish
Drug Product Formulations & Fill-finish
- Marc Taraban - Assistant Professor, University of Maryland
- Sisi Zhang, Msc. - Lead Research Specialist, Analytical Chemistry, Regeneron
2:30pm - 3:00pm30 mins
Pre-Conference Symposia: Cell Line Development & Engineering
Epigenetic Comparison Reveals Divergent Methylation and Transcription Patterns across CHO Lineages
- Meiping Chang - ., Merck
3:00pm - 3:30pm30 mins
Pre-Conference Symposia: Cell Line Development & Engineering
Spotlight Presentation
3:30pm - 4:00pm30 mins
Networking Break
4:00pm - 5:00pm60 mins
Principles and Practices of CMC Analytics for Cell and Gene Therapy
Principles and Practices of CMC Analytics for Cell and Gene Therapy
- Nadine Ritter - President and Analytical Advisor, Global Biotech Experts, LLC.
4:00pm - 5:00pm60 mins
CDMO Partnerships- Selection, Negotiation, Tech Transfer, Life Cycle Management
CDMO Partnerships- Selection, Negotiation, Tech Transfer, Life Cycle Management
- James Blackwell - President and Principal Consultant, The Windshire Group, LLC
4:00pm - 5:00pm60 mins
Data Management and Predictive Analytics for Sound Pharma 4.0 Process Understanding
Data Management and Predictive Analytics for Sound Pharma 4.0 Process Understanding
- Christoph Herwig - Head Biochemical Engineering, Institute of Chemical Engineering, TU Wien, Austria
4:00pm - 5:00pm60 mins
Analytical Technologies and CMC Comparability of Biotechnology Products
Analytical Technologies and CMC Comparability of Biotechnology Products
- Kevin Zen, PhD - Executive Director, Chemistry Manufacturing and Control, AnaptysBio, AnaptysBio
4:00pm - 4:30pm30 mins
Pre-Conference Symposia: Cell Line Development & Engineering
Cell Lines for AAV Gene Therapies
- Saurabh Sen - Associate Director, Cell Line Development, Sanofi
4:00pm - 5:00pm60 mins
Pre-Conference Symposia Drug Product Formulation & Fill/Finish
Drug Product Formulations & Fill-finish
- Marc Taraban - Assistant Professor, University of Maryland
- Sisi Zhang, Msc. - Lead Research Specialist, Analytical Chemistry, Regeneron
4:30pm - 5:00pm30 mins
Pre-Conference Symposia: Cell Line Development & Engineering
Novel Modalities from BMS
- Jacqualyn Schulman, Ph.D. - Scientist, Cell Line Development & ‘Omics Biologics Development, Bristol-Myers Squibb
6:30pm - 11:00pm270 mins
Biotech Week Boston Awards Ceremony
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