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Delivered as a Hybrid Event from September 20-30, 2021
Live In-Person Experience Delivered September 20-23Boston Convention and Exhibition Centerkeyboard_arrow_right
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CONFERENCE DAY 1 - EST/EDT (Eastern Daylight, GMT-4)
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CONFERENCE DAY 1 - EST/EDT (Eastern Daylight, GMT-4)
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7:00am - 8:00am60 mins
Coffee and Registration
Plenary Session
8:00am - 8:15am15 mins
Keynote Session
Conference Opening and Welcome
- Muthiah (Mano) Manoharan, PhD - Senior Vice President of Drug Discovery, Alnylam Pharmaceuticals, Inc.
8:15am - 9:00am45 mins
Keynote Session
Keynote Presentation: RNAi Therapeutics: Past, Present, and (Mostly) Future
- John Maraganore, PhD - Chief Executive Officer, Alnylam Pharmaceuticals, Inc
9:00am - 9:45am45 mins
Keynote Session
Keynote Presentation: My Long Road from the 2’-5’ Oligos to the mRNA Vaccine
- Katalin Karikó, PhD - Senior Vice President RNA Protein Replacement Therapy, BioNTech
9:45am - 10:25am40 mins
Networking Refreshment Break
10:25am - 10:30am5 mins
Cell Culture and Upstream Processing
Chairperson's Remarks
10:25am - 10:30am5 mins
Recovery & Purification
Chairperson’s Remarks
10:25am - 10:30am5 mins
Manufacturing Strategy & Bioprocessing 4.0
Chairperson’s Remarks
10:25am - 10:30am5 mins
Intensified and Continuous Processing
Chairperson’s Remarks
10:25am - 10:30am5 mins
Analytical & Quality
Chairperson’s Remarks
10:25am - 10:30am5 mins
Cell Therapy
Chairperson’s Opening Remarks:
- Shashi Murthy, PhD - Founder & CTO, Flaskworks
10:25am - 10:30am5 mins
Gene Edited Ex Vivo Cell Therapy / In Vivo Gene Therapy
Chairperson’s Opening Remarks:
10:25am - 10:30am5 mins
In Vivo Gene Therapy
Chairperson’s Opening Remarks:
10:30am - 11:00am30 mins
Cell Culture and Upstream Processing
Correlation of Online and Offline Techniques to Measure CHO Cell Health for Early Detection and Control of Cell Stress
- Kyle McHugh - Scientist, Bristol-Myers Squibb
10:30am - 11:00am30 mins
Recovery & Purification
Extracellular Vesicles: Strategies for Their Engineering and Scalable Purification and Fractionation
- Dan Bracewell, Ph.D. - Professor of Bioprocess Analysis, University College London
10:30am - 11:00am30 mins
Manufacturing Strategy & Bioprocessing 4.0
Scale Up & Manufacture of CRISPR Gene Edited Hematopoietic Stem Cell (eHSC) Therapies for AML
- Sadik H. Kassim - Chief Technology Officer, Vor Biopharma
10:30am - 11:00am30 mins
Intensified and Continuous Processing
Process Characterization Strategy for a Semi-Continuous Capture Step
- Gregory Shimamura - Process Scientist, Boehringer Ingelheim
10:30am - 11:00am30 mins
Analytical & Quality
Process Characterization Strategy for a Semi-Continuous Capture Step
- Gregory Shimamura - Process Scientist, Boehringer Ingelheim
10:30am - 11:00am30 mins
Speed from Gene to Market
Correlation of Online and Offline Techniques to Measure CHO Cell Health for Early Detection and Control of Cell Stress
- Kyle McHugh - Scientist, Bristol-Myers Squibb
10:30am - 11:00am30 mins
Cell Therapy
Adherent Cell Manufacturing & Process Development
- Lior Raviv - Vice President Development & Operations, Pluristem Therapeutics Inc.
10:30am - 11:00am30 mins
Gene Edited Ex Vivo Cell Therapy / In Vivo Gene Therapy
Scale Up & Manufacture of CRISPR Gene Edited Hematopoietic Stem Cell (eHSC) Therapies for AML
- Sadik H. Kassim - Chief Technology Officer, Vor Biopharma
10:30am - 11:00am30 mins
In Vivo Gene Therapy
A Simple and Robust AAV Manufacturing System to Achieve High Titer And Quality Gene Therapy Vector
- Shenjiang (Shawn) Liu - President & CEO, Avirmax Inc.
11:00am - 11:30am30 mins
Cell Culture and Upstream Processing
Accelerating Process Development Using On-Line & At-Line Technologies
- Zachary Houle - Senior Development Specialist, Upstream Process Development, Takeda
11:00am - 11:30am30 mins
Recovery & Purification
Development of ADC Purification Tool Box to Address Manufacturing Challenges
- Lihua Yang - Principal Scientist, Bioprocess Development, AbbVie
11:00am - 11:30am30 mins
Manufacturing Strategy & Bioprocessing 4.0
Manufacturing Concepts for Gene-Edited Allogeneic CAR-T Cell Products
- Chris Gemmiti, Ph.D. - Executive Director of Technical Operations; Head of Early Stage CMC and Product Launch Programs, CRISPR Therapeutics
11:00am - 11:30am30 mins
Intensified and Continuous Processing
On-Line Monitoring of Metabolites and Glycosylation in High Cell Density Perfusion Process
- Veronique Chotteau, PhD - Director, AdBIOPRO - Competence Centre for Advanced Bioproduction by Continuous Process
11:00am - 11:30am30 mins
Analytical & Quality
On-Line Monitoring of Metabolites and Glycosylation in High Cell Density Perfusion Process
- Veronique Chotteau, PhD - Director, AdBIOPRO - Competence Centre for Advanced Bioproduction by Continuous Process
11:00am - 11:30am30 mins
Speed from Gene to Market
Accelerating Process Development Using On-Line & At-Line Technologies
- Zachary Houle - Senior Development Specialist, Upstream Process Development, Takeda
11:00am - 11:30am30 mins
Cell Therapy
Risk Based Approaches to Comparability
- Silky Kamdar - Manager, BMS
11:00am - 11:30am30 mins
Gene Edited Ex Vivo Cell Therapy / In Vivo Gene Therapy
Manufacturing Concepts for Gene-Edited Allogeneic CAR-T Cell Products
- Chris Gemmiti, Ph.D. - Executive Director of Technical Operations; Head of Early Stage CMC and Product Launch Programs, CRISPR Therapeutics
11:00am - 11:30am30 mins
In Vivo Gene Therapy
AAV Production Optimisation
- Hélène Trottin - Senior Technical Specialist, Process Sciences, Allergan Biologics (an Abbvie company)
11:30am - 12:00pm30 mins
Cell Culture and Upstream Processing
Scientific Track Presentation
11:30am - 12:00pm30 mins
Recovery & Purification
Scientific Track Presentation
11:30am - 12:00pm30 mins
Manufacturing Strategy & Bioprocessing 4.0
Scientific Track Presentation
11:30am - 12:00pm30 mins
Intensified and Continuous Processing
Scientific Track Presentation
11:30am - 12:00pm30 mins
Analytical & Quality
Scientific Track Presentation
11:30am - 12:00pm30 mins
Speed from Gene to Market
Scientific Track Presentation
11:30am - 12:00pm30 mins
Cell Therapy
Spotlight Presentation
11:30am - 12:00pm30 mins
Gene Edited Ex Vivo Cell Therapy / In Vivo Gene Therapy
Spotlight Presentation
11:30am - 12:00pm30 mins
In Vivo Gene Therapy
Spotlight Presentation
12:00pm - 12:30pm30 mins
Cell Culture and Upstream Processing
Sponsored Luncheon Presentations
12:00pm - 12:30pm30 mins
Recovery & Purification
Sponsored Luncheon Presentations
12:00pm - 12:30pm30 mins
Manufacturing Strategy & Bioprocessing 4.0
Sponsored Luncheon Presentations
12:00pm - 12:30pm30 mins
Intensified and Continuous Processing
Sponsored Luncheon Presentations
12:00pm - 12:30pm30 mins
Analytical & Quality
Sponsored Luncheon Presentations
12:00pm - 12:30pm30 mins
Speed from Gene to Market
Sponsored Luncheon Presentations
12:30pm - 1:30pm60 mins
Networking Refreshment Break
1:30pm - 2:00pm30 mins
Cell Culture and Upstream Processing
Using Hybrid Continuous Biomanufacturing Approaches to increase efficiency and decrease cost in the manufacture of Biosimilars
- Andrew Falconbridge - Vice President of Process Technology and Innovation, Alvotech
1:30pm - 2:00pm30 mins
Recovery & Purification
Challenges and Adventures in Purification Development for Novel Diabody
- Jian Ren, Ph.D. - Senior Scientist, AbbVie
1:30pm - 2:00pm30 mins
Manufacturing Strategy & Bioprocessing 4.0
Next Generation Biomanufacturing and Facility Implementation: Technical Advances in Manufacturing Technologies to Improve Process Productivity
1:30pm - 2:00pm30 mins
Intensified and Continuous Processing
Hybrid Approaches to Continuous Manufacturing
- Andrew Falconbridge - Vice President of Process Technology and Innovation, Alvotech
1:30pm - 2:00pm30 mins
Analytical & Quality
Automation and Analytics
- Adam Washburn - Senior Research Scientist, Eli Lilly
1:30pm - 2:00pm30 mins
Cell Therapy
Strategies for Maximizing MSC-EV Productivity and Lot Size
- Jon A. Rowley, Ph.D. - Founder & Chief Product Officer, RoosterBio Inc.
1:30pm - 2:00pm30 mins
Gene Edited Ex Vivo Cell Therapy / In Vivo Gene Therapy
Raw Materials: BOMs, Risks & Securing Supply
- Tom Walls - Global Planning and Logistics Lead, Spark Therapeutics
2:00pm - 2:30pm30 mins
Cell Culture and Upstream Processing
Intensifying Fed-Batch Processes: When Continuous Is Just Not Possible
2:00pm - 2:30pm30 mins
Recovery & Purification
Challenges and strategies for large-scale production and purification of oncolytic viruses
- Alexander Brix, Ph.D., - Head of Laboratory ATMP II, Boehringer Ingelheim Pharma GmbH & Co. KG
2:00pm - 2:30pm30 mins
Manufacturing Strategy & Bioprocessing 4.0
Strategies to enhance speed and efficiency in manufacturing for Non-mAbs
2:00pm - 2:30pm30 mins
Intensified and Continuous Processing
Intensifying Fed-Batch Processes: When Continuous Is Just Not Possible
2:00pm - 2:30pm30 mins
Analytical & Quality
Product Quality of antibody-based therapeutics direct from cell culture supernatants
- Jose Bonfiglio - Research Fellow, Roche
2:00pm - 2:30pm30 mins
Cell Therapy
iPSC Processes: Road to Automation and Closed System
- Cenk Sumen - Chief Technology Officer, Stemson Therapeutics
2:00pm - 2:30pm30 mins
Gene Edited Ex Vivo Cell Therapy / In Vivo Gene Therapy
bluebird bio Supply Chain Strategy Case Study
- Roy Sorek - Director, Quality Assurance, bluebird bio
2:30pm - 3:00pm30 mins
Cell Culture and Upstream Processing
Scientific Track Presentation
2:30pm - 3:00pm30 mins
Recovery & Purification
Scientific Track Presentation
2:30pm - 3:00pm30 mins
Manufacturing Strategy & Bioprocessing 4.0
Scientific Track Presentation
2:30pm - 3:00pm30 mins
Intensified and Continuous Processing
Scientific Track Presentation
2:30pm - 3:00pm30 mins
Analytical & Quality
Scientific Track Presentation
2:30pm - 3:00pm30 mins
Cell Therapy
Spotlight Presentation
2:30pm - 3:00pm30 mins
Gene Edited Ex Vivo Cell Therapy / In Vivo Gene Therapy
Spotlight Presentation
3:00pm - 3:55pm55 mins
Networking Refreshment Break in Exhibit & Poster Hall
3:55pm - 4:00pm5 mins
Gene Edited Ex Vivo Cell Therapy
Chairperson’s Opening Remarks
- Lior Raviv - Vice President Development & Operations, Pluristem Therapeutics Inc.
4:00pm - 4:30pm30 mins
Cell Culture and Upstream Processing
Sanofi Case Study: Upstream Continuous Processing
- William Napoli - Scientist, Sanofi
4:00pm - 4:30pm30 mins
Recovery & Purification
Paving the Way for Real time Product Quality Attribute Analysis in Bioprocess Development
- Julia Ding, PhD - Head, Global Process Analytics, Bristol Myers Squibb
4:00pm - 4:30pm30 mins
Manufacturing Strategy & Bioprocessing 4.0
Paving the Way for Real time Product Quality Attribute Analysis in Bioprocess Development
- Julia Ding, PhD - Head, Global Process Analytics, Bristol Myers Squibb
4:00pm - 4:30pm30 mins
Intensified and Continuous Processing
Sanofi Case Study: Upstream Continuous Processing
- William Napoli - Scientist, Sanofi
4:00pm - 4:30pm30 mins
Speed from Gene to Market
Paving the Way for Real time Product Quality Attribute Analysis in Bioprocess Development
- Julia Ding, PhD - Head, Global Process Analytics, Bristol Myers Squibb
4:00pm - 4:30pm30 mins
Analytical & Quality
Paving the Way for Real time Product Quality Attribute Analysis in Bioprocess Development
- Julia Ding, PhD - Head, Global Process Analytics, Bristol Myers Squibb
4:00pm - 4:30pm30 mins
Cell Therapy
Selection & Management of Suppliers and Contract Service Providers
- Ruti Goldberg - Compliance and Methods Validations Manager, Pluristem
4:00pm - 4:30pm30 mins
Gene Edited Ex Vivo Cell Therapy
Automation, Modules and Innovative Tech for End to End Processing
- Ali Mohamed - Vice President, CMC, Immatics, USA
4:00pm - 4:30pm30 mins
In Vivo Gene Therapy
How to Develop and Leverage an Integrated Manufacturing Process and Platform to Increase Speed to Clinic
- Alex Meola - Scientist II, Downstream Process Development, Homology Medicines
4:30pm - 5:00pm30 mins
Cell Culture and Upstream Processing
Use of a Process Analytic Technology for On-Line Monitoring of Production Bioreactors
- Nick Morse - Scientist, Upstream Process Development, Alexion
4:30pm - 5:00pm30 mins
Recovery & Purification
Visualizing Manufacturing Data in Real Time and How the Data Relates to Models for the Process
- Francisca Gouveia, Ph.D - Senior Process Expert, MS&T, Novartis
4:30pm - 5:00pm30 mins
Manufacturing Strategy & Bioprocessing 4.0
Visualizing Manufacturing Data in Real Time and How the Data Relates to Models for the Process
- Francisca Gouveia, Ph.D - Senior Process Expert, MS&T, Novartis
4:30pm - 5:00pm30 mins
Intensified and Continuous Processing
Use of a Process Analytic Technology for On-Line Monitoring of Production Bioreactors
- Nick Morse - Scientist, Upstream Process Development, Alexion
4:30pm - 5:00pm30 mins
Speed from Gene to Market
Visualizing Manufacturing Data in Real Time and How the Data Relates to Models for the Process
- Francisca Gouveia, Ph.D - Senior Process Expert, MS&T, Novartis
4:30pm - 5:00pm30 mins
Analytical & Quality
Visualizing Manufacturing Data in Real Time and How the Data Relates to Models for the Process
- Francisca Gouveia, Ph.D - Senior Process Expert, MS&T, Novartis
4:30pm - 4:45pm15 mins
Cell Therapy
Fitting Product to Process: Raw Materials Customization for Cell Therapy Manufacturing Success
- Lili Belcastro - Senior Scientist, Cell Therapy Dev and Ops (CTDO), Technical Center of Excellence (TCoE) for Early Development Raw Materials, BMS
4:30pm - 5:00pm30 mins
Gene Edited Ex Vivo Cell Therapy
PANEL: Let’s Settle the Debate – Can Auto and Allo Therapies Co-Exist?
- Jon A. Rowley, Ph.D. - Founder & Chief Product Officer, RoosterBio Inc.
- Ali Mohamed - Vice President, CMC, Immatics, USA
4:30pm - 5:00pm30 mins
In Vivo Gene Therapy
Mechanistic Modelling for the Production of Recombinant Adeno-Associated Virus via Triple Transfection of HEK293 Cells
- Tam Nguyen - PhD Candidate, Massachusetts Institute of Technology, USA
4:45pm - 5:00pm15 mins
Cell Therapy
Fitting Product to Process: Raw Materials Customization for Cell Therapy Manufacturing Success
- Raymond Luke - Associate Director, MS&T, Adaptimmune, USA
5:00pm - 5:30pm30 mins
Cell Culture and Upstream Processing
Scientific Track Presentation
5:00pm - 5:30pm30 mins
Recovery & Purification
Scientific Track Presentation
5:00pm - 5:30pm30 mins
Manufacturing Strategy & Bioprocessing 4.0
Scientific Track Presentation
5:00pm - 5:30pm30 mins
Intensified and Continuous Processing
Scientific Track Presentation
5:00pm - 5:30pm30 mins
Speed from Gene to Market
Scientific Track Presentation
5:00pm - 5:30pm30 mins
Analytical & Quality
Scientific Track Presentation
5:00pm - 5:30pm30 mins
Cell Therapy
Spotlight Presentation
5:00pm - 5:30pm30 mins
Gene Edited Ex Vivo Cell Therapy
Spotlight Presentation
5:00pm - 5:30pm30 mins
In Vivo Gene Therapy
Spotlight Presentation
5:30pm - 6:30pm60 mins
Grand Opening of the Poster & Exhibit Hall and Cocktail Reception
6:30pm - 6:35pm5 mins
End of Day One
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