Key Sessions
Craig Malzahn
Keynote: Commercial Manufacturing Strategies for Large-Market and Rare Disease AAV Gene Therapy Products
REGENXBIO Inc.
Ryan Bartock
Keynote – Addressing the Challenges of Transferring and Manufacturing Gene Therapies Externally and At-Scale
Spark Therapeutics
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Main Conference - Day 1 - EST/EDT (Eastern Daylight, GMT-4)
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Main Conference - Day 1 - EST/EDT (Eastern Daylight, GMT-4)
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7:00am - 7:55am
Breakfast and Registration
Showing 4 of 4 Streams
Cell Therapy Manufacturing - Room 206AB
Gene Edited Ex Vivo Manufacturing - Room 205C
In Vivo Gene Therapy Manufacturing - Room 205AB
Well Characterized Biologics & Biological Assays - Room 208
7:55am - 10:00am
CGT Opening Plenary Session in In Vivo Gene Therapy Room 205AB
7:55am - 10:00am
CGT Opening Plenary Session in In Vivo Gene Therapy Room 205AB
7:55am - 8:00am
Chairperson’s Opening Remarks
- Morten Sogaard - President and Division Head, Gene Therapy Research and Technical Operations, Astellas Gene Therapies
8:00am - 8:40am
Keynote: State of the Industry and Future Perspectives for Cell and Gene Therapies
- Tim Hunt - CEO, Alliance for Regenerative Medicine
8:40am - 9:20am
Keynote: Partnering to Enable Industrialization of Allogeneic Cell Therapy
- Thomas Bieringer - SVP, Global Head of AMES, Bayer
- Aaron Dulgar-Tulloch - CTO, Genomic Medicine, Cytiva
9:20am - 9:40am
A Robust Scalable Suspension Process for AAV Manufacturing
- Samir Acharya - Associate Director of Process Development, Andelyn Biosciences
9:40am - 10:00am
Genomic Medicine Keeps Innovating. Manufacturing Should Too.
- Clive Glover, PhD - Business Leader, Viral Vectors, Cytiva
7:55am - 8:00am
Chairperson’s Opening Remarks
8:00am - 8:30am
KEYNOTE ADDRESS – Specifying Spokes – Fit for Purpose Specifications
- Jeffrey Baker - Senior Fellow, NIIMBL; Strategic Advisor, CBI-MIT
8:30am - 9:00am
KEYNOTE ADDRESS – Emergence of Documentary Standards and Reference Materials for Biological Products
- Nadine Ritter, Ph.D. - President and Analytical Advisor, Global Biotech Experts, LLC
9:00am - 9:30am
KEYNOTE ADDRESS - Total Analytical Control Strategy for Base Editing Gene Therapy
- Johnson Varghese - Vice President, Head of Analytical Sciences & Development, Beam Therapeutics
9:30am - 10:00am
Scientific Track Presentation
10:00am - 10:55am
Morning Break
Showing 4 of 4 Streams
Cell Therapy Manufacturing - Room 206AB
Gene Edited Ex Vivo Manufacturing - Room 205C
In Vivo Gene Therapy Manufacturing - Room 205AB
Well Characterized Biologics & Biological Assays - Room 208
10:55am - 11:00am
Chairperson's Opening Remarks
- Lara Lonescu Silverman, PhD - Principal Consultant, LIS BioConsulting
11:00am - 11:30am
Keynote: Manufacturing and Process Development Strategies for Cell Therapies
- Robert Zamboldi - Site Head, US Cell & Gene Therapy, Morris Plains NJ, Novartis
11:30am - 12:00pm
Creating a completely closed process solution from multi-vendor off-the-shelf process tools resulting in a low investment semi-automated workflow to compete with “all in one” cell processing systems for human MSC expansion, harvest, and final fill
- Kyle Harvey, PharmD, PhD - Research Scientist, MED Institute Inc.
12:00pm - 12:30pm
Accelerating CAR-T Cell Manufacturing with a Next-Day Process and Automation
- Xavier de Mollerat du Jeu - Senior Director, Research and Development, Thermo Fisher Scientific, USA
10:55am - 11:00am
Chairperson's Opening Remarks
- Francesca Vitelli, PhD - VP Cell Therapy and Viral Vector PD and MSAT, Intellia Therapeutics, Inc
11:00am - 11:30am
Process Development for Autologous Gene-Edited Stem Cell Therapies
- Corrina Lucini - Scientist, Beam Therapeutics
11:30am - 12:00pm
Best Practices for Successful Tech Transfers
- Pia Mountford - Head of External Manufacturing, Cell and Genetic Therapies, Vertex Pharmaceuticals
10:55am - 11:00am
Chairperson's Opening Remarks
- Shashi Murthy, PhD - Co-Founder & CTO, Nanite
11:00am - 11:30am
Keynote: Commercial Manufacturing Strategies for Large-Market and Rare Disease AAV Gene Therapy Products
- Craig Malzahn - Senior Vice President, Technical Operations, REGENXBIO Inc.
11:30am - 12:00pm
Keynote – Addressing the Challenges of Transferring and Manufacturing Gene Therapies Externally and At-Scale
- Ryan Bartock - VP & Head of Engineering, Technical & Digital, Spark Therapeutics
12:00pm - 12:30pm
How Novel Tools Can Accelerate AAV Development Timelines?
- Yatindra Tirunagari - Business Development Technical Specialist, Rentschler Biopharma
10:55am - 11:00am
Chairperson's Opening Remarks
11:00am - 11:30am
Characterizing Color by online cIEF/MS and Peptide Mapping as a Result of Process Intensification of Biotherapeutics
- Kristen Nields - Senior Scientist, Cell Engineering and Analytical Sciences, The Janssen Pharmaceutical Companies of Johnson & Johnson
11:30am - 12:00pm
New Mass Spec Tool to Characterize Copper Oxidation Induced Crosslinks in mAbs
12:00pm - 12:30pm
Emerging Trends in Characterization of Impurity and Degradant Peaks
12:30pm - 12:45pm
Transition to Lunch Presentations
Showing 3 of 3 Streams
Sponsored Lunch Presentation - Room 205C
Sponsored Lunch Presentation - Room 205AB
Sponsored Lunch Presentation - Room 206AB
12:45pm - 1:30pm
Overcoming Cell and Gene Therapy Manufacturing Roadblocks: How Strategic Partnerships Enable Robust Early-Stage Clinical Manufacturing
- Sarah Li, Ph.D - Associate Director of Technical Support of Process Development and MSAT, GenScript Probio
- Huiyi Zhu - Associate Director of Technical Support, GenScript Probio
- Carmine Carpenito - PhD - Senior Director, Cell Therapy Laboratories, Comprehensive Cell Solutions
12:45pm - 1:30pm
Viral Vector Manufacturing: How to Work with Technology and Service Providers to Overcome Challenges
- Sybil Danby - Global Commercial Leader, Viral Vectors, Cytiva
- Francesca Vitelli, PhD - VP Cell Therapy and Viral Vector PD and MSAT, Intellia Therapeutics, Inc
- Paul Herzich - Chief Technology Officer, Solid Biosiences, USA
- Susan D'Costa. PhD - Chief Technology Officer and Head of the AAV Business Unit, Genezen, USA
- Dan Leblanc - Chief Technology Officer, Ensoma
12:45pm - 1:30pm
Introducing KascadeTM– a Column-Free and Single-Use platform for High Recovery and High Efficiency Capture of AAVs and Other Biologics using Continuous Countercurrent Tangential Chromatography (CCTC)
- Oleg Shinkazh - CTO, Chromatan Corporation
1:30pm - 1:55pm
Networking Break
Showing 4 of 4 Streams
Cell Therapy Manufacturing - Room 206AB
Gene Edited Ex Vivo Manufacturing - Room 205C
In Vivo Gene Therapy Manufacturing - Room 205AB
Well Characterized Biologics & Biological Assays - Room 208
1:55pm - 2:00pm
Chairperson’s Remarks
- Lara Lonescu Silverman, PhD - Principal Consultant, LIS BioConsulting
2:00pm - 3:00pm
Panel Discussion: Cell and Gene Therapy CDMO Selection and External Manufacturing Best Practices
- Amish Patel, PhD - SVP Technical Operations, Calidi Biotherapeutics
- Joseph Graskemper - Founder & Principal, Pathways Pharma Consulting, LLC
- Brian Greven - Sr. Director of Operations, Matica Biotechnology Inc.
- Catherine Tomaro-Duchesneau, PhD - Senior Director of Manufacturing Science & Technology, RoslinCT
- Venkata Indurthi, PhD - Chief Scientific Officer, Aldevron
3:00pm - 3:30pm
Leveraging the TESSATM Technology for Versatile AAV Manufacturing
- Seiga Ohmine - Head of Global Technical Sales, Wuxi Advanced Therapies
1:55pm - 2:00pm
Chairperson’s Remarks
- Francesca Vitelli, PhD - VP Cell Therapy and Viral Vector PD and MSAT, Intellia Therapeutics, Inc
2:00pm - 2:30pm
Development and Commercialization of Gamma-Delta T Cell Therapies
- Kate Rochlin - Chief Operating Officer, IN8bio, USA
2:30pm - 3:00pm
Tiered-Characterization and Release-Testing of Gene-Edited iPSCs for Use as Starting Materials for Early-Phase Cell Therapy Manufacturing
- Leanne Jamieson - Manager of Quality Control, Notch Therapeutics Inc.
3:00pm - 3:30pm
Improving the Purification of Viral Vectors for Gene Therapy Using A Novel Cell Lysis Solution
- Courtney O'dell, MS - Senior Scientist, Avantor
1:55pm - 2:00pm
Chairperson’s Remarks
- Shashi Murthy, PhD - Co-Founder & CTO, Nanite
2:00pm - 2:30pm
The Only Constant is Change: Demonstrating Control and Comparability in Gene Therapy Products
- Sarah Thomas - Senior Vice President, Quality, REGENXBIO Inc.
2:30pm - 3:00pm
Build it Right: A Quality Perspective on the Design and Build of a Viral Vector CDMO Manufacturing Facility
- Chris Berger - Executive Director, Quality, Viral Vector, Avid Bioservices
3:00pm - 3:15pm
AAV Production with All-In-One Stable ELEVECTATM Producer Cell Lines – High Vector Quality At Large Scale
- Vanessa Kress, PhD - Business Development Manager, CEVEC – now part of Cytiva
1:55pm - 2:00pm
Chairperson’s Remarks
2:00pm - 2:30pm
Strategies for Accelerated Characterization
- Xiaoxiao Liu - Process Development Scientist, Amgen
2:30pm - 3:00pm
Accelerating Method Preparation to Speed Up Development Timelines
- Aaron Morgan - Director of QC Analytical, Wheeler Bio
3:00pm - 3:30pm
Scientific Track Presentation
Showing 2 of 2 Streams
Break
BWB Main Stage
3:30pm - 4:30pm
Afternoon Break and Grand Opening of the Exhibit Hall
4:20pm - 4:25pm
Welcome from Informa Connect
- Louisa Maitland - Festival Director, Informa Connect
4:25pm - 4:30pm
Chairpersons Opening Remarks
- Anne Montgomery - Editor in Chief, BioProcess International Magazine, Informa
Showing 1 of 1 Streams
BWB Main Stage
4:30pm - 5:30pm
Leading with Passion and Compassion
Every successful leader must know what they are fighting for—and to know that whatever “it” is that you’re fighting for, it’s bigger than you and bigger than all of us. John F. Crowley believes leading with passion and compassion is exactly what the biotech industry needs today. John will share his entrepreneurial journey that led him to success at multiple biotech companies, how the rare disease community, including two of his children who have Pompe disease, are the reason he continues to fight and actionable tips for leaders shaping the future of biotech
- John Crowley - Executive Chairman, Amicus Therapeutics
Showing 2 of 2 Streams
Break
Power Hour Exhibit Tour
5:30pm - 7:00pm
Cocktail Reception in Exhibit & Poster Hall & Product Launch Power Hour
5:40pm - 6:50pm
POWER HOUR EXHIBIT TOUR
- Visit seven key exhibitors on this tour who will present a demo or other brief introduction to their products or service: FUJIFILM Irvine, Asahi, Parker Hannifin, Avantor, 3M and Omnibrx
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