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Cell & Gene Therapy Manufacturing & Commercialization US

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September 18-21, 2023
Boston Convention and Exhibition CenterBoston, MA
Register by June 16 Save $900
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Main Conference - Day 3 - EST/EDT (Eastern Daylight, GMT-4)

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Main Conference - Day 3 - EST/EDT (Eastern Daylight, GMT-4)

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8:30am - 9:00am
Coffee and Registration
Showing 5 of 5 Streams
9:00am - 9:30am
Lessons Learnt for Supply Chain Standardisation for Cell and Gene Therapies
  • Chris Baldwin - Sr Director, Cell & Gene Therapy Supply Chain, GSK, UK
9:30am - 10:00am
Case Study: Improving Vein to Vein Time and Reliable Distribution of Cell and Gene Therapy Products
  • Priya Chary - Associate Specialist, CAR T-Cell Therapy Supply Chain, Bristol Myers Squibb
10:00am - 10:30am
Addressing Industry Challenges in Cell and Gene Therapy Supply Chain Through Integrated End-to-End Solutions
  • Andreas Kouri - Senior Vice President, Supply Chain Strategic Operations, ElevateBio
9:00am - 10:00am
Panel Discussion: Opportunities for Next Generation Non-Viral Delivery
  • Shashi Murthy, PhD - Co-Founder & CTO, Nanite
  • Bo Yan, PhD - Director, Head of Attribute Sciences, Beam Therapeutics
10:00am - 10:30am
Scientific Track Presentation
9:00am - 9:30am
Optimizing Gene Therapy Productivity: Innovations for Efficient Downstream Processing
  • Ying Hou - Director, Downstream Process Development – Gene Therapy, PTC Therapeutics, Inc
9:30am - 10:00am
High Throughput Assessment of Robustness for Early Phase AAV Downstream Processes
  • Jeff Plegaria - High Throughput Process Development Senior Scientist, Spark Therapeutics
10:00am - 10:30am
Scientific Track Presentation
9:00am - 9:30am
KEYNOTE ADDRESS - Recent Trends and Lessons Learned from Cell and Gene Therapy Reviews
9:30am - 10:00am
Cell and Gene Therapies: FDA’s Initiatives in Accelerating Product Development
10:00am - 10:30am
Current Status and Challenges for Development of Gene Therapy Products – CMC Perspective
9:15am - 10:15am
Panel Discussion: BPI Insider- State of the Industry
10:30am - 11:15am
Morning Break in the Exhibit & Poster Hall
Showing 5 of 5 Streams
11:15am - 12:15pm
Preparing Supply Chain Infrastructure, Planning for Commercial Readiness and Surge in Cell and Gene Therapies on the Market
  • Amish Patel, PhD - Vice President of Technical Operations, Calidi Biotherapeutics
  • Bob Amareld - Head of Supply Chain, Precision BioSciences, Inc.
  • Chris Baldwin - Sr Director, Cell & Gene Therapy Supply Chain, GSK, UK
  • Nick Bayrakdarian - Vice President, US Cell Therapy Operations, Gamida Cell Inc.
12:15pm - 12:45pm
Scientific Track Presentation
11:15am - 11:45am
Application of LNPs for In Vivo Delivery
11:45am - 12:15pm
Machine Learning-Driven Design of Non-Viral Delivery Vehicles for In Vivo Gene Therapies
  • Shashi Murthy, PhD - Co-Founder & CTO, Nanite
12:15pm - 12:45pm
Scientific Track Presentation
11:15am - 11:45am
Evaluating New Technologies to Overcome Downstream Processing Bottlenecks -Increase Titre Yields and Reducing Cost of Goods
  • Chen Wang - Scientist, Purification Process Development, Genomic Medicine Unit CMC Process Development, Sanofi
11:45am - 12:15pm
Challenges for Enrichment of Full Capsids for rAAV Therapeutics
  • Aaron Collier - Senior Scientist – Downstream Process Development, Passage Bio
12:15pm - 12:45pm
Scientific Track Presentation
11:15am - 11:45am
Complexity & Expectations of Infectious Titer Assay
  • Svitlana Rose - Scientist I, Solid Biosciences
11:45am - 12:15pm
Accelerated Tech Transfer of Customized Flow Cytometry Assay by Spectral Flow Cytometer
  • Greg Gmyrek - Senior Scientist, Scorpius BioManufacturing
12:15pm - 12:45pm
Scientific Track Presentation
11:55am - 12:35pm
Panel Discussion: Outlining the Processes and Methods for Increasing Sustainability in BioProcessing
  • Jason Cordeiro - Chief Operating Officer, MassBio
  • Kyle Cahill - Senior Director, Environmental Sustainability Disclosure and Engagement Lead, Takeda
  • Kenneth Wu - Executive Director, Corporate Sustainability, Gilead Sciences
  • Jim Massey - Chief Sustainability Officer, Zai Lab
Showing 2 of 2 Streams
12:45pm - 2:00pm
Lunch in the Exhibit & Poster Hall
12:45pm - 1:30pm
Panel Discussion: Talent Acquisition, Retention and Training Strategies for the Bioprocessing Industry
  • Anna O'Driscoll - Chief People Officer, Cellarity
  • Adam Thomas - Chief People Officer and Secretary, Synlogic
  • Jeanne LeClair - Senior Director of Business Development and Workforce Partnerships, Massachusetts Life Sciences Center
  • Karen Anderson - Chief People Officer, Centessa Pharmaceuticals
  • Manny Contomanolis - Director, Office of Career Services, Harvard University
Showing 5 of 5 Streams
2:00pm - 2:30pm
Maintaining Chain of Identify and Chain of Custody Within Cell and Gene Therapy Supply Chains
2:30pm - 3:00pm
Driving Digitalisation and Systems Integration to Supply Complex CGT Supply Chains for End-to-End Monitoring
3:00pm - 3:30pm
Strategies to Overcome Supply Chain Challenges to Secure Robust Supply
2:00pm - 2:30pm
Case Study: Application of Non Viral Vectors in CGT Development and Manufacturing
2:30pm - 3:00pm
Case Study: In Vivo CAR Therapies
3:00pm - 3:30pm
Development of a Continuous Platform for rAAV Manufacturing via Mechanistic Modeling
  • Tam Nguyen - Scientist, BioNTech US / Massachusetts Institute of Technology
2:00pm - 2:30pm
Viral Reduction Filters for Gene Therapy Drug Production
  • Namila Fnu - Downstream Process Development Scientist, Spark Therapeutics
2:30pm - 3:00pm
The Only Constant is Change: Demonstrating Control and Comparability in Gene Therapy Products
  • Sarah Thomas - Senior Vice President, Quality, REGENXBIO Inc.
3:00pm - 3:30pm
Analytical Assessment of Changes in the Manufacturing Platform
  • Rajeev Boregowda - Director, Analytical Development, Solid Biosciences
2:00pm - 2:30pm
Using Clarification Innovation to Eliminate Endonuclease from an AAV Production Process
  • Garima Thakur - Process Development Engineer III, Regeneron Pharmaceuticals
2:30pm - 3:00pm
Using Crystallization Tech to Improve AAV Yields
  • Richard Braatz, PhD - Edwin R. Gilliland Professor, Faculty Research Officer, Massachusetts Institute of Technology
3:00pm - 3:30pm
Novel Ligands and Modalities for the Purification of Gene Editing Products: CRISPR-Cas and Viral Vectors
  • Stefano Menegatti - Associate Professor, North Carolina State University
2:00pm - 2:30pm
Next Generation Therapies have Next Generation Analytical Challenges
  • Mary Beth Pelletier, PhD - Associate Director, QC Analytical Technology, Biogen
2:30pm - 3:00pm
Characterization of Full/Empty Capsids for AAV Gene Therapy
  • Andrea Sobjak - Director, Janssen R&D
3:00pm - 3:30pm
Analytical Strategies for Gene-Edited Hematopoietic Stem Cell Therapies
  • Brent Morse - Principal Consultant, Dark Horse Consulting Group
3:30pm - 3:35pm
End of Event
Main Conference - Day 2
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