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Cell & Gene Therapy International

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September 23-26, 2024
Hynes Convention CenterBoston, MA
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Key Sessions
Sarah Glaven
Keynote Address from White House Office of Science and Technology Policy
White House Office of Science and Technology Policy
Niklas Engler
Next Generation Process Development and Manufacturing for Cell and Gene Therapies - Improving Efficiencies and Reducing Cost of Goods
F. Hoffmann-La Roche
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Tuesday, September 24, 2024 - Day One of Main Conference - ET (Eastern Time, GMT-05:00)

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Tuesday, September 24, 2024 - Day One of Main Conference - ET (Eastern Time, GMT-05:00)

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8:00am - 9:00am
Registration and Morning Coffee
Showing 1 of 1 Streams
9:00am - 9:10am
Chairperson's Welcome to Biotech Week Boston 2024
9:10am - 9:45am
Keynote Address from White House Office of Science and Technology Policy
  • Sarah Glaven - Principal Assistant Director, Biotechnology and Biomanufacturing, White House Office of Science and Technology Policy
9:45am - 10:20am
Next Generation Process Development and Manufacturing for Cell and Gene Therapies - Improving Efficiencies and Reducing Cost of Goods
  • Niklas Engler - Global Head and Vice President, Technical Development Portfolio and Projects, F. Hoffmann-La Roche
10:20am - 10:30am
Fireside Chat

Gather around the 'fire' for a captivating conversation with our Keynote Speakers. Gain candid insights, get inspired, and dive deeper in a relaxed, conversational setting hosted by BioProcess International/Insider Editors & Thought Leaders.

10:30am - 11:10am
Networking Break
Showing 3 of 3 Streams
11:10am - 11:15am
Chairperson's Remarks: Development of Emerging Cell & Gene Therapies
11:15am - 11:45am
Revolutionizing Substantive Off-the-shelf MSC Therapeutics for Restoring Immune Balance
  • Sung Hyun Choi, Ph.D. - Director & Head of R&D Center, Affyxell Therapeutics Co., Ltd.
11:45am - 12:15pm
An AI- and Laser-based Biomanufacturing Platform to Scale Production of Personalized Regenerative Cell Therapies
  • Marinna Madrid - Co-Founder & Chief Product Officer, Cellino
12:15pm - 12:45pm
Scientific Track Presentation by InDevR
11:10am - 11:15am
Chairperson's Remarks: Cell Therapy Manufacturing
  • Nicola Ambler - Co-Founder, CGT Circle
11:15am - 11:45am
3-D Suspension Scale-up of iPSC-derived Cell Therapies and Commercial Research Products
  • Kathryn Golden - SVP, Technical Operations and Cell Manufacturing, bit.bio
11:45am - 12:15pm
Scale-Down Model Development to Screen Dedicated Donor Pool for CAR-T Drug Product Manufacturing Process
  • Tania Emi - Senior Scientist - Cell Process Development, Beam Therapeutics
12:15pm - 12:45pm
Scientific Track Presentation by ThermoFisher
11:10am - 11:15am
Chairperson's Remarks: Gene Therapy Manufacturing
  • Ashish Saksule - Principal Scientist, Core Lead, Vertex Pharmaceuticals
11:15am - 11:45am
Navigating the clinical development journey of an AAV drug product: considerations for a seamless CMC from Phase I to BLA
  • Nathalie Clément - Vice President of Vector Development, Siren Biotechnology, Inc.
11:45am - 12:15pm
Viral Design: Impact of Early Integration Across RD and PD Workflow to Accelerate Development
  • Stacie Seidel - Senior Director Molecular/Viral Vector Biology, elevatebio
12:15pm - 12:45pm
Scientific Track Presentation by Cytiva
12:45pm - 12:50pm
Transition to Lunch Presentations
Showing 8 of 8 Streams
12:50pm - 1:35pm
Scientific Lunch with Sartorius
12:50pm - 1:35pm
Scientific Lunch with Cytiva
12:50pm - 1:35pm
Scientific Lunch with Millipore Sigma
12:50pm - 1:35pm
Scientific Lunch with JSR
12:50pm - 1:35pm
Optimizing Charge Variant Profiles of mAbs Through Targeted Media and Additive Screening During Upstream Process Development
  • Janet Lee - Principal Scientist, Head of Cell Line Development, Samsung Biologics
  • YeonTae Jeong - Head of Upstream Process Development, Samsung Biologics
1:35pm - 2:00pm
Lunch
Showing 3 of 3 Streams
2:00pm - 2:30pm
Pioneering Macrophage Cell Therapy in End Stage Liver Disease
  • Amir Hefni, PhD MBA - CEO, Resolution Therapeutics
2:30pm - 3:00pm
From Discovery to Preclinical: Developing a Tissue-Engineered iPSC Therapy for Hair Follicle Generation
  • Meghan Samberg - Chief Development Officer, Stemson Therapeutics
3:00pm - 3:30pm
Scientific Track Presentation
2:00pm - 2:30pm
Building a Collaborative Distributed Manufacturing Ecosystem
  • Reducing wait times and logistical magnitude to reduce overhead costs
  • Increasing accessibility, distributing to multiple locations closer to patient populations and remove transportation cost barriers
  • How QC release testing and material kitting and management will be handled for POC manufacturing in this ecosystem.
  • Establishing harmonized regulatory standards across different regions
  • Implementing robust oversight mechanisms to ensure compliance with regulatory requirements and maintain product in a distributed manufacturing model.
  • EMA vs FDA approach
  • Peter Peumans - CTO Health, imec
  • Amol Ketkar - CMTO (Chief Manufacturing and Technical Officer), Resolution Therapeutics
  • A Representative from - :, Aldevron
2:30pm - 3:00pm
Current Status and Challenges for Development of Cell Therapy and Tissue Engineered Products- CMC perspectives
  • Jin Sung Hong - Biologist, OTP, OCTHT, CBER, FDA
3:00pm - 3:30pm
Technology Transfer of Late Phase Cell Therapy Products into GMP Operations
  • Stuart Macnab - Manufacturing Sciences & Technology CMO Associate Director, Novartis Contract Manufacturing
2:00pm - 2:30pm
Navigating the Interplay between Advanced Vectors and Manufacturing Challenges
  • Shiliang Hu - Senior Scientist, Genomic Medicine, Alexion Pharmaceuticals
2:30pm - 3:00pm
Predictive Optimal Production by Developing a Mechanistic Model for AAV Assembly
  • Sha Sha - Senior Scientist, Upstream Process Development, Ultragenyx
3:00pm - 3:30pm
Scientific Track Presentation by Teknova
3:30pm - 4:00pm
Grand Opening of the Exhibit Hall
Showing 4 of 4 Streams
4:30pm - 5:30pm
Phase-Appropriate Manufacturing: Trial and Error...or Trial and Triumph?
  • Navigating the complex grey area of manufacturing for Phase 1 and 2 trials
  • Keeping efficiency while complying with limited guidance
  • Need conversation between regulators and developers
  • Lessons learnt and case studies from companies moving between clinical phases
  • Therapeutic Developer/CDMO dynamics in the phase 1 and beyond
  • How to best leverage CDMO expertise and capital efficiency
  • Rachel Legmann - Senior Director of Technology, Gene Therapy, Repligen
  • Sarah Thomas - Senior Vice President, Quality, REGENXBIO Inc.
  • Kathryn Golden - SVP, Technical Operations and Cell Manufacturing, bit.bio
  • Kate Rochlin - Chief Operating Officer, IN8bio, USA
  • Shankar Swaminathan, PhD - Team Lead, Drug Product Development, CMC-Tech Ops, Astellas Institute for Regenerative Medicine
4:30pm - 5:00pm
US FDA Regulatory Considerations for Cell and Gene Therapies
  • Stella Lee, PhD. - Senior Scientist, , OTP, OGT, CBER, FDA
5:00pm - 5:30pm
Building Winning Teams: Essential Ingredients for Advanced Therapy Success
  • What are the key criteria for choosing a cell or gene therapy manufacturing partner? (Expertise, capacity, regulatory knowledge, technology fit)
  • Ensuring preparedness for CDMOs and supplier partnerships
  • How can different stakeholders identify complementary strengths to build mutually beneficial partnerships?
  • Best practices to ensure quality control and compliance throughout manufacturing.
  • Approaching start-up build from the ground up to develop new therapeutics
  • Building trust and transparency in long-term CGT manufacturing partnerships
  • Amish Patel - SVP, Technical Operations, Calidi Biotherapeutics
  • Carolina Alarco - Founder & Principal, Bio Strategy Advisors
4:30pm - 5:00pm
US FDA Regulatory Considerations for Cell and Gene Therapies
  • Stella Lee, PhD. - Senior Scientist, , OTP, OGT, CBER, FDA
5:00pm - 5:30pm
Building Winning Teams: Essential Ingredients for Advanced Therapy Success
  • What are the key criteria for choosing a cell or gene therapy manufacturing partner? (Expertise, capacity, regulatory knowledge, technology fit)
  • Ensuring preparedness for CDMOs and supplier partnerships
  • How can different stakeholders identify complementary strengths to build mutually beneficial partnerships?
  • Best practices to ensure quality control and compliance throughout manufacturing.
  • Approaching start-up build from the ground up to develop new therapeutics
  • Building trust and transparency in long-term CGT manufacturing partnerships
  • Amish Patel - SVP, Technical Operations, Calidi Biotherapeutics
  • Carolina Alarco - Founder & Principal, Bio Strategy Advisors
4:00pm - 4:10pm
Scientific Presentation by IFF
4:10pm - 4:30pm
Rapidly measure AAV empty/full ratios and genome titre with a single technology
4:30pm - 4:40pm
Tech Showcase Presentation
4:40pm - 4:50pm
Tech Showcase Presentation
4:50pm - 5:00pm
Tech Showcase Presentation
5:00pm - 5:10pm
Tech Showcase Presentation
5:10pm - 5:20pm
Tech Showcase Presentation
5:20pm - 5:30pm
Tech Showcase Presentation
5:30pm - 7:00pm
Networking Drinks in Exhibit & Poster Hall
7:00pm - 7:05pm
Close of Day Two
Monday, September 23, 2024 - Pre-Conference Workshops
NextWednesday, September 25, 2024 - Day Two of Main Conference
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