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Tuesday, September 24, 2024 - Day One - ET (Eastern Time, GMT-05:00)
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Tuesday, September 24, 2024 - Day One - ET (Eastern Time, GMT-05:00)
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Streams
8:00am - 9:00am
Registration and Morning Coffee
Showing 1 of 1 Streams
Keynote Plenary
9:00am - 9:10am
Chairperson's Welcome to Biotech Week Boston 2024
9:10am - 9:50am
Keynote Address
9:50am - 10:30am
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
10:30am - 11:10am
Networking Break
Showing 3 of 3 Streams
Development of Emerging Cell & Gene Therapies
Cell Therapy Manufacturing
Gene Therapy Manufacturing
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 autonomous Biomanufacturing platform to scale production of autologous iPSC-derived cell therapies
- Marinna Madrid - Co-Founder & Chief Product Officer, Cellino
12:15pm - 12:45pm
Scientific Track Presentation
11:10am - 11:15am
Chairperson's Remarks: Cell Therapy Manufacturing
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
Viral Design: Impact of Early Integration Across RD and PD Workflow to Accelerate Development
- Stacie Seidel - Senior Director Molecular/Viral Vector Biology, elevatebio
11:45am - 12:15pm
Upstream Process Development for Intracellularly Delivered Genetic Therapeutics
12:15pm - 12:45pm
Scientific Track Presentation by Cytiva
12:45pm - 12:50pm
Transition to Lunch Presentations
Showing 8 of 8 Streams
Scientific Lunch 1
Scientific Lunch 2
Scientific Lunch 3
Scientific Lunch 4
Scientific Lunch 5
Scientific Lunch 6
Scientific Lunch 7
Scientific Lunch 8
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
Scientific Lunch with Samsung
12:50pm - 1:35pm
Scientific Lunch with ChromaTan
12:50pm - 1:35pm
Scientific Lunch with Advanced Instruments
12:50pm - 1:35pm
Scientific Lunch with Cytiva
1:35pm - 2:00pm
Lunch
Showing 3 of 3 Streams
Development of Emerging Cell & Gene Therapies
Cell Therapy Manufacturing
Gene Therapy Manufacturing
2:00pm - 2:30pm
Pioneering Macrophage Cell Therapy for transformative outcomes in Inflammatory Organ Disease
- Amir Hefni - 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 - 3:00pm
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
3:00pm - 3:30pm
Scientific Track Presentation by SmartLabs
2:00pm - 2:30pm
Navigating the Interplay between Advanced Vectors and Manufacturing Challenges
- Jing Liao - Director of Vector Development and Operations, Alexion Pharmaceuticals
2:30pm - 3:00pm
Case Study: Navigating the Virus-Vector Design Landscape for Successful Gene Therapy Commercialization
- Nathalie Clement - VP Vector Development for Translational Gene Therapies, Siren Biotechnology
3:00pm - 3:30pm
Scientific Track Presentation by Teknova
3:30pm - 4:30pm
Grand Opening of the Exhibit Hall
Showing 3 of 3 Streams
Development of Emerging Cell & Gene Therapies
Cell Therapy Manufacturing
Gene Therapy Manufacturing
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
- 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 - 5:30pm
Building Winning Teams - Plenary Discussion Session
- What are the key criteria for choosing a cell or gene therapy manufacturing partner? (Expertise, capacity, regulatory knowledge, technology fit)
- Approaching start-up build from the ground up to develop new therapeutics
- Ensuring preparedness for CDMOs
- How can different stakeholders identify complementary strengths to build mutually beneficial partnerships?
- Best practices to ensure quality control and compliance throughout manufacturing.
- 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 - 5:30pm
Building Winning Teams - Plenary Discussion Session
- What are the key criteria for choosing a cell or gene therapy manufacturing partner? (Expertise, capacity, regulatory knowledge, technology fit)
- Approaching start-up build from the ground up to develop new therapeutics
- Ensuring preparedness for CDMOs
- How can different stakeholders identify complementary strengths to build mutually beneficial partnerships?
- Best practices to ensure quality control and compliance throughout manufacturing.
- Building trust and transparency in long-term CGT manufacturing partnerships
- Amish Patel - SVP, Technical Operations, Calidi Biotherapeutics
- Carolina Alarco - Founder & Principal, Bio Strategy Advisors
5:30pm - 7:00pm
Networking Drinks in Exhibit & Poster Hall
7:00pm - 7:05pm
Close of Day Two
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