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September 18-21, 2023
Boston Convention and Exhibition CenterBoston, MAKey Sessions
Brian Anthony
KEYNOTE: Digitalization in manufacturing and human health from sensors, to data, to AR/VR
Massachusetts Institute of Technology
John Mikitsh
iPSC Derived NK Cultures in Suspension Systems
Century Therapeutics, LLC
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7:00am - 7:55am55 mins
Coffee and Registration
7:55am - 8:00am5 mins
Plenary Session - Future Visions for Cell and Gene Therapies
Chairperson's Opening Remarks
- Maribel Rios - Managing Editor, BioProcess International
8:00am - 8:40am40 mins
Plenary Session - Future Visions for Cell and Gene Therapies
Keynote: State of the Industry and Future Perspectives for Cell and Gene Therapies
- Mike Lehmicke - VP for Science and Industry Affairs, Alliance for Regenerative Medicine
8:00am - 9:40am100 mins
Pall Site Tour
Site Tour of Pall Facility
8:40am - 9:20am40 mins
Plenary Session - Future Visions for Cell and Gene Therapies
Plenary Panel Discussion: Beyond Rare Diseases - Overcoming the Challenges of Expanding to Larger Patient Populations with Cell and Gene Therapies
- Shashi Murthy, - CTO and Co-Founder, Nanite Inc.
- Stephane Berthier - VP and General Manager, Atara Biotherapeutics
- Alex Klarer - Director of MSAT and Acting Head of R&D, BioCentriq
- Armon Sharei - Chief Executive Officer & Founder, SQZ Biotechnologies, USA
9:20am - 9:40am20 mins
Plenary Session - Future Visions for Cell and Gene Therapies
Keynote: Future Perspectives for Cell and Gene Therapy Industry - A CDMO Perspective
- Eric Blair - Chief Commercial Officer, Andelyn Biosciences
9:40am - 10:25am45 mins
Networking Refreshment Break
10:25am - 10:30am5 mins
Cell Therapy
Chairperson's Opening Remarks
- Gregg Nyberg - Chief Technology Officer, Landmark Bio
10:25am - 10:30am5 mins
Gene Edited Ex Vivo Therapy
Chairperson's Opening Remarks
- Chris Gemmiti, Ph.D. - Vice President of Technical Operations, CRISPR Therapeutics
10:25am - 10:30am5 mins
In Vivo Gene Therapy
Chairperson's Opening Remarks
- Shenjiang (Shawn) Liu - President & CEO, Avirmax Inc.
10:25am - 12:00pm95 mins
Pall Site Tour
Site Tour of Pall Facility
10:30am - 11:00am30 mins
Cell Therapy
Roadmap to Establishing An IND Program for Novel Cell Therapies
- Lara Lonescu Silverman, PhD - Principal Consultant, LIS BioConsulting
10:30am - 11:00am30 mins
Gene Edited Ex Vivo Therapy
Overcoming the Scale Up and Manufacturing Challenges of Next Generation ''Off the Shelf'' Allogeneic Cell Therapies
- Lior Raviv - CTO, PLURI
10:30am - 11:00am30 mins
In Vivo Gene Therapy
Cell Line Development and Plasmid Optimization to Improve AAV Titers
- Ping Liu - Associate Director, Cell Line Development, REGENXBIO
11:00am - 11:30am30 mins
Cell Therapy
Potency Assays
- Knut Niss - Chief Technology Officer, Mustang Bio, Inc.
11:00am - 11:30am30 mins
Gene Edited Ex Vivo Therapy
iPSC Derived NK Cultures in Suspension Systems
- John Mikitsh - Engineer, Process and Product Development, Century Therapeutics, LLC
11:00am - 11:30am30 mins
In Vivo Gene Therapy
Business Advantages of Starting Early with Gene Therapy Manufacturing + Key Considerations
- Scott Bertch - Executive Director, Clinical Manufacturing Site Head, Tenaya Therapeutics
11:30am - 12:00pm30 mins
Cell Therapy
Counting, Sizing, Imaging, and Identifying AAV and Cell Therapy Product Aggregates
- Adam Ross - Product Manager, Halo Labs, USA
11:30am - 11:50am20 mins
Gene Edited Ex Vivo Therapy
Fully Automated Process For Manufacturing of TILs For Clinical Use
- Arina Riabinska, PhD - R&D Team Coordinator, Personalized Immunotherapy, Miltenyi Biotec
11:30am - 12:00pm30 mins
In Vivo Gene Therapy
Strategies to Propel Your Viral Vector Therapy from Lab to Clinic
- Ian P Goodwin - Director, Program Design, Fujifilm Diosynth Biotechnologies
12:00pm - 1:25pm85 mins
Cell Therapy
Sponsored Luncheon Presentation 1
12:00pm - 1:25pm85 mins
Gene Edited Ex Vivo Therapy
Sponsored Luncheon Presentation 2
12:00pm - 1:25pm85 mins
In Vivo Gene Therapy
Sponsored Luncheon Presentation 2
1:25pm - 1:30pm5 mins
Cell Therapy
Chairperson's Opening Remarks
- Gregg Nyberg - Chief Technology Officer, Landmark Bio
1:25pm - 1:30pm5 mins
Gene Edited Ex Vivo Therapy
Chairperson's Opening Remarks
- Chris Gemmiti, Ph.D. - Vice President of Technical Operations, CRISPR Therapeutics
1:30pm - 2:00pm30 mins
Cell Therapy
Analytical Characterization of Gene and Cell Therapy Products within the Context of the International Regulatory Landscape
- Jared Auclair, PhD - Associate Dean of Professional Programs and Graduate Affairs, College of Science at Northeastern University
1:30pm - 2:00pm30 mins
Gene Edited Ex Vivo Therapy
Scale Up Enabling Technologies to Improve Scale Up Success for Allogeneic Cell Therapies
- Kate Rochlin - Chief Operating Officer, IN8bio, USA
1:55pm - 2:00pm5 mins
In Vivo Gene Therapy
Chairperson's Opening Remarks
- Shenjiang (Shawn) Liu - President & CEO, Avirmax Inc.
2:00pm - 2:30pm30 mins
Cell Therapy
Improvement and Optimization Repertoire's Multi-Targeted T Cell (MTC) Manufacturing Process and Product
- Barrett J. Nehilla - Director, Analytical Development/Quality Control, Repertoire Immune Medicines
2:00pm - 2:30pm30 mins
Gene Edited Ex Vivo Therapy
Overcoming the Scale Up and Manufacturing Challenges of Next Generation “Off the Shelf” Allogeneic Cell Therapies
- Mark Plavsic - Chief Technical Officer, Fate Therapeutics, Fate Therapeutics Inc
2:00pm - 2:30pm30 mins
In Vivo Gene Therapy
Viral Safety Evaluation for AAV Gene Therapy Manufacturing Platforms
- Ying Cai - Executive Director, Manufacturing Sciences and Technology, Ultragenyx Pharmaceutical
2:30pm - 3:00pm30 mins
Cell Therapy
Implementing Automated, Closed and Integrated Systems in Cell Therapy Manufacturing
- Øystein Åmellem, PhD - Director, Cell Biology, Thermo Fisher Scientific
2:30pm - 3:00pm30 mins
In Vivo Gene Therapy
Approaching Purpose Built Viral Vector Facility based on Quality and Engineering Controls
- Atef Khezri - Executive Director of Manufacturing, Avid Bioservices
3:00pm - 3:20pm20 mins
In Vivo Gene Therapy
Next Level AAV Manufacturing Using Stable ELEVECTA® Producer Cells
- Michael Muehle - Head of Viral Vector Production, CEVEC Pharmaceuticals GmbH
3:20pm - 4:00pm40 mins
Networking Refreshment Break in the Exhibit & Poster Hall
4:00pm - 4:10pm10 mins
Keynote Plenary Session
Chairperson's Remarks
4:10pm - 4:50pm40 mins
Keynote Plenary Session
KEYNOTE: Digitalization in manufacturing and human health from sensors, to data, to AR/VR
- Brian Anthony - Director of MIT’s Master of Engineering in Manufacturing Program, Massachusetts Institute of Technology
4:50pm - 5:30pm40 mins
Keynote Plenary Session
Keynote: The Evolution of the Pharma and Biotech Business Development/M&A Environment
- David Lee - Chief Executive Officer, Servier Pharmaceuticals
5:30pm - 7:00pm90 mins
Cocktail Reception in Exhibit & Poster Hall
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