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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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7:00am - 8:00am
Rise & Shine Yoga - Registration Desk @ Boston Convention & Exhibition Center Main Lobby
Join us for a beginner yoga class at the BCEC in the Ballroom Foyer to exercise as the sun comes up. Modifications provided for more advanced students. The first 25 participants will receive a travel yoga mat to take home.
RSVP FOR YOGA
8:00am - 8:55am
Breakfast and Registration
Showing 5 of 5 Streams
CGT Supply Chain, Cryopreservation, Logistics and Delivery - Room 206AB
Non Viral Delivery Development & Manufacturing - Room 205C
In Vivo Gene Therapy Manufacturing - Room 205AB
Well Characterized Biologics & Biological Assays - Room 208
BWB Main Stage
8:55am - 9:00am
Chairperson’s Opening Remarks
- Amish Patel, PhD - SVP Technical Operations, Calidi Biotherapeutics
9:00am - 9:30am
Key considerations in formulation and drug product development for cell therapy
- Rafi Mohammad - Associate Director, Bayer
9:30am - 10:00am
Driving Digitalisation and Systems Integration to Supply Complex CGT Supply Chains for End-to-End Monitoring
- 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
8:55am - 9:00am
Chairperson’s Opening Remarks
- Shashi Murthy, PhD - Co-Founder & CTO, Nanite
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
- Stefano Menegatti - Associate Professor, North Carolina State University
10:00am - 10:30am
A Next-Generation Plasmid Demonstrated to Improve Non-Viral Vector Manufacturing – NanoplasmidTM
- Patrick Paez, PhD - Technical Marketing Manager, Aldevron
8:55am - 9:00am
Chairperson’s Opening Remarks
- David Dobnik - Scientific Associate, National Institute of Biology, Slovenia
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
A deep dive into capture and polishing of AAV
- Asa Hagner McWhirter, PhD - Principal Scientist, Cytiva
8:55am - 9:00am
Chairperson’s Opening Remarks
9:00am - 9:30am
KEYNOTE ADDRESS - Recent Trends and Lessons Learned from Cell and Gene Therapy Reviews
9:30am - 10:00am
ORSI and Extramural Research at FDA
- Tina Morrison, Ph.D. - Director, Office of Regulatory Science and Innovation, FDA
10:00am - 10:30am
Current Status and Challenges for Development of Gene Therapy Products – CMC Perspective
9:05am - 9:15am
Chair Opening Remarks
- Bob Castellucci - Founder and President, Partnership To Prosperity
9:15am - 10:15am
Fireside Chat: BioProcess Insider State of the Industry Q3 2023
Managing editor Dan Stanton sits down live on the BPI stage with a select panel of experts to reflect on how the quarterly movements of the biopharma industry are affecting the biomanufacturing space. Topics to be discussed include:
- Bioprocess ‘normalization’ post-COVID
- Big Pharma M&A and its impact on suppliers
- Consolidation in the bioprocess space
- Reflection on the latest macro news events
- Dan Stanton - Managing Editor, Bioprocess International, Informa Connect
- Andrew Harmon - Senior Consultant, Strategic Consulting, Latham Biopharm Group
10:15am - 10:20am
5 Min Break
10:20am - 10:30am
How much Money does this really save us? | Economic Modeling of Multi-Column Chromatography for Protein A
- Jennifer Knister - Product Specialist, Multi-Column Chromatography, Tosoh Bioscience
Showing 2 of 2 Streams
Break
BWB Main Stage
10:30am - 11:15am
Morning Break in the Exhibit & Poster Hall
10:30am - 10:40am
How much Money does this really save us? | Economic Modeling of Multi-Column Chromatography for Protein A (Continued)
- Jennifer Knister - Product Specialist, Multi-Column Chromatography, Tosoh Bioscience
10:40am - 11:00am
Overcoming Gene Therapy Development Barriers with Enhanced Transfection and Lower Production Costs
- Leisha Kopp - Senior Field Applications Scientist, Mirus Bio LLC
11:00am - 11:15am
[11:00-11:30] Fast Manufacturing Setup with Pre-Engineered Process Solution
- Cecilia Annerén - Head of Product Management, Sartorius Stedim Data Analytics AB, Sartorius Stedim
- Lorraine Borland - Manager of Process Technologies, Sartorius
Showing 5 of 5 Streams
CGT Supply Chain, Cryopreservation, Logistics and Delivery - Room 206AB
Non Viral Delivery Development & Manufacturing - Room 205C
In Vivo Gene Therapy Manufacturing - Room 205AB
Well Characterized Biologics & Biological Assays - Room 208
BWB Main Stage
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 - SVP Technical Operations, Calidi Biotherapeutics
- Bob Amareld - Head of Supply Chain, Precision BioSciences, Inc.
- Brian Taylor - Executive Vice President, Biopharma Solutions, SmartLabs
- Nick Bayrakdarian - Vice President, US Cell Therapy Operations, Gamida Cell Inc.
12:15pm - 12:45pm
Maximizing Impact: Treat More Cell and Gene Therapy Patients with Smart Resource Utilization
- Stefanie Leysen - CGT Solution Manager, Bluecrux
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
Crazy Simple Nanoparticle Characterization with Stunner
- Nelis Denys - Product Manager, Stunner & Lunatic, Unchained Labs
11:15am - 11:45am
Development of a Harvest Clarification Platform Process for Recombinant AAV
- Chen Wang - Scientist, Purification Process Development, Genomic Medicine Unit CMC Process Development, Sanofi
- Ethan Butler - Senior Scientist, Sanofi
11:45am - 12:15pm
Challenges with Enriching Full Capsids for rAAV Therapeutics
- Aaron Collier - Senior Scientist – Downstream Process Development, Passage Bio
12:15pm - 12:45pm
Next-generation nanofiber technology enables efficient downstream processing of viral vectors, extracellular vesicles, and nucleic acid targets
- Ian Scanlon - DSP Lead, ATMP Purification, Astrea Bioseparations
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
11:15am - 11:30am
Fast Manufacturing Setup with Pre-Engineered Process Solution
- Cecilia Annerén - Head of Product Management, Sartorius Stedim Data Analytics AB, Sartorius Stedim
- Lorraine Borland - Manager of Process Technologies, Sartorius
11:30am - 11:50am
Accelerating Commercialization and Improving Efficiency Across the Network Through Digital Transformation
- Anthony DeBiase - ., Rockwell Automation
11:50am - 12:10pm
Cell Culture Solutions to Unlock Your Cell Performance
- Alyssa Master - Vice President, Sales Enablement and Customer Experience, Nucleus Biologics
12:10pm - 12:15pm
5 Min Break
12:15pm - 12:45pm
[12:15-1:00] Panel Discussion: Outlining the Processes and Methods for Increasing Sustainability in BioProcessing
- Kenneth Wu - Executive Director, Corporate Sustainability, Gilead Sciences
- Jason Cordeiro - Chief Operating Officer, MassBio
- Kyle Cahill - Senior Director, Environmental Sustainability Disclosure and Engagement Lead, Takeda
- Sri Madabhushi - Principal Scientist, Merck & Co., Inc.
- Horacio Caperan - Executive Director for External Affairs, MIT Joint Program on the Science and Policy of Global Change
Showing 2 of 2 Streams
Break
BWB Main Stage
12:45pm - 1:55pm
Lunch in the Exhibit & Poster Hall
12:45pm - 1:00pm
[12:15-1:00] Panel Discussion: Outlining the Processes and Methods for Increasing Sustainability in BioProcessing (Continued)
- Kenneth Wu - Executive Director, Corporate Sustainability, Gilead Sciences
- Jason Cordeiro - Chief Operating Officer, MassBio
- Kyle Cahill - Senior Director, Environmental Sustainability Disclosure and Engagement Lead, Takeda
- Sri Madabhushi - Principal Scientist, Merck & Co., Inc.
- Horacio Caperan - Executive Director for External Affairs, MIT Joint Program on the Science and Policy of Global Change
1:00pm - 1:05pm
5 Min Break
1:05pm - 1:45pm
Panel: Talent Acquisition, Retention and Training Strategies for the Biotech and Pharma Industries
- Anna O'Driscoll - Chief People Officer, Cellarity
- Adam Thomas - Chief People Officer and Secretary, Synlogic
- Jeanne LeClair - Vice President of Economic Development and Partnerships, Massachusetts Life Sciences Center
- Karen Anderson - Chief People Officer, Centessa Pharmaceuticals
- Manny Contomanolis - Director, Office of Career Services, Harvard University
- Erika Marder - Global Head of HR for Research & Development, Takeda Pharmaceutical
1:45pm - 1:55pm
[13:45-2:00] Passport Giveaway
Showing 4 of 4 Streams
In Vivo Gene Therapy Manufacturing - Room 205AB
Recovery & Purification - Room 210B
Well Characterized Biologics & Biological Assays - Room 208
BWB Main Stage
1:55pm - 2:00pm
Chairperson’s Remarks
- David Dobnik - Scientific Associate, National Institute of Biology, Slovenia
2:00pm - 2:30pm
Viral Reduction Filters for Gene Therapy Drug Production
- Namila Fnu - Downstream Process Development Scientist, Spark Therapeutics
2:30pm - 3:00pm
Development of a Continuous Platform for rAAV Manufacturing via Mechanistic Modeling
- Tam Nguyen - Scientist, BioNTech US / Massachusetts Institute of Technology
1:55pm - 2:00pm
Chairperson’s Remarks
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
1:55pm - 2:00pm
Chairperson’s Remarks
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
1:55pm - 2:00pm
[13:45-2:00] Passport Giveaway
3:30pm - 3:35pm
End of Event
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