Key Sessions
Andrea Little
KEYNOTE: Engineering ADC Success from the Start: The Critical Role of Cell Culture
Pfizer
Nelly Viseux
Keynote: Journey from R&D to Clinical Manufacturing
Regeneron
Robert Hofmeister
Keynote: Programming Immunity In Vivo: Targeted RNA-LNP Platforms for Precision CAR Engineering
CREATE Medicines
Friday 25th September - Main Conference Day Three - ET (Eastern Time, GMT-05:00)
Friday 25th September - Main Conference Day Three
- ET (Eastern Time, GMT-05:00)
8:00am - 8:50am50 mins
Registration Break
Registration and Morning Coffee
8:50am - 9:00am10 mins
Cell Line Development & Engineering
Chairperson
8:50am - 9:00am10 mins
Cell Culture & Upstream Processing
Chair
8:50am - 9:00am10 mins
Downstream Processing
Chair
8:50am - 9:00am10 mins
Digital Biomanufacturing and Data Driven Operations
Chair
8:50am - 9:00am10 mins
CMC Strategy & Manufacturing Performance
Chair
8:50am - 9:00am10 mins
Development of Emerging Cell & Gene Therapies
Chairperson’s Opening Remarks: Development of Emerging Cell & Gene Therapies
8:50am - 9:00am10 mins
Cell Therapy Manufacturing & Analytics
Chairperson’s Opening Remarks: Cell Therapy Manufacturing & Analytics
8:50am - 9:00am10 mins
Gene Therapy Manufacturing & Analytics
Chairperson’s Opening Remarks: Gene Therapy Manufacturing & Analytics
9:00am - 9:30am30 mins
Cell Line Development & Engineering
Fireside Chat: New Modalities, Old Playbook: Are Multispecifics and Gene Therapy Cell Lines Stuck in mAb Thinking?
9:00am - 9:30am30 mins
Cell Culture & Upstream Processing
Strategic Vision, Planning, and Implementation of a Fully Automated, Bench-Scale Bioreactor Platform
- Brandon Veres - Staff Engineer, Regeneron
9:00am - 9:30am30 mins
Downstream Processing
Split, Switch, and Stitch: Generating multispecific antibodies using column based redox reactions
- Verzhiniya Aho - Senior Scientist, Pfizer
9:00am - 9:30am30 mins
Digital Biomanufacturing and Data Driven Operations
PAT and product quality toolbox study
- Bingyu Kuan - Scientist II, Abbvie
9:00am - 9:30am30 mins
CMC Strategy & Manufacturing Performance
Critical Quality Attributes in Modern Biopharmaceutical Development: From Established mAbs to Emerging Modalities
- Elisabeth Krug - Executive Director, Eli Lilly & Company
9:00am - 9:30am30 mins
Development of Emerging Cell & Gene Therapies
Keynote: Journey from R&D to Clinical Manufacturing
- Nelly Viseux - Vice President, Cell Therapies Development, Manufacturing, Supply & Quality, Regeneron
9:00am - 9:30am30 mins
Cell Therapy Manufacturing & Analytics
Panel Discussion: Decentralized Manufacturing in Cell Therapy: Overcoming Implementation Challenges and Enhancing Patient-Centric Solutions
- Therese Choquette - Chief Technical Officer, Tigen Pharma SA
9:00am - 9:30am30 mins
Gene Therapy Manufacturing & Analytics
Keynote Panel Discussion: Navigating BLA Success - Strategies for Streamlined Gene Therapy Approval Success
9:30am - 10:00am30 mins
Cell Line Development & Engineering
Complex Bispecifics CLD strategy
- Paul Rousseau - Engineer I, Biogen
9:30am - 10:00am30 mins
Cell Culture & Upstream Processing
KEYNOTE: Engineering ADC Success from the Start: The Critical Role of Cell Culture
- Andrea Little - Associate Research Fellow - Cell Culture, Pfizer
9:30am - 10:00am30 mins
Downstream Processing
ADC Purification and The Platform Gap
- Mark Shannon, Ph.D. - Associate Director of Operations, Abbvie
9:30am - 10:00am30 mins
Digital Biomanufacturing and Data Driven Operations
Automation in analytical assay development
- Pernesso Geffrard - Scientist, BMS
9:30am - 10:00am30 mins
CMC Strategy & Manufacturing Performance
Case Study: Ankyra Therapeutics
- Gregory Zarbis-Papastoitsis, Ph.D - Chief Process and Manufacturing Officer, Ankyra
9:30am - 10:00am30 mins
Development of Emerging Cell & Gene Therapies
Keynote: Programming Immunity In Vivo: Targeted RNA-LNP Platforms for Precision CAR Engineering
- Robert Hofmeister - Chief Scientific Officer, CREATE Medicines
9:30am - 10:00am30 mins
Cell Therapy Manufacturing & Analytics
Novel Analytical Technologies for Cell Therapy Product and Process Characterisation Strategies
- Kelly Bowen - Senior Scientist, Analytical and Process Development, KSQ Therapeutics, Inc.
9:30am - 10:00am30 mins
Gene Therapy Manufacturing & Analytics
Process Characterisation and Process Performance Qualification (PPQ) Strategies for Gene Therapies
10:00am - 10:30am30 mins
Cell Line Development & Engineering
Sponsored Presentation
10:00am - 10:30am30 mins
Cell Culture & Upstream Processing
Sponsored Scientific Presentation
10:00am - 10:30am30 mins
Downstream Processing
Sponsored Scientific Presentation
10:00am - 10:30am30 mins
Digital Biomanufacturing and Data Driven Operations
Sponsored Presentation
10:00am - 10:30am30 mins
CMC Strategy & Manufacturing Performance
Sponsored Presentation
10:00am - 10:30am30 mins
Development of Emerging Cell & Gene Therapies
Sponsored Scientific Track Presentation
10:00am - 10:30am30 mins
Cell Therapy Manufacturing & Analytics
Sponsored Scientific Track Presentation: Application and Validation of Rapid Cell Analytical Technologies for Product Release at Scale
10:00am - 10:30am30 mins
Gene Therapy Manufacturing & Analytics
Sponsored Scientific Track Presentation
10:30am - 11:15am45 mins
Break
Morning Break
11:15am - 11:45am30 mins
Cell Line Development & Engineering
Advanced Analytical and Tracking Methods for Optimizing Cell Line Development
- Yizhou Zhou - Director, Cell Line Development & Engineering, BMS
11:15am - 11:45am30 mins
Cell Culture & Upstream Processing
Upstream Matters for ADCs: Locking High-Performance Upstream to Simplify Downstream
- Xiaolin Zhang - Associate Principal Scientist, Merck & Co
11:15am - 11:45am30 mins
Downstream Processing
End-to-end high throughput platform leveraging resin tip technology to accelerate AAV purification process development
- Qingxuan Li - Principal Scientist, Sanofi
11:15am - 11:45am30 mins
Digital Biomanufacturing and Data Driven Operations
Proving Digital Value To CMC Leadership: ROI, Risk, Reduction & Inspection Readiness
11:15am - 11:45am30 mins
CMC Strategy & Manufacturing Performance
A Practical Workflow for Assessing Glass Vial Performance in Drug Product Development
- Manasi Nawathe - Scientist I, Macrogenics
11:15am - 11:30am15 mins
Development of Emerging Cell & Gene Therapies
Development of Next Generation Cell Therapies for Autoimmune Disease
- Mayo Pujols - CTO, Kyverna
11:15am - 11:45am30 mins
Cell Therapy Manufacturing & Analytics
Culture and Non-Culture-Based Approaches to Cell Therapy Potency
- Ronnie Lum - Director Analytical Development, Analytical and Quality Control, BlueRock Therapeutics
11:15am - 11:45am30 mins
Gene Therapy Manufacturing & Analytics
Advances in Analytical Method Development for the Characterisation of AAVs
11:30am - 11:45am15 mins
Development of Emerging Cell & Gene Therapies
The Siren Experience: Advancing SRN-101 for High Grade Gliomas
- Lauren Kelly - Director of Translational Research, Siren Biotechnology
11:45am - 12:15pm30 mins
Cell Line Development & Engineering
Rebuilding CLD Without Legacy Constraints: A Strategy- and Data-Driven Case Study
- Sowmya Balasubramanian - Associate Director, Cell Line Development, Gilead Sciences
11:45am - 12:15pm30 mins
Cell Culture & Upstream Processing
Transforming complex biological systems into scalable, intelligent, and manufacturing-ready bioprocesses
- Utsavi Sevak - Senior Associate Scientist, BMS
11:45am - 12:15pm30 mins
Downstream Processing
Reducing COG in Downstream Biologics Production
- Eashwar Rajaraman - Principal Scientist I, Novartis
11:45am - 12:15pm30 mins
Digital Biomanufacturing and Data Driven Operations
Fireside Chat: From Pilot to Plant: What It Really Takes To Scale Digital Biomanufacturing
11:45am - 12:15pm30 mins
CMC Strategy & Manufacturing Performance
Process Validation: When is “Enough” Enough?
11:45am - 12:00pm15 mins
Development of Emerging Cell & Gene Therapies
Gene Therapy for Immune Reprogramming and the Treatment of Inflammatory Diseases
- Shahrooz Rabizadeh - CEO & Co-Founder, Sagittarius Bio, Inc
11:45am - 12:15pm30 mins
Cell Therapy Manufacturing & Analytics
Case Study from Arcellx: Application of MOI Titrations to Evaluate Vector Lots and Aid Process Decisions and Process Control
- Brian Murphy - VP Cell Process Science, Arcellx
11:45am - 12:15pm30 mins
Gene Therapy Manufacturing & Analytics
Application of AI and Machine Learning in Gene Therapy Process Development and Manufacturing
12:00pm - 12:15pm15 mins
Development of Emerging Cell & Gene Therapies
Case Studies: Development of Next-Gen Cell & Gene Therapies - Overcoming Challenges and Breakthroughs
12:15pm - 12:45pm30 mins
Cell Line Development & Engineering
Sponsored Presentation
12:15pm - 12:45pm30 mins
Cell Culture & Upstream Processing
Sponsored Scientific Presentation
12:15pm - 12:45pm30 mins
Downstream Processing
Sponsored Presentation
12:15pm - 12:45pm30 mins
Digital Biomanufacturing and Data Driven Operations
Sponsored Presentation:
12:15pm - 12:45pm30 mins
CMC Strategy & Manufacturing Performance
Sponsored Presentation
12:15pm - 12:45pm30 mins
Development of Emerging Cell & Gene Therapies
Sponsored Scientific Track Presentation
12:15pm - 12:45pm30 mins
Cell Therapy Manufacturing & Analytics
Sponsored Scientific Track Presentation: Latest Advances in Cryopreservation Techniques and Maintaining Cell Viability at Scale
12:15pm - 12:45pm30 mins
Gene Therapy Manufacturing & Analytics
Sponsored Scientific Track Presentation
12:45pm - 2:00pm75 mins
Break
Lunch
2:00pm - 2:30pm30 mins
Cell Line Development & Engineering
Causal intelligence through multiplex cell line engineering
- Stefan Smith - Advisor, Optigenomics Bio
2:00pm - 2:30pm30 mins
Cell Culture & Upstream Processing
How targeted process optimization can improve efficiency and robustness and improve overall protein yield through controlled bioprocessing conditions
- Ramona Cheriaparambil - PhD Student, University of Massachusetts Amherst
2:00pm - 2:30pm30 mins
Downstream Processing
A Case Study
- Stefano Menegatti - Professor, Chemical and Biomolecular Engineering, NC State University, North Carolina State University
2:00pm - 2:30pm30 mins
Digital Biomanufacturing and Data Driven Operations
What We Stopped Digitalising - and Why It Made Manufacturing Better?
2:00pm - 2:30pm30 mins
CMC Strategy & Manufacturing Performance
Using Process Analytics to Protect PPQ Yield and Supply Reliability
2:00pm - 2:05pm5 mins
Cell & Gene Keynote Plenary
Chairperson’s Opening Remarks
2:05pm - 2:45pm40 mins
Cell & Gene Keynote Plenary
Keynote Patient Fire Side Chat: Amplifying Patient Voices- Patient Centric CGT Innovation
2:30pm - 3:30pm60 mins
Cell Line Development & Engineering
PANEL DISCUSSION: Precision Cell Line Engineering for Biologics: Focused Innovations and Applications
2:30pm - 3:30pm60 mins
Cell Culture & Upstream Processing
PANEL DISCUSSION: Shared Pain Points Between Upstream and Downstream Processes
- Ken Lee - Director, AstraZeneca
2:30pm - 3:30pm60 mins
Downstream Processing
PANEL DISCUSSION: Shared Pain Points Between Upstream and Downstream Processes
- Ken Lee - Director, AstraZeneca
2:30pm - 3:30pm60 mins
Digital Biomanufacturing and Data Driven Operations
PANEL DISCUSSION: The Future of Facilities: Enabling Autonomous Bioprocessing
2:30pm - 3:30pm60 mins
CMC Strategy & Manufacturing Performance
PANEL DISCUSSION: Strategies to Future-Proof Manufacturing Processes for Large-Scale Production
2:45pm - 3:30pm45 mins
Cell & Gene Keynote Plenary
Keynote Presentation: Lessons Learnt of the Path to Commercialisation
- Silviu Itescu - CEO, Mesoblast
3:30pm - 3:35pm5 mins
Break
Close of Conference
* 不測の事態により、事前の予告なしにプログラムが変更される場合があります。