Tuesday 22nd September: Pre-Conference Day - ET (Eastern Time, GMT-05:00)
Tuesday 22nd September: Pre-Conference Day
- ET (Eastern Time, GMT-05:00)
8:00am - 8:50am50 mins
Registration Break
Registration and Morning Coffee
8:50am - 9:00am10 mins
Symposia 1: CMC Roadmap
Extended Chairperson’s Workshop Opening
8:50am - 9:00am10 mins
Symposia 2: Intensified & Continuous Manufacturing
Extended Chairperson’s Workshop Opening
8:50am - 9:00am10 mins
Symposia 3: AI and ML Applicability in Bioprocessing Training
Extended Chairperson’s Workshop Opening
9:00am - 10:30am90 mins
Symposia 1: CMC Roadmap
Setting the Scene : CMC Studies in the life cycle
- Thomas Chattaway - Senior Life Science Consultant, Independent
- Margit Holzer - Scientific Director, Ulysse Consult
9:00am - 9:30am30 mins
Symposia 2: Intensified & Continuous Manufacturing
Perfusion Bioprocessing and High-throughput Scale-Down Studies Drive Productivity and Quality in a Labile Molecule
- Xinbo Zhang - Scientist II, Alexion Pharmaceuticals
9:00am - 9:30am30 mins
Symposia 3: AI and ML Applicability in Bioprocessing Training
AI 101 For Bioprocessing Scientists (What You Actually Need To Know)
9:00am - 9:45am45 mins
Symposia 4: BPI School
Introduction To Upstream Manufacturing
- Muhammad "Arshad" Chaudhry - Principal Engineer, Alkermes
9:30am - 10:00am30 mins
Symposia 2: Intensified & Continuous Manufacturing
N-1 perfusion coupled with intensified production bioreactor process
- Dunie Navarro - Senior Scientist, Pfizer
9:30am - 10:00am30 mins
Symposia 3: AI and ML Applicability in Bioprocessing Training
Mechanistic Versus AI Models: When Physics Beats Pattern Recognition
- Christoph Herwig - Senior Scientific Advisor, Körber Pharma Austria GmbH, Austria
9:45am - 10:30am45 mins
Symposia 4: BPI School
Introduction To Downstream Manufacturing
- Stefano Menegatti - Professor, Chemical and Biomolecular Engineering, NC State University, North Carolina State University
10:00am - 10:30am30 mins
Symposia 2: Intensified & Continuous Manufacturing
Scientific Track Presentation
10:00am - 10:30am30 mins
Symposia 3: AI and ML Applicability in Bioprocessing Training
Sponsored Talk
10:30am - 11:00am30 mins
Break
Morning Break
11:00am - 12:00pm60 mins
Symposia 1: CMC Roadmap
Requirements from Pre-Clinical to Phase 2 CT
- Thomas Chattaway - Senior Life Science Consultant, Independent
- Margit Holzer - Scientific Director, Ulysse Consult
11:00am - 11:30am30 mins
Symposia 2: Intensified & Continuous Manufacturing
Accelerating Chemically Defined Media and Feed Optimization via Integrated High Throughput Screening Methodologies
- Lynn Mao - Senior Scientist, AstraZeneca
11:00am - 12:00pm60 mins
Symposia 3: AI and ML Applicability in Bioprocessing Training
Building and Deploying AI Tools
- Eva Aning - CMMS & AI Solution Architect, Moderna
11:00am - 12:00pm60 mins
Symposia 4: BPI School
Introduction To Digitalization in Bioprocessing
- Christoph Herwig - Senior Scientific Advisor, Körber Pharma Austria GmbH, Austria
11:30am - 12:00pm30 mins
Symposia 2: Intensified & Continuous Manufacturing
Development and Optimization of a Hollow Fiber-Based Countercurrent Diafiltration Process for Continuous Manufacturing of Monoclonal Antibodies
- Vishwanath Hebbi - Senior Scientist, Merck & Co., Inc.
12:00pm - 1:00pm60 mins
Break
Lunch
1:00pm - 2:00pm60 mins
Symposia 1: CMC Roadmap
Requirements from Pre-Clinical to Phase 2 CT
- Thomas Chattaway - Senior Life Science Consultant, Independent
- Margit Holzer - Scientific Director, Ulysse Consult
1:00pm - 1:30pm30 mins
Symposia 2: Intensified & Continuous Manufacturing
Process Analytical Technology (PAT), Automation and Control Strategies for Continuous Biomanufacturing
1:00pm - 1:30pm30 mins
Symposia 3: AI and ML Applicability in Bioprocessing Training
CMC Modeling Fundamentals: Connecting Data, Models, and Scale-Up for Better Decisions
- Mark Duerkop - Chief Executive Officer, Novasign
- Matthias Müllner - CEO, bespark*bio
1:00pm - 2:00pm60 mins
Symposia 4: BPI School
PANEL DISCUSSION: An Introduction to Emerging Therapies: Unlocking the Future of Medicine
1:30pm - 2:00pm30 mins
Symposia 2: Intensified & Continuous Manufacturing
A Pilot-Scale Continuous Purification Process Enabling High-Efficiency Manufacturing of Recombinant Adeno-Associated Viral Vectors from Harvest to Drug Substance
- Garima Thakur - Staff Engineer, Regeneron Pharmaceuticals
1:30pm - 2:00pm30 mins
Symposia 3: AI and ML Applicability in Bioprocessing Training
Sponsored Presentation:
2:00pm - 2:30pm30 mins
Symposia 1: CMC Roadmap
Requirements from Pre-Clinical to Phase 2 CT
- Thomas Chattaway - Senior Life Science Consultant, Independent
- Margit Holzer - Scientific Director, Ulysse Consult
2:00pm - 2:30pm30 mins
Symposia 2: Intensified & Continuous Manufacturing
Scientific Track Presentation
2:00pm - 2:30pm30 mins
Symposia 4: BPI School
Analytical & Quality PART 1
2:30pm - 3:00pm30 mins
Break
Afternoon Break
3:00pm - 4:00pm60 mins
Symposia 1: CMC Roadmap
Requirements from Pre-Clinical to Phase 2 CT
- Thomas Chattaway - Senior Life Science Consultant, Independent
- Margit Holzer - Scientific Director, Ulysse Consult
3:00pm - 3:30pm30 mins
Symposia 2: Intensified & Continuous Manufacturing
Continuous Processing: A View on Practical Adoption for CDMOs
3:00pm - 4:00pm60 mins
Symposia 3: AI and ML Applicability in Bioprocessing Training
CMC Modeling Fundamentals: Connecting Data, Models, and Scale-Up for Better Decisions
- Mark Duerkop - Chief Executive Officer, Novasign
- Matthias Müllner - CEO, bespark*bio
3:00pm - 3:30pm30 mins
Symposia 4: BPI School
Analytical & Quality PART 2
3:30pm - 4:00pm30 mins
Symposia 2: Intensified & Continuous Manufacturing
Process Intensification for Biologics: How Fast, How Dense, How Disposable?
3:30pm - 4:00pm30 mins
Symposia 4: BPI School
BPI School Round Up
- Muhammad "Arshad" Chaudhry - Principal Engineer, Alkermes
- Stefano Menegatti - Professor, Chemical and Biomolecular Engineering, NC State University, North Carolina State University
- Christoph Herwig - Senior Scientific Advisor, Körber Pharma Austria GmbH, Austria
4:00pm - 4:30pm30 mins
Symposia 1: CMC Roadmap
Final Q&A Session & Closing Remarks
- Thomas Chattaway - Senior Life Science Consultant, Independent
- Margit Holzer - Scientific Director, Ulysse Consult
4:30pm - 4:35pm5 mins
Break
Close of Pre-Conference day
* 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。