Pre-Conference Focus Day 2024
Tuesday | April 16 2024
07:00 Check-In & Coffee
08:00 Workshop A
Understanding the Regulatory Landscape to Hone Global Regulatory Requirements & Optimize Analytical Methods
With the newly updated ICH Q14 guidelines and the ever-changing regulatory landscape, questions surrounding regulatory expectations are at an all-time high. Filing in different countries also poses as an additional challenge due to the lack of regulatory harmonization. The question then is how do you meet regulatory standards across the globe while also ensuring optimal analytical methods?
Join this workshop to develop analytical methods that answer all regulatory questions to ensure you can be confident in subsequent filings, by:
- Navigating challenging regulatory expectations globally
- Developing an analytical panel that answers all regulatory questions
- Selecting the correct analytical methods for conjugated ADCs
- Answering all the different questions thrown at you by regulatory agencies
- Understanding control strategy and its importance
Workshop Leader
Mark Eggink
Principal Scientist
Byondis
David Lee
Executive Director, Analytical Chemistry
Mersana Biotherapeutics
10:30 Morning Break
11:00 Workshop B
Optimizing Comparability Studies to Reduce Costs & Demonstrate Equivalence Within Your ADCs
No matter how much comparability is discussed, it always remains at the forefront of everyone’s minds. Demonstrating comparability, equivalence, setting up comparability studies, managing reference materials are some of the key challenges that no one can seem to overcome.
Join this workshop to delve deeper into all of your key challenges and allow you to carry out comparability studies with confidence by:
- Calculating and judging of what is comparable and what isn’t
- Generating a full set of data from your comparability studies
- Confidently concluding which antibodies are comparable
- Using comparability studies to characterize modifications within your molecule
- Managing reference materials to overcome challenges with overtime changes
Workshop Leader
Renpeng Liu
Principal Scientist
Pyxis Oncology
Yuan Gao
Head of Analytical Development
ADC Therapeutics
13:30 Networking Lunch
14:30 Workshop C
Overcoming Heterogeneity of ADCs to Platform Analytical Methods
Variability within the ADC molecule is the bane of every drug developer trying to analyze and produce an ADC. It results in having to carry out multiple analytical methods, increases workload, lengthens development timelines and so much more.
This workshop will endeavour to give you the solution to your problems by diving into platforming techniques by:
- Developing a uniform approach to ADC analysis
- Navigating complexity of the molecule to reduce process variation
- Finding standardized approaches to quantify conjugation
- Honing consistency in analytical methods
- Decreasing workload and time taken to carry out analytical development
Workshop Leader
May Zhu
Director - Pharmaceuticals
Takeda
Chris Chumsae
Director of Biophysical Chemical Characterization
Bristol Myers Squibb