7:30 am Check In & Light Refreshments
08:30am Workshop A
Developing a Comprehensive Product Understanding & Extended Characterization for Presenting a Robust Physicochemical Data Package for BLA, IND & FIH Trial Regulatory Submissions
Synopsis
Developing a comprehensive understanding of product attributes and conducting extended physicochemical characterization are essential to ensuring that ADCs meet the stringent requirements for regulatory submissions, including BLA, IND applications, and FIH trials. Extended characterization and continuous refinement of CQAs from discovery through to late-stage development enhance product consistency, efficacy, and safety, supporting robust regulatory submissions.
Join this workshop to:
• Discover the systematic evolution of CQAs and advancements in analytical techniques which enable ADCs to meet regulatory standards while improving clinical trial outcomes and commercialization readiness
• Explore how the identification and definition of CQAs evolve from early-stage
discovery to late-stage development, with a focus on improving product consistency and performance
• Discuss advancements in analytical methods (e.g., LC-MS, SEC, HIC) to monitor changes in CQAs as ADCs progress through development, ensuring robust data for regulatory submissions
• Examine how regulatory requirements influence the evolution of CQAs and ensuring that analytical development strategies are aligned with these evolving standards to support clinical trials and commercialization
10:30 am Morning Break
11:00am Workshop B
Analytical Strategies for Comprehensive Profiling & Potency Optimization of Complex ADCs
Synopsis
Exploring advanced analytical methodologies to characterize the conjugation processis crucial to ensuring detailed profiling of ADCs. Placing emphasis on integrating analytical techniques to elucidate conjugation heterogeneity, determine DAR, and assess the impact of these parameters on ADC potency is a key focus which will be emphasized. Strategies will be evaluated for aligning analytical insights with potency optimization, addressing challenges posed by increasingly complex ADCs and heterogenous conjugation profiles, therefore facilitating robust ADC development.
Join this workshop to:
• Evaluate tools to understand the conjugation process and ADC profiles
• Examine analytical tools to understand the conjugation process and ADC profiles
• Explore potency strategies of complex ADCs
• Address challenges in complex ADC analytical development
1:00 pm Lunch
2pm Workshop C
Addressing Analytical Strategies for Accelerated Approval
Synopsis
As the ADC landscape becomes increasingly crowded, the speed of getting approval becomes a more and more important factor. Alongside this increased progress to approval comes an unforeseen set of challenges for analytical development.
Join this workshop to:
• Discuss the roadmap to accelerated approval from an analytical perspective
• Optimize strategies for accelerated IND and BLA application
• Streamline late-stage analytical development
• Mitigate analytical risk for accelerated approval