8:00 am Check-In & Coffee
8:50 am Chair’s Opening Remarks
Exploring Novel ADC Linker & Conjugation Technologies to Usher in the Next-Generation of ADCs & Increase Efficacy
9:00 am Highlighting the Specific Critical Quality Attributes for an Acceptable ADC From a Regulatory Stance
Synopsis
- Overviewing the specific criteria required by regulatory agencies such as average time to manufacturing, stability, DAR and cytotoxicity of your ADC
- Understanding the limit of active substance impurities such as linker-payload and mAb
- Delving into the control strategies for ADCs to understand which quality attributes to start with in process development
9:30 am Comprehending & Facing Regulatory Approval Challenges to Overcome Hurdles in ADC Scale-Up Processes
Synopsis
- Exploring real life approved ADC case studies to understand the lessons learnt from adjusting processes to regulatory requirements
- Setting wide enough specifications for scale up, which still fall within regulatory acceptance criteria of impurity limits
- Understanding the regulatory frameworks for speeding up time to manufacturing
10:00 am Morning Break & Speed Networking
Synopsis
This informal session will provide the process development community valuable networking time, enabling you to forge new and lasting connections to plot paths to see future successes within the field.
11:00 am Session Reserved for BSP Pharmaceuticals
11:15 am CMC Regulatory Considerations for Setting Small Molecule Impurity & Control Strategies
Synopsis
- Understanding the regulatory frameworks for an ADC to reflect the production processes and the combined approach to quality
- Justifying the specification setting for small molecule impurity limits
- Regulatory benchmarking of critical quality attributes and control strategies for marketed ADC products
11:45 am Roundtable Discussion – Setting Optimal CQAs to Ensure Appropriate Impurity Removal & Achieve Regulatory Approval
Synopsis
- Discussing standardized general control strategy for ADCs
- Understanding what the “must-do” aspects of process development are, and what can be deferred for IND approval, in order to improve cost and speed
12:30 pm Networking Lunch
Maximizing ADC Process Efficiency Through Unlocking Maximum Conjugation Yield
1:30 pm Technical Challenges & Opportunities in Early-Stage ADC Process Development & Manufacturing
Synopsis
- Evaluating challenges specific to early-stage ADC process development and manufacturing
- Highlighting strategies across drug-linker, mAb, DS, and DP
- Ensuring effective clinical supply for early-stage manufacturing
2:00 pm Development of a Site-Specific Conjugation Reaction to Improve Efficiency
Synopsis
- Understanding process levers with a focus on reaction efficiency and impurity generation
- Building predictive models to determine ideal conditions for operation
2:30 pm Panel Discussion – Optimizing Conjugation Processes to Decrease Heterogeneity & Prepare for Scale-Up
Synopsis
- Understanding the quantity of mAb fragments which must be removed and what can be dosed in small amounts
- Considering the conjugation technology and conditions used as well as their upscale applications
- Creating a platform to increase conjugation yield
3:15 pm Afternoon Networking Break
Anticipating Specific Strategies to Onboard Your Drug Product Development Decrease Costs & Improve Timelines
3:45 pm Challenges in the Drug Product Development & Manufacturing of ADC Therapeutics
Synopsis
- Discussing stability considerations in early and late phase ADC programs
- Understanding various formulation, administration, container-closure and manufacturing strategies
- Presenting a stable business, patient and user-friendly drug product
4:15 pm From Bench to Bedside: Fast-Tracking ADC Drug Product Development
Synopsis
- Leveraging platform and prior knowledge
- Developing a robust process that enables scale-up from bench to commercial scale
- Establishing strategies to shorten development timelines and improve efficiencies while performing seamless tech transfer