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

  • Hui Wei Director - Chair, Biologics Specification Committee, Analytical Chemistry Manufacturing & Controls Strategy Lead, Bristol Myers Squibb


  • 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

  • Linan Ha Director, Regulatory Affairs, CMC, AstraZeneca


  • 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


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

  • Jianxin Guo Director - Regulatory Chemistry Manufacturing & Controls Biotechnology, Eli Lilly & Co.


  • 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


  • 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

  • Engin Ayturk Senior Director, CMC Bioconjugation, Process Development & Manufacturing, Exelixis Inc.


  • 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

  • Nimish Gupta Senior Staff Engineer, Regeneron Pharmaceuticals Inc


  • 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

  • Robert Hughes Senior Director - Pharmaceutical Sciences, Cidara Therapeutics Inc.
  • Eric Lacoste Head of ADC Conjugation Development/Global CMC Development, Sanofi


  • 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

  • Vineet Kumar Senior Director - Development, DP manufacturing & Chemistry, Manufacturing, & Controls Project Management, Exelixis Inc.


  • 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


  • 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

4:45 pm Chair’s Closing Remarks

4:50 pm End of Conference Day One