Post-Conference Workshop Day

Despite ADC’s raging success as oncology therapies, translational barriers still plague bioconjugate development, with pressure to enter the clinic quickly but preclinical activity not matching early clinical readouts.

As the field turns its attention to advance more non-traditional ADC translation, join this workshop to break down best strategy to balance depth of characterization against time, contextualized with reverse translational learnings to better advance ADCs to the clinic with confidence.   

Workshop highlights include:

• Leveraging reverse translation insights to streamline ADC preclinical efficacy assessment through intentional deployment of CDX and PDX models 
• Understanding when and how to position toxicity assessments for an integrated and balanced picture of ADC assets 
• Debating optimized strategies to balance preclinical characterization against time and cost to best advance ADCs to the clinic with confidence 
• Conducting translational studies to identify biomarkers for ADC sensitivity and resistance

With more and more ADCs entering the clinic, it has never been more important to optimize clinical characterization and development strategies to demonstrate differentiation and benefit oncology patients.

Attend this session to dive into ADC clinical development strategy from bioanalytical characterization to support clinical dosing, understanding mechanisms of ADC resistance, and contextualizing opportunities to maximize differentiation in crowded oncology indications.

Workshop Highlights Include:

• Laying out ADC bioanalytical characterization to support clinical pharmacology, dosing strategy and trial design in early ADC clinical development
• Contextualizing ADC clinical development in an increasingly busy oncology therapeutic landscape: What are the strategies to deliver clinical impact with the bar for success raised?
• Breaking down tumor target expression and ADC resistance mechanisms to optimize approaches to unlock clinical benefit across combination and sequencing approaches  

As the ADC field shifts to novel payload mechanisms and more complex ADC design to deliver meaningful patient impact, quality characterization and control strategies need to be adapted and updated to keep up with the rate of ADC innovation.

Join this workshop led by big pharma leaders and members of the IQ consortium to investigate best approaches for non-cytotoxic and non-traditional ADC control strategies.

Workshop highlights include:

• Defining the control strategy for noncytotoxic bioconjugates including AOCs and antibody–peptide conjugates across CQAs, release testing, and stability
• Comparing control strategies for noncytotoxic versus cytotoxic bioconjugates, highlighting differences in potency assays, impurity profiles, and safety controls
• Applying patient centric quality control to non-cytotoxic bioconjugates by linking specifications to clinical relevance

As more companies emerge and pivot to enter the field of ADC development, understanding analytical and CMC principles, requirements, and timelines is vital to advance to IND and stay competitive

in a busy biopharma ecosystem.

Designed for ADC biotech C-level, CMC, analytical and quality leaders currently in discovery stage, don’t miss this workshop to learn the CMC roadmap and accelerate your ADC development from gene to IND.

Workshop highlights include:

• Outlining and optimizing the CMC timeline to achieve clinical supply readiness and enable patient dosing immediately upon IND allowed-toproceed
• Navigating the process development activities and delving into cell line development, biologic design, linkerpayload and conjugation
• Detailing the core principles of analytical development and specifications