Workshop Day

8:00 am Morning Coffee & Check In

9:00 am Workshop A

Predicting & Mitigating Toxicities Associated With Novel Payloads in ADC Development

  • Anna Engstrom Senior Principal Scientist & Toxicologist Safety Assessment, Genentech

Synopsis

As ADC development expands to new payload classes, understanding how to predict, minimize, and manage toxicity is critical for early-stage drug development.

This interactive workshop will provide hands-on discussions and case studies to help:

  • Preview the current landscape of novel payloads in preclinical and clinical development
  • Understand how novel payloads impact ADC toxicity? Exploring the mechanisms of emerging payload classes, including their on- and off-target toxicity risks
  • Case Study: What can we learn from past ADC failures? – Reviewing clinical and preclinical toxicity data to identify early warning signals for payload-driven toxicities
  • Interactive Discussion: What are the key challenges in predicting payload toxicities and how do we tailor the preclinical safety characterization for novel payloads?

12:00 pm Lunch Break

1:00 pm Workshop B

Rethinking Patient Selection for Addressing Unique Toxicity Challenges From ADC Therapy – Balancing Risk & Access

  • Funda Meric-Bernstam Chair of Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center
  • Paolo Tarantino Clinical Research Fellow, Dana-Farber Cancer Institute

Synopsis

Current ADC trials often exclude high-risk patients due to concerns about toxicity, but is this the best approach? This session will explore how we can better predict, manage, and personalize ADC-related toxicities rather than defaulting to exclusion.

Join this workshop to discuss topics such as:

Who is at higher risk of ADC toxicity?

  • Understanding the role of clinical characteristics, pre-existing conditions, and biomarker-driven patient selection in predicting adverse events. Examples include: Patients with pre-existing lung disease and ADC-induced interstitial lung disease (ILD)
  • Ocular toxicity risks in multiple myeloma patients receiving BCMA-targeting ADCs

Managing toxicity without eliminating patients from treatment

  • Industry-wide, patients with risk factors are often excluded from trials. But should we:
  • Implement risk-mitigation strategies (e.g. pre-treatment, monitoring, dose adjustments) instead?
  • Develop guidelines for overlapping toxicities, such as ocular surface damage due to prior cancer therapies?

Moving toward a patient-first approach to ADC development

  • Can the industry harmonize how toxicity is factored into patient selection? Rather than focusing on which ADC lacks a certain toxicity, how can we optimize how to manage different toxicities across ADC classes?

4:00 pm End of Pre-Conference Workshop Day