Hi Cancer, We Come Bearing Gifts, Antibody-Drug Conjugate

Session Description

ADCs combine the specificity of an antibody with the cytotoxicity of a chemical agent. They represent a rapidly evolving area of oncology drug development and hold significant promise. There are currently 11 ADCs on the market, and more than 80 ADCs are in the pipeline with multiple drugs in advanced stages of clinical trials. Recent positive results from a Phase III study show that Polatuzumab Vedotin plus R-CHP is the first regimen in 20 years to significantly improve outcomes in previously untreated aggressive forms of lymphoma compared to standard of care. Collectively, a critical gap remains regarding how we can widen ADC therapeutic windows. This knowledge gap is particularly problematic because it prevents patients from receiving effective treatments for their life-threatening illnesses. Several questions are unclear such as how can we improve the benefit-risk ratio of ADCs, strategies to accelerate ADC developments, and improve ADC tolerability in patients. This innovative interactive session will define problems and gaps, provide perspectives from the biopharmaceutical industry, and regulations on maximizing the therapeutic index of ADCs, and provide the audience with a deep dive into the hottest and emerging areas in the ADC field, which can foster research in the community to develop the next generation ADCs.

Learning Objectives

1. Upon completion, participants will be able to understand the hottest and emerging areas in the ADC and identify the scientific, clinical practice, and regulatory challenges of the development ADCs.

2. Upon completion, participants will be able to develop strategies to address knowledge gaps, scientific, and regulatory challenges and foster research to develop ADCs that have maximizing efficacy, tolerability, and minimizing adverse effects.

Session Schedule

9:30 AM - 9:35 AM ET
Introduction
Mike Liao, PhD

9:35 AM - 9:45 AM ET
Patient’s Needs and Preferences: Far More Than an Efficacious Dose, What Outcomes Really Matter to Cancer Patients, and How Can Clinical Pharmacologists Help?
Lorna Warwick

9:45 AM - 9:55 AM ET
Model Informed Therapeutic Dose Optimization Strategies for Antibody-Drug Conjugates (ADCs) in Oncology: What Can We Learn from FDA-Approved ADCs?
Chunze Li, PhD

9:55 AM - 10:05 AM ET
A Regulatory Perspective on Clinical Pharmacology in ADC Development – Experiences and Opportunities
Salaheldin Hamed, PhD

10:05 AM - 10:30 AM ET
Q&A and Closing Remarks
Zhu Zhou, PhD