Author: [AUTHOR] Published on 11/7/2019 10:14:00 AM
ASCPT Members-Only Webinar presented by the Early Career (EC) Community
Title: Clinical Pharmacology Considerations in the Development of Immune-Oncology Drugs
Date and Time: Thursday, April 30, 2020, 1:00 pm ET
Speaker: Nidal Al-Huniti, PhD
Moderator: Malek Okour, PhD, and Nithya Srinivas, PhD
Description: Building on the success of PD-1 (or PD-L1) inhibitors, a wave of next generation immunotherapies with different mechanisms of action (e.g., LAG3, CD40, ICOS, TIM-3, IDO1, GITR, STING, OX40, TIGIT) are being developed across multiple oncology indications. A key characteristic of immune-oncology programs is the assessment of clinical pharmacology information in patients within safety and efficacy studies, rather than through the use of healthy volunteer studies. As a result of this condensed trajectory of development, unique opportunities exist for the use of modeling and simulation strategies to address several important questions in immune-oncology development - from translation of pre-clinical data into first-in-human studies, to the characterization of relationships between exposure and safety/efficacy in pivotal clinical trials. This webinar will focus on strategies to optimize and highlight immuno-oncology drug development and expand on pharmacometrics, clinical pharmacology and statistical strategies to optimize clinical trial design and development of immune-oncology drugs.
Registration Link: https://zoom.us/webinar/register/WN_ZziZ45ahSci1dMlOumy0bA