Development, Regulatory, & Outcomes (DRO) Network

Network Goals

Enhance communication, cross-training and collaborations among members from multiple sectors including industry, government, and academia.
Apply principles of clinical pharmacology in the continuum of drug development, regulation, and post-marketing research and surveillance, as well as safe and effective utilization of medicines.

ASCPT Pharmacometrics & Pharmacokinetcs (PMK) and Regulatory Science (RS) Communities Members-Only Webinar
Title: Pharmacokinetic Characterization of Antibody-Drug Conjugates in Clinical Development: An IQ Consortium Perspective
Date and Time: 1:00 PM ET, Friday, September 11, 2020
Speaker: Rajeev Menon, PhD
Moderators: Chunze Li, PhD, and Lakshmi Vasist, PharmD
Description: This webinar will update attendees on the common pharmacokinetic strategies for Antibody-Drug Conjugates (ADCs) and will discuss analytes used for exposure-response analyses for safety and efficacy as well as which analytes correlate best to safety and efficacy. Attendees will learn how to use this information to determine pharmacokinetic strategies across various stages of drug development. For additional information, please click the registration link below.
Registration Link: https://us02web.zoom.us/webinar/register/WN_LJcYvu8pQGeO7rAAqI6onQ

Past Webinars

First-in-Human Starting Dose Selection: Learnings from Survey by IQ MABEL Working Group and Experiences of the Regulatory Agency

Application of Quantitative Systems Toxicology in Drug Cardiovascular Safety Assessment

Using Concentration – QTc as the Primary Analysis in TQT & Phase 1 Studies: Considerations, Methods and Case Studies; and an Introduction to Comprehensive in vitro Proarrhythmia Assessment (CiPA) initiative

Breaking Down Barriers for Acceleration of Development of New Anti-Infectives

FDA’s Sentinel System and the Regulatory Process

PBPK Modeling and Clinical Evaluation of a Natural Product-Drug Interaction

When are Transporters Important in Drug Disposition Including Tissue Distribution of Drugs?