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 Members-Only Webinar Presented by the Pharmacometrics & Pharmacokinetics (PMK) and Regulatory Science (RS) Communities
Title: Clinical Pharmacology Considerations for Antibody Drug Conjugates
Date and Time: Friday, January 29, 2021, 1:00 pm ET
Speaker: Krithika Arun Shetty, PhD
Moderators: Bilal AbuAsal, PhD, and Chunze Li, PhD
Description: Since 2000, ten Antibody Drug Conjugates (ADCs) have been approved by the US Food & Drug Administration all for oncology indications. Several other ADC products are in various stages of development. This presentation will provide an overview of the clinical pharmacology considerations in ADC development with a focus on the utility of PK-PD modeling and simulation in the ADC drug development process and in regulatory decision making. Summaries/case examples of population PK and E-R models that have been utilized in the regulatory review, approval and labeling of current ADCs will be discussed.
Registration Link: https://us02web.zoom.us/webinar/register/1616076355147/WN_beLmdFaISS-gsi4Be0UuTQ

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?