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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.

Upcoming Community Webinars
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

Anuradha Ramamoorthy, PhD

Network Chair

 

J Liu

Jing Liu, PhD

Network Vice Chair

 

Robin O'Connor-Semmes, PharmD, PhD

Network Past Chair

 

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