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.

Network Connection

Past Webinars

Clinical Pharmacology Considerations for Antibody Drug Conjugates
Regulatory Challenges for the Complex Drug Class of Nanomedicines
Pharmacokinetic Characterization of Antibody-Drug Conjugates in Clinical Development: An IQ Consortium Perspective
Using Preclinical Data in Phase I Oncology Trials: A Bayesian Decision-Theoretic Approach
Pediatric Master Protocols: Clinical Pharmacology Challenges and Opportunities (open access)
Intestinal OATP-Mediated Drug Interactions: Where Are We?
Systems Pharmacology Modeling to Support Clinical Development of Anti-CD20/CD3 T-Cell Dependent Bispecific Antibody

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?