A Message from the Co-Chairs of the FDA-Duke Global Regulatory Workshop

Welcome to this workshop!Cancer remains a serious global health threat. Oncology drug development has continued to lead other therapeutic areas in addressing the highly unmet medical needs of the cancer patients and their treatment, attested by ever-increasing numbers of global oncology clinical trials. Therefore, speeding up the development and making drugs available as rapidly as […]

Challenges with Novel Clinical Trial Designs: Master Protocols.

As seen on https://www.ncbi.nlm.nih.gov/pubmed/30696689 Cecchini M1, Rubin EH2, Blumenthal GM3, Ayalew K4, Burris HA5, Russell-Einhorn M6, Dillon H7, Lyerly HK8, Reaman GH9, Boerner S10, LoRusso PM10. The 2018 Accelerating Anticancer Agent Development (AAADV) Workshop assembled a panel of experts for an in-depth discussion session to present Challenges with Novel Clinical Trial Designs. This panel offered assessments of the challenges faced by industry, the Food and […]

AAADV Workshop 2016, Julie Bullock

Director of Clinical Pharmacology for d3 Medicine and Workshop planning committee member Julie Bullock explains how the unusual opportunity to interact informally with FDA officials involved in the drug approval process is an important opportunity for AAADV Workshop participants.

AAADV Workshop 2016, Tatiana Prowell

AAADV Workshop Published by Lori Wile · May 4 at 12:53pm · .. U.S. FDA’s Breast Cancer Scientific Lead and Workshop planning committee member Tatiana Prowell talks about AAADV’s goals and purpose at opening day of the 2016 Workshop.

AAADV Workshop 2016, Caleb Egweunu

Caleb Egwuenu, project director for Stand Up to Cancer, Nigeria, talks about his experience at the AAADV Fundamentals pre-workshop for patient advocates sponsored by Susan G. Komen. He is an advocate for bringing clinical trials to Nigeria, and learned more about the science behind cancer and cancer drug development at the Workshop.