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May 8th 2019 May 9th 2019 May 10th 2019 Wed May 8th 2019 8:00am – 9:30am Registration for AAADV Workshop; Continental Breakfast 9:30 am – 12:00 pm Moderator Lola Fashoyin-Aje, M.D., M.P.H. ; U.S. Food and Drug Administration Core Curriculum For New Learners Faculty from U.S. Food and Drug Administration: Denise Casey, M.D. Christy Osgood, M.D. […]

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 […]

Schedule for FDA-Duke Global Pre-Workshop

FDA-Duke Global Regulatory Pre-Workshop White Flint Amphitheater Date: Tuesday, May 7, 2019 8:00 – 8:30 AM Registration/Continental Breakfast 8:30 – 8:35 am Welcome/Introduction/Goals of the Workshop Speaker Ke Liu US FDA 8:35 – 10:05 am Moderator Richard Pazdur, US FDA Session I: International Regulators’ Forum Agnes Chan Singapore HSA Larissa Higgins EMA Representative Jaigi Mathai Health […]

Schedule for AAADV Pre-Workshop for Patient Advocates

Agenda AAADV Pre-Workshop for Patient Advocates Location: Salon H Date: Tuesday, May 7, 2019Time: 12:30 PM-5:00 PM 11:45 AM-12:30 PM Registration 12:30 PM-1:00 PM Introduction/ Challenges and Questions for the Day Speakers H Kim Lyerly, MD DAAD Director and Duke University Mary (Dicey) Jackson Scroggins M.A.  (International Gynecologic Cancer Society) Virginia Kwitkowski, MS, ACNP-BC FDA, Div. of […]

Fundamentals Pre-Workshop for Patient Advocates

This custom course is held immediately before the 15th Annual AAADV Workshop and will focus on how advocates can work more effectively with all stakeholders The custom course preceding the 15th Annual AAADV Workshop will provide valuable insights on how advocates can build better relationships with all stakeholders. The course aims to equip participants with the […]

Challenges with Novel Clinical Trial Designs: Master Protocols.

As seen on 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 […]

Duke University Conference

Duke University conference Pea horseradish azuki bean lettuce avocado asparagus okra. Kohlrabi radish okra azuki bean corn fava bean mustard tigernut jícama green bean celtuce collard greens avocado quandong fennel gumbo black-eyed pea. Grape silver beet watercress potato tigernut corn groundnut. Chickweed okra pea winter purslane coriander yarrow sweet pepper radish garlic brussels sprout groundnut […]

15th Annual AAADV Workshop

Leaders in clinical and translational cancer research from academic, industry, government and the nonprofit advocacy sector focus on understanding and efficiently negotiating the drug development process.  May 2-4, 2018

Keynote Speaker Anna Abram

2018 AAADV Keynote Speaker Anna Abram, FDA Deputy Commissioner for Policy, Planning, Legislation and Analysis with Richard Pazdur, M.D., Director of FDA Oncology Center of Excellence.