Anna Abram, Deputy Commissioner for Policy, Planning, Legislation and Analysis, US FDA
Rick Pazdur, Director, Oncology Center of Excellence, US FDA
May 8-10, 2019, Bethesda, Maryland – Registration Opens Feb. 1
Co-sponsored by the U.S. Food and Drug Administration, the AAADV Global Regulatory Workshop is conducted to learn from senior international regulatory agency personnel from other countries. This unique educational offering is a rare opportunity for investigators, regulatory experts,and drug developers involved in global anti-cancer drug development to interact, in particular those examining populations or sub-populations in which drug development must be conducted internationally.
Investigators, regulatory experts and drug developers involved in global anti-cancer drug development, particularly in examining populations or sub-populations in which drug development must be conducted internationally.
The Pre-Workshop for Patient Advocates is a one-day course held the day before the AAADV Workshop and is intended as an extension of the workshop. It is open to advocates from all disease sites and focuses on how advocates can work more effectively with all stakeholders in the research process to ensure that the patient voice is incorporated across all conversations and decision making.
Open to advocates from all disease sites who are interested in basic training on the role of the U.S. Food and Drug Administration and cancer patient advocates in oncology product development.
Scholarships for patient advocates for the registration fee and support for travel and housing are available. Please click HERE for a Patient Advocate scholarship application.
16th Annual Workshop May 8-10, 2019, Bethesda, Maryland
Leaders in clinical and translational cancer research from academia, industry, government and nonprofit advocacy sectors convene each spring in Bethesda, Maryland, for the AAADV Workshop, a unique forum designed to speed cancer treatments to patients. This three-day, on-site interactive workshop offers a mix of small group lectures, moderated discussions, plenary lectures and facilitated case studies of successful drug applications. Participants gain valuable insights on negotiating the spectrum of successful drug development and hone their strategic planning skills with a focus on target validation and pathway identification. AAADV is the only workshop held in collaboration with the U.S. Food and Drug Administration designed specifically to help participants understand and negotiate the drug development approval process so effective cancer treatments can reach patients more quickly.
The AAADV Workshop is designed for scientists and consumer advocates with clinical trial experience interested in developing agents for the diagnosis, treatment or prevention of cancer. Individuals with limited experience in the regular aspects of oncology drug development will benefit from the knowledge of and networking with more experienced investigators and advocates.
Scholarships covering the cost of registration, travel and accommodations for the Pre-Workshop for Patient Advocate attendees are available.
• Examine the most urgent issues and meaningful trends in anticancer agent development and validation.
• Learn new approaches for diagnosing, treating and preventing cancer.
• Benefit from a mix of small group lectures, moderated discussions, facilitated case studies of successful new drug applications and plenary lectures.
• Network with researchers, regulators, patient advocates and others working on the front lines of cancer research and treatment.
Case studies of successful new drug applications feature pharmaceutical drug development teams and U.S. Food and Drug Administration officers involved in the drug approval process. Four drugs will be presented twice over the course of the Workshop.
The Core Curriculum is designed for early-career drug development investigators and covers all aspects of clinical studies: preclinical and clinical science, statistical structure of trials, ethical requirements and regulatory considerations. It is taught by U.S. Food and Drug Administration (FDA) medical officers and senior scientists. Core Curriculum sessions occur concurrently with AAADV Workshop morning sessions on May 7, and offer breakfast discussion groups May 8-9.
Satellite Sessions are additional meetings or presentations held the afternoon of May 10 after conclusion of the AAADV Workshop. VIsit back for details and room locations.