About AAADV

About

Accelerating Anticancer Agent Development and Validation (AAADV) annually brings together leaders in clinical and translational cancer research from academia, industry, government and the nonprofit advocacy sector to assist investigators in understanding and improving the process of cancer drug development.

The goal is to expedite the development and validation processes for new anticancer and cancer prevention agents so they can be made available to patients at an accelerated rate.

Changes in the law in recent years has given the U.S. Food and Drug Administration new tools to move especially promising new drug applications more quickly through the approvals process. Still, only one agent in 20 emerges successfully from the clinical evaluation process.

AAADV provides the opportunity for education as well as timely, open communication between drug sponsors and the FDA that can help anticipate and circumvent problems that may slow the approval process and help more treatments reach patients sooner.

History

The AAADV Workshop was created in 2004 by Duke University professor of surgery and cancer researcher H. Kim Lyerly, M.D., with Drs. Richard Pazdur of the U.S. Food and Drug Adminstration (FDA), Richard Schilsky, the current chief medical officer of the American Society for Clinical Oncology (ASCO), Margaret Foti of the American Association for Cancer Research (AACR) and Renzo Canetta of Bristol-Myers Squibb.

It has served more than 2,000 attendees since inception.

Four founding partners – FDA, AACR, NCI and Duke – join other sponsors in collaborating to host the workshop each year with financial support from advocacy organizations.

Two new custom workshops launched in 2016 introduce new investigators from academia and private industry and the nonprofit patient advocacy sector to the basics of drug development. AAADV Scholars and AAADV Fundamentals for Advocates are designed to introduce participants to the basics of drug development that will help them engage and benefit more fully from the AAADV Workshop.

Experts from FDA, industry, academia and the nonprofit sector serve on program committees that design each workshop.

AAADV workshops are held each spring in Bethesda, Md., close to FDA, which provides many of the instructors.

Evaluations Affirm AAADV’s Value

Two recent evaluations of the program affirm its value for the knowledge, insights and networks that promote meaningful communications among investigators, advocates and FDA.

An evaluation conducted by the accreditation provider, the American Association for Cancer Research, of participants who sought CME credit during the 2015 Workshop showed it increased participants’ knowledge of the FDA approval process, provided content relevant to their practice, met the learning objectives and, importantly, was free from commercial bias, a priority for partners and participants.

A comprehensive, independent evaluation of the program conducted in May 2015 by Matt Serra, Ph.D., director of the Office of Assessment, Trinity College of Arts and Sciences at Duke University, examined its impact. Serra found the Workshop achieved its three specific learning objectives in that participants who completed the program could successfully:

  • Assess the key decision points in determining if an anticancer agent or combination has clinical benefit.
  • Analyze and more effectively follow FDA safety and efficacy guidelines during the development and clinical testing of anticancer and cancer prevention drugs and in their long-term safety evaluation.
  • Design and participate in oncology clinical trials with meaningful endpoints and accrual goals.

Overall, Serra said, the Workshop achieved two key goals:

“First, the event brought together organizers, participants and presenters from the relevant stakeholder groups. Second, it clearly met its goal to ‘expedite the development and validation processes for new anticancer and cancer prevention agents by educating investigators, so that new agents can be made available to patients at the most efficient rate, hopefully more rapidly in the future than in the present’.”