AAADV Workshop



Planning Committee



Satellite Symposia

AAADV Workshop

Leaders in clinical and translational cancer research from academia, industry, government and the nonprofit advocacy sectors convene each spring in Bethesda, Maryland, for a unique forum designed to speed cancer treatments to patients. Our two and one-half day, on-site interactive AAADV 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. The 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 that effective cancer treatments can reach patients more quickly.

Who Should Attend

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 regulatory aspects of oncology drug development will benefit from the knowledge and networking with more-experienced investigators and advocates.

Participants Will:
  • Examine the most urgent issues and meaningful trends in anticancer agent development and
  • 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 frontlines of
    cancer research and treatment.

Executive Committee

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H. Kim Lyerly, M.D.
Duke University
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Richard Pazdur, M.D.
U.S. Food and Drug Administration
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Gregory Reaman, M.D.
U.S. Food and Drug Administration
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Mary Scroggins, M.A.
Pinkie Hugs, LLC

Annual Workshop Planning Committee

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Julia Beaver, M.D.
U.S. Food and Drug Administration
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Renzo Canetta, M.D.
Independent Consultant
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Helen Chen, M.D.
National Cancer Institute
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Howard Fingert, M.D.
Takeda Oncology Company
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Thomas Fleming, Ph.D.
University of Washington
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Joseph Gootenberg, M.D.
U.S. Food and Drug Administration
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Ramaswamy Govindan, M.D.
Washington University
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Axel Hoos, M.D., Ph.D.
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Pasi A. Jänne, M.D., Ph.D.
Harvard Medical School
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Virginia Kwitkowski, M.S., ANCP-BC
U.S. Food and Drug Administration
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Ke Liu, M.D., Ph.D.
U.S. Food and Drug Administration
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Patricia LoRusso, D.O.
Yale University
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Tatiana Prowell, M.D.
U.S. Food and Drug Administration
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Richard Schilsky, M.D.
American Society of Clinical Oncology
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Sarah Schrieber, Pharm.D.
U.S. Food and Drug Administration
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Patricia Spears, B.S.
Susan G. Komen

Continuing Medical Education

Accreditation Statement

The American Association for Cancer Research (AACR) is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education activities for physicians.

Credit Designation Statement

AACR has designated this live activity for a maximum of 19.25 AMA PRA Category 1 Credits™. Physicians should only claim credit commensurate with the extent of their participation in the activity.

Credit certification for individual sessions may vary, dependent upon compliance with the ACCME Accreditation Criteria. The final number of credits may vary from the maximum number indicated above.


Physicians and other health care professionals seeking AMA PRA Category 1 Credits™ for this live continuing medical education activity must complete the online CME Request for Credit Survey, below, by Friday, June 17, 2016. Certificates will only be issued to those who complete the survey. The Request for Credit Survey will be available via this link, CME REQUEST FOR CREDIT SURVEY, and via email. Your CME certificate will be sent to you via email after the completion of the activity.

Statement of Educational Need, Target Audience, and Learning Objectives

This course provides a comprehensive review of agent (including drugs and biological) development including preclinical and clinical evaluation, and regulatory procedures and endpoints required to bring discovery into clinical use that provide benefit to patients.

Few individual investigators have the entire scope of this knowledge, and the Workshop integrates this knowledge with real-life examples, specifically illustrating the role that the community, including the investigator, plays in the process from discovery and approvals and beyond. Only one agent is successfully produced for every 20 that enter into clinical evaluation.

The goal of this Workshop is to accelerate and increase efficiency in the development of anticancer agents by providing insight and guidance into the process to make better informed decisions about which agents are likely to have efficacy and a satisfactory safety profile. The Workshop provides examples of success and real life solutions to the challenges of producing successful development plans and clinical trials with an aim of developing anticancer agents that benefit patients. The Workshop provides an opportunity for dialogue between regulatory agencies, patient advocates and scientist investigators including basic, translational and clinical populations.

After participating in this CME activity, physician-scientists should be able to:

  • Improve the efficiency of testing and increase the success rate of development plans for agents that provide benefit to patients.
  • Have the opportunity for open dialogue between regulatory agencies and the oncology community, including physician-scientists.
  • Use creative thinking in addressing current challenges and developing useful and informative oncology clinical trials.

Disclosure Statement

It is the policy of the AACR that the information presented at AACR CME activities will be unbiased and based on scientific evidence. To help participants make judgments about the presence of bias, AACR will provide information that Scientific Program Committee members and speakers have disclosed about financial relationships they have with commercial entities that produce or market products or services related to the content of this CME activity. This disclosure information will be made available in the Program/Proceedings of this workshop.


Please contact the AACR Office of CME at (215) 440-9300 or

Industry: $2,400

Academic: $1,000

Must be employed by a recognized academic institution to receive reduced registration fee rate.

Advocates: $1,000

Must be sponsored by a nationally recognized advocacy organization or foundation to receive reduced registration fee rate.

Government: $0

Limited space available. Must be employed at the fellow or trainee level by a U.S. government agency and involved in oncology drug discovery and/or development.

Cancellation policy:

  • Full registration fee refund if cancelled by March 31, 2016.
  • 50% of registration fee refunded if cancelled between April 1 and 15, 2016.
  • No refunds or registration transfers after April 15, 2016.

The AAADV Workshop will offer several Satellite Symposia on the afternoon of Friday, May 6. The satellite topics will expand on material presented within the framework of the workshop sessions, and/or offer material not able to be covered within the program. Symposia are independently sponsored, and do not fall under the purview of the AAADV Planning Committee, nor are they certified for continuing medical education credits.

There is no additional cost to attend the Satellite Symposia, but advance sign-up is requested at the time of enrollment to the Workshop so that appropriate accommodations can be provided. Box lunches will be made available to Symposia attendees. Please refer to the AAADV Workshop Schedule, for complete topic and speaker information.

Satellite Symposium I: The Quantified Patient: Capturing the Patient Experience in the Age of Mobile Apps and Wearables

Satellite Symposium II: Accelerating Anti-Metastatic Drug Development

Satellite Symposium III: The Technology Infrastructure and Next-gen Analytics of Tomorrow’s Biomedical Enterprise