2017 AAADV Schedule

Published by aaadv workshop on

08:00 AM
Introductions and Overview
H. Kim Lyerly, M.D.
AAADV Chair

08:15 AM
Plenary Session I
A Systems Biology Approach to Cancer Drug Discovery and Development: Master Regulators as Drug Targets
Moderator :
Gregory Reaman, M.D.; U.S. Food and Drug Administration
A Systems Biology Approach to Cancer Drug Discovery and Development
Speaker :
Andrea Califano, Ph.D.; Columbia University
Systems Pharmacology
Speaker :
Peter Sorger, Ph.D.; Harvard University
Panel Discussion

10:15 AM
Break

10:45 AM
Regulatory Sciences I (learners choose one)
Biomarkers in Cancer Clinical Trials : Eligibility, Endpoints and Surrogates; Moderator: Thomas Fleming, Ph.D., University of Washington
Panelists :
Thomas Fleming, Ph.D.; University of Washington
Lisa McShane, Ph.D.; National Cancer Institute
Mary Redman, Ph.D.; Fred Hutchinson Cancer Research Center
Rajeshwari Sridhara, Ph.D.; U.S. Food and Drug Administration
Expanding Role of Data Science and Bioinformatics in Drug Discovery and Development
Moderator :
Ari Caroline, Ph.D.; Memorial Sloan-Kettering Cancer Center
Panelists : 

Sean Khozin, M.D., M.P.H.; U.S. Food and Drug Administration
Howard Fingert, M.D.; Takeda Oncology
Shahram Ebadollahi, Ph.D., M.B.A.; IBM Watson Health
Martin Murphy, D.Med.Sc., Ph.D., FASCO; Project Data Sphere, CEO Roundtable on Cancer

12:45 PM
Lunch

01:45 PM
Keynote Session
White House Cancer Moonshot: Realities for Cancer Drug Development Through Implementation of NCI and FDA Moonshot Initiatives
Speakers :
Richard Pazdur, M.D.; U.S. Food and Drug Administration
Jeffrey Abrams, M.D.; National Cancer Institute
Panel Discussion: Implementation of the Oncology Center of Excellence; Moderator: Richard Pazdur, M.D., U.S. Food and Drug Adminstration

03:15 PM
Break

03:45 PM
In-Depth Discussion Groups I (learners choose one)
Incorporating the Role of Radiotherapy in Clinical Trials of New Drugs
Moderator :
Amanda Walker, M.D.; U.S. Food and Drug Administration
Panelists : 

Silvia Formenti, M.D.; Weill Cornell Medicine
David Raben, M.D.; University of Colorado
Ozlem Ataman, M.D., Ph.D.; Eisai Pharmaceuticals
Ricky Sharma, M.D., Ph.D.; University College London
Adaptive Clinical Trial Designs: What Works
Moderator :
Brian P. Hobbs, Ph.D.; MD Anderson Cancer Center
Enrolling Adolscents in Disease- and Target-Appropriate Adult Oncology Clinical Trials
Moderator :
Meredith Chuk, M.D.; U.S. Food and Drug Administration
Panelists : 

Ruby Leong, Pharm.D.; U.S. Food and Drug Administration
Micah Hester, Ph.D.; University of Arkansas for Medical Sciences
Lara Davis, M.D.; Oregon Health and Sciences University
Nita Seibel, M.D.; National Cancer Institute
Vicki Traller, Patient Advocate; 4Nathalie
Special Considerations for Cancer Drug Development in Older Adults
Moderators : 

Bindu Kanapuru, M.D.; U.S. Food and Drug Administration
Harpreet Singh, M.D.; U.S. Food and Drug Administration
Panelists –

Stuart Lichtman, M.D.; Memorial Sloan-Kettering Cancer Center
Beverly Canin, Patient Advocate; Cancer and Aging Research Group
Eric H. Rubin, M.D. | Merck Research Laboratories
Heidi Klepin, M.D., M.S.; Wake Forest University
Mihaela Popa McKiver | M.D., Ph.D.; Bristo-Myers Squibb

05:45 PM | Welcome Reception
08:00 AM

Plenary Session II

  • Histology-Agnostic Drug Development: Biologic Rationale, Opportunities, Challenges and Industry Perspective
    Moderators : 
  • Biologic Insights to Tissue-Agnostic Development of Immune-Oncology Drugs
    Speaker : 
  • Pre-Clinical Rationale and Strategies for Tissue-Agnostic Drug Development
    Speaker : 
  • Industry Perspective on Opportunities and Challenges to Histology-Agnostic Development Programs
    Speaker : 
  • Panel Discussion
10:00 AM

Break

10:30 AM

Regulatory Sciences II (learners choose one)

  • Biomarker Assay Validation and Companion Diagnostics Requirements for Tissue-Agnostic Drug Development
    Moderator : 

    Panelists : 

  • Regulatory Challenges with Histology-Agnostic Drug Development 
    Moderator : 

    Panelists : 

12:30 PM

Lunch

01:30 PM

Case Studies I (learners choose one)

03:30 PM

Break

04:00 PM

In-Depth Disscussion Groups II (learners choose one)

  • Modernizing Eligibility Criteria
    Moderator : 
    • Gwynn Ison, M.D.; U.S. Food and Drug Administration

    Panelists : 

  • Global Drug Development: Regulatory and Scientific Issues with Foreign Data
    Moderator : 

    Panelists : 

  • Real World Evidence and Pragmatic Clinical Trials: Introduction by Sean Khozin, M.D., U.S. Food and Drug Administration
    Moderators : 

    Panelists : 

06:00 PM

Networking Reception

08:00 AM

Plenary Session III

  • New Developments in Cancer Immunotherapy: Generating Prolonged Anti-Cancer Immunity
    Moderators : 
    • Ke Liu, M.D., Ph.D.; U.S. Food and Drug Administration
    • Jeffrey Weber, M.D., Ph.D.; New York University Langone Medical Center
  • Improving Adaptive Cell Therapy (ACT) for Cancer
    Speaker : 
  • Designing New CARs for Cancer Treatment
    Speaker : 
  • Beyond Checkpoint Inhibitors: New Approaches to Altering the Tumor Environment
    Speaker : 
    • Roy S. Herbst, M.D., Ph.D.; Yale Cancer Center, Yale School of Medicine
  • Panel Discussion
10:00 AM

Break

10:30 AM

Regulatory Sciences III (learners choose one)

  • Immunotherapy Endpoints
    Moderator : 
  • Evolving Combination Therapies on an Immuno-Oncology Backbone; Regulatory Issues and Pathways
    Panelists : 
    • Jeffrey Weber, M.D., Ph.D.; New York University Langone Medical Center
    • Ke Liu, M.D., Ph.D.; U.S. Food and Drug Administration
12:30 PM

Box Lunches

01:00 PM

Case Studies II (learners choose one)

03:00 PM

Adjourn

Categories: 2017 AAADV Workshop