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
Plenary Session II
- Histology-Agnostic Drug Development: Biologic Rationale, Opportunities, Challenges and Industry Perspective
Moderators :- Patricia LoRusso, D.O.; Yale University
- Gregory Reaman, M.D.; U.S. Food and Drug Administration
- Biologic Insights to Tissue-Agnostic Development of Immune-Oncology Drugs
Speaker :- Eric H. Rubin, M.D.; Merck Research Laboratories
- Pre-Clinical Rationale and Strategies for Tissue-Agnostic Drug Development
Speaker :- Priti Hegde, Ph.D.; Genentech/Roche
- Industry Perspective on Opportunities and Challenges to Histology-Agnostic Development Programs
Speaker :- Josh Bilenker, M.D.; Loxo Oncology
- Panel Discussion
Break
Regulatory Sciences II (learners choose one)
- Biomarker Assay Validation and Companion Diagnostics Requirements for Tissue-Agnostic Drug Development
Moderator :- Reena Philip, Ph.D.; U.S. Food and Drug Administration
Panelists :
- Ignacio Wistuba, M.D.; MD Anderson Cancer Center
- Girish Putcha, M.D., Ph.D.; Palmetto GBA MoIDX
- Regulatory Challenges with Histology-Agnostic Drug Development
Moderator :- Rajeshwari Sridhara, Ph.D.; U.S. Food and Drug Administration
Panelists :
- David Hyman, M.D.; Memorial Sloan Kettering Cancer Center
- Francis J. Giles, M.D.; Northwestern University
- Richard Pazdur, M.D.; U.S. Food and Drug Administration
- Mary Redman, Ph.D.; Fred Hutchinson Cancer Research Center
Lunch
Case Studies I (learners choose one)
Break
In-Depth Disscussion Groups II (learners choose one)
- Optimizing the Patient Experience in Cancer Drug Development: Stakeholder Perspectives
Moderator :- Lola Fashoyin-Aje, M.D., M.P.H.; U.S. Food and Drug Administration
Panelists :
- Rajeshwari Sridhara, Ph.D.; U.S. Food and Drug Administration
- Patricia Spears, Patient Advocate; Susan G. Komen
- Sonya L. Eremenco, M.A.; Critical Path Institute
- Danielle Leach, M.P.A.; St. Baldrick’s Foundation
- Selena Daniels, Pharm.D., M.S.; U.S. Food and Drug Administration
- Oliver Rosen, M.D.; Deciphera Pharmaceuticals
- Michael Carducci, M.D.; Johns Hopkins University
- Modernizing Eligibility Criteria
Moderator :- Gwynn Ison, M.D.; U.S. Food and Drug Administration
Panelists :
- Edward Kim, M.D.; Levine Cancer Institute
- Thomas Uldrick, M.D., M.S.; National Cancer Institute
- Nancy Lin, M.D.; Dana Farber Cancer Institute
- Joohee Sul, M.D.; U.S. Food and Drug Administration
- Nam Atiqur Rahman, Ph.D.; U.S. Food and Drug Administration
- Global Drug Development: Regulatory and Scientific Issues with Foreign Data
Moderator :- Renzo Canetta, M.D.; Independent Consultant
Panelists :
- Janet Wittes, Ph.D.; Statistics Collaborative
- Patricia Keegan, M.D.; U.S. Food and Drug Administration
- Edward Trimble, M.D., M.P.H.; National Cancer Institute
- Philip Johnson, M.D., F.R.C.P.; University of Liverpool
- Real World Evidence and Pragmatic Clinical Trials: Introduction by Sean Khozin, M.D., U.S. Food and Drug Administration
Moderators :- Sean Khozin, M.D., M.P.H.; U.S. Food and Drug Administration
- Howard Fingert, M.D.; Takeda Oncology
Panelists :
- Robert S. Miller, M.D., FACP, FASCO; CancerLinQ at American Society of Clinical Oncology
- Amy Abernethy, M.D., Ph.D.; Flatiron Health
- Jan Liphardt, Ph.D.; Stanford University
Networking Reception
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 :- Steven Rosenberg, M.D., Ph.D.; National Cancer Institute
- Designing New CARs for Cancer Treatment
Speaker :- Marcela Maus, M.D., Ph.D.; Massachusetts General Hospital
- 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
Break
Regulatory Sciences III (learners choose one)
- Immunotherapy Endpoints
Moderator :- Marc Theoret, M.D.; U.S. Food and Drug Administration
- 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
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