Regulatory Science and Policy Track
The Regulatory Science and Policy track provides attendees with an opportunity to interact with the U.S. Food and Drug Administration (FDA), National Cancer Institute, industry, and many in academia, including basic researchers and physician scientists. These informative sessions are designed to highlight recent regulatory developments and provide an open forum for the discussion of cutting-edge issues in cancer drug, biologic, and diagnostic regulation.
2024 | 2023 | 2022 | 2021 | 2020 | 2019 | 2018 | 2017 | 2016 | 2015 | 2014 | 2013 | 2012
annual meeting 2024
DC01. Navigating Laboratory Developed Tests in Oncology: Emerging Needs and Opportunities
Apr 6 2024 10:00AM Room 1 – Upper Level – Convention Center
DC06. Rethinking Risk and Risk Assessment for Liquid Biopsy-Based Single- and Multi-Cancer Screening
Apr 6 2024 12:30PM Room 1 – Upper Level – Convention Center
DC02. FDA’s Project Endpoint and Overall Survival in Oncology Clinical Trials
Apr 6 2024 2:30PM Room 1 – Upper Level – Convention Center
DC10. Perioperative Pandemonium: Trial Designs in Solid Tumors
Apr 7 2024 1:00PM Room 1 – Upper Level – Convention Center
DC04. Trading Places: Regulator as Patient, Patient as Regulator
Apr 8 2024 10:15AM Room 1 – Upper Level – Convention Center
DC03. FDA Center for Tobacco Products’ Priorities to Reduce Tobacco Use and Support the Cancer Moonshot
Apr 8 2024 10:15AM Room 5 – Upper Level – Convention Center
DC05. Disparities in Pediatric Oncology
Apr 8 2024 12:30PM Room 1 – Upper Level – Convention Center
DC09. In the Eye of the Beholder: Equipoise in Cancer Clinical Trials
Apr 8 2024 2:30PM Room 1 – Upper Level – Convention Center
DC07. Diversity Plans in Action: FDA, Industry, and Community Perspectives
Apr 9 2024 10:15AM Room 1 – Upper Level – Convention Center
DC08. Putting the Precision Back in Precision Oncology
Apr 9 2024 12:30PM Room 1 – Upper Level – Convention Center
annual meeting 2023
DC06. Project Livin’ Label: Fam-trastuzumab Deruxtecan-nxki in Breast Cancer— Redefining HER2 Status
- Apr 15 2023 2:30PM – Room W315 – Convention Center
- Apr 16 2023 1:00PM – Room W315 – Convention Center
DC09. Importance of Overall Survival in Assessing Risk/Benefit: The PARP and PI3K Inhibitor Stories
- Apr 17 2023 10:15AM – Room W315 – Convention Center
DC10. Implementing Diversity Action Plans for Clinical Trials
- Apr 17 2023 12:30PM – Room W315 – Convention Center
DC11. Using Real World Evidence to Advance Pediatric Cancer Drug Development
- Apr 17 2023 2:30PM – Room W315 – Convention Center
DC12. Project Site Selector: Navigating Oncology Drug Development through Troubled Waters
- Apr 18 2023 10:15AM – Room W315 – Convention Center
DC13. Multi-cancer Early Detection (MCED) Assays: Early Detection Versus Early Distraction
- Apr 18 2023 12:30PM – Room W315 – Convention Center
DC14. Liquid Biopsies for Curative-Intent Solid Tumor Drug Development
- Apr 18 2023 2:30PM – Room W315 – Convention Center
AACR ANNUAL MEETING 2022
DC04. Using Patient-Generated Data to Optimize the Dose for Oncology Drugs
April 8, 2022, 3:00 PM – 4:30 PM (CT)
Room 265-268, Convention Center
PARTICIPANTS: Mirat Shah, FDA; Paul Kluetz, FDA; Vishal Bhatnagar, FDA; Jeanne Fourie Zirkelbach, FDA; Mallorie Fiero, FDA; Serban Ghiorghiu, AstraZeneca; Gita Thanarajasingam, Mayo Clinic; and Karen Arscott, Patient Advocate
DC05. Dose Optimization for Antibody-Drug Conjugates
April 9, 2022, 8:00 AM – 9:30 AM (CT)
Room 356-357, Convention Center
PARTICIPANTS: Mirat Shah, FDA; Shan Pradhan, FDA; Salaheldin Hamed, FDA; Sumithra Mandrekar; Mayo Clinic; Chunze Li, Genentech; Dikla Benzeevi, Patient Advocate; Sara Tolaney, Dana Farber Cancer Institute; Jonathon Vallejo
DC08. Highlighting the AACR/HBS/MMRF Summit: Reducing Disparities and Democratizing Cancer Care
April 10, 2022, 1:00 PM – 2:30 PM (CT)
Room 356-357, Convention Center
PARTICIPANTS: Kathy Giusti, Multiple Myeloma Research Foundation; John Carpten, Keck School of Medicine, USC; Richard Hamermesh, Harvard Business School; Douglas Lowy, NCI; Lola Fashoyin-Aje, FDA; David Wholley, The Foundation for the National Institutes of Health (FNIH); Andy Schmeltz, Pfizer; Peter Lebowitz, Janssen/Johnson and Johnson; Patricia Doykos, Bristol Myers Squibb; Leo Seoane, Ochsner Health; Richard Barakat, Northwell Health Cancer Institute; Brian Rivers, Morehouse School of Medicine; Rob Winn, VCU Massey Cancer Center; Edith Mitchell, Sidney Kimmel Cancer Center at Jefferson; Ajay Nooka, Winship Cancer Institute of Emory University; and Catherine Chao, Ad Council
DC02. Quality Over Quantity: Advancing Real World Data toward Real World Evidence
April 10, 2022, 3:00 PM – 4:30 PM (CT)
Room 356-357, Convention Center
PARTICIPANTS: Donna Rivera, FDA; Deborah Schrag, Memorial Sloan-Kettering Cancer Center; Katherine Panageas, Memorial Sloan-Kettering Cancer Center; Marcelo C. Pasquini, Medical College of Wisconsin; Ran Balicer, Clalit Health Services (Israel); Nicole Gatto, Aetion; and Keith Marsolo, Duke University
DC11. Molecular Tumor Profiling (MTP) for Clinical Care and Research for Pediatric Oncology
April 11, 2022, 10:15 AM – 11:45 AM (CT)
Room 356-357, Convention Center
PARTICIPANTS: Greg Reaman, FDA; Katherine Janeway, Dana-Farber Cancer Institute; Pablo Berlanga, University Hospital La Fe (Valencia, Spain); Gwen Nichols, Leukemia & Lymphoma Society (LLS); Jack Shern, NCI; and Nickhill Bhakta, St. Jude Children’s Research Hospital
DC03. Accelerated, Conditional, Provisional, or Temporary? A Comparison of International Expedited Approval Programs
April 11, 2022, 12:30 PM – 2:00 PM (CT)
Room 356-357, Convention Center
PARTICIPANTS: Gautam Mehta, FDA; Lauren Tesh Hotaki, FDA; Angelo DeClaro, FDA; Michael Shum, Australian Government Department of Health; Francesco Pignatti, European Medicines Agency (EMA); and Ulrich P. Rohr, Swissmedic Swiss Agency for Therapeutic Products (Switzerland)
DC07. Successful Development of Cancer Therapies for Ultra-Rare Indications
April 11, 2022, 2:30 PM – 4:30 PM (CT)
Room 356-357, Convention Center
PARTICIPANTS: Jeff Summers, FDA; Marc Theoret, FDA; Donald Lo, NIH; Deepa Narayanan, NIH; Josh Sommer, Chordoma Foundation; Jeffrey Toretsky, Georgetown University; and Michael Stebbins, Science Advisors, LLC
DC01. Supporting Smoking Cessation Among Patients with Cancer Who Use Tobacco Products
April 12, 2022, 10:15 AM – 11:45 AM (CT)
Room 356-357, Convention Center
PARTICIPANTS: Roy Herbst, Yale University School of Medicine; Stephanie Land, NCI; Michael Fiore, University of Wisconsin School of Medicine; Sarah V. Clark, Northwestern University; Tracy E. Crane, University of Miami
DC09. FDA Oncology Center of Excellence Patient Engagement Initiatives: An Interactive Roundtable Discussion
April 12, 2022, 12:30 PM – 2:00 PM (CT)
Room 356-357, Convention Center
PARTICIPANTS: Rea Blakey, FDA;Vishal Bhatnagar, FDA; Yelak Biru, International Myeloma Foundation; Marcia Cruz-Correa, University of Puerto Rico Comprehensive Cancer Center; Shonte’ Drakeford, Metastatic Breast Cancer Patient Advocate; Donna Rivera, FDA; Julie Schneider, FDA; and Karen Winkfield, Vanderbilt University Medical Center
DC06. Defining Clinical Benefit: Accelerated Approval in Precision Oncology
April 12, 2022, 2:30 PM – 4:00 PM (CT)
Room 356-357, Convention Center
PARTICIPANTS: Gautam Mehta, FDA; Diana Bradford, FDA; Lori Wirth, Dana Farber Cancer Center; Vivek Subbiah, MD Anderson Cancer Center; and Sara Whitlock, RET Renegades
DC10. Educating the Next Generation of Oncology Leaders
April 13, 2022, 10:15 AM – 11:45 AM (CT)
Room 288-290, Convention Center
PARTICIPANTS: Paz Vellanki, FDA; Christopher Chen, Stanford, former FDA-AACR fellow; Ashkan Emadi, University of Maryland; Aakash Desai, Mayo Clinic, current FDA-AACR fellow; Tatiana Young, FDA Summer Scholar; Amanda Redig, Blackstone Life Sciences; and Dawn Aldrich, Solutions Cancer Resource Center
AACR VIRTUAL ANNUAL MEETING II 2021
FDA OCE Engagement Efforts: Building an Inclusive Cancer Community
Paul G. Kluetz, Chair, U.S. Food and Drug Administration
Rea Blakey, U.S. Food and Drug Administration
Lola A. Fashoyin-Aje, U.S. Food and Drug Administration
Claudia M. Hardy, University of Alabama, O’Neal Comprehensive Cancer Center
Chanita Hughes-Halbert, Medical University of SC Hollings Cancer Center
Desiree Walker, Young Survival Coalition
Jackson Sarter, Washington University in St. Louis
Lessons Learned from COVID-19: Adaptations and Approaches for Trial Modernization
Donna R. Rivera, Chair, U.S. Food and Drug Administration
Sundeep Agrawal, Chair, U.S. Food and Drug Administration
Susan Winckler, Reagan-Udall Foundation
Nicole J. Gormley, U.S. Food and Drug Administration
Elizabeth Barksdale, LUNGevity Foundation
Jill Feldman, EGFR Resisters
James H. Doroshow, National Cancer Institute, NIH
Noolie Gregory, Syneos Health
Use of Liquid Biopsies in Identifying Minimal Residual Disease in Solid Tumors in the Adjuvant Setting
Reena Philip, Chair, U.S. Food and Drug Administration
Paz Joan Vellanki, Chair, U.S. Food and Drug Administration
Laura Greco, Patient Advocacy
Ben Ho Park, Vanderbilt-Ingram Cancer Center
Jeanne Tie, Peter MacCallum Cancer Centre
Alexey Aleshin, Natera
Darren Hodgson, AstraZeneca
Anand Pathak, U.S. Food and Drug Administration
Mark D. Stewart, Friends of Cancer Research
James H. Godsey, Illumina
The Promise and Perils of Germline Testing in the Management of Patients with Cancer
Steven Lemery, Chair, U.S. Food and Drug Administration
Heather L. Hampel, The Ohio State University Comprehensive Cancer Center
Allison W. Kurian, Stanford University
Zsofia K. Stadler, Memorial Sloan Kettering Cancer Center
Richard M. Weinshilboum, Mayo Clinic College of Medicine
Anand Pathak, U.S. Food and Drug Administration
Michael Pacanowski, U.S. Food and Drug Administration
Wenora Y. Johnson, FORCE
ACCELERATE-ing Pediatric Cancer Drug Discovery and Development
Gregory H. Reaman, Chair, U.S. Food and Drug Administration, CDER
Lori Ehrlich, U.S. Food and Drug Administration
Mark W. Kieran, Bristol-Myers Squibb Co.
Gilles Vassal, Gustave Roussy
Steven DuBois, Dana-Farber Cancer Institute
Nancy F. Goodman, Kids v Cancer
Martha Donoghue, U.S. Food and Drug Administration
Brenda J. Weigel, University of Minnesota
Andrew D J Pearson, ACCELERATE
Scott J. Diede, Merck
Hot Topics in Oncology Regulation
Chana Weinstock, Chair, U.S. Food and Drug Administration
Kelly J. Norsworthy, Chair, U.S. Food and Drug Administration
Bill Pierce, U.S. Food and Drug Administration
Donna R. Rivera, U.S. Food and Drug Administration
Mirat Shah, U.S. Food and Drug Administration
Andrea Baines, U.S. Food and Drug Administration
Poornima Sharma, U.S. Food and Drug Administration
Lola Fashoyin-Aje, U.S. Food and Drug Administration
Racial and Ethnic Diversity in Clinical Trials Evaluating Hematologic Malignancies
Ashley Woods, Chair, U.S. Food and Drug Administration
Bindu Kanapuru, Chair, U.S. Food and Drug Administration
Loriana Hernandez -Aldama, ArmorUp for LIFE
Christopher Flowers, UT MD Anderson Cancer Center
Bhavana Bhatnagar, Schiffler Cancer Center
Raoul Tibes, AstraZeneca
Kenneth C. Anderson, Dana-Farber Cancer Institute
AACR Virtual Annual Meeting II 2020
Under-representation in Clinical Trials and the Implications for Drug Development
Kenneth C. Anderson (Cochair) – Dana-Farber Cancer Institute, Boston, Massachusetts
Nicole J. Gormley (Cochair) – FDA, Silver Spring, Maryland
Richardae Araojo – FDA, Silver Spring, Maryland
Yelak Biru – Patient Advocate, Bentonville, Arkansas
Lola A. Fashoyin-Aje – FDA, Silver Spring, Maryland
Daniel J. George – Duke University Medical Center, Durham, North Carolina
Ruben Mesa – Mays Cancer Center at UT Health San Antonio, San Antonio, Texas
Ajay K. Nooka – Winship Cancer Institute at Emory University, Atlanta, Georgia
COVID-19 and Cancer: Guidance for Clinical Trial Conduct and Considerations for RWE
Harpreet Singh (Chair) – FDA, Silver Spring, Maryland
Amy Abernethy – FDA, Silver Spring, Maryland
Jonathan Hirsch – Syapse, San Francisco, California
Paul G. Kluetz – FDA, Silver Spring, Maryland
Wendy Rubinstein – FDA, Silver Spring, Maryland
C.K. Wang – COTA, Boston, Massachusetts
Engaging the Oncology Community to Advance Regulatory Science: FDA’s Project Renewal and Project Socrates
Jennifer Gao (Cochair) – FDA, Silver Spring, Maryland
Patricia Keegan (Cochair) – FDA, Silver Spring, Maryland
Paul G. Kluetz (Cochair) – FDA, Silver Spring, Maryland
George Demetri – Dana-Farber Cancer Institute, Boston, Massachusetts
R. Donald Harvey – Emory University School of Medicine, Atlanta, Georgia
Justin N. Malinou – University of Maryland Greenebaum Comprehensive Cancer Center, Baltimore, Maryland
Tumor Response Evaluation Criteria for Intratumoral Therapy
Ke Liu (Chair) – FDA, Silver Spring, Maryland
Sanjay Goel – Montefiore Medical Center, Bronx, New York
Gregory Goldmacher – Merck, West Point, Pennsylvania
Howard L. Kaufman – Immuneering Corporation, Boston, Massachusetts
Aurelian Marabelle – Institute Gustave Roussy, Villejuif, France Lawrence H. Schwartz – Columbia University Medical Center, New York, New York
Hot Topics in Oncology Regulation
Lola A. Fashoyin-Aje (Chair) – FDA, Silver Spring, Maryland
Soma Ghosh – FDA, Silver Spring, Maryland
Nicole J. Gormley – FDA, Silver Spring, Maryland
Paul G. Kluetz – FDA, Silver Spring, Maryland
Steven J. Lemery – FDA, Silver Spring, Maryland
Ke Liu – FDA, Silver Spring, Maryland
Marc Theoret – FDA, Silver Spring, Maryland
Jeanne Fourie Zirkelbach – FDA, Silver Spring, Maryland
AACR Annual Meeting 2019 (Atlanta, Georgia)
PD-1 Pandemonium: FDA Speaks with Industry on the Past, Present, and Future of PD-1 Drugs
Richard Pazdur (Moderator) – FDA, Silver Spring, Maryland
Marc Theoret (Moderator) – FDA, Silver Spring, Maryland
Hesham A. Abdullah – AstraZeneca, Rockville, Maryland
Kevin Chin – EMD Serono, Billerica, Massachusetts
Scot W. Ebbinghaus – Merck, Lansdale, Pennsylvania
Israel Lowy, Regeneron – Tarrytown, New York
Fouad Namouni – Bristol-Myers Squibb, Princeton, New Jersey
Alan B. Sandler – Genentech, South San Francisco, California
FDA 201 – Topics in Oncology Regulation
Harpreet Singh (Cochair) – FDA, Silver Spring, Maryland
Lola A. Fashoyin-Aje (Cochair) – FDA, Silver Spring, Maryland
R. Angelo de Claro – FDA, Silver Spring, Maryland
Nicole J. Gormley – FDA, Silver Spring, Maryland
Ke Liu – FDA, Silver Spring, Maryland
Pallavi Mishra-Kalyani – FDA, Silver Spring, Maryland
Rajeshwari Sridhara – FDA, Silver Spring, Maryland
Cancer Genomic Reference Samples – MDIC Somatic Reference Sample Collaborative Initiative
Živana Težak (Chair) – FDA, Silver Spring, Maryland
Wenming Xiao – FDA, Silver Spring, Maryland
J.D. Alvarez – Janssen, Spring House, Pennsylvania
Chris Karlovich – Frederick National Laboratory, Frederick, Maryland
Diana M. Merino – Friends of Cancer Research, Washington, D.C.
Barbara A. Zehnbauer – Emory University School of Medicine, Atlanta, Georgia
Impact of a Brexit on Oncology Drug Development and Regulation
C. Simone Fishburn (Chair) – BioCentury, Redwood City, California
Susan M. Galbraith – AstraZeneca, Cambridge, United Kingdom
Joanne M. Hackett – Genomics England, London, United Kingdom
John Haurum – Cambridge, United Kingdom
Richard M. Marais – Cancer Research UK Machester Institute, Manchester, United Kingdom
East Looks West: Chinese Pharma Explores Western Markets
Joshua L. Berlin (Chair) – BioCentury, Redwood City, California
Frank Jiang, CStone Pharmaceuticals, Shanghai, China
Joan Shen – I-Mab Biopharma, Shanghai, China
Dan Zhang – Foundation Medical Development, Beijing, China
West Looks East: Western Pharma Explores the China Mainland
Ke Liu (Chair) – FDA, Silver Spring, Maryland
George Chen – AstraZeneca, Shanghai, China
Xiaoyuan Chen – Tsinghua University, Beijing, China
Fangning Zhang – McKinsey & Company, Beijing, China
Hyper-progression and Immuno-oncology: Scientific, Clinical, and Regulatory Challenges
Victoria L. Chiou (Cochair) – FDA, Silver Spring, Maryland
Elad Sharon (Cochair) – NCI, Bethesda, Maryland
Marina C. Garassino – Istituto Nazionale dei Tumori, Milan, Italy
Razelle Kurzrock – UCSD Moores Cancer Center, San Diego, California
Susan L. Leighton – Patient Advocate, Huntsville, Alabama
Lawrence H. Schwartz – Columbia University Medical Center, New York, New York
Jean-Charles Soria – MedImmune, Gaithersburg, Maryland
Artificial Intelligence and Machine Learning for Regulatory Science and Drug Development Applications
Sean Khozin (Chair) – FDA, Silver Spring, Maryland
Metin N. Gurcan – Wake Forest School of Medicine, Winston-Salem, North Carolina
Lawrence H. Schwartz, Columbia University Medical Center, New York, New York
Pratik Shah – Massachusetts Institute of Technology, Cambridge, Massachusetts
Differentiation Syndrome in Acute Myeloid Leukemia: Challenges for Drug Development and Regulation
Kelly J. Norsworthy (Cochair) – FDA, Silver Spring, Maryland
E. Dianne Pulte (Cochair) – FDA, Silver Spring, Maryland
Jessica K. Altman – Northwestern Medicine, Chicago, Illinois
Mark J. Levis – Johns Hopkins Sidney Kimmel Cancer Center, Baltimore, Maryland
B. Douglas Smith – Johns Hopkins School of Medicine, Baltimore, Maryland
Feng Wang – UT MD Anderson Cancer Center, Houston, Texas
ACCELERATE-ing Pediatric Oncology Drug Discovery and Development
Crystal L. Mackall (Chair) – Stanford University, Stanford, California
Gregory H. Reaman – FDA, Silver Spring, Maryland
Peter C. Adamson – Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania
Nancy F. Goodman – Kids v. Cancer, Washington, D.C.
Mark W. Kieran – Bristol-Myers Squibb, Lawrenceville, New Jersey
Andrew Pearson – ACCELERATE, London, United Kingdom
Gilles Vassal – Institute Gustave Roussey, Villejuif, France
Susan Weiner – Children’s Cause for Cancer Advocacy, Brooklyn, New York
Recently Approved Breakthrough Therapies
Ashley F. Ward (Chair) – FDA, Silver Spring, Maryland
Emily Y. Jen – FDA, Silver Spring, Maryland
Yvette L. Kasamon – FDA, Silver Spring, Maryland
Roger J. Kurlander – FDA, Silver Spring, Maryland
Leigh Marcus – FDA, Silver Spring, Maryland
David M. Hyman – Memorial Sloan Kettering Cancer Center, New York, New York
Naveen Pemmaraju – UT MD Anderson Cancer Center, Houston, Texas
Lauren Pinter-Brown – University of California Irvine, Irvine, California
Regulatory Considerations for Utilizing Liquid Biopsies in Drug and Diagnostic Development
Gideon M. Blumenthal (Cochair) – FDA, Silver Spring, Maryland
Reena Philip (Cochair) – FDA, Silver Spring, Maryland
Soma Ghosh – FDA, Silver Spring, Maryland
J. Carl Barrett – AstraZeneca, Waltham, Massachusetts
James H. Godsey – Thermo Fisher Scientific, South San Francisco, California
Dana W.Y. Tsui – Memorial Sloan Kettering Cancer Center, New York, New York
AACR Annual Meeting 2018 (Chicago, Illinois)
NGS Oncopanels: Regulatory Considerations
Reena Philip (Chair) – FDA, Silver Spring, Maryland
You Li – FDA, Silver Spring, Maryland
Yali Li – Foundation Medicine, Inc., Cambridge, Massachusetts
Katherine B. Szarama – Centers for Medicare and Medicaid Services (CMS), Baltimore, Maryland
Ahmet Zehir – Memorial Sloan Kettering Cancer Center, New York, New York
Biosimilars: Biological Science, Regulatory Science, and Clinical Practice
Sara A. Hurvitz (Chair) – UCLA, Santa Monica, California
Joseph Franklin – FDA, Silver Spring, Maryland
Sue Lim – FDA, Silver Spring, Maryland
Simon Hotchin – Amgen, Inc., Thousand Oaks, California
Cancer Genomic Reference Samples – Sequencing Consortium Results and Beyond
Zivana Tezak (Chair) – FDA, Silver Spring, Maryland
Wenming Xiao – FDA/NCTR, Jefferson, Arizona
Michael F. Berger – Memorial Sloan Kettering Cancer Center, New York, New York
Li Tai Fang – Roche Sequencing Solutions, Belmont, California
Howard Jacob – AbbVie, North Chicago, Illinois
Rasika Kalamegham – Genentech, Washington, D.C.
Maryellen De Mars – ATCC, Manassas, Virginia
Jeffrey M. Trent – TGen (The Translational Genomics Research Institute), Phoenix, Arizona
Has Pandora’s Box Been Opened? The Site Agnostic Approval of Pembrolizumab
Steven J. Lemery (Chair) – FDA, Silver Spring, Maryland
Janaki Veeraraghavan – FDA, Silver Spring, Maryland
Russell R. Broaddus – UT MD Anderson Cancer Center, Houston, Texas
Heather L. Hampel – The Ohio State University Comprehensive Cancer Center, Columbus, Ohio
Michael J. Overman – UT MD Anderson Cancer Center, Houston, Texas
Zsofia K. Stadler – Memorial Sloan Kettering Cancer Center, New York, New York
Scientific and Regulatory Challenges in Development of CAR-T Therapy for Solid Tumors
Ke Liu (Chair) – FDA, Silver Spring, Maryland
Peter F. Bross – FDA, Silver Spring, Maryland
Gary E. Archer – Duke University Medical Center, Durham, North Carolina
Behnam Badie – City of Hope, Duarte, California
Stephen Gottschalk – St. Jude’s Research Hospital, Memphis, Tennessee
Carl H. June – University of Pennsylvania, Philadelphia, Pennsylvania
Real World Evidence in Oncology and its Implications
Amy P. Abernethy (Chair) – Flatiron Health, New York, New York
Sean Khozin – FDA, Silver Spring, Maryland
Jeff D. Allen – Friends of Cancer Research, Washington, D.C.
William Capra – Genentech, San Francisco, California
Cynthia Huang – Pfizer, Inc., New York, New York
Elad Sharon – National Cancer Institute, Bethesda, Maryland
Precision Therapy: When Is Better: Up Front or at Relapse?
Gideon Blumenthal (Chair) – FDA, Silver Spring, Maryland
Scott Kopetz – UT MD Anderson Cancer Center, Houston, Texas
Alice T. Shaw – Massachusetts General Hospital Cancer Center, Boston, Massachusetts
Recently Approved Breakthrough Therapies and New Approval Endpoints
Ashley F. Ward (Chair) – FDA, Silver Spring, Maryland
Najat Bouchkouj – FDA, Silver Spring, Maryland
Dow-Chung Chi – FDA, Silver Spring, Maryland
Noelle Frey – University of Pennsylvania, Philadelphia, Pennsylvania
Mark J. Levis – Johns Hopkins Sidney Kimmel Cancer Center, Baltimore, Maryland
Matthew R. Smith – Massachusetts General Hospital, Boston, Massachusetts
FDA Priorities: A Conversation with Deputy Commissioner Anna Abram
Permission not granted for webcast.
Anna Abram – FDA, Silver Spring, Maryland
Implications of the 2017 FDA Reauthorization Act (FDARA) on Pediatric Cancer Drug Development
Gregory H. Reaman (Chair) – FDA, Silver Spring, Maryland
Nancy F. Goodman – Kids v. Cancer, Washington, D.C.
D. William Parsons – Baylor College of Medicine, Dan L. Duncan Cancer Center, Houston, Texas
Gilles Vassal – Institute Gustave-Roussy, Villejuif, France
Brenda Weigel – University of Minnesota, Minneapolis, Minnesota
AACR Annual Meeting 2017 (Washington, D.C.)
Understanding Mechanism-based, Cardiovascular Adverse Events Associated with Immune Checkpoint Blockade: Implications for Prevention and Management
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Laleh Amiri Kordestani (Co-chair) – FDA, Silver Spring, Maryland
Javid Moslehi (Co-chair) – Vanderbilt University, Nashville, Tennessee
George Demetri – Dana-Farber Cancer Institute, Boston, Massachusetts
David Feltquate – Bristol-Myers Squibb, New York, New York
Shiv Pillai – Harvard Medical School, Cambridge, Massachusetts
Suzanne Topalian – Johns Hopkins Sidney Kimmel Cancer Center, Baltimore, Maryland
Real World Evidence in Oncology and its Implications
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Amy Abernethy (Chair) – FlatIron Health, New York, New York
Kassa Ayalew – FDA, Silver Spring, Maryland
Sean Khozin – FDA, Silver Spring, Maryland
Jeff Allen – Friends of Cancer Research, Washington, D.C.
Raymond DuBois – Medical University of South Carolina, Charleston, South Carolina
Jacqueline Law – Genentech Inc., San Francisco, California
Tables Turned: A Conversation with the Press about the Future of Cancer Research and Treatment
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Richard Pazdur (Chair) – FDA, Silver Spring, Maryland
Adam Feuerstein – TheStreet, New York, New York
Matt Herper – FORBES, New York, New York
Laurie McGinley – The Washington Post, Washington, D.C.
Meg Tirrell – CNBC, Englewood, New Jersey
Regulatory Considerations for Utilizing Liquid Biopsies in Drug and Diagnostic Development
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Gideon Blumenthal (Co-chair) – FDA, Silver Spring, Maryland
Reena Philip (Co-chair) – FDA, Silver Spring, Maryland
Pasi Jänne (Co-chair) – Dana-Farber Cancer Institute, Boston, Massachusetts
Abraham Tzou – FDA, Silver Spring, Maryland
Suzanne Jenkins – AstraZeneca, Cheshire, United Kingdom
Gary Kellof – National Cancer Institute, Bethesda, Maryland
Walter Koch – Roche, Pleasanton, California
Howard Scher – Memorial Sloan Kettering Cancer Center, New York, New York
Phil Stephens – Foundation Medicine, Cambridge, Massachusetts
Amirali Talasaz – Guardant Health, Redwood City, California
Reference Materials for Next Generation Sequencing (NGS)-based Tests
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David Litwack (Co-chair) – FDA, Silver Spring, Maryland
Elaine Mardis (Co-chair) – Nationwide Children’s Hospital, Columbus, OH
Zivana Tezak – FDA, Silver Spring, Maryland
Maryellen de Mars – ATCC, Manassas, Virginia
Girish Putcha – PALMETTO GBA/MOLDX, Columbia, South Carolina
Marc Salit – NIST, Stanford, California
Kenna Mills Shaw – UT MD Anderson Cancer Center, Houston, Texas
Jeffrey Trent – TGen, Phoenix, Arizona
Immuno-oncology Combination Therapies
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Geoffrey Kim (Chair) – FDA, Silver Spring, Maryland
Chao Liu – FDA, Silver Spring, Maryland
Amy Rosenberg – FDA, Silver Spring, Maryland
Daniel Chen – Genentech Inc., San Francisco, California
Bernard Fox – Earle A. Chiles Research Institute, Portland, Oregon
Elizabeth Jaffee – Johns Hopkins Sidney Kimmel Cancer Center, Baltimore, Maryland
Sreeneeranj Kasichayanula – Amgen Inc., Thousand Oaks, California
New Drugs – A Review of Recently Approved Breakthrough Therapies
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Amy McKee (Chair) – FDA, Silver Spring, Maryland
Sanjeeve Balasubramaniam – FDA, Silver Spring, Maryland
Leslie Doros – FDA, Silver Spring, Maryland
Daniel Suzman – FDA, Silver Spring, Maryland
Deborah Armstrong – Johns Hopkins Sidney Kimmel Cancer Center, Baltimore, Maryland
Elad Sharon – National Cancer Institute, Bethesda, Maryland
Dan Theodorescu – University of Colorado Cancer Center, Aurora, Colorado
Katie Thornton – Dana-Farber Cancer Institute, Boston, Massachusetts
AACR Annual Meeting 2016 (New Orleans, Louisiana)
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Next Generation Sequencing (NGS)-based Oncology Panels:
Saturday, April 16 | 10 – 11 a.m.
Eunice Lee
FDA Regulation of Companion and Complementary Diagnostics:
Saturday, April 16 | 11 a.m. – noon
Pamela Bradley and David Litwack
FDA’s Approach to Regulating Biosimilars: A Case Study
Saturday, April 16 | 1 – 2:30 p.m.
Darrell Abernethy, Leah Christl, Marjorie Shapiro, and Tanya Wrobleski
New FDA Initiatives in Personalized Medicine:
Saturday, April 16 | 3 – 4:30 p.m.
Katherine Donigan and Laura Koontz
A Discussion of Early-phase Expansion Cohort Trial Design in the Development of Future Oncology Products
Sunday, April 17 | 1 – 3 p.m.
Tatiana Prowell (chair), Philippe L. Bedard, Eric H. Rubin, Roy Jones, and Samantha Roberts
A Conversation with FDA Oncologic Drugs Advisory Committee (ODAC) Chairs
Monday, April 18 | 10:30 a.m. – 12:30 p.m.
Richard Pazdur (chair), Deborah Armstrong, S. Gail Eckhardt, Mikkael Sekeres, and
Wyndham E. Wilson
Update on Next Generation Sequencing (NGS) Technologies and the Precision Medicine Initiative (PMI)
Monday, April 18 | 10:30 a.m. – 12:30 p.m.
Elaine R. Mardis (co-chair), Victor E. Velculescu (co-chair), David Litwack, Charles L. Sawyers, Girish Putcha, and Michael Berger
Regulatory Implications of Complex Genetic Signatures to Predict Response to Targeted Therapies
Tuesday, April 19 | 10:30 a.m. – 12:30 p.m.
Elizabeth M. Jaffee (chair), Julia Beaver, Abraham Tzou, Ira Mellman, Giulia Kennedy, Avrum E. Spira, and Suzanne L. Topalian
The Blueprint Project: Harmonizing Companion Diagnostics Across a Class of Targeted Therapies
Tuesday, April 19 | 1 – 3 p.m.
Fred R. Hirsch (chair), Reena Philip, Steven D. Averbuch, Kenneth Emancipator, Abigail McElhinny, John Longshore, Dave Stanforth, Jill Walker, and J. Andy Williams
New Drugs: A Review of Recent Breakthrough Therapies?
Tuesday, April 19 | 3:30 – 5:30 p.m.
Amy E. McKee (chair), Lori Ehrlich, Nicole J. Gormley, Sean Khozin, James Xu, David McDermott, S. Vincent Rajkumar, and Suresh S. Ramalingam
AACR Annual Meeting 2015 (Philadelphia, Pennsylvania)
The Past, Present, and Future of FDA Regulation of Next Generation Sequencing
David Litwack
The Role of Neo-adjuvant Treatment in Drug Development for Solid Tumors
Tatiana Prowell, Marc Theoret, Renzo Canetta, Paul Chapman, Robert Dreicer, Caitlin Riley
Evolution of Personalized Drug Development in Oncology — Kinase Inhibitors
Gideon Blumenthal, Reena Philip, Pasi Janne, Scott Kopetz, Gideon Bollag, Mehdi Shahidi
New Drugs: Breakthrough Therapies and Beyond
Amy McKee, Leigh Marcus, Mark Theoret, Antoni Ribas, Angelo de Claro, John Byrd, Julia Beaver, Ian Krop, Donna Przepiorka, Susan Rheingold
Integrating Patient Reported Outcomes into Regulatory Evaluation
Paul Kluetz, Laura Lee Johnson, Lori Minasian, Alicyn Campbell, Arturo Molina, Patricia Spears
Incorporating Next-generation Sequencing into Oncology Diagnostics, Therapeutics, and Treatment
Laura van ‘t Veer, Elizabeth Mansfield, Barbara Conley, Mia Levy, Dane Dickson
Clinical Trial Enrichment Strategies: Designing a Prospectively Defined Retrospective Analysis Study
Eric Rubin, Geoffrey Kim, Richard Simon, Lisa McShane, Cyrus Mehta, Yun-Fu Hu
Regulatory Strategies to Expedite Oncology Drug Development
Tatiana Prowell, Mace Rothenburg, Julia Beaver, Deborah Armstrong, Hans Loland, John Burke, Jorge Martinalbo
FDA’s Proposed Framework to Regulate Laboratory-developed Tests
Laura van ‘t Veer, Elizabeth Mansfield, Curtis Hanson
AACR Annual Meeting 2014 (San Diego, California)
Biomarker Assays and Drug Trials: What Cancer Researchers Should Know About FDA regulation
David Litwack
Breakthrough Therapies: Case Studies of Successful Applications in Oncology
William Hait, Paul Kluetz, Nancy Valente, Ellen Sigal, Peter Lebowitz
Everything You Wanted to Know About Codevelopment of a Diagnostic with a Therapeutic But Were Afraid to Ask
Pamela Bradley
Novel Clinical Trial Designs in the Whole-Exome Era
David Chang, Eric Rubin, Elizabeth Mansfield, Gideon Blumenthal, Patricia Lorusso, Laura Esserman, Roy Herbst
Regulatory Considerations for Targeted Immunotherapies
Renzo Canetta, Ke Liu, Marc Theoret, Jeffrey Weber, Suzanne Topalian, Lillian Siu, Samir Khleif
Regulatory Perspectives in the Codevelopment of Molecular Diagnostic Tests with Targeted Therapies and Their Use in Clinical Settings
Laura van ‘t Veer, Geoffrey Kim, Elizabeth Mansfield, Richard Klausner, Mickey Williams, Andrea Ferris
The Role of Research Biopsies in Trials of Molecularly-Targeted Agents: Scientific, Ethical, and Practical Considerations
Nancy Lin, Tatiana Prowell, W. Fraser Symmans, Lillian Siu, Elizabeth Frank
Safety Reporting Requirements for an Investigational New Drug (IND) and Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products
Peter Bross, Robert Le
Successful Oncology Drug Development: Balancing Knowledge, Speed, and Risk
Mace Rothenberg, Tatiana Prowell, Gwendolyn Fyfe, Charles Sawyers, Clifford Hudis, Elizabeth Garrett-Mayer, Michael Kolodziej
AACR Annual Meeting 2013 (Washington, D.C.)
“Breakthrough Therapy” Designation and Its Implications for Accelerating Oncology Drug Development
Ellen Sigal, Rachel Sherman, Jeff Allen, Jonathan Leff, Sandra Horning, Howard Scher
A Conversation on a Decade of Drug Development: Perspectives from FDA Oncologic Drugs Advisory Committee (ODAC)
Richard Pazdur, Mikkael Sekeres, Wyndham Wilson, Gail Eckhardt, Maha Hussain, Silvana Martino, Donna Przepiorka
A Conversation on Oncology Drug Development: An International Regulatory Perspective from the United States, the European Union, and Canada
Richard Pazdur
Evaluation of Cancer Vaccine and Immunotherapy Products at FDA/CBER
Xiaobin Lu
Harnessing the Immune System to Treat Cancer: Personalized and Targeted Therapy
Ke Liu, Carl June, Douglas Olson, Angela Shen
Pitfalls in Oncology Drug Development
Tatiana Prowell
The Promise and Challenges of Pathological Complete Response (pCR) as Novel Endpoint for Drug Approval in High-Risk, Early-stage Breast Cancer
Eric Winer, Patricia Cortazar, Tatiana Prowell, W. Fraser Symmans, Kelly Hunt, Andrea Richardson, Elizabeth Cahn
Regulatory Considerations for Integrative Biomarker Development Using Whole Genome Technologies
Laura van ‘t Veer, Elizabeth Mansfield, Anna Barker, Vincent Miller, Leslie Farmington
When to File an Investigational Device Exemption (IDE)
Elizabeth Mansfield
Annual Meeting 2012 (Chicago, Illinois)
Co-development of Two or More Investigational Drugs
Frank McCormick, Jeffrey Engelman, Roy Herbst, Stuart Lutzker, Janet Woodcock
Comparative Effectiveness and Implications for Trial Design
Jan Schellens
Highly Adaptive Trials in Drug Development: Scientific and Regulatory Considerations
Eric Rubin, Stuart Bailey, Donald Berry, Keaven Anderson, Sue-Jane Wang
Pathway Versus Histology in Drug Development
George Demetri, Janet Woodcock, Grant McArthur
Scientific and Regulatory Challenges in Co-development of Predictive
In Vitro Diagnostics
Mark Ratain, Rachel Humphrey, Janet Dancey, Samir Khleif