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​​​​​​​​​​​​Regulatory Science and Policy Tracks at the AACR Annual Meetings

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.

​​2017     2016       2015        2014         2013         2012

AACR Annual Meeting 2018 (Chicago)

NGS Oncopanels: Regulatory Considerations

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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

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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

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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

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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

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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

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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?

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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

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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

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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.)  

Links to the webinar version of these sessions will be posted here.

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 GenerationSequencing (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)         

Click on each speaker name to view their presentation. Note: not all speakers have given permission for their presentation to be webcast.​​

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. BedardEric H. Rubin​Roy Jones, and Samantha Roberts​

A Conve​rsation 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 o​n 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

Regulator​y 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 Proj​ect: 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 LongshoreDave 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 EhrlichNicole J. Gormley​, Sean KhozinJames Xu,
David McDermott, S. Vincent Rajkumar, and Suresh S. Ramalingam

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AACR Annual Meeting 2015 (Philadelphia)

The Past, Present, and Future of FDA Regulation of Next Generation Sequencing
Da​​​vid 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: Breakthroug​h 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-gen​eration 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 Framew​ork to Regulate Laboratory-developed Tests​
​Laura van 't Veer, Elizabeth Mansfield, Curtis Hanson​

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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

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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

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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 

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