​​​​​​​​​​​​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.

​​2016       2015        2014         2013         2012

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

Watch the webcast of this session.

  • Laleh Amiri Kordestani (Co-chair) – FDA
  • Javid Moslehi (Co-chair) – Vanderbilt Univ.
  • George Demetri – Dana-Farber Cancer Institute
  • David Feltquate – Bristol-Myers Squibb
  • Shiv Pillai – Harvard Medical School
  • Suzanne Topalian – Johns Hopkins Kimmel Cancer Ctr.

Real World Evidence in Oncology and its Implications

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  • Amy Abernethy (Chair) – FlatIron Health
  • Kassa Ayalew – FDA
  • Sean Khozin – FDA
  • Jeff Allen – Friends of Cancer Research
  • Jacqueline Law – Genentech, Inc.
  • Raymond DuBois – Medical Univ. South Carolina

Tables Turned: A Conversation with the Press about the Future of Cancer Research and Treatment

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  • Richard Pazdur (Chair) – FDA
  • Adam Feuerstein – The Street
  • Matthew Herper – FORBES
  • Laurie McGinley – The Washington Post
  • Meg Tirrell – CNBC

Regulatory Considerations for Utilizing Liquid Biopsies in Drug and Diagnostic Development

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  • Pasi Jänne (Co-chair) – Dana-Farber Cancer Institute
  • Gideon Blumenthal (Co-chair) – FDA
  • Reena Philip (Co-chair) – FDA
  • Abraham Tzou – FDA
  • Suzanne Jenkins – AstraZeneca
  • Gary Kelloff – National Cancer Institute
  • Walter Koch – Roche
  • Howard Scher – Memorial Sloan Kettering Cancer Ctr.
  • Phil Stephens – Foundation Medicine
  • AmirAli Talasaz – Guardant Health

Reference Materials for Next GenerationSequencing (NGS)-based Tests

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  • Elaine Mardis (Co-chair) – Nationwide Children’s Hospital
  • David Litwack (Co-chair) – FDA
  • Zivana Tezak – FDA
  • Maryellen de Mars – ATCC
  • Girish Putcha – Freenome
  • Marc Salit – NIST
  • Kenna Mills Shaw – MD Anderson Cancer Ctr.
  • Jeffrey Trent – TGen

Immuno-oncology Combination Therapies

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  • Geoffrey Kim (Chair) – FDA
  • Chao Liu – FDA
  • Amy Rosenberg – FDA
  • Daniel Chen – Genentech, Inc.
  • Bernard Fox – Earle A. Chiles Research Inst.
  • Elizabeth Jaffee – Johns Hopkins Kimmel Cancer Ctr.
  • Sreeneeranj Kasichayanula – Amgen, Inc.

New Drugs – A Review of Recently Approved Breakthrough Therapies

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  • Amy McKee (Chair) – FDA
  • Sanjeeve Balasubramaniam – FDA
  • Leslie Doros – FDA
  • Daniel Suzman – FDA
  • Deborah Armstrong – Johns Hopkins Kimmel Cancer Ctr. 
  • Dan Theodorescu – Univ. of Colorado Cancer Ctr.
  • Katie Thornton – Dana-Farber Cancer Institute

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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