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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. The Drug Development Paradigm in Oncology: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24742.
×

THE DRUG DEVELOPMENT
PARADIGM IN
ONCOLOGY

PROCEEDINGS OF A WORKSHOP

Amanda Wagner Gee, Erin Balogh, Margie Patlak, and
Sharyl J. Nass, Rapporteurs

National Cancer Policy Forum

Board on Health Care Services

Health and Medicine Division

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THE NATIONAL ACADEMIES PRESS
Washington, DC
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. The Drug Development Paradigm in Oncology: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24742.
×

THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW Washington, DC 20001

This activity was supported by Contract No. 200-2011-38807 (Task Order No. 0051) and Contract No. HHSN263201200074I (Task Order No. HHSN26300052) with the Centers for Disease Control and Prevention and the National Cancer Institute/National Institutes of Health, respectively, and by the American Association for Cancer Research, American Cancer Society, American College of Radiology, American Society for Radiation Oncology, American Society of Clinical Oncology, American Society of Hematology, Association of American Cancer Institutes, AstraZeneca, Bristol-Myers Squibb, Cancer Support Community, CEO Roundtable on Cancer, Flatiron Health, Helsinn Healthcare SA, LIVESTRONG Foundation, Merck, National Comprehensive Cancer Network, Novartis Oncology, Oncology Nursing Society, and Pfizer Inc. Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project.

International Standard Book Number-13: 978-0-309-45794-1
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Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2018. The drug development paradigm in oncology: Proceedings of a workshop. Washington, DC: The National Academies Press. doi: https://doi.org/10.17226/24742.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. The Drug Development Paradigm in Oncology: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24742.
×

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The National Academy of Sciences was established in 1863 by an Act of Congress, signed by President Lincoln, as a private, nongovernmental institution to advise the nation on issues related to science and technology. Members are elected by their peers for outstanding contributions to research. Dr. Marcia McNutt is president.

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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. The Drug Development Paradigm in Oncology: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24742.
×

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Consensus Study Reports published by the National Academies of Sciences, Engineering, and Medicine document the evidence-based consensus on the study’s statement of task by an authoring committee of experts. Reports typically include findings, conclusions, and recommendations based on information gathered by the committee and the committee’s deliberations. Each report has been subjected to a rigorous and independent peer-review process and it represents the position of the National Academies on the statement of task.

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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. The Drug Development Paradigm in Oncology: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24742.
×

WORKSHOP PLANNING COMMITTEE1

RICHARD L. SCHILSKY (Chair), Senior Vice President and Chief Medical Officer, American Society of Clinical Oncology

AMY P. ABERNETHY, Chief Medical Officer, Chief Scientific Officer, and Senior Vice President for Oncology, Flatiron Health

JEFF ALLEN, President and Chief Executive Officer, Friends of Cancer Research

KENNETH ANDERSON, Kraft Family Professor of Medicine, American Cancer Society Clinical Research Director, Jerome Lipper Multiple Myeloma Center, Harvard Medical School, Dana-Farber Cancer Institute

MARGARET ANDERSON, Executive Director, FasterCures, A Center of the Milken Institute

MONICA M. BERTAGNOLLI, Richard E. Wilson Professor of Surgery, Harvard Medical School; Chief, Division of Surgical Oncology, Dana-Farber/Brigham and Women’s Cancer Center; Group Chair, Alliance for Clinical Trials in Oncology

GIDEON BLUMENTHAL, Acting Deputy Director, Office of Hematology and Oncology Projects, Food and Drug Administration

HEDVIG HRICAK, Chair, Department of Radiology, Memorial Sloan Kettering Cancer Center

RONALD M. KLINE, Medical Officer, Patient Care Models Group, Center for Medicare & Medicaid Innovation, Centers for Medicare & Medicaid Services

AMY McKEE, Supervisory Associate Director, Office of Hematology and Oncology Projects, Food and Drug Administration

REBECCA PENTZ, Professor of Hematology and Oncology in Research Ethics, Emory University School of Medicine

STEVEN PIANTADOSI, Phase One Foundation Distinguished Chair, Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center

MACE L. ROTHENBERG, Chief Development Officer, Oncology, Pfizer Global Product Development, Pfizer Inc.

___________________

1 The National Academies of Sciences, Engineering, and Medicine’s planning committees are solely responsible for organizing the workshop, identifying topics, and choosing speakers. The responsibility for the published Proceedings of a Workshop rests with the workshop rapporteurs and the institution.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. The Drug Development Paradigm in Oncology: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24742.
×

DANIEL J. SARGENT, Professor of Biostatistics and Oncology, Director of Cancer Statistics, Mayo Clinic Cancer Center

DEBORAH SCHRAG, Chief, Division of Population Sciences, Professor of Medicine, Department of Medical Oncology, Harvard Medical School, Dana-Farber Cancer Institute

MARC THEORET, Lead Medical Officer, Division of Oncology Products, Office of Hematology and Oncology Products, Food and Drug Administration

SUZANNE L. TOPALIAN, Professor, Surgery and Oncology, Johns Hopkins University School of Medicine

Project Staff

ERIN BALOGH, Senior Program Officer

MORGAN L. BONAME, Associate Program Officer

SYLARA MARIE CRUZ, Senior Program Assistant (until June 2017)

REBECCA A. ENGLISH, Program Officer

CYNDI TRANG, Research Assistant

AMANDA WAGNER GEE, Program Officer

ANNE B. CLAIBORNE, Director, Forum on Drug Discovery, Development, and Translation

SHARYL J. NASS, Director, National Cancer Policy Forum and Board on Health Care Services

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. The Drug Development Paradigm in Oncology: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24742.
×

NATIONAL CANCER POLICY FORUM1

EDWARD J. BENZ, JR. (Chair), President and Chief Executive Officer Emeritus, Dana-Farber Cancer Institute; Richard and Susan Smith Distinguished Professor of Medicine, Genetics and Pediatrics, Harvard Medical School

KALD A. ABDALLAH, Oncology External Alliances Leader, U.S. Medical Affairs, AstraZeneca

AMY P. ABERNETHY, Chief Medical Officer, Chief Scientific Officer, and Senior Vice President for Oncology, Flatiron Health

LUCILE L. ADAMS-CAMPBELL, Professor of Oncology, Associate Director for Minority Health and Health Disparities Research, Georgetown University Lombardi Cancer Center

GARNET L. ANDERSON, Senior Vice President and Director, Public Health Sciences Division, Fred Hutchinson Cancer Research Center; Affiliate Professor, Department of Biostatistics, University of Washington

KENNETH ANDERSON, Kraft Family Professor of Medicine, American Cancer Society Clinical Research Director, Jerome Lipper Multiple Myeloma Center, Harvard Medical School, Dana-Farber Cancer Institute

KAREN BASEN-ENGQUIST, Annie Laurie Howard Research Distinguished Professor, Professor of Behavioral Science, and Director, Center for Energy Balance in Cancer Prevention and Survivorship, The University of Texas MD Anderson Cancer Center

CATHY J. BRADLEY, Associate Director, Cancer Prevention and Control, University of Colorado Cancer Center

OTIS W. BRAWLEY, Chief Medical Officer, American Cancer Society

ROBERT W. CARLSON, Chief Executive Officer, National Comprehensive Cancer Network

CHRISTOPHER R. COGLE, Professor of Medicine, Pierre Chagnon Professor of Stem Cell Biology and Bone Marrow Transplant, University of Florida; Scholar in Clinical Research, Leukemia & Lymphoma Society

___________________

1 The National Academies of Sciences, Engineering, and Medicine’s forums and roundtables do not issue, review, or approve individual documents. The responsibility for the published Proceedings of a Workshop rests with the workshop rapporteurs and the institution.

Page viii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. The Drug Development Paradigm in Oncology: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24742.
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ROGER D. DANSEY, Senior Vice President, Clinical Research—Late Stage Development, Merck

NANCY E. DAVIDSON, President and Executive Director, Seattle Cancer Care Alliance; Senior Vice President, Director, and Full Member, Clinical Research Division, Fred Hutchinson Cancer Research Center; Head, Department of Medicine, Division of Medical Oncology, University of Washington

GEORGE D. DEMETRI, Professor of Medicine and Director, Ludwig Center, Harvard Medical School; Senior Vice President for Experimental Therapeutics, Dana-Farber Cancer Institute; Associate Director for Clinical Sciences, Dana-Farber/Harvard Cancer Center

JAMES H. DOROSHOW, Deputy Director for Clinical and Translational Research, National Cancer Institute

KOJO S. J. ELENITOBA-JOHNSON, Professor, Perelman School of Medicine; Founding Director, Center for Personalized Diagnostics and Division of Precision and Computational Diagnostics, University of Pennsylvania

STANTON L. GERSON, President, Association of American Cancer Institutes; Director, Case Comprehensive Cancer Center; Professor of Hematological Oncology, Case Western Reserve University; Director, University Hospitals Seidman Cancer Center

LORI HOFFMAN HŌGG, Veterans Health Administration National Oncology Clinical Advisor and Program Manager, Prevention Policy, Department of Veterans Affairs

LINDA HOUSE, President, Cancer Support Community

HEDVIG HRICAK, Chair, Department of Radiology, Memorial Sloan Kettering Cancer Center

LISA KENNEDY SHELDON, Chief Clinical Officer, Oncology Nursing Society; Editor, Clinical Journal of Oncology Nursing

SAMIR N. KHLEIF, Professor of Medicine, Biochemistry, Molecular Biology, and Graduate Studies, Medical College of Georgia, Augusta University

RONALD M. KLINE, Medical Officer, Patient Care Models Group, Center for Medicare & Medicaid Innovation, Centers for Medicare & Medicaid Services

LEE M. KRUG, Disease Area Head, Lung and Head & Neck Cancer, Immuno-Oncology, Bristol-Myers Squibb

FRANCOIS LAFLEUR, U.S. Head and Vice President, Medical Affairs, Helsinn Healthcare SA

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. The Drug Development Paradigm in Oncology: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24742.
×

MICHELLE M. LE BEAU, Arthur and Marian Edelstein Professor of Medicine and Director, The University of Chicago Comprehensive Cancer Center

MIA LEVY, Director of Cancer Health Informatics and Strategy, Ingram Associate Professor of Cancer Research; Associate Professor of Biomedical Informatics and Medicine, Vanderbilt-Ingram Cancer Center

GRETA MASSETTI, Associate Director for Science, Division of Cancer Prevention and Control, Centers for Disease Control and Prevention

MARTIN J. MURPHY, Chief Executive Officer, CEO Roundtable on Cancer

RICHARD PAZDUR, Director, Oncology Center of Excellence; Acting Director, Office of Hematology and Oncology Products, Food and Drug Administration

LISA C. RICHARDSON, Director, Division of Cancer Prevention and Control, Centers for Disease Control and Prevention

MACE L. ROTHENBERG, Chief Development Officer, Oncology, Pfizer Global Product Development, Pfizer Inc.

RICHARD L. SCHILSKY, Senior Vice President and Chief Medical Officer, American Society of Clinical Oncology

DEBORAH SCHRAG, Chief, Division of Population Sciences, Professor of Medicine, Department of Medical Oncology, Harvard Medical School, Dana-Farber Cancer Institute

LAWRENCE N. SHULMAN, Professor of Medicine, Deputy Director for Clinical Services, and Director, Center for Global Cancer Medicine, Abramson Cancer Center, University of Pennsylvania

DAN THEODORESCU, Paul A. Bunn, Jr. Endowed Chair in Cancer Research, Professor of Surgery and Pharmacology, and Director, University of Colorado Cancer Center

GEORGE J. WEINER, C. E. Block Chair of Cancer Research, Professor of Internal Medicine, Director, Holden Comprehensive Cancer Center, University of Iowa

ROBERT A. WINN, Associate Vice Chancellor for Community-Based Practice; Professor of Medicine, Division of Pulmonary and Critical Care Medicine, University of Illinois College of Medicine; Director, University of Illinois Health Cancer Center

RICHARD C. WOODMAN, Senior Vice President and Head, North America Oncology Clinical Development and Medical Affairs, Novartis Pharmaceuticals Corporation

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. The Drug Development Paradigm in Oncology: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24742.
×

WENDY A. WOODWARD, Associate Professor and Service Chief, Breast Cancer Radiation Oncology, Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center

National Cancer Policy Forum Staff

ERIN BALOGH, Senior Program Officer

PATRICK BURKE, Financial Officer

NATALIE LUBIN, Senior Program Assistant (from June 2017)

SYLARA MARIE CRUZ, Senior Program Assistant (until June 2017)

CYNDI TRANG, Research Assistant

WILLIAM SONG, Summer Intern (June 2017–July 2017)

SHARYL J. NASS, Forum Director and Director, Board on Health Care Services

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. The Drug Development Paradigm in Oncology: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24742.
×

Reviewers

This Proceedings of a Workshop was reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise. The purpose of this independent review is to provide candid and critical comments that will assist the National Academies of Sciences, Engineering, and Medicine in making each published proceedings as sound as possible and to ensure that it meets the institutional standards for quality, objectivity, evidence, and responsiveness to the charge. The review comments and draft manuscript remain confidential to protect the integrity of the process.

We thank the following individuals for their review of this proceedings:

JESSE BERLIN, Johnson & Johnson

FRANKLIN G. MILLER, Weill Cornell Medical College

ELDA RAILEY, Research Advocacy Network

MARK RATAIN, The University of Chicago

ERIC H. RUBIN, Merck Research Laboratories

RAJESHWARI SRIDHARA, Food and Drug Administration

Although the reviewers listed above provided many constructive comments and suggestions, they were not asked to endorse the content of the proceedings nor did they see the final draft before its release. The review of this proceedings was overseen by ELAINE LARSON, Columbia University School of Nursing. She was responsible for making certain that an indepen-

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. The Drug Development Paradigm in Oncology: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24742.
×

dent examination of this proceedings was carried out in accordance with standards of the National Academies and that all review comments were carefully considered. Responsibility for the final content rests entirely with the rapporteurs and the National Academies.

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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. The Drug Development Paradigm in Oncology: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24742.
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In Memoriam

This Proceedings of a Workshop is dedicated to Dr. Daniel J. Sargent, an internationally renowned statistician, a valued member of the workshop planning committee, and an irreplaceable colleague and friend.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. The Drug Development Paradigm in Oncology: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24742.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. The Drug Development Paradigm in Oncology: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24742.
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Acknowledgments

Support from the many annual sponsors of the National Academies of Sciences, Engineering, and Medicine’s National Cancer Policy Forum is crucial to the work of the forum. Federal sponsors include the Centers for Disease Control and Prevention and the National Cancer Institute/National Institutes of Health. Non-federal sponsors include the American Association for Cancer Research, American Cancer Society, American College of Radiology, American Society for Radiation Oncology, American Society of Clinical Oncology, American Society of Hematology, Association of American Cancer Institutes, AstraZeneca, Bristol-Myers Squibb, Cancer Support Community, CEO Roundtable on Cancer, Flatiron Health, Helsinn Healthcare SA, LIVESTRONG Foundation, Merck, National Comprehensive Cancer Network, Novartis Oncology, Oncology Nursing Society, and Pfizer Inc.

The forum wishes to express its gratitude to the expert speakers whose presentations helped examine the drug development paradigm for cancer therapy. The forum also wishes to thank the members of the planning committee for their work in developing an excellent workshop agenda.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. The Drug Development Paradigm in Oncology: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24742.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. The Drug Development Paradigm in Oncology: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24742.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. The Drug Development Paradigm in Oncology: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24742.
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Acronyms and Abbreviations

ALK amplastic lymphoma kinase
ASCO American Society of Clinical Oncology
BATTLE-1 Biomarker-integrated Approaches of Targeted Therapy for Lung Cancer Elimination
CAP College of American Pathologists
CDER Center for Drug Evaluation and Research
CDK cyclin-dependent kinases
CLIA Clinical Laboratory Improvement Amendments of 1988
CMS Centers for Medicare & Medicaid Services
CT computed tomography
CY cyclophosphamide
DOE Department of Energy
DSMB data and safety monitoring board
EGFR epidermal growth factor receptor
EHR electronic health record
EMA European Medicines Agency
ER estrogen receptor
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. The Drug Development Paradigm in Oncology: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24742.
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FDA Food and Drug Administration
FNIH Foundation for the National Institutes of Health
HDAC histone deacetylase
HER2 human epidermal growth factor receptor 2
HIPAA Health Insurance Portability and Accountability Act
IND investigational new drug
IRB Institutional Review Board
I-SPY TRIAL Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging and Molecular Analysis
Lung-MAP Lung Cancer Master Protocol
MRI magnetic resonance imaging
NCI National Cancer Institute
NCI-MATCH National Cancer Institute-Molecular Analysis for Therapy Choice
NDA New Drug Application
NGS next-generation sequencing
OCE Oncology Center of Excellence
OHOP Office of Hematology and Oncology Products
ORR overall response rate
OS overall survival
PD-1 programmed death-1
PD-L1 programmed death-ligand 1
PERCIST PET Response Criteria in Solid Tumors
PET positron emission tomography
PFS progression-free survival
POC proof of concept
PRECIS Pragmatic-Explanatory Continuum Indicator Summary
RECIST Response Evaluation Criteria in Solid Tumors
START South Texas Accelerated Research Therapeutics
TAPUR Targeted Agent Profiling Utilization Registry Study
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. The Drug Development Paradigm in Oncology: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24742.
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Advances in cancer research have led to an improved understanding of the molecular mechanisms underpinning the development of cancer and how the immune system responds to cancer. This influx of research has led to an increasing number and variety of therapies in the drug development pipeline, including targeted therapies and associated biomarker tests that can select which patients are most likely to respond, and immunotherapies that harness the body’s immune system to destroy cancer cells. Compared with standard chemotherapies, these new cancer therapies may demonstrate evidence of benefit and clearer distinctions between efficacy and toxicity at an earlier stage of development. However, there is a concern that the traditional processes for cancer drug development, evaluation, and regulatory approval could impede or delay the use of these promising cancer treatments in clinical practice. This has led to a number of efforts—by patient advocates, the pharmaceutical industry, and the Food and Drug Administration (FDA)—to accelerate the review of promising new cancer therapies, especially for cancers that currently lack effective treatments. However, generating the necessary data to confirm safety and efficacy during expedited drug development programs can present a unique set of challenges and opportunities.

To explore this new landscape in cancer drug development, the National Academies of Sciences, Engineering, and Medicine developed a workshop held in December 2016. This workshop convened cancer researchers, patient advocates, and representatives from industry, academia, and government to discuss challenges with traditional approaches to drug development, opportunities to improve the efficiency of drug development, and strategies to enhance the information available about a cancer therapy throughout its life cycle in order to improve its use in clinical practice. This publication summarizes the presentations and discussions from the workshop.

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