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Suggested Citation:"Appendix D: Registered Attendees." Institute of Medicine. 2014. Refining Processes for the Co-Development of Genome-Based Therapeutics and Companion Diagnostic Tests: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18617.
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Appendix D


Registered Attendees

Brian Abbott

AstraZeneca

Hesham Abdullah

MedImmune

Deborah Applebaum-Bowden

National Heart, Lung, and Blood Institute

Joanne Armstrong

Aetna

Euan Ashley

Stanford University

Eric Assaraf

WRG

Stephanie Beasley

FDA Week

Judith Benkendorf

American College of Medical Genetics and Genomics

Paul Billings

Life Technologies

Giselle Bleecker

Medical Market Strategists, Inc.

Bruce Blumberg

Kaiser Permanente

Jeffrey Bojar

Biodesix

Denise Bonds

National Heart, Lung, and Blood Institute

Mary Bordoni

Personalized Medicine Coalition

Khaled Bouri

U.S. Food and Drug Administration

Christopher Bradburne

Johns Hopkins University, Applied Physics Laboratory

Suggested Citation:"Appendix D: Registered Attendees." Institute of Medicine. 2014. Refining Processes for the Co-Development of Genome-Based Therapeutics and Companion Diagnostic Tests: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18617.
×

Pamela Bradley

U.S. Food and Drug Administration

Joel Brill

Predictive Health, LLC

Apryl Brown

Wayne County Community College District

Heather Brown

Blue Cross Blue Shield Association

Richard Buller

Pfizer Inc.

Wylie Burke

University of Washington

Khatereh Calleja

AdvaMed

Joseph Campbell

National Institute of Allergy and Infectious Diseases

Carolyn Carroll

STAT TECH Inc.

Cathy Craft

Myraqa, Inc.

Sean David

Stanford University

Ulyana Desiderio

American Society of Hematology

Patricia Deverka

Center for Medical Technology Policy

Michael Dougherty

American Society of Human Genetics

Victor Dzau

Duke University Health System

Raith Erickson

Complete Genomics

Raith Ewing

Johns Hopkins University

Ross Filice

U.S. Food and Drug Administration

Felix Freuh

Third Rock Ventures

Edna Garcia

American Society for Clinical Pathology

John Gardenier

Independent

Turkan Gardenier

Pragmatica Corp

Geoffrey Ginsburg

Duke University

Monica Gonzalez

The George Washington University

Federico Goodsaid

Vertex Pharmaceuticals

Klaus Gottlieb

U.S. Food and Drug Administration

Steven Gutman

Myraqa, Inc.

Suggested Citation:"Appendix D: Registered Attendees." Institute of Medicine. 2014. Refining Processes for the Co-Development of Genome-Based Therapeutics and Companion Diagnostic Tests: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18617.
×

Natalie Hamm

American Cancer Society Cancer Action Network

Kim Harp

Mary Breckinridge School of Nursing

Gerald Higgins

AssureRX Health, Inc.

Richard Hodes

National Institutes of Health

Laurie Huard

Precision Therapeutics, Inc.

Dora Hughes

Sidley Austin, LLP

Sam Johnson

Kaiser Permanente Colorado

Rasika Kalamegham

American Association for Cancer Research

Francis Kalush

U.S. Food and Drug Administration

Chris Khoury

PricewaterhouseCoopers

Muin Khoury

Centers for Disease Control and Prevention

Vanessa King

Siemens

Walter Koch

Roche Molecular Systems, Inc.

Sheryl Kochman

U.S. Food and Drug Administration

Gabriela Lavezzari

PhRMA

Thomas Lehner

National Institute of Mental Health

Debra Leonard

Weill Cornell Medical College

Sharon Liang

U.S. Food and Drug Administration

Kimberly Linthicum

Myriad Genetic Laboratories

David Litwack

U.S. Food and Drug Administration

Deborah Mackenzie

AstraZeneca

Jennifer Madsen

American Clinical Laboratory Association

Elizabeth Mansfield

U.S. Food and Drug Administration

Jean-Claude Marshall

Center for Translational Research

Brian Masterson

Department of Defense

James Matthews

Sanofi Pasteur

Michael McCaughan

The RPM Report

Suggested Citation:"Appendix D: Registered Attendees." Institute of Medicine. 2014. Refining Processes for the Co-Development of Genome-Based Therapeutics and Companion Diagnostic Tests: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18617.
×

Robert McCormack

Veridex, LLC

Kathryn McLaughlin

Health Resources and Services Administration

Kelly McVearry

Northrop Grumman

Alan Mertz

American Clinical Laboratory Association

Ronald Miller

Air Force Medical Support Agency

Kyung Moon

J. Craig Venter Institute

James Mule

Moffitt Cancer Center

Padmaja Mummaneni

U.S. Food and Drug Administration

Jennifer Nuzzo

Center for Biosecurity

Kristina Obom

Johns Hopkins University

Steven Oh

U.S. Food and Drug Administration

Michael Pacanowski

U.S. Food and Drug Administration

Aaron Packman

AstraZeneca

Danielle Pambianco

HillCo HEALTH

Lydia Pan

Pfizer Inc.

Qiulu Pan

Quest Diagnostics

Scott Patterson

Amgen Inc.

Godfrey Pearlson

Olin Research Center

Michelle Penny

Eli Lilly and Company

John Pfeifer

Washington University School of Medicine

William Pignato

Novartis

Aidan Power

Pfizer Inc.

Victoria Pratt

Quest Diagnostics

Bruce Quinn

Foley Hoag, LLP

Lakshman Ramamurthy

Avalere Health, LLC

Andrew Robertson

Merck and Co.

Laura Lyman Rodriguez

National Human Genome Research Institute

Allen Roses

Duke University

Suggested Citation:"Appendix D: Registered Attendees." Institute of Medicine. 2014. Refining Processes for the Co-Development of Genome-Based Therapeutics and Companion Diagnostic Tests: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18617.
×

Franklin Salisbury, Jr.

National Foundation for Cancer Research

Derek Scholes

National Human Genome Research Institute

Michele Schoonmaker

Cepheid

Joan Scott

National Coalition for Health Professional Education in Genetics

Cecili Sessions

Air Force Medical Support Agency

Vicki Seyfert-Margolis

Precision Health

Donna Mare Seyfried

DMS Associates

Fay Shamanski

College of American Pathologists

Paul Sheives

BIO

Sam Shekar

Northrop Grumman Information Systems

Ray Silkaitis

Merck and Co.

Tania Simoncelli

U.S. Food and Drug Administration

Naoko Simonds

National Cancer Institute

Skip Singer

NOVA Health Care Group

Ipsita Smolinski

Capitol Street

Daniela Starcevic

Mount Sinai

Cheryl Sullivan

American Nurses Association

Pamela Swatkowski

Abbott Molecular

Katie Johansen Taber

American Medical Association

Kevin Teichman

Office of Research and Development, U.S. Environmental Protection Agency

Sharon Terry

Genetic Alliance

Zivana Tezak

U.S. Food and Drug Administration

Bradley Thompson

Epstein Becker Green, P.C.

Sylvia Trujillo

American Medical Association

David Veenstra

University of Washington

Guanghua Wang

The Joint Pathology Center

Suggested Citation:"Appendix D: Registered Attendees." Institute of Medicine. 2014. Refining Processes for the Co-Development of Genome-Based Therapeutics and Companion Diagnostic Tests: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18617.
×

Daniel Wattendorf

Defence Advanced Research Projects Agency, Department of the Air Force

Catherine Wicklund

National Society of Genetic Counselors

David Wierz

OCI Group, Inc.

Mary Steele Williams

Association for Molecular Pathology

Catherine Witkop

Air Force Medical Support Agency

Suggested Citation:"Appendix D: Registered Attendees." Institute of Medicine. 2014. Refining Processes for the Co-Development of Genome-Based Therapeutics and Companion Diagnostic Tests: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18617.
×
Page 77
Suggested Citation:"Appendix D: Registered Attendees." Institute of Medicine. 2014. Refining Processes for the Co-Development of Genome-Based Therapeutics and Companion Diagnostic Tests: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18617.
×
Page 78
Suggested Citation:"Appendix D: Registered Attendees." Institute of Medicine. 2014. Refining Processes for the Co-Development of Genome-Based Therapeutics and Companion Diagnostic Tests: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18617.
×
Page 79
Suggested Citation:"Appendix D: Registered Attendees." Institute of Medicine. 2014. Refining Processes for the Co-Development of Genome-Based Therapeutics and Companion Diagnostic Tests: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18617.
×
Page 80
Suggested Citation:"Appendix D: Registered Attendees." Institute of Medicine. 2014. Refining Processes for the Co-Development of Genome-Based Therapeutics and Companion Diagnostic Tests: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18617.
×
Page 81
Suggested Citation:"Appendix D: Registered Attendees." Institute of Medicine. 2014. Refining Processes for the Co-Development of Genome-Based Therapeutics and Companion Diagnostic Tests: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18617.
×
Page 82
Refining Processes for the Co-Development of Genome-Based Therapeutics and Companion Diagnostic Tests: Workshop Summary Get This Book
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 Refining Processes for the Co-Development of Genome-Based Therapeutics and Companion Diagnostic Tests: Workshop Summary
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Many drug developers have examined new strategies for creating efficiencies in their development processes, including the adoption of genomics-based approaches. Genomic data can identify new drug targets for both common and rare diseases, can predict which patients are likely to respond to a specific treatment, and has the potential to significantly reduce the cost of clinical trials by reducing the number of patients that must be enrolled in order to demonstrate safety and efficacy. A key component of the approval of targeted therapeutics is the ability to identify the population of patients who will benefit from treatment, and this has largely hinged on the co-development and co-submission to the FDA of a companion diagnostic test.The co-development process, or the development of the test and drug for the simultaneous submission to FDA, has led to a major alteration in the way that drugs are being developed, with traditionally separate entities—pharmaceutical and diagnostic companies—now working in close collaboration.

Refining Processes for the Co-Development of Genome-Based Therapeutics and Companion Diagnostic Tests is the summary of a workshop held by the Roundtable on Translating Genomic-Based Research for Health on February 27, 2013 to examine and discuss challenges and potential solutions for the codevelopment of targeted therapeutics and companion molecular tests for the prediction of drug response. Prior to the workshop, key stakeholders, including laboratory and medical professional societies, were individually asked to provide possible solutions to resolve the concerns raised about co-development of companion diagnostic tests and therapies. Workshop speakers were charged with addressing these solutions in their presentations by providing insight on (1) whether the proposed solutions address the problems described, (2) whether there are other solutions to propose, and (3) what steps could be taken to effectively implement the proposed solutions.

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