A Review of the Development of Companion Diagnostic Assays and their Relationship to Public Health Open Access

Abstract

Bringing a companion diagnostic (CDx) to market is a complex process involving several stakeholders including the pharmaceutical industry, regulatory bodies, health financing entities (payers) and healthcare providers. In order to capitalize on synergies between public health policy makers and CDx developers, both groups should better understand the motivations of the other. Policy makers interested in maximizing the public health impact of CDxs through increased development, adoption and use should take into account financial and investment decisions affecting CDx development.

This SSP presents a synthesis of existing literature to educate/inform public health policy makers about the motivations of developers responsible for CDx generation. This information can assist public health decision makers responsible for guidelines and public finance to make such decisions with an appreciation of the dynamic environment in which developers of companion diagnostics operate in the private sector.

Table of Contents

TABLE OF CONTENTS

CHAPTER ONE: INTRODUCTION 1 1.1 CONTEXT 1 1.2 PURPOSE / PROBLEM STATEMENT 3 CHAPTER TWO: METHODS 3 2.1 SEARCH PROCEDURE 3 2.2 INCLUSION/ EXCLUSION CRITERIA 5 CHAPTER THREE: RESULTS REVIEW 6 3.1 ASSESSMENT OF KEY STAKEHOLDERS 6 3.2 BIOMARKER STATUS / FDA MEDICAL DEVICE: 9 3.3 REGULATORY AVENUES TO MARKET 10 3.4 FDA RECCOMENDATION FOR PARALLEL DEVELOPMENT 13 3.5 PHARMACEUTICAL DEVELOPMENT PROCESS 15 3.6 CO-APPROVAL PROCESS 16 3.7 LABELING 18 3.8 INTERNATIONAL REGUALTION 18 3.9 REIMBURSMENT 19 3.10 COMPANION DIAGNOSTIC MARKET EVALUATION 25 3.11 MARKET GROWTH 27 3.12 SPECIALTY GROWTH AREAS 28 3.13 ONCOLOGY MARKET 33 3.14 TYPES OF CDX TESTING 34 3.15 INTERNATIONAL MARKETS 36 CHAPTER FOUR: DISCUSSION 37 4.1 PUBLIC HEALTH IMPACT 37 4.2 STRATEGIC BUSINESS MODEL 40 4.3 DECREASED CLINICAL TRIAL COSTS 40 4.4 INCREASE IN TO MARKET SUCCESS RATE 43 4.5 PHYSICIAN UPTAKE 45 4.6 DIFFERENTIATION 46 4.7 CDX VALUE PROPOSAL FOR DEVELOPERS 47 4.8 CASE STUDY KEYTRUDA & OPTIVO 48 4.9 CONCLUSION 50 SOURCES 53

About this Master's Thesis

Rights statement

• Permission granted by the author to include this thesis or dissertation in this repository. All rights reserved by the author. Please contact the author for information regarding the reproduction and use of this thesis or dissertation.

School	Rollins School of Public Health
Department	Hubert Department of Global Health
Degree	MPH
Submission	Master's Thesis
Language	English
Research Field	Health Sciences, Public Health Business Administration, General Sociology, Public and Social Welfare
Keyword	precision medicine diagnostic development companion diagnostics
Committee Chair / Thesis Advisor	McFarland, Deborah A, Emory University
Partnering Agencies	Emory University schools, faculty or affiliated programs

Last modified

Primary PDF

Thumbnail	Title	Date Uploaded	Actions
	A Review of the Development of Companion Diagnostic Assays and their Relationship to Public Health ()	2018-08-28 16:28:11 -0400	Press to Select an action Download

Supplemental Files

Thumbnail	Title	Date Uploaded	Actions