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Disruption or Advantage? Update on Companion Diagnostics

Published by: Decision Resources

Published: Sep. 15, 2009 - 25 Pages


Table of Contents


Executive Summary

Strategic Considerations

Stakeholder Implications

Introduction

Continued Efforts to Engage Stakeholders

Companion Diagnostics by Therapeutic Area: Focus on Oncology

Drug-Diagnostics Dialogue—Work in Progress

Technological Advances

Complex Codevelopment Workfl ows

Reimbursement Rules! But Not Without Challenges

Is Guidance from Regulators Suffi cient?

Building Capacity—Key Companies

Pharmaceutical Companies

Diagnostics Companies

Clinical Data

Dako

DxS

LabCorp

Outlook

Ugly Myth, Annoying Truth, or Advantage?

Bottom Line

Expert Commentary

Companion Diagnostics—Looking to the Future by Cheryl Barton, Ph.D., PharmaVision

Tables

1. Select Companion Diagnostic Tests and Corresponding Targets

2. Select KRAS Testing Companion Diagnostics

3. Common Technologies Underlying Companion Diagnostic Tests

4. Recent Companion Diagnostic-Drug Development Collaboration Activity

5. Dako’s Companion Diagnostic Tests

A. Examples of Targeted Drugs and Associated Companion Diagnostics Launched in the Past Five Years

Figures

1. The FDA Vision of Drug-Diagnostic Codevelopment

2. Coverage of Select Targeted Cancer Therapies by Private Health Plans

3. Coverage of Select Targeted Cancer Therapies by Medicare Plans

4. Benefi t of the Personalized Medicine Model

Abstract

Introduction

Some naysayers disagree, but we regard companion diagnostics as a win-win scenario for all stakeholders. Companion diagnostics combines drug and diagnostic test development. The potential for effi cient drug development is huge because companion diagnostics can be used to predict drug response and treatment effi cacy- therefore, companion diagnostics are also the perfect means to fulfi llment of the promise of personalized medicine. But the advantages of companion diagnostics are only one side of the equation: they are also seen as disruptors of the pharmaceutical market that could restrict the size of treatable populations. Bringing the differing viewpoints together to form a unifi ed idea of what companion diagnostics really mean to the industry is a challenge, but one that companies must heed because companion diagnostics are making their mark-like it or not.

Questions Answered in This Report
  • Regulatory and payer decisions on certain types of testing are increasingly infl uencing physician, patient, and
    • industry perspectives. For instance, how has the FDA's recent decision to alter the Vectibix and Erbitux labels affected industry dynamics?
  • Companies that have developed companion diagnostics are viewed as valuable acquisition targets. Which
    • companies are attracting potential buyers? What is the perceived impact of these acquisitions on the overall strategies of pharmaceutical companies?
  • The availability of companion diagnostics in oncology is greater than in other therapy areas. Why is oncology
    • such an attractive area for growth in personalized medicine? In what other areas is development of personalized medicine growing?
Scope
  • Stakeholder analysis: Pharmaceutical companies, diagnostics companies, payers, regulatory agencies,
    • physicians, and patients.
  • Recent trends and decisions: Regulating KRAS mutation tests, identifi cation of genetic markers of
    • response to Vanda's Fanapt (iloperidone), reimbursement for warfarin testing, partnering and dealmaking in companion diagnostics.
  • Indications: Non-small-cell lung cancer (NSCLC), colorectal cancer (CRC), breast cancer, heart
    • failure, arthritis, depression, chronic myelogenous leukemia (CML).
  • Company profi les: Pharmaceutical companies-Wyeth, Vanda Pharmaceuticals, Roche, Pfi zer,
    • Novartis, Johnson & Johnson, Eli Lilly, ARCA BioPharma, Amgen, and Abbott. Diagnostics companies- LabCorp, DxS, Dako, and Clinical Data.
  • Outlook: Spectrum Expert Commentary on future growth, therapeutic area emphasis, the promise of personalized medicine
Please note, the PDF e-mail from publisher version of this report is for a global site license.

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