Key Trends In Drug-diagnostic Co-development: Identifying collaborative opportunities and navigating regulatory challenges

Table of Contents

Executive summary

• Introduction to drug-diagnostic co-development
• Regulatory challenges
• Commercial challenges
• Emerging business models
• Rx-Dx collaborations
• Future trends

Chapter 1 Introduction to drug-diagnostic co-development

• Summary
• Introduction
• Technology driving change
• Biomarkers & personalized medicine
• Convergence of players
• The role of Dx in personalized medicine
• Targeted therapeutic developments
• New industry partnerships
• Companion test development models

Chapter 2 Regulatory challenges

• Summary
• Introduction
• US regulatory landscape
• Voluntary genomic data submissions (VGDS)
• Rx-Dx co-development guidance
• IVDMIA guidance
• Dx usage determines risk
• Study design
• EU regulatory process
• IVD regulatory framework under discussion
• Pharmacogenomics in drug development
• Potential advantages of the EU system
• Case Study: K-RAS

Chapter 3 Key commercial challenges

• Summary
• Introduction
• Reimbursement
• Information requirements
• European situation
• Case Study: Oncotype DX
• Role of health economics
• Third-party studies
• Clinical use
• Different clinical settings
• Intellectual property

Chapter 4 Emerging business models

• Summary
• Introduction
• One-stop shop
• Case Study: Roche
  • Acquisitions
  • Alignment of business areas
  • Companion Dx programs
• Rx-Dx industry partnerships
• Drivers of co-development partnerships
• Types of agreements
• Case Study: Pfizer-Monogram Biosciences
• Collaborations underway

Chapter 5 Rx-Dx collaborations

Summary

• Introduction

Asuragen

• Background
• Collaboration
  • Merck & Co

BG Medicine

• Background
• Collaboration
  • Cordex Pharma

bioMerieux

• Background
• Collaboration
  • Ispen
  • Merck & Co
• ADNA project

Celera

• Background
• Collaboration
  • Abbott
  • Merck & Co
  • Ipsen

Curidium

• Background
• Collaboration
  • Takeda

Dako

• Background
• Collaboration
  • OSI Pharmaceuticals
  • Genentech
  • Bristol-Myers Squibb

DxS

• Background
• Collaboration
  • Amgen
  • Roche Molecular Diagnostics

GE Healthcare

• Background
• Collaboration
  • Eli Lilly

Genomic Health

• Background
• Collaboration
  • Pfizer
  • Bristol-Myers Squibb and Imclone Systems

HistoRx

• Background
• Collaboration
  • Lilly

LabCorp

• Background
• Collaboration
  • ARCA biopharma
  • Vanda Pharmaceuticals
  • Medco Health Solutions

Monogram Biosciences

• Background
• Collaboration
  • Pfizer HIV partnership
  • Oncology

OncoMethylome Sciences

• Background
• Collaboration
  • Merck KGaA
  • Schering-Plough
  • GlaxoSmithKline Biologicals
  • Abbott

Source MDx

• Background
• Collaboration
  • Pfizer

XDx

• Background
• Collaboration
  • Bristol-Myers Squibb

Chapter 6 Future trends

• Summary
• Introduction
• New paradigm for pharma R&D
• Rx-Dx combinations in pipeline
• Changing dynamics of the IVD industry
• Biomarker discovery for existing drugs
• Next generation tests
• Conclusions

Appendix 112

• Research methodology
• Glossary
• Index

List of Figures

• Figure 1.1: Biomarker discovery is comparable to drug discovery
• Figure 1.2: Convergence of drug and diagnostic industries
• Figure 1.3: Main therapy areas for Rx-Dx co-development (number of diagnostic tests)
• Figure 1.4: Ideal Rx-Dx co-development scenario
• Figure 1.5: Alternative co-development scenarios
• Figure 2.6: Regulatory pathways for diagnostics in the US
• Figure 2.7: Problems when patient accrual is gated via non-final IVD
• Figure 3.8: Pre and post-approval challenges of Rx-Dx co-development
• Figure 3.9: Difference between obtaining reimbursement in US and Europe
• Figure 4.10: Roche Group sales by type (% of revenues), 2008
• Figure 4.11: Diagnostic input for pharma projects
• Figure 4.12: Rx-Dx partnership opportunities
• Figure 6.13: Biomarker R&D expenditure ($bn), 2003 vs 2009
• Figure 6.14: Forecast sales in IVD market ($bn), 2007-2012

List of Tables

• Table 1.1: Drugs for which testing is recommended/required in the US
• Table 1.2: Co-developed Rx-Dx combinations on market
• Table 4.3: Biomarker strategy for Phase I/II oncology drugs
• Table 4.4: Summary of Rx-Dx Co-Development Projects
• Table 5.5: Rx-Dx co-development projects under review
• Table 6.6: Patient population in whom selected drugs do not work (% population)