SPI Infoamtion

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

bioMèrieux

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

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)