Key Trends In Drug-diagnostic Co-development: Identifying collaborative opportunities and navigating regulatory challenges published by Business Insights in June, 2009. This report consists of 114 pages and the price starts from US $ 3835.
Introduction
Abstract
The development of genomics-based molecular diagnostics that are linked to
therapeutic products is critical to targeted drug developments of the future.
The potential for molecular diagnostics to be used as companion products for
personalized treatments that are based on patient characteristics will
contribute to a growing trend for new partnerships between drug companies and
diagnostic firms. ' Key Trends in Drug-Diagnostic Co-Development' is a new
report published by Business Insights that explores the potential for applying
genomic-based diagnostics to new drug developments, and the resultant
implications for the pharma/biotech and diagnostic industries. This report
examines the commercial and regulatory challenges facing drug-diagnostic
combinations and evaluates emerging business models to identify the most
effective forms of pharmacodiagnostic partnership. This report also reviews 28
collaborative agreements for the co-development of drug-diagnostics and
determines which combinations can be expected to result in commercial products
in the near future.
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)
