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

Published by: Business Insights

Published: Jun. 1, 2009 - 114 Pages


Table of Contents


Key Trends in Drug-Diagnostic Co-Development
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
bioMérieux
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)

Abstract

Key Trends in Drug-Diagnostic Co-Development

Identifying collaborative opportunities and navigating regulatory challenges

Report Overview

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 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.

Key Findings

There have been 28 Rx-Dx co-development projects identified, of which 17 are in the oncology area. The remainder have been found to cover cardiovascular, CNS, autoimmune, infectious diseases, HIV and growth factors.

There is a growing trend for co-development partnerships to be made during the early stages of drug development. An analysis of ongoing co-development projects indicates that more deals are being concluded well in advance of Phase II clinical trial completion.

Gaining physicians’ support is crucial to ensure clinical adoption for drug-test combinations, although labelling is also of great importance. It is estimated that 80-90% of US prescriptions are being written for cetuximab or panitumumab based on a K-Ras negative test result.

Third-party studies will be a significant driver in gaining acceptance for the use of pharmacogenomic information to optimize drug usage. Work currently being done by US PBM Medco to generate data in the real-world setting will support manufacturers’ own initiatives.

Roche’s ‘one-stop shop’ model is being emulated by a number of companies across the pharma industry. Novartis is the latest major company to establish a molecular diagnostics business.

Use this report to...
  • Identify recent regulatory trends in the field of Rx-Dx co-development and determine how these will affect the use of biomarker data at different stages of drug development with this report’s analysis of the US and EU regulatory landscape.
  • Understand how to overcome the commercial challenges associated with drug-diagnostic combinations and evaluate the benefits and disadvantages of emerging business models and collaborative agreements.
  • Compare 28 Rx-Dx co-development projects at various stages of development with this report’s review of collaborative agreements involving 15 diagnostic companies and 17 pharma companies.
  • Assess the future outlook for pharma and diagnostic collaborations by analyzing the impact of pharmacogenomics-based patient management and changing approaches to pharma R&D.
Explore issues including...

Technology is outpacing regulatory guidance on Rx-Dx co-development. Pharma and diagnostic companies face numerous regulatory hurdles when developing combination products. Although final US FDA guidance is pending, the EU is developing a reflection paper on the co-development of PGx biomarkers and test platforms, which is due by the end of 2009.

Personalized medicine becoming a reality. The use of PGx information in drug development will contribute to individualized medical treatments and a shift away from the 'onesize fits all' drug. The increasing number of drugs with genetic biomarkers will foster collaborations with diagnostic partners.

The evolving pharma R&D model. The shift from the blockbuster model towards targeted therapies will require a different strategic approach to R&D. With pharma spending on biomarker R&D more than doubling over 2003-09, new alliances with diagnostic players will become common. More drugs will be granted orphan status as target patient populations become better defined.

Discover...
  • What are the key regulatory and commercial challenges in co-developing drug-test combinations?
  • What type/amount of data is needed to support product labelling using biomarkers?
  • How will the emergence of new biomarker data impact drug development programmes?
  • What are the advantages of having drug and diagnostic development based at one location?
  • Why is it important to complete analytic validation of an IVD test before applying the test to specimens in clinical trials that will be used for regulatory review?
  • How can companies work with payors to encourage uptake of tests?
  • What factors need to be considered to ensure that tests to guide clinical decisions do not impede patient access to treatment?


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