It's All About the Biomarkers: How 2008's Biomarker-Based Partnering Is Driving Personalized Medicine
Decision Resources, Inc, December 2008, Pages: 35
Introduction
Biomarkers—physical characteristics that are objectively evaluated as indicators of normal biological
processes, pathogenic processes, or pharmacological responses to therapeutic intervention—are high-value-added commodities in drug and diagnostics discovery and development, and biomarker-based strategies are the key to success in personalized medicine. In 2008, these strategies were manifest in a variety of biomarker centered partnerships that involved pharmaceutical and biotech companies, academic institutions, and government agencies and in several significant M&As that we examine in this report.
Get the Answers You Need to Shape Your Strategy
- The push for personalized - medicine is gathering momentum. What are the driving forces? What are the advantages and challenges of the personalized medicine paradigm shift for pharma companies? For diagnostics companies? For healthcare in general?
- Biomarker proponents often point to the success of Genentech/Roche/Chugai’s Herceptin to illustrate the value of biomarker-based drug/diagnostic development. What makes Herceptin a prime example? What other success stories in biomarker-related research, development, partnering, and regulatory approval can companies use as models?
- Researchers at your company have discovered a target that is amenable to biomarker development, drug development, or both. What are your options? When should you pursue an alliance? What are the benefits of partnering, or not partnering, to realize the full potential of the discovery? What are other companies doing?
- Despite the promise of personalized medicine, investment of resources in biomarkers presents challenges. What are the pros and cons of investing in biomarkers? What can companies do to secure their buy-in?
Scope
- Key trends in biomarker partnering, November 2 - 007 to November 2008: biopharmaceutical
and diagnostics company alliances, diagnostics company partnerships, industry and academia collaborations, and government-sponsored, biomarker-based product development.
- Five biomarker deal models: whole company acquisitions, asset purchases, collaborations, licensing deals, and government-funded deals.
- Biomarker deal drivers: demand for more-precise diagnostics and safer, more-effective drugs; Lower-cost, lower-risk drug development; growth potential of the diagnostics market.
- Expert Commentary: Spectrum Senior Program Manager Lulu Pickering, Ph.D., offers “Ten Insights on Integrating Personalized Medicine into Pharma Business Strategies.”
Executive Summary
Strategic Considerations
Stakeholder Implications
Overview
Biomarker Development Versus Drug Development
Sidebar: Where Do Novel Biomarkers Come From?
Biomarkers in Drug Development
Model Case Studies
Biomarker Diagnostics and Progress Indicators
Making Strategic Partnering Decisions
Factors That Influence Alliances
Partnering…
…Or Not Partnering
Common Types of Biomarker-Centric Alliances
Whole Company Acquisition
Affymetrix Complements Its Product Line with the Addition of Panomics
Johnson & Johnson Acquires Amic
Immucor Acquires BioArray Solutions
Asset Purchase
Collaborations
Roche Will Work with Arcxis on Infectious Disease and Cancer
Rosetta Genomics Worked with Columbia University to Validate its NSCLC Test
The European Group for the Study of Insulin Resistance Will Contribute Samples
to Metabolon
ApoCell Will Support Pfizer’s Phase I Clinical Trial
Genomic Health Is Developing a Renal Cell Carcinoma Test for Pfi zer
Licensing Opportunities
Ipsogen Licenses to Quest Diagnostics
Genomic Nanosystems Licenses to Sequenom
Johns Hopkins University Licenses to Orion Genomics
OncoMethylome Sciences Licenses to Merck KGaA
20/20 GeneSystems/Ortho-Clinical Diagnostics
Government’s Vested Interest
Conclusions and Outlook
Trends by Therapy Area
“Blockbuster Diagnostic” Is an Oxymoron—for the Moment
Drug Development Is a Driver
Growth Comes from Undersized Sectors
Spectrum Expert Commentary:
Ten Insights on Integrating Personalized Medicine into Pharma Business Strategies
Sidebar
Where Do Novel Biomarkers Come From?
Expert Commentary
Ten Insights on Integrating Personalized Medicine into Pharma Business Strategies
Lulu Pickering, Ph.D., Decision Resources
Tables
1. Use of Biomarkers in Drug Development
2. Valid Genomic Biomarkers in the Context of Approved Drug Labels, for Required and Recommended Tests
3. Valid Genomic Biomarkers in the Context of Approved Drug Labels, for Information Only
4. Whole Company Acquisitions Related to Biomarkers and Diagnostics, November 2007 - November 2008
5. Asset Purchase Deals Related to Biomarkers and Diagnostics, November 2007 - November 2008
6. Select Collaborations Related to Biomarkers and Diagnostics, November 2007 - November 2008
7. Select Licensing Opportunities Related to Biomarkers and Diagnostics, November 2007 - November 2008
8. Select Government-Based Alliances Related to Biomarkers and Diagnostics,November 2007 - November 2008
Figures
1. Drug Discovery, Development, and Approval Process
2. Diagnostic Technologies Can Increase Treatment Effi cacy
3. Cycle of Funding Gained Through Academic Research
4. Payer Attitudes Toward Diagnostic Regulatory Pathways
5. Trends in Biomarker and Diagnostics Alliances by Therapy Area, November 2007 - November 2008
- 20/20 GeneSystems
- AB Biodisk
- Abbott
- Acrongenomics
- Affymetrics
- Allergan
- Amgen
- Amic
- ApoCell
- Arcxis Biotechnologies
- AstraZeneca
- Avalon Pharmaceuticals
- BBI Holdings
- BD Diagnostics
- Beckman Coulter
- BioAray Solutions
- Bio-Manguinhos
- BioMerieux
- Bio-Rad Pasteur
- Biotage
- BioTrove
- Biovail
- Bristol-Myers Squibb
- Caprion Proteomics
- Castle Biosciences
- Celera Genomics
- Celgene
- Chembio Diagnostic Systems
- China Medical Technologies
- Chugai
- Clinical Data
- Corbett Life Science
- Daichi Sankyo
- Diagnostic Chemicals
- DioGenix
- DNAPrint
- Electra Lab
- Eli Lilly
- Elitech
- Exigon
- Gene Express
- GeneData
- Genentech
- Genomic Health
- Genomic Nanosystems
- Gen-Probe
- Genzyme
- GeoPharma
- GlaxoSmithKline
- HistoRx
- Hologic
- ImClone
- Immucor
- Immunicon
- Innogenetics
- Inova Diagnostics
- Inverness Medical Innovations
- Ipsogen
- Johnson and Johnson
- Lab21
- Luminex
- Medicis Pharmaceutical
- Merck KGaA
- Meridian Bioscience
- Metabolon
- Microchip Biotechnologies
- Molecular Diagnostics Technologies
- Molecular Vision
- MTS Health Investors
- Nanobac
- Nanogen
- Nerveda
- NexGen Diagnostics
- Novartis
- NPTech
- Nycomed
- Oncomethylome Sciences
- Oncotech
- Orion Genomics
- Ortho-Clinical Diagnostics
- Otsuka Pharmaceutical
- Panomics
- Parkway Clinical Laboratories
- Pfizer
- Qiagen
- Quest Diagnostics
- Regeneron
- Roche
- Rosetta Genomics
- Sanofi -Aventis
- Sequenom
- Spectral Diagnostics
- Stratagene
- Takeda
- TheraGenetics
- Third Wave Technologies
- Veridex
- Vermillion
- Vital Diagnostics
- Vybion
- Werfen Group
- Wyeth
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