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Driving Drug and Diagnostic R&D: The Undeniable Influence of Biomarkers
Decision Resources, Inc., May 2010, Pages: 25
Pharmaceutical companies can either take action that will ensure their position as knowledgeable and influential partners in drug prescribing or watch as others help doctors determine which drugs are best for which patients. The pharma industry has typically lacked an aggressive biomarker strategy for their R&D efforts. Biomarkers were considered as an afterthought, pursued when regulatory agencies demanded them. However, with the focus on safety (by regulators and physicians) and cost-cutting (by patients and payers) inspiring an emphasis on personalized medicine, pharmaceutical companies are starting to realize the benefits of utilizing biomarkers and are becoming more open to the idea of actively searching for markers of drug response.
Questions answered in this report:
- We are in the midst of a paradigm shift in the way pharmaceutical companies view biomarkers. While a reluctance to proactively pursue drug-diagnostic combinations was the norm five to ten years ago, the pairing is becoming more common. Increased investment in biomarkers and diagnostics by venture capitalists is but one contributing factor. What factors contributed to the once-negative outlook on biomarkers by the pharma industry? What are some of the main events attributed to the positive shift in strategic thinking?
- Proponents of personalized medicine often describe the success of Roche/Genentech/Chugai’s Herceptin to illustrate the value of biomarker-based drug-diagnostic development. Other notable examples include Amgen’s Vectibix, AstraZeneca’s Iressa, Bristol-Myers Squibb’s Erbitux, and possibly Novartis’s Prexige. Why is Herceptin a prime case study? How do the other examples compare with Herceptin in biomarker-related discovery, development, and regulatory approval? Will Novartis’s Prexige and its associated diagnostics join the success stories?
- Biomarker validation is one of the greatest challenges constraining proper use of biomarkers in drug development. Use of clinical repositories of biological samples and innovative drug trials that use biomarkers are bringing renewed optimism toward meeting this challenge. How do these solutions affect the availability of biomarkers and their use in drug development? What regulatory impact on drug development is anticipated as a result of these trends?
Scope of the report:
- Market forecast features: Global sales over 2004-2015 for Herceptin, Vectibix, and Erbitux from Decision Resources’ Pharmaview.
- Biomarkers, repositories, and landmark clinical trials: Insight into key markers that continue to shape drug development: HER2, KRAS, EGFR, and BRAF; innovative ways to rethink validation of biomarker data: The Cancer Genome Atlas for gene expression and Genetic Alliance for rare diseases; drug trials that showcase study designs incorporating biomarker data: ToGA, SATURN, IPASS, I-SPY, I-SPY 2, BATTLE.
- Dealmaking assessment: Biomarker and diagnostic deals from 2005 through February 2010; select companion diagnostics deals from 2007-2010.
- Investing in biomarker-based strategies: VC and pharmaceutical company interest in biomarkers and personalized medicine, focusing on select next-generation diagnostics companies that highlight the importance of this strategy.
Key terms for this report:
Biomarkers, Biomarkers in drug development, Companion diagnostics, KRAS testing, Clinical trials, Oncology, Targeted therapies, Herceptin, Adaptive trial design, I-SPY, SATURN, ToGA, Biobank, Biomarker Consortium
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