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Personalized Medicine 2010
Arrowhead Publishers, May 2010, Pages: 261
Assessing the Opportunities and Challenges in Commercializing Companion Diagnostics and Targeted Therapies
The era of Personalized Medicine is set to revolutionize the healthcare industry. As our knowledge of genetics and molecular biology rapidly expands, a personalized approach to medical care is becoming increasingly important. Not only does this paradigm promise to improve an individual’s treatment outcome and reduce healthcare expenditure, personalized medicine is set to transform the pharmaceutical/biotechnology and companion diagnostic markets.
The era of Personalized Medicine is set to revolutionize the healthcare industry. As our knowledge of genetics and molecular biology rapidly expands, a personalized approach to medical care is becoming increasingly important.
Not only does this paradigm promise to improve an individual’s treatment outcome and reduce healthcare expenditure, personalized medicine is set to transform the biopharmaceutical and molecular diagnostics markets.
Arrowhead’s Personalized Medicine 2010 report provides an in-depth assessment of this burgeoning market, and examines the major challenges that need to be overcome to maximize success.
Key features of Arrowhead’s Personalized Medicine 2010 include:
- Case studies of leading pharmacogenomic products
- Analysis of the personalized medicine market, including seven major market sales forecasts to 2016
- Regulatory and legal issues surrounding personalized medicine
- Payer reimbursement challenges
- Marketing strategies to capitalize profits
Key questions answered by Personalized Medicine 2010 include:
- What are the major challenges in this market and how can these be overcome?
- How will pharmacogenomics transform clinical trials?
- What are the leading pharmacogenomic products on the market?
- Who are the key players involved in the market and what strategies are they using to enhance product performance?
- What pharmaceutical/biotechnology and diagnostic companies are seeking alliances in 2010?
- How can company alliances maximize commercial success?
Key Findings
Rather than developing blockbuster drugs that target broad populations, in an era of personalized medicine, industry must discover and develop tailored therapies for smaller markets and the development of new therapeutics based on genomics and proteomics will require an entirely new level of tailoring.
There are many benefits associated with the pursuit of personalized medicine, among them the ability to understand risks and benefits at the level of the individual, the expanded use of biomarkers to identify unpromising drugs early in the R&D process and to run smaller, accelerated clinical trials that can be modified in mid-stream as evidence emerges.
By targeting subpopulations, the market for personalized medicine may follow the niche orphan drug structure. Currently, orphan drug status is awarded to therapeutics that target rare diseases or conditions, where the target population is less than 200,000 people. With the FDA offering funding grants for clinical research in rare diseases, this could be further incentive for personalized medicine companies wishing to gain commercial success.
Personalized medicine may breathe new life into drug programs that were abandoned during the development process or withdrawn from the market due to safety concerns.
Recommendations for Moving Forward
Articulate the benefits of products in the pipeline to payers and regulators as early as possible in the R&D process to win their support and avoid the time and expense of developing a drug or diagnostic that cannot be commercialized.
To help make the business case for reimbursement, develop health economic models that project the potential cost savings of products in development.
Work proactively with regulators to educate them about the need for a reasonable period of IP exclusivity as well as new pathways for approval of targeted diagnostics, therapeutics and MTT companion diagnostics. Assist in offering novel solutions.
Collaborate with payers in developing novel reimbursement strategies that minimize your risks and costs, such as an accelerating schedule of reimbursements as products progress through their lifecycle and demonstrate their efficacy.
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