Building a Better R&D Model: Personalized Medicine

Problem, according to a PricewaterhouseCoopers report, patient response rates to medicines can be very low, ranging from 20%-75%. Every year 100,000 American’s die from adverse medical reactions with another 2,000,000 hospitalized. Does this seem wasteful to anyone else?  In a time when we are trying to reduce the cost of healthcare, we need to start to invest the research and the small companies that are paving the way for this new model.

Def: Personalized medicine or PM is a medical model that proposes the customization of healthcare – with medical decisions, practices, and/or products being tailored to the individual patient. The use of genetic information has played a major role in certain aspects of personalized medicine, and the term was even first coined in the context of genetics (though it has since broadened to encompass all sorts of personalization measures). To distinguish from the sense in which medicine has always been inherently “personal” to each patient, PM commonly denotes the use of some kind of technology or discovery enabling a level of personalization not previously feasible or practical.

Colin Palmer,  head of pharmacogenomics at Dundee University, explains the pharma industry needs to “try and get rid of the one-size fits all approach to medicine. Instead, he says, the future of medicine lies in creating more effective drugs that are tailored to the individual.

While the market for diagnostic tests and therapies that leverage this new science is growing, the biggest opportunities exist outside of the traditional healthcare sector. The U.S. personalized medicine market is estimated at about $232 billion and is projected to grow 11% annually, nearly doubling in size by 2015 to over $450 billion. The core diagnostic and therapeutic segment of the market—comprised primarily of pharmaceutical, medical device and diagnostics companies—is estimated at $24
billion, and is expected to grow by 10% annually, reaching $42 billion by 2015. The personalized medical care portion of the market—including telemedicine, health information technology, and disease management services offered by traditional health
and technology companies—is estimated at $4-12 billion and could grow tenfold to over $100 billion by 2015. And the related nutrition and wellness market—including retail, complementary and alternative medicine offered by consumer products, food
and beverage, leisure and retail companies—is estimated at $196 billion and projected to grow by 7% annually to over $290 billion by 2015.

Similar to building a better R&D Model focused on key diseases, Personalized Medicine is a disruptive innovation that will require new business models and collaboration between phamra/biotech, providers & provider systems, payers, and government.

Hurdles/Areas of Collaboration:

  • Identify regulatory pathways of approval for targeted diagnostics and therapeutics
  • Design the framework for privacy and IP to support new product development
  • Develop new reimbursement strategies that encourage innovation and distributes the risk between the different players
  • Accelerate the translation of discoveries to the market

MedCity News identified 4 barriers that need to fall before the personalized medicine revolution can start:

  1. Ultrafast, accurate, low-cost DNA sequencing (timeline: now)
  2. Rapid, low-cost, and accurate secondary analysis (timeline: 3-6 months)
  3. Injecting genetic information into medical care (timeline: 12-36 months)
  4. Getting the “Big guys” to pay for it (timeline: 24-48 months)

Personalized medicine is a hot topic in the industry, and it provides a great business opportunity. But the focus should be on the patient and quickly bringing personalized medicine to market. Working collaboratively is the best way.

This is a conversation, not an editorial. Did I forget something, get it wrong or do you agree? Please Comment, Like, Re-Tweet and Share.

For more on where we are now and what needs to be done, here is a lecture by Penn State’s Marylyn Ritchie, Director- Center for Systems Genomics and Associate Professor, Biochemistry and Molecular Biology.

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