From Niche to Norm - Diaceutics

From Niche to Norm

July 15th, 2013

Tiffany Olson, BSc MBA

Tiffany Olson discusses PM2.0 and provides insight on how it will change the industry as whole.

As one of the personalized medicine industry veterans, it was in 2000 that I gave my first presentation on this ‘new concept’, about using in vitro diagnostics for personalized medicine. Over the years, many have felt that the promise has exceeded the actual benefits. However, the last few years have supplied concrete examples of the power of personalized medicine. The acceptance has accelerated and, in fact, there have been several indications that the industry has hit the tipping point. This is the point where personalized medicine is recognized as a standard and is generally accepted by most stakeholders, especially big pharma. This is the time when personalized medicine goes from niche to norm.

Over the past two years, we have seen a rapid acceleration of acceptance in personalized medicine [2013]. Most big pharma companies have some form of diagnostics competency in the organization and have made significant investments in structure. There are many different models and types of organizational structure with not one specific model that is dominant. It is estimated that by 2025, 70 per cent of pharma’s pipeline will include personalized medicine-related drugs. This surpasses the 50 per cent point that marks the general acceptance and tipping point of personalized medicine.

We are on track to see over a five-fold increase in personalized medicine products that are commercially available. Today, there are over 200 products that carry labels recommending genetic testing or the influence of genetic variation on drug response. It is predicted by the Personalized Medicine Coalition that by 2017 there will be over 350 personalized medicine products commercially available. This growth curve and available products shows we are moving rapidly from niche to norm for personalized medicine.

Pharma sees personalized medicine as a solution to holding a new standard in clinical trials. This new level was established with Roche and Pfizer accelerating approvals of their drugs and getting to market years sooner than others.  Zelboraf saved 4.7 years and Xalkori 3.9 years of development time. The cost savings are tremendous. Moreover, the ability to market the product sooner and have peak sales accelerated by four to five years earlier than originally planned holds incredible financial benefits.  Recently, Franz Hummer, Chairman of Roche, revealed that he expects clinical trial costs to be cut in half by 2017.  Not such a far-fetched statement given the recent success of Zelboraf and other companion products.

So the tipping point of acceptance within Big Pharma for personalized medicine is occurring. But what is next?  Like any new initiative, when one milestone is reached a new milestone must be set, hence PM2.0.

What is PM2.0?  It brings personalized medicine to the next level and makes sure that the ‘personalized’ part of medicine—the individual patient—is not forgotten. The entire patient journey must be considered when personalizing medicine. In the future, all the diagnostic touch points that the patient should experience for optimum diagnosis and treatment need to be considered when developing a drug. Today, personalized medicine is only focused on the companion diagnostic specific to the drug. This will not bring personalized medicine to the next level in its evolution. PM2.0 focuses on the patient pathway and the entire array of complementary diagnostics, bringing the next level to the industry.

In order to be successful at the next level, cooperation and integration between all stakeholders must occur.  The early leaders will be able to transform the current business models in the market, allowing for integration of many different players.

PM2.0 will change our industry to one where the value of diagnostics will be clearly seen. As we move from niche to norm, PM2.0 will continue to change our industry and enable us to realize the promise of better patient outcomes.  The change will include a clear understanding of the value of diagnostics in a patient-centric model. Systems integration will not be easy but there will be large rewards for those willing to be the first.



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