When Will Precision Medicine Work?

We have been talking about precision medicine for a long time now but so far we are still in its infancy. The human genome was sequenced in 2003,with the promise of rapid medical advances and genetically tailored treatments. However, development and adoption of these treatments has been slow. Today with the advent of large cohorts, and in particular, the construction of the U.S. Government’s Precision Medicine Cohort, conditions are being set up for precision medicine to flourish. 

Protocols are analogous to laws. There are many parties, normally ones selling interventions or diagnostics, interested in wrestling for the control of a part of the protocol in order to optimize their own benefits. So like the laws, the number of places where a protocol can be diverged is dependent on the body that is building the protocol being able to deal with the divergent inputs from the many interested parties.

This paradigm of the protocol needs a major refresh to accomplish the goal of making a transition to a new world of precision medicine. For example,in HER-2 positive breast cancer patients we have learned to use Herceptin because it is a well understood variant and treatable because of the biology of the drug and cancer cells. But the Herceptin test is only a small part of cancer diagnostics and precision treatment options. 

We need to invest in more people with regulatory science and medical ethics to sort this out to figure out the right model since getting to bigger data only exacerbates this issue.

While there is a clear opportunity to provide a better service through mass personalization, there are some big financial issues to resolve for any first mover offering an intervention in the space. The current economic model for drug development still requires a drug to have a return on investment in the range of billions of dollars. This means that creating diagnostics that can significantly limit the potential addressable market are still economically disadvantageous. 

Currently, no one has found a way to disrupt the current pharma business model by identifying when drugs will not work and paying for that research with a diagnostic that is reimbursed to do so. But no break-out story about the AirBnB or Uber drug diagnostics company cutting down the cost of drugs in this way has been established. 

Currently we have a number of technology companies that are “using Big Data” to be able to support decisions. A big data cognitive engine is needed to break through the protocol-driven system to formulate a model driven system where the decision path is more opaque but technology can still provide the right recommendations based on the body of available collected genetic and clinical evidence. 

As of today, systems like this haven’t been built and approved for broad medical use yet. One of the reasons these systems don’t exist yet is because such a system is a medical device and should comply with the same rules. We have seen the sorts of trouble that have occurred from the disposition of “medical device” being applied to Silicon Valley generated innovations.The regulatory world may need to catch-up to the capabilities and model of the newer technology, and the newer technologies will also need to admit that they need to modify their operating model to acquire FDA approvals to be trustable and involved in the liability of medical decision making.

I am optimistic about the transition from current medicine into a precision medicine world. It seems that most of the barriers have fallen from a technical point of view. We just need to work on the areas that are the key drivers. 

Some of these will get solved by market forces but others are still in the hands of regulators and leaders of the medical community managing the creation and diffusion of protocols. 

Big data businesses will get smart and involved in approving their systems as components of medical devices or they will not be players.

Dan Housman is the chief technology officer at Converge Health. A version of this article originally appeared on The Health Care Blog.