Unleashing the full potential of precision medicine – equitable access to cutting edge data for research at every scale
Requester: Psephisma Health
Even though medicine has always been personal, in a sense, it hasn’t been very personalized. The steady development of diagnostic and research technologies has made it abundantly clear that individuals differ in many aspects. It is the appreciation of molecular differences (genetic, transcriptomic and proteomic ones) that gave rise to term of “personalized” or “precision” medicine as something worth striving to. The promise of it – “The right drug for the right patient at the right time” – remains elusive still, the main reason being our lack of understanding as to what some of the molecular features really mean and which ones to observe when prescribing treatments. The key in making further progress is to study greater volumes of such molecular profiling data in the context of health and disease. That is, however, easier said than done as such data is very scarce due to the costs and efforts associated with its generation. Also, positive legal regulations in the domain of patient privacy and research on humans make the extension of existing data attributes challenging, if not impossible, which negatively impacts data reuse. With that, simply scaling up current efforts and ways of working is inefficient and unable to produce the desired outcome. We need qualitatively different approaches.
To address existing shortcomings and create a robust precision medicine framework that scales easily in the future, we have conceived an innovative health data management platform – Psephisma Health. The platform holds molecular profiling data generated in the course of clinical research directly associated with its owner – the patient. By having patients directly involved, molecular data attributes can easily be extended and data itself augmented by matching data from other sources, like regular diagnostics. For customers, external entities which require molecular real-world data for research (biotechnology and pharmaceutical companies, other), our platform functions as a virtual cohort builder and data marketplace. It allows simple access and provides powerful search tools, allowing to narrow down on the data of interest which can then be leased for research according to the available consent. The lease proceeds are automatically distributed between the patient, care-providing institution and the entity that funded the initial data generation. With the above, a whole new model of precision medicine takes shape, one which offers numerous additional opportunities for the patients to take part in and profit from the clinical research.
Our proposal assumes redistribution of existing roles between patients and physicians, some of which requires ethics-focused attention.
In general, there appear to be 3 main areas in the PH business model which need such attention:
a. New roles for patients/individuals, as they are now able to manage secondary research
uses of their protected health information (PHI) directly.
b. The implications of the transactions associated with the data lease (lease proceeds for
patients, healthcare institutions and entities that funded the data generation). What is
the most ethically appropriate way to distribute monetary proceeds associated with the data lease. What is the meaningful way to reimburse the funders of data generation when those are public institutions?
c. How to best address possible caveats stemming from the ability of patients to “learn” from their data and indirect interaction with research entities without involvement of their healthcare institution?
2. Business and financial projections
Assistance in formulating metrics expected by the potential investors – exit strategies, margins, returns.
3. Investor outreach
Assistance in setting the scope and depth of investor materials best suited for recommended/prospective funding sources.