Personalisation isn't new. In the UK, you have been able to buy Ordnance Survey maps with your home at the very centre for years. More recently, McDonalds announced a $300 million acquisition of personalisation technology business Dynamic Yield, to tailor experiences based on the time of day and the weather, giving customers more seamless experiences and reducing food waste.
Technology and data know-how offer massive transformative opportunities (and challenges) for organisations when it comes to personalising products and services, from paying taxes to buying dog food. And life sciences are no exception.
Indeed, the sector could be said to be an early adopter. This trend has been accelerated in the life sciences sector by breakthroughs in biotechnology and data analysis, with artificial intelligence (AI) set to advance the discovery of drugs for little understood diseases and diseases specific to smaller populations.
Data and AI
A recent example of where drug discovery is heading is the announcement in April by AstraZeneca and BenevolentAI of a long-term collaboration to use AI and machine learning for the discovery and development of treatments for chronic kidney disease (CKD) and (IPF). These are complex diseases in which the underlying disease biology is poorly understood and requires the interrogation of vast datasets.
The collaboration is intended to combine AstraZeneca's genomics, chemistry and clinical data with BenevolentAI's target identification platform and biomedical knowledge graph – a network of contextualised scientific data (genes, proteins, diseases and compounds) and the relationship between them.
At the public healthcare level, the NHS has outlined how it intends to use the wealth of data that it holds, once depersonalised, to identify groups of people who are vulnerable to health risks and predict which individuals are likely to benefit from healthcare interventions.
The NHS also expects this data to be beneficial to companies within the life sciences sphere, as it makes it available to industry with the aim of driving research and innovation.
The use of patient data inevitably raises issues of data protection, which we discuss further in this month's edition of Synapse:
Then there is the issue of how innovative companies ensure a return on their investment in personalised medicines – what challenges do innovative drug products for smaller groups of patients raise in the area of exclusivity production?
Orphans and SPCs
Personalised drug treatments receive structural support and encouragement from regulators in orphan drug legislation. Orphan drugs are personalised in that as they must treat fewer than 1 in 50,000 people to achieve orphan status. Orphans also receive market exclusivity protection for ten years under EU law.
Less clear is how the application of patents and their extensions – known as supplementary protection certificates (SPCs) – apply to the use of medicines that have been tested and cleared for use for one community, but have a different use and effect on another.
Some personalised drugs have been re-purposed from medicines originally designed for a wider patient group. This can happen where a drug that fails to work for a group sharing particular disease symptoms is found to be effective for a smaller sub-group within it – the members all sharing what is known as a biomarker. Biomarkers are naturally occurring characteristics – genes or proteins – by which a particular pathological or physiological process can be identified.
Aside from orphan drug status, the protection of exclusivity of such drugs by patents may pose a challenge, because novelty is a fundamental requirement for a patent, and re-purposed drugs are, by their nature, old. The diagnostics needed to identify the presence of a biomarker must also steer around patent exclusions designed to protect doctors from patent infringements when diagnosing patients.
The current rules allow SPCs for 'different applications', but it's unclear whether the application is for different disease, or a different group within that disease, or both.
The Court of Justice of the European Union is currently being asked what qualifies as a different application capable of SPC protection. The answer may define whether SPCs can extend to drugs directed to sub-groups with a biomarker.
If they can, it will have significant impact on exclusivity incentives for developing personalised medicines, as well as funding, investment and research.
We will be addressing these exclusivity issues in subsequent editions of Synapse.