The Patient Will See You Now

Words by Michaila Byrne

Not only does the very idea of a medicine being created by patients undermine our abiding belief in the traditional drug development process, but on first impression, it sounds pretty preposterous. Is such a knee-jerk reaction warranted? Typically, the timeline of drug development begins at discovery, moves into development, market access, commercialisation, and then, right at the very end of the line, sits the patient. It’s an orthodox structure held at the very core of pharmaceutical practices for almost a century. But as our faith in data intensifies, these foundations start to erode and pharma must begin its preparations for a new template: one where this line bends, variations emerge, and patients are present from the onset.

Consider the contrast between video content today and the film industry of the 1960s. Not only is video more easily accessible, but the number of people actually creating their own films has shot up exponentially. As the monopoly on information dissipated and trickled down to the everyman, people became empowered and subsequently, impatient. Information was democratised, triggering the advent of content being composed and distributed inhouse and by ordinary citizens. Industries across the board are restructuring and Paul Simms, Chairman, eyeforpharma, hypothesises that pharma is no exception:

“Dataism and belief in the data is becoming stronger. That is the basis upon which we can develop our own drugs”, he states.

Given the power an individual will hold in an increasingly data-centric society, realistically we should expect the early stages of drug formation to manifest at the ground level, commandeered by patients themselves. For evidence of this shift, look no further than last year’s FDA approvals where, of the 59 drug approvals granted, 40% were to start-ups who had never had a drug released before and a record low of 26% were granted to big pharma. “You don’t have to be a big pharma company to do research anymore. It’s becoming something that smaller companies do. It’s not at human scale yet, but it is certainly democratising”, Simms continues.

Suppose you possessed all the tools to create your own medicines; you would undoubtedly alter processes to take matters into your own hands. Patient-led innovation groups emboldening this sentiment are galvanising and emerging support networks, including a community app, HealthUnlocked, on which patients connect and the forum ‘patientinnovation.eu’ wherein patient entrepreneurs hack solutions to their own problems. One diabetes patient-led innovation group aptly named ‘We Are Not Waiting’ have begun developing their own treatments, hacking glucose monitors, connecting smart watches to data systems in the cloud, publishing algorithms online, and sharing data on the cloud.

Paul Wicks, Vice President of Innovation, PatientsLikeMe, an online community for people living with medical conditions, explains: “Turning over some of the power to people living with conditions and non-profits is something that HealthUnlocked does. Equally I think there are great patient-led innovations… that really show you what can happen when systems themselves take back control.”

One pharma company embracing this change is LEO Pharma, who have involved patients in the actual scientific creation of medications during R&D. As a result of patient engagement, LEO laboratories have already seen several dozen new compounds emerging and now entering clinical trials. Geraldine Murphy, Vice President, Cluster Europe North, Australia & New Zealand, LEO Pharma, stresses the importance of treating patients as equal collaborators.

“We partner with patients on an equal level, we seek advice from them, and we give them advice… it takes active listening to a new level when patients come into our organisation and sit with us. Our patients tell us what we are getting right - which is great - but they also tell us what we don’t get right, which is just as important.’’

Simms continues: “Motivation eats regulation for breakfast. You don’t care what the regulations say if you’re a patient and you need your treatment.” Citing peer-to-peer digital audio sharing platform Napster, Simms concludes: “Don’t expect that the regulatory system will define or prevent patient-created medicine from becoming reality.”

In times of poor health, people once collectively turned to religion, then they turned to the experts, and now they’re looking inwards. As past doctrines are superseded by the guiding force of data, pharma must gear up as patient-made medicines are expected to make an appearance momentarily. Crucially, pharma can frame this change as an incentive for collaboration and a catalyst for uncharted innovation.

Dataism and belief in the data is becoming stronger. That is the basis upon which we can develop our own drugs