Do you know how hard it is to get a drug to market?

I can give you an idea, but for health and safety reasons, I'd sit down and buckle up.

OK, so, first of all, it’s going to cost you $1b. But prepare for more.

Second, it’s going to take you 10 years. Could easily be 15 .

Third, at best, you have a 1 in 10 chance of success; 1 in 1000 if your mission is something complex like Alzheimer's.

Fourth, you’re going to try 10,000 different molecules before you find The One.

If, by now, your thinking that drug development is a form of professional insanity, you’re not on your own.

The funny thing is, I’ve met with many stakeholders in the pharma industry since the start of this year, in the US, Europe, and the UK, and none of them seem mad at all.?

Far from it. They have been incredibly helpful, thoughtful, kind, and generous with their time. Together, they have helped me find a place in their world for a university spinout that I’m working with.

Regulators want more

Getting your billion-dollar, decade-long and highly unlikely molecular experiment approved by regulators is the goal. This will enable you to sell your drug to hospitals, physicians, pharmacies, national organisations like the NHS in Britain, or international organisations like UNICEF.

Whittling 10,000 molecules down to The One is a process governed by trials. Initially, you’ll be pleased to hear that they don’t involve humans. The later stages, the clinical trials, do.

In clinical trials, for a molecule to progress to the next stage, regulators will be looking at efficacy, toxicity, and dose. Simply put: does the molecule work, what harmful side effects are there, and what dose provides the optimum balance between the two?

Increasingly, though, this is not enough. Regulators are looking for more.

Patient-reported outcomes

Regulators want drug companies to prove not just that efficacy outweighs toxicity, but that real-world outcomes for patients and health services will be improved.

The US Food & Drug Administration (FDA) says that it “increasingly looks to patients to understand how patients describe their health status, because patients are the experts in living with their disease or condition. They play a central role in ensuring that what matters to patients is factored into regulatory decision-making.”

The FDA describes patient-reported outcomes (PROs) as “measures of a patient’s health status as reported directly from the patient without added interpretation by a healthcare worker or anyone else, such as a pain scale.”

For those familiar with the idea of ‘voice of the customer’, think of PROs as ‘voice of the patient’.

Medical experts interpret what patients tell them, codifying what they hear so that comparisons can be made and progress can be charted.

But interpretations, like a pain scale, don't tell you whether the patient has been able to get back to work. Or exercise. Or walk the dog. It doesn’t tell you about their mental health, their relationships, or their financial situation. It doesn’t tell you about their quality of life.

These things seem to be of paramount importance, don't they??

Which is why regulators such as the FDA, the European Medicines Agency, and the British Pharmacological Society are pushing so hard for PROs.

PROs aren’t easy

Unfortunately, clearly hearing the voice-of-the-patient is not easy. In fact, getting sufficient patient-reported outcome data for it to be meaningful is extremely challenging. The approach tends to be:

• Surveys and Questionnaires (most common)
• Electronic Patient Diaries
• Wearable Devices and Mobile Health Applications
• Patient Interviews and Focus Groups

But there are important ethical and privacy issues to resolve in order to gain access to the data. This is time-consuming, and so are surveys and interviews. Data is fragmented and needs integration. Biases in the data can be hard to remove.?

All of this is expensive.

In plain sight

Wouldn’t it be great if there was a giant, untapped pool of voice-of-the-patient data waiting to be discovered?

Fortunately, there is, and it sits in plain sight.

For decades, millions of patients have used online health communities such as Inspire , HealthBoards , HealthUnlocked , and Patient Info to help each other cope better with disease or illness.

This giant and historical pool has remained untapped until now because, like shale oil, it requires special techniques to make it available.

This is where Mebomine comes in. Its brilliant founders, Professor Conrad Bessant , Dr Maryam Abdollahyan , and Dr Fabrizio Smeraldi , have been hard at work solving this problem for the last decade.

They want to radically improve patient outcomes by providing the entire pharmaceutical ecosystem with easy-to-access PROs.

They have developed a specialised medical AI. It is able to analyse messages from large groups of patients, discussing numerous wide-ranging issues relating to their condition, in order to build a detailed picture of the impact that a disease and its treatment are having and how this develops over time.

Patients are never identified or contacted. But their practically focused advice and assistance that they share with each other is the richest source of outcome-oriented voice-of-the-patient data on the planet.

Through Mebomine, it is available in near real-time, can be carefully controlled to remove biases, and is rigorously analysed to produce actionable information.

This is exactly what the regulators are after.