MyMeds&Me is a UK-based software-as-a-service company focused on pharmacovigilance in the healthcare sector. The company, which was founded in 2011, aims to simplify the reporting of adverse events and product complaints to pharmaceutical companies from the public and healthcare professionals, as well as through affiliate staff such as call centre operatives.

Drug safety data collected through its Reportum platform is auto-encoded and transferred directly into databases maintained by both pharmaceutical companies and industry regulators. Reportum is available in multiple languages and the mobile version can be used both online and offline in the field. The aim of the company and its solution is to simplify and improve the efficiency of drug safety monitoring.

MyMeds&Me CEO Andrew Rut, who has a professional background in drug safety, discusses the pharmacovigilance sector, how his company and the Reportum technology could transform the space, and the biggest changes likely to occur in the sector in the coming years.

Allie Nawrat: What motivated you to create MyMeds&Me and the related Reportum platform within the drug safety monitoring and pharmacovigilance space?

Andrew Rut: When I was working at GlaxoSmithKline, I had headed up drug safety and seen the way we do things and what could be possible with new technology. This motivated me to set up an organisation that looks at how we now address the problems of scale and resource quality data at the source of process.

My general view was if you want to know what is wrong with someone, then go back to them, find out the details from them and make it easy for them to provide the information.

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So it was basically how do we get back to the source of truth, the source of true information, which is what the patient is providing. We must enable them to provide it in a structured way, so we prompt them to provide information that is relevant, enable them to put them into the system, and then code that information.

We also ensure it is available very rapidly because we strip many of the intermediate steps; each time a step is introduced, the quality of the data halves and the noise increases two-fold. So by eliminating those steps we get purer data, we get it through faster and enable it to be used for analysis or to be provided to other agencies and regulators in a rapid manner.

AN: What were the main challenges you faced in creating MyMeds&Me?

AR: The pharma industry, and particularly in the area of drug safety, is highly conservative, and so highly regulated. Building a software product within this space is challenging because it requires a lot of diligence to meet very specific, pharmaceutical regulatory guidance; the barriers for entry are high.

Also, pharma companies tend to revert back to the belief that doing things using human beings is probably better than via technology. So another challenge is convincing pharma companies that actually using technology and using it in a sensible way is better than not having it in place. If I’ve got 50 people managing a process using a paper guidance, the probability of them doing it differently is very high. If I digitise the way the data is collected and structured, then the probability of them doing it differently is very low, and therefore the data is much more robust to downstream.

AN: How can technology transform drug safety monitoring and drug development?

AR: There are a variety of technologies being used that are trying to get close to the source of information and reduce the number of manual processes between the patients, the investigator and downstream analysis of that data.

There are electronic tools running electronic clinical trials, electronic reported outcomes or electronic clinical outcome and electronic drug safety capture, like we do. The important thing is to try to get the data at the earliest point from the doctor or the patient, create a standardised input of that data in a coded structure and therefore minimise the structure of the data between all the interim processing steps where humans intervene, which tend to destroy the quality of the data and also increases time.

AN: Who are MyMeds&Me’s typical clients and how does the Reportum system work?

AR: Our customers are essentially the top 30 global pharma companies. Reportum essentially works across the range of intake routes that pharmaceutical companies have for their safety data. So safety data comes direct from patients, doctors, study nurses, study teams and local company staff out in the regions.

Essentially we have developed an application, which can be configured to meet each of those use cases in the best possible way – the type of use that a patient would make of a solution like ours is very different to a doctor or a senior nurse running a study, or a call centre operative.

We provide the software as a service, so we manage the product, we host the product, we upgrade the product and we do all the security.

We can configure the application based upon the pharma company’s portfolio and how they are using the product. For example for deploying it in the field, we have got mobile versions of the application that can be used on or offline, as well as whether they are using it in English language or in a foreign language, but the data is back translated into English for regulatory reporting.

Reportum is not just the front end that the patients or users see, but the whole way we workflow it so we can do quality control of the reports within the application. We can look at workflow to see if reports are getting into the system or out of the system on time, and we can do reconciliation so if we are sending data to multiple systems, we can ensure that the final customer knows that that data has been transferred properly to those different systems.

AN: What have been the major developments in the pharmacovigilance space in the past few years?

AR: The appreciation that multiple data sources are needed to learn a complete picture of the safety profile of a product as it changes over time and to understand that the type of data that is used to evaluate those products is different at different stage gates.

Algorithms and downstream signal detection processes also continue to improve, so how companies look at safety signals continues to improve based on better computing power, better algorithms.

There has been an appreciation that although the data that patients provide may have less medical terminology, their experiences have fundamental value in how a product is being used and if the adherence to that product is appropriate.

AN: What do you predict will cause the biggest changes in the sector in the next five years?

AR: Everyone in all industries is predicting a greater use of robotics, artificial intelligence and machine learning over the coming years. AI and machine learning are particularly useful for patent detection, looking for patented safety and efficacy data, and for data analytics. However, using AI or machine learning to take documents or information… and take the relevant output through those and put them into structured fields is quite a long way off.

The challenges from the teams I work with in those areas are they need very large data sets, and the data that is used to train the systems needs to reliable; if it is not reliable, then the system doesn’t learn very well.

This is why there is a big interest from the AI providers in what we do; we can provide a standardised feed into AI engines that can then begin to provide the training data sets.