Do we have the correct regulatory framework here in the UK and around the world to adapt to AI and big data?

As the fourth Industrial Revolution continues at pace, biotech and life sciences companies are investing significant time and resource into Artificial Intelligence (AI), while at the same time the use of patient data and who can use that data is becoming a point of debate for governments, patients groups and health providers across the world.  

Yet with such great potential comes great risk, do we have the correct regulatory framework here in the UK and around the world to adapt to this changing environment?

We interviewed Ginny Acha, Executive Director for Global Regulatory Policy at MSD who explains the challenges and opportunities that new technologies pose in the regulation of medicines and how these themes will be explored, amongst many others, at the BIA’s Regulatory and Innovation Conference on September 17.

Ginny, we are in an era of change, new technologies and the emergence of big data pose significant opportunities and challenges for companies, patients and the wider life sciences eco- system. What questions are AI and big data posing in medicine regulation?

With any set of data, the big question is, do you have the skills, expertise and statistical innovations to interrogate the data and understand what it says?  AI is not a rubber stamp fix; you could give me the best data there is on how to design a spaceship, but I am not going to be able to do anything with that – I’m no rocket scientist. Somebody has to design the AI and you must understand what you want to answer and go about delivering that. In short, it isn’t just the quality of data but the quality of the analysis of said data.

A big challenge alongside that is whether you have the regulatory science to make use of the data. Do you have regulators agreeing internationally, “I see this data, I see how you interrogated it and therefore what decision needs to be made about this data?”

This is why I’m looking forward to attending the BIA Regulatory Innovation conference as an underlying theme of the day will be, how do we keep the ball rolling on regulatory science? As a sector how do we stay at the frontier and keep pace with developments to make sure the patient (who is ultimately dependent on us getting this right) is not kept waiting in the wings for somebody to make their mind up? 

Patient data is a hot topic of conversation. Where do you see the risks and where do you see the opportunities?

Look at the way we developed our packages in the past, we had clinical research that we as a company or as a trialist would be setting up by ourselves. We could control how it would be put together, where it would be saved and how the quality of the data was put together.

The more we are looking to use a combination of clinical trial data and real-world data this is increasingly going to complicate matters. Who is the owner? Who is the single owner of any of these points of data and under what conditions can we use this data? We must be very mindful about this.

Data isn’t a single or static entity, it’s always dynamically evolving. While there are features of it that should always be the same – robust, reproducible, high fidelity – data must answer the question for which it is designed. In practice, we are dealing with a real ecosystem of data that we haven’t necessarily had in the past.

Where can data and new technologies improve patient care?

The opportunity space is huge, and I think the UK is in a strong position to bring together new technologies that can create a step-change in medicine development and discovery. Not only do we have life sciences academics and companies that are strong in this space, but we also have AI and computer science companies that could bring together some exciting areas of joint working.

Your goal in drug development is to try and identify the answer to your question with greater precision. Do I really understand what this medicine does, what it delivers and for whom? The more we can make that a precise process the better we will have done our jobs and if AI can influence that (and I have no doubt that it will) that will be a good outcome.

Are there therapy areas where these emerging technologies are already making a difference?

You see it most clearly in Oncology where people are trying to identify more and better biomarkers and better understand the underlying disease biology. We see the results of this in breast cancer, where survival rates have increased and where many patients are now treating this as a chronic illness rather than a life sentence.

At the more complicated end of the discovery space is how we approach Alzheimer’s Disease and dementia. To what extent can we interrogate the information we have either through AI or other measures to help us better understand progressive diseases?  These diseases take a long time to manifest and there are many aspects of the disease progression we don’t understand. Through these new methodologies we can get closer and closer to the end goal of halting the disease in its tracks and even dare I say, prevent it.

The BIA Regulatory Innovation Conference has been a launching pad for discussions and actions in the past. What are you hoping for from this year’s conference?

In the US there has been a partnership between the FDA, leading hospitals and private sector companies, it’s that triple helix effect of bringing in government, industry and academia to say here “if we were to try and answer our own questions about when and where to use this data, how to better approach drug development and approvals – how would we do it?” It’s that will to work together, which will determine whether something will work in the UK and I look forward to discussing this with a wide variety of stakeholders attending the day. 

I hope by the end of the conference we’ll have had meaningful discussions and have real projects to get behind.  

To book your place or to find out more information about the BIA Regulatory Innovation Conference please follow this link.