Fiona Maini – principal, global compliance and strategy at Medidata, Dassault Systèmes company reflects on the year just gone, and predicts what lies ahead for life sciences.
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From 2022 to 2023
Reflecting on the past year, what have been your key learnings and what would you say have been key learnings for the industry?
The power of collaboration has been a key learning for me this year. As we demonstrated during the pandemic, if we collaborate seamlessly, we can achieve anything and solve the impossible. Industry collaboration during the pandemic led to the development of vaccines at the speed of light and without collaboration between sponsors, CROs and regulators such efforts would not have been possible. It has been encouraging to see such collaboration continue into 2022, using channels established during the pandemic to share knowledge that will hopefully help accelerate clinical research across a broad spectrum of therapeutic areas.
On a personal level, I’ve learned a lot more about artificial intelligence and its potential not just within the healthcare industry. In this area, the new ACT EU will have a significant impact on the industry – getting up to speed with it and looking at how AI can be inspected to ensure that it is working for patients and that they remain safe.
What particular challenges did the industry and regulators face in 2022?
One of the key challenges the industry has faced in 2022 was the general uncertainty about clinical trial guidance. At the moment, it is difficult to know which of the COVID-19 flexibilities granted by regulators will remain in place and what will change. Another challenge we are facing is future pandemic preparedness. More broadly, the war in Ukraine, Brexit and going back to a ‘new normal’ have also been challenges.
As the world continued to return to normal in 2022, have any of the changes we saw during the COVID-19 pandemic been maintained or has the industry begun to return to previous norms?
Earlier this year, I have had the privilege of attending one of the European Medicines Agency’s meetings, which included the members of the European Commission and the Heads of Medicines Agencies. A key highlight from the meeting were comments made on DCTs – noting that there should be a move away from categorising trials with the term DCT, but instead recognising that all trials are likely to benefit from using some form of decentralisation or technology, which should be integrated into the study design from the start. The move showcases that the industry is embracing technology as an integral part of the clinical trial process, rather than as an add on.
What key regulatory events have impacted the industry in 2022?
There have been a number of events or milestones that have had an impact on the industry, such as the European Health Data Space programme, which integrates patients’ GP records across Europe, and looks to leverage secondary use of data. This programme will have a significant impact on improving patient burden and doctors’ capacity, as it enables them to have access to patients’ full medical records, reducing time spent re-diagnosing the patient. This programme will also empower individuals across the EU to exercise their rights over their health data. Secondary data collected could also be used to supplement clinical trial data and provide a ‘real world’ perspective.
Another programme discussed in 2022 that will have a significant impact on the industry is the big data programme being run by the European Medicines Agency, which is looking at how real-world data can be used in regulatory decision making.
What word would you use to describe 2022?
Recovery and collaboration would be the words I use to describe 2022. We have been recovering from the pandemic and have seen the power of collaboration. There is a huge potential that can be achieved due to better science and technology.
Predictions for 2023
What key trends in healthcare/tech do you think will dominate 2023?
2023 will see a continuation of the trends we’ve observed in 2022: AI, technology, use of real-world evidence to supplement clinical trial insights and improve decision making processes. In addition, we will continue to see discussions on DCTs, patient centricity and synthetic control arms. These approaches have the potential to transform the way clinical trials are approached.
Are there any key industry milestones/events that you are particularly excited for in 2023? What regulatory milestones are you expecting for next year?
The life sciences and healthcare world is guided by international regulations, such as the ICH GCP guidelines. Although there were minor updates to these guidelines in 2016, much of what they say dates back to the 1990s. There is therefore a huge opportunity for us, as an industry, to renovate and modernise these guidelines. Updates have been ongoing for a couple of years and are due to be published for consultation in May 2023, which will be a key regulatory milestone of this year.
The Accelerating Clinical Trials in the EU (ACT EU) workplan will be another important milestone which will include a recommendation paper on DCTs – looking at all of the national provisions of the EU27 countries.
Regulators are embracing industry innovation and have become more approachable to discussing new approaches. Regulators are no longer just focused on inspections, but are also embracing the future and recognising the fast pace at which science and technology is progressing.
What topics do you expect to dominate regulatory discussions in 2023?
There are a number of hot topics that will dominate regulatory discussions next year such as AI, DCTs, and synthetic control arms. AI has the potential to disrupt the industry, but regulators need to ensure that it works for patients and that they are safe. Synthetic control arms could change the way clinical trials are managed as they enable to cut costs and accelerate clinical research timelines.
What word would you use to describe your feelings going into 2023?
I am excited about 2023 and very much looking forward to this year, given we are expecting a number of new interesting industry milestones. Regulators are embracing innovative change, they certainly have more of an ‘open door’ policy than in the past.
