Fiona Maini, principal - global compliance and strategy at Medidata Solutions, a Dassault Systèmes company, outlines some achievements from life sciences in 2021, and her hopes and expectations for 2022.
COVID-19 has shaken all industries over the past year and a half, in what ways would you say the industry changed this year? What key learnings did the industry see?
The pandemic has forced a change and modernisation of our lives with a significant uptake of technologies across all industries. We’ve seen a significant acceleration in the pace and scale of technology-enabled transformation across the global life sciences and health ecosystem.
The power of cross collaboration has shown it is possible to solve what we have seen traditionally as impossible, and that human ingenuity and intelligence can overcome great challenges. Our communities are more empathetic - we’ve solved challenges in unity and celebrated achievements together. There has been huge public appreciation of the contribution that healthcare and life sciences companies are making and how these companies are paving the way for a new era of collaboration to identify and implement solutions to healthcare problems.
The pandemic really highlighted the fragility of the clinical trial landscape and drug development process - and it showed that it can be accelerated. It highlighted the ability for regulatory authorities to be more flexible and that authorities and countries can be more innovative. It emphasised the availability of established technologies and processes and the necessity to leverage these more going forward.
What sort of challenges did the industry have to face, looking at COVID and beyond?
We’ve seen a huge impact on people’s wellbeing and on communities. In drug development, we saw mass halting and postponement of clinical trials, which meant delayed access to new drugs and treatments for patients in need. With the restrictions and hesitancy to travel, patients were unable to get to clinics and hospitals, which meant many trials could not continue.
What positives have you seen this past year?
For those working within the industry, their roles in developing new vaccines, therapies and diagnostics gained greater prominence, urgency and need. This brought about unprecedented collaboration between competitors, regulators, and academia to help unravel the crisis. These partnerships have revolutionised the way that medicine and products will be developed in the future, and the hope is that the present situation leads to a greater emphasis and commitment to human health.
We also saw the armies of heroes - frontline and key workers - across the world rise to the challenge, with many people directly placing themselves in clear and present danger. The COVID pandemic only reinforced the fragility of our existence, as well as a collective responsibility to help one another.
Human innovation and creativity knows no boundaries, especially when in a stressful and urgent situation. The pandemic showed our ability to do things differently and to leverage new technologies.
Besides COVID vaccines, what do you think has been the industry’s biggest success this year?
Other than the speedy development of COVID vaccines, the biggest success this year was the ability for the industry to come together in a time of global humanitarian crisis. Clearly, we are not out of the woods yet, but the pathway forward is much clearer and certain than a year ago today. Additionally, the ability of the regulatory authorities to become more flexible and help to accelerate pathways for drug approvals was really impressive.
What sort of key trends in healthcare do you think will continue to dominate in 2022?
I think the technological transformation of the healthcare industry will continue into 2022 and beyond, as well as the realisation that technology is perhaps the only way to innovate clinical research and the drug development process. I think trends like predictive and personalised medicine, preventative treatments, and the use of artificial intelligence in clinical research will continue. Our industry is constantly evolving but at a slower pace than other industries - this year has helped redefine the way we look at the clinical trial process overall.
The regulators will continue to evolve and innovate - with more modernised and agile regulatory frameworks, we can accelerate the development of new treatments.
Patients are owning their illnesses and their own health more now and this is something that will continue. Patients have so much information and sources for information at their fingertips so they’re more likely to self-diagnose and gain control of their own health. Patients are owning the knowledge more than ever before.
Additionally, patients are truly becoming the centre of clinical research and they’re being asked about how they want to engage with clinical trials. This trend will definitely continue as well.
With the use of technology, you can increase your pool of participants and reach more patients - not only does this help increase the diversity in a clinical trial, leading to better treatments, but you’re also able to reach patients with rare diseases, who are harder to find. So clinical trials will continue to become more diverse and hopefully we’ll see more drugs and treatments approved for rare diseases.
Do you expect more collaboration within the industry next year?
Given how much we accomplished the last 18 months through industry collaboration, I would expect this to continue.
I also think non-traditional partnerships and relationships (for example with competitors or unexpected organisations) will continue to grow, as well as increased knowledge sharing across the industry and across stakeholders. At the end of the day, we’re pushing things forward for a common gain and we’re all trying to achieve the same thing. It might have taken the pandemic to realise that, but now we have.
What are your hopes for the industry in 2022 and beyond?
My hopes for 2022 are that COVID will become, something that we live with just like the flu and the common cold. I hope we really learn the lessons from the pandemic and continue to implement changes that accelerate clinical research across all therapeutic areas and not just COVID trials. I hope that the regulatory flexibilities that have been allowed during the pandemic will be permitted beyond the pandemic.
