Why did you decide to specialise in life sciences law?
In 2009, in my previous life as a molecular biologist at the Cancer Research UK institute, I experienced the multiple issues and complexities facing researchers and people involved in the development of life-saving treatments and methods. Life sciences emerged as the natural field of law for me and, while I am biased, I believe it is the most exciting field of law.
It’s so topical, dynamic and varied, as it covers medicines, medical devices, digital health, AI, food, cosmetics and everything in between!
It is the one legal area that, one way or another, affects every single one of us and is, above all, human-centred. You really can make an impact as a life sciences lawyer, in health policy but also through access to innovative products for patients in need. Plus there is never a boring day, with a slew of new legislation, regulation and guidance coming out at EU and UK level on a daily basis!
What do you see as the key challenges facing the life sciences sector?
The life sciences sector has long been grappling with the Catch-22 of balancing costly and speculative research and development with ensuring accessibility to diagnostics and treatments for as broad a patient population as possible. The rising cost of innovation and new emerging regulatory frameworks and proposals pose hurdles to achieving this balance, so policymakers need to think about how the legislative proposals of today may affect the innovation of tomorrow. In addition, there is a high bar to gaining public trust when dealing with sensitive data. Public trust is required so overcoming this hurdle has become a priority for the industry.
What impact do you think AI is going to have on the life sciences industry?
AI is primarily being looked at for its potential to automate, streamline and accelerate processes and also to harvest large amounts of data speedily and accurately. The real promise of disruptive AI lies in the use of generative AI tools for a number of applications. It will become the norm across all operations of a life sciences company through assisting and automating: drug discovery, pre-clinical and clinical trials operation, marketing authorisation submissions and approvals and in the post-authorisation context.
I also believe it will be a game changer in diagnostics and precision medicine. I believe it will work as an aid to, rather than replacement of, healthcare professionals. I also believe we will continue seeing blurred lines between the concepts of digital health and AI, which are becoming increasingly intertwined as terms.
What impact do you think AI will have on the role of lawyers?
AI will continue to be used to streamline processes and more mundane tasks and free up time for more commercial and strategic work. In-house lawyers can be more agile to also manage their outside counsel and budgets, but also be more ingrained in other areas of the business. A space of great promise for the use of AI is for the purposes of sustainability and ESG objectives.
What do you think are the key skills needed to succeed as a life sciences lawyer?
Life sciences is one of the more technical areas of law, so curiosity and a healthy interest in continuous learning and ensuring understanding of technical contexts, such as cell/gene therapies, are key. Apart from helping to speak the same language as your clients, it also makes the job even more fun!
As an adviser, life sciences lawyers have to be pragmatic and embedded in the business on which they advise. It is important to be vigilant, able to respond immediately to matters as they come up (because they may genuinely have to do with ‘life or death’ situations) and also anticipate issues – often a change today may impact products and pipelines of tomorrow. Creativity is also important as the legislation can often be a few steps behind the scientific developments and therefore not clearly cover questions that arise.