Life sciences is a rapidly evolving sector, where lawyers need to be well-versed in the ever-changing regulatory landscape. Lawyers at Sidley Austin tell us more about what to expect from a career in the space...
Chambers Student: What range of work falls under the life sciences umbrella?
Chris Boyle, partner: Life sciences covers a broad and dynamic range of work which makes it such an exciting industry to work in; as the development of new science and technology continues to accelerate - unlocking possibilities that were hard to conceive of only a few years ago - the law has to constantly evolve as it tries to keep up. We advise companies across the life sciences spectrum. That really does range from startups and biotech companies right through to international pharmaceutical companies. We also work with some of the world’s largest and most advanced pharmaceutical, MedTech, food and technology companies to help them solve their most complex regulatory challenges. We help companies to solve challenges that they face throughout the product lifecycle, wherever there’s an intersection with regulatory law.
Zina Chatzidimitriadou, senior managing associate: Broadly speaking our work covers regulatory, contentious and transactional work – anything that touches a product’s life cycle, from funding and pre-clinical to regulatory strategy, IP strategy, manufacturing, market access and beyond. Product liability is another side of the practice, where we try to resolve matters before they escalate to litigation, although we do handle that, too. On top of that, we assist with collaborations and licensing, helping with any required documentation throughout the process. We're all excited about the inevitable convergence and ‘marriage’ of MedTech and pharma, and the new ways of generating evidence (including real world evidence) provided by AI or other digital health tools, as well as new models and avenues for exchange of and access to health data. That’s an area in which we work very closely with data privacy colleagues, and it’s expanding and becoming increasingly exciting.
“We work hand in glove with clients as and when they have any challenges.”
CS: Do most life sciences lawyers have a strong technical background?
CB: I originally qualified as a veterinary surgeon so, as well as human health, I have developed a unique animal health practice. That’s an example of how familiarity with scientific language, and a particular industry and it’s processes is particularly helpful. We work hand in glove with clients as and when they have any challenges. It’s not essential by any means, but having a scientific background does provide additional value when working with clients, as we can slot in with the business and speak their own language. What is essential though is to have an interest in science and healthcare. We have many colleagues who are scientists or former regulators, but we also have many great colleagues who have backgrounds in the arts and humanities. Coming in with an analytical mind is key, as is an ability to be strategic and commercial when thinking about clients’ problems.
ZC: I am going to preface my response with that technical background is certainly not needed, although my past as a molecular biologist 15 years ago (with most of my technical knowledge now being obsolete), has naturally made me have a genuine interest in the subject matter of my practice. A former colleague used to be an OBGYN and is now a brilliant in-house lawyer and entrepreneur. We have a lot of career changers, as we want diversity in law! . We have teachers, former consultants, and even musicians. It’s never too late to make the switch, as long as you want to make it and are curious enough. The most important asset is to not be put off by the idea of dealing with technical concepts. Having a STEM degree could help when talking about very technical areas of life sciences law like patents, but scientific literacy, curiosity and commercial awareness are the things that make a good life sciences lawyer.
CS: What is unique about Sidley Austin’s life sciences practice?
CB: Our depth in regulatory experience is an asset. The regulatory environment is changing constantly, and we are so closely involved with the process of both developing and guiding companies through the evolution of new regulations in the EU, UK and US. It helps that we have colleagues in the US who are former regulators and worked at the Food and Drug Administration, colleagues in Switzerland who worked at Swissmedic, and EU colleagues who have worked at the European Commission. That depth of regulatory experience together with our platform of fantastic transactional lawyers really makes a unique combination. We have over 200 life sciences lawyers from the west coast of the US all the way through to Beijing and beyond to Australia.
ZC: I cannot emphasise enough the firm’s global footprint element, with regulatory lawyers in US, EU and APAC and repeated third party recognition. We go to Brussels regularly, especially with the new European laws being debated and we’re on the ground in Switzerland (I was in Geneva and Zurich just a few weeks ago), where many pharma companies are based. Clients are increasingly looking at their global operations and find this sort of breadth and regulatory depth as a useful one stop shop.
CS: What are the main roles of trainees, associates and partners on a matter?
CB: For each matter, there will be a partner with overall responsibility. I would certainly have the strategic overview and would leverage my many years of experience, working regularly with the client to get to know their business and what will be of most value to them in any given situation. I will then work very closely with a senior managing associate and other associates in the team who are subject matter lawyers. They will also have direct client contact and will do lots of the heavy lifting with advisory notes, litigation or papering transaction and contracts. They are supported very closely by our trainees, who get responsibility as quickly as they can take it on. While there is clearly a pyramid in terms of experience and knowledge, all team members have an input and bring value to the client.
ZC: We run lean teams, so trainees get junior‑associate‑level work early: researching and drafting, managing data rooms and sitting in on regulator/counterparty calls. Business development is also important; from my first year as a junior associate, I was involved in public speaking opportunities, client exposure, and the various networks that Sidley’s group maintains. Conferences, panels and presentations expose you to real life training as opposed to one-off advice that might not always give you a full picture. As a senior associate, you are usually the person interacting with client, but you can also run calls and drive workstreams as a mid-level associate. Partners set the strategy but are always there to guide you and offer support.
“... keeping the product available for women who needed it was really valuable.”
CS: Has there been a highlight or memorable case/transaction for you?
CB: We had a client who had a really exciting product that was supporting women’s health, and we got to see just how positive this was to the community and to their health. It was a young company that needed some guidance on the regulations as there was a risk of their product being withdrawn from the market. Being able to support that company by interfacing with the UK regulator and keeping the product available for women who needed it was really valuable. We like to work with regulators, who also have patient needs and safety at the forefront of their mind, to get solutions. We also won an award-winning case for a major pharma company before the UK Supreme Court – that doesn’t happen every year!
ZC: My top highlight was when I got my own first client. It involved a very complex analysis of a proposed draft of European AI regulation, and its interplay with another piece of EU law - it felt like university all over again! Another memorable instance was a meeting in Brussels with the Commission, which we only achieved after ‘hunting’ down the responsible head of department at a conference. During the meeting, we were interrupted by a fire alarm and ended up going to a café across the street from the European Commission. We ended up having a longer meeting than the time originally allocated to us and got a good result for the client. It was random and fun but underscores the value of human connection alongside good technical analysis skills.
“Digital and AI are really reshaping the way healthcare is working...”
CS: What trends are currently impacting the work you’re doing?
ZC: Digital and AI are really reshaping the way healthcare is working, from diagnosis and drug development, to treating, managing and monitoring conditions. We want it to help doctors and patients, but do so in a safe and trustworthy way. New EU frameworks related to pharma, MedTech, AI and cybersecurity are also having an effect, especially when considering how they work together without unintentionally stifling innovation or patient access. We are also seeing drug pricing pressures from US policy initiatives ripple globally. And a wave of novel modalities (ATMPs, ADCs, RNA) continues to raise fresh regulatory and data questions.
CB: The changes in the administration in the US have been putting a lot of pressure on the pricing of medicines, and that has a global impact. The development of medicines is extremely expensive and has to be funded, often through public payers such as the NHS. Ultimately, the commercial environment has to be sufficiently attractive for companies to take on the risk of spending billions gambling on the development of a new product. What we’re already seeing is a shift towards recognising that, while a key aim is making medicines as widely available as possible, we need to consider the value attributed to medicines to make the UK attractive to investments. That will stimulate the medicines of tomorrow and continue to provide solutions to patients and healthcare professionals. We’re lucky to be at the forefront of such a hot topic.
CS: How do you see the life sciences sector evolving over the next five years?
CB: We’re just scratching the surface of collecting and properly leveraging health data. Huge volumes can be used, recorded and used effectively to help develop and improve medicines. That will be accelerated by AI but there are still many problems and hurdles to overcome for its full potential to be realised. Health data is a very regulated environment, and we all must be totally on top of cybersecurity. I think we’ll also see the resolution of shorter-term challenges such as access to capital and investment. That will mean that companies will be able to develop and provide access to medicines more quickly and broadly, and those medicines will be increasingly more targeted and personalised. They are also likely to be more closely connected with devices, wearables and other technologies.
“Lawyers have to be aware of what’s happening so that they can understand how the macro can affect the micro and advise clients accordingly.”
ZC: We also see clients trying to adapt. We’re seeing smarter supply chains which are questioning the traditional structures we’re used to. There has been an emergence of public-private partnerships. It's about health data exchange, and regulators are realising that enabling public and private entities to come together will allow them to make full use of capital on one hand and data on the other. Lawyers have to be aware of what’s happening so that they can understand how the macro can affect the micro and advise clients accordingly.
CS: What advice do you have for anyone interested in working in life sciences?
CB: For someone who doesn’t come from a life sciences background, I'd encourage them to read about scientific developments, whether that’s new technologies or the commercial issues that life sciences companies are facing. That way, they can start to develop an interest in that space from a science perspective. Individuals in medicine or veterinary medicine often ask me about converting to law, and in those cases it’s more about an interest in the legal side. They should speak to as many lawyers as they can to understand what the law is about and how that intersects with life sciences. Only through speaking with people and getting legal work experience can confirm their interest.
ZC: Fluency in and a curiosity about what’s happening is paramount. We have people who are training and doing a masters in AI just so they can speak same language as our technical clients and understand the science. Whether you’re a lawyer or not, you should also seek out experience, including secondments with clients or regulators. They are available from an early stage and give you amazing commercial insights which translate to work as a lawyer or advisor. And finally, you can of course pick up the ability to give practical advice through experience, but clients value practical “go / no‑go / mitigate” answers to decisions under time pressure.