We are a niche life sciences firm. We have specialised in a small sector of technology and science – but we can say with confidence that we are the leading experts in the legal, regulatory and ethical issues in this field.
As continuous innovation and evolution are hallmarks of the life sciences and healthcare sector, we recognise the need to keep up with the dynamic and diverse nature of the field. Our clients will have very different perspectives and requirements depending on their status – whether they are a startup, an established business, a large multinational firm, or a hospital or university.We have worked with clients a every stage of their growth and development in different areas of the law relating to life sciences and health.
Our experience of working with a variety of companies and organisations enhances our ability to manage their competing requirements and also ensures that our advice takes account of practicalities and commercial reality.
We have advised clients ranging from public research institutions, small start-ups to pharmaceutical companies on commercial relationships. Our experience includes drafting consortium agreements for multinational research collaborations, material and data transfer agreements, sponsorship arrangements in clinical trials, and advising university spin-off companies on commercial risk factors. Recent work includes advice on material transfer agreements for human biomaterials to ensure freedom to operate.
We have experience in advising on regulatory matters in science and technology, in particular in the areas of clinical trial authorisations, ethics approvals, as well as marketing authorisations and recalls. Recent work includes regulatory advice on the design and implementation of a decentralised clinical trial, drafting submissions to obtain ethics approval for NHP experimentation, and advising on marketing authorisation processes for novel tissue-engineered products.
We have been involved in a significant number of complex judicial review proceedings to challenge public body decision-making, as well as litigation to secure legal certainty for our clients in contexts where ethically and legally difficult decisions have to be taken. Recent work includes litigation in relation to posthumous gamete use, judicial review proceedings to challenge licence suspension proceedings in a highly regulated sector, and human rights litigation on behalf of gamete donors.
Inquiries, Investigations and Committees
We represent clients as part of inquiries, investigations and before committees, such as licensing and ethics committees, and fitness to practice panels. We also draft submissions, coordinate counsel (where appropriate) and negotiate with opponents in these contexts. Recent work includes ethics approval submissions for large scale clinical trials using AI enabled health applications.
Compliance and Scientific Integrity
We are particularly experienced in assisting clients in identifying and addressing normative compliance and risk factors in a scientific setting. This includes investigation, analysis and reporting on aspects of scientific integrity. We assist clients in managing risks, mitigating reputational harm, and restoring trust in science when research processes are called into question. We draft compelling submissions to funders and regulators as part of integrity audits.
Collaborations and Startups
We are particularly proud to be approachable and uncomplicated partners to start-up companies, especially those coming from a university setting. We understand the financial and commercial pressures of early-stage spin-off companies and strive to help ease those pressures, rather than add to them. We are experienced in stewarding companies through their phases of development, into larger collaborations, investments and joint ventures, especially in the context of due diligence.