WHAT WE DO
We are a life sciences advisory firm. We specialise 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. We advise clients on legal, ethical, and policy issues arising out of innovative research, product development, and clinical application.
As innovation and evolution are the hallmarks of the life sciences and healthcare sectors, we recognise the need to keep pace with the dynamic nature of the ecosystem. Our clients will have different perspectives, requirements, and needs depending on whether they are a startup, an established business, a large multinational, a hospital, university or research institution.
PERSONAL APPROACH
CORPORATE AND
COMMERCIAL TRANSACTIONS
We have advised clients in public research institutions, small start-ups, and established biotech and pharma companies on commercial relationships.
Regulatory Matters
We have advised on all aspects of regulatory governance in science and technology, and in particular in clinical trials, ethics approvals, market authorisation, post-trial surveillance and recalls.
Dispute Resolution
We advise and represent clients in relation to complaints, disputes and litigation. We have been involved in many of the leading cases relating to reproductive and genetic technologies, embryo research and genetic testing, together with a significant number of complex judicial review proceedings to challenge the decisions of various public authorities. We also conduct litigation to secure legal certainty for our clients in contexts in which legally and ethically difficult decisions have to be taken.
Our recent experience includes:
- conducting due diligence exercises in relation to investments in and acquisitions of life science companies
- drafting consortium agreements for multinational research collaborations
- drafting and advising on material and data transfer agreements
- advising on sponsorship arrangements for clinical trials
- advising university spin-offs on commercial risk factors
- advising large, cross-border clinical trials on contractual relationships between trial sites
Our recent experience includes:
- regulatory foresighting on the design and implementation of decentralised clinical trials
- drafting submissions for the authorisation of animal experiments
- advising a global pharmaceutical company on the legal and regulatory issues relating to medicinal cannabis
- advising on marketing authorisation processes for novel tissue-engineered products
- assisting in ethics approval submissions for AI-enabled health technologies
- representations to licensing committees in a highly regulated biotechnology sector
- advising on an extensive range of regulatory and licensing issues relating to IVF and embryo research in the UK and EU
Our recent experience includes:
- litigation in relation to the posthumous use of gametes and embryos
- representing private clinics in licence suspension proceedings
- human rights litigation in relation to gamete donation and storage
- successfully defending a claim for breach of contract relating to the use of stored embryos
- acting for a hospital in their successful court application for first-in-man compassionate use of a monoclonal antibody for the treatment of an incurable disease
- acting for a publicly listed company in relation to a regulatory investigation and criminal prosecution by the UK Human Tissue Authority and police
SUPPORTING INQUIRIES AND INVESTIGATIONS
We represent clients in relation to their involvement in inquiries, investigations, and before committees. This includes statutory, public inquiries, licensing and ethics committees, as well as fitness to practise panels. We also draft statements and submissions, coordinate counsel (where appropriate), and negotiate with opponents in these contexts.
DE-RISKING AND COMPLIANCE
We are experienced in assisting clients in identifying and addressing normative compliance issues and providing de-risking strategies. This includes investigations, analysis and reporting on scientific and/or corporate integrity issues, mitigating reputational harm, and restoring trust in research and development processes.
PROFESSIONAL DEVELOPMENT
We provide professional development opportunities through our ethics and compliance training programme, offering clients the possibility to increase regulatory, legal, and ethical awareness within their organisations to spot and address issues before they become problems.
Our recent experience includes:
- acting for two public bodies involved in the UK Covid-19 Inquiry
- acting for a public body in a public inquiry into non-consensual human tissue retention
- chairing an independent Inquiry into stem cell research governance
- acting as solicitor to an inquiry into the suspension of a senior judge
Our recent experience includes:
- Chairing a committee tasked with investigating scientific misconduct
- Advising a public research institution in relation to governance of ethically volatile research methods
- Advising on compliance and risk elements of allowing self-experimentation in a commercial R&D context
Our recent experience includes:
- Providing training events on responsible research practices
- Providing training on commercialisation aspects in human tissue and cell research
- Providing training in regulatory and legal issues in clinical translation
GET IN TOUCH
Every client is different and the first step to providing the right advice is to understand
your needs – please get in touch with us to arrange for one of our advisors
to speak to you to find out how we can assist.
