<p>Marek is a partner in the corporate practice and advises companies and investors who are active in IP-rich sectors; in particular the life sciences, technology and consumer products sectors.</p> <p>Marek has a broad transactional practice that includes debt and equity financings, M&A, spin-outs, joint ventures, restructurings and complex commercial agreements.</p> <p>Marek’s clients include several of the world’s largest biopharmaceutical and technology companies, as well as fast-growing companies and specialist investors.</p>

<p>Xisca is a dual-qualified lawyer in England & Wales and Spain who specialises in all aspects of EU and UK regulatory law in the biopharmaceutical and medical technologies sectors.</p> <p>Xisca advises on a broad range of regulatory law topics including: regulatory strategies for bringing products to market, product life cycle management, regulatory exclusivities, clinical trials and non-interventional trials, including the implementation of the Clinical Trial Regulation, orphan medicinal products, obligations and rewards in relation to paediatric research including agreeing and modifying PIPs, waivers and deferrals and compliance with agreed PIPs, and parallel trade of medicines. She also advises on the regulatory framework applicable to medical devices and in vitro diagnostics.</p> <p>Xisca has broad experience in manufacturing and distribution issues, including supply management policies, product shortages and recalls, and compliance with GMP, GDP and labelling requirements. She has supported GCP and GMP inspections, both at national and EU level.</p> <p>She also advises life sciences companies on the consequences of Brexit, including changes required to ensure business continuity further to the UK’s withdrawal from the EU.</p> <p>Previously she was an in-house lawyer at a leading innovative biopharmaceutical company, where she provided regulatory law support to all business units and functions at EU and global level, gaining excellent knowledge of the pharmaceutical industry enabling her to bring a strong business approach to her legal advice. Prior to that, she was an associate in the IP litigation team at a magic circle law firm in Barcelona for almost 10 years.</p>

<p>Ellie is a dual-qualified lawyer in England & Wales and Ireland who advises on EU and UK life sciences regulatory law. Ellie focuses on pharmaceutical and medical device matters.</p> <p>Ellie has extensive experience working for medical technology companies and tech clients working in the software and AI space. She advises on a broad range of topics including: the qualification and classification of devices, clinical investigations, pre-market and post-market requirements, Brexit and the implications of new laws and guidance on AI. Ellie has also provided companies with advice on <em>in vitro</em> diagnostic medical devices. Particularly considering the issues around performance evaluations and companion diagnostics.</p> <p>Ellie advises on a broad range of regulatory matters for pharmaceutical companies. These include: strategies to bring products to market, regulatory exclusivities, clinical trials, orphan medicinal products, requirements and rewards for paediatric research, and manufacturing and distribution. Ellie has previously spent a number of years working at a US law firm. She has gained valuable in-house experience on secondment at a large pharmaceutical company.</p> <p>Some of Ellie’s work highlights include:</p> <ul> <li>Advising leading tech companies on issues around qualification of software products as medical devices and the classification rules.</li> <li>Advising medtech clients on issues under the EU’s Medical Devices Regulation (EU) 2017/745, including user error reporting requirements, transition periods and QMS requirements.</li> <li>Advising tech companies on the implications of the EU’s AI Act.</li> <li>Advising leading pharmaceutical and device companies on the application of the EU’s <em>In Vitro</em> Diagnostic Medical Devices Regulation (EU) 2017/746, including performance evaluations and companion diagnostics.</li> <li>Advising pharmaceutical companies on EMA submissions, including for duplicates and paediatric investigation plans.</li> <li>Advising pharmaceutical clients on regulatory protection periods.</li> <li>Advising pharmaceutical companies on claims and advertising rules.</li> <li>Advising pharmaceutical companies on supply chain issues involving importation and distribution.</li> </ul> <p>Ellie undertook a legal secondment to Gilead from 2019 – 2020. She also completed University of Oxford’s Online Short Course: Artificial Intelligence: An Introduction.</p>

<p>Laura specialises in <a href="https://www.bristows.com/expertise/transactions/commercial-ip-transactions/">non-contentious IP and commercial matters</a>. She has broad experience of advising on, drafting and negotiating strategic and complex agreements across the full life cycle of IP rights from development to protection and exploitation.</p> <p>While Laura’s practice covers a range of sectors, she has particular expertise in the life sciences, luxury brands, consumer products and retail sectors. Much of her work is cross-border or global in nature, and her clients range from large multinationals to start-ups to academic institutions and not-for-profit research organisations.</p> <p>Within the life sciences sector, Laura advises clients on a variety of IP-focused transactions including joint ventures, research and development collaborations, consortium arrangements and licensing and option deals (with commercial and academic partners). She also assists with commercial matters such as manufacturing and distribution arrangements, research funding agreements and service agreements. Laura has a particular interest in the legal issues affecting the women’s health sector.</p> <p>Within the luxury and consumer products sectors, Laura supports clients with licensing and other complex arrangements relating to the exploitation and protection of their brands. She also helps clients to bring products to market by advising on supply chain and marketing arrangements, including franchise and concession agreements, as well as brand collaborations and sponsorship deals.</p> <p>Laura also assists our corporate and financing teams by advising on the commercial and IP aspects of corporate and investment deals, and supports our IP litigation teams by advising on agreements to resolve complex, high-value patent and trade mark disputes.</p> <p>Having spent time seconded to the in-house legal department of various clients, including a multinational pharmaceutical company and a global luxury goods brand, Laura recognises the importance of understanding her clients’ businesses and the industries in which they operate.</p> <p>Laura is actively involved in initiatives designed to expand access to the legal profession, including mentoring aspiring solicitors. Within the firm, Laura is involved in trainee recruitment and acts as a mentor to junior lawyers through the Bristows mentoring scheme.</p>