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Taking back control – the post-pandemic landscape for life sciences regulation

After years of delays caused by geopolitical instability and the Covid-19 pandemic, the new regulatory landscape for the life sciences industry is beginning to take shape in both the UK and the EU.

As the UK pushes ahead with its post-Brexit journey of divergence, establishing itself as an innovation-friendly environment in the global life sciences market has become of paramount importance. In contrast, the EU’s attempts to draft comprehensive laws on AI have attracted criticism from the medical devices industry, prompting overburdened innovators to turn to more investment-friendly locations. Continue reading “Taking back control – the post-pandemic landscape for life sciences regulation”

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Life Sciences perspectives: Grant Castle

Why did you decide to specialise in life sciences?

I have a science background – a PhD in organic chemistry – and worked for a short time as a medicinal chemist for Glaxo. I also had an interest in the humanities at school, so law had always seemed to be an option, and life sciences law made sense. I had assumed that I would go into IP/patents, but was lucky enough to meet a life sciences regulatory lawyer from Covington and spent some time there before my training contract. I came back to Covington on qualification and I am still here 25 years later. I clearly made the right choice. Continue reading “Life Sciences perspectives: Grant Castle”

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Rising stars: Zina Chatzidimitriadou – ‘It is the one legal area that affects every single one of us and is, above all, human-centred’

Zina Chatzidimitriadou, senior managing associate at Sidley, on why she picked a career in life sciences law

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. Continue reading “Rising stars: Zina Chatzidimitriadou – ‘It is the one legal area that affects every single one of us and is, above all, human-centred’”

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Rising stars: Jaspreet Takhar – ‘EU regulators are preparing an avalanche of new laws that are going to have a monumental impact on pharma and medtech’

Baker McKenzie’s Jaspreet Takhar on the future of digital health solutions

What made you decide to specialise in life sciences law?

I specialise in advising on digital health solutions – that means advising on the regulation of health data, digital health solutions (including AI solutions, software and medical devices), as well as contracting in this space. I genuinely find the digital health space as exciting as it gets! The legal landscape is changing at breakneck speed, and I spend a few minutes every morning scanning for new regulations, new announcements and new guidance. Hot topics for legal developments include the regulation of AI, the European Health Data Space, and local laws on medical confidentiality. Continue reading “Rising stars: Jaspreet Takhar – ‘EU regulators are preparing an avalanche of new laws that are going to have a monumental impact on pharma and medtech’”

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Rising stars: Dr Chris Boyle – ‘AI is going to have a transformative impact on the life sciences industry’

Dr Chris Boyle, counsel at Sidley, on the risks and opportunities facing the industry

What do you most enjoy about being a life sciences lawyer?

My passion for science led me to qualify and practice as a veterinary surgeon before I discovered that scientists and clinicians are uniquely placed to make a big impact in law, and I requalified as a life sciences lawyer. The best thing about being a life sciences lawyer is that I can harness my scientific interest and knowledge to serve clients on a far greater scale than I could in veterinary practice, to help them develop the health technologies and services of tomorrow. It is particularly helpful to ‘speak the same language’ when I am advising on matters that require interactions with healthcare professionals and regulators – for example it has proven key in assisting clients with NICE health technology assessments. Continue reading “Rising stars: Dr Chris Boyle – ‘AI is going to have a transformative impact on the life sciences industry’”

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Rising stars: David Gibson – ‘There are so many great new technologies and medicines with potential to make a difference to populations and treatment pathways but key challenges remain in regulating them’

David Gibson, senior associate at McDermott Will & Emery

Why did you decide to specialise in life sciences law, and what’s the best thing about being a life sciences lawyer?

I find the subject matter fascinating, and I am genuinely curious about new technologies and medicines and how they can be used, shared and applied to improve healthcare for patients across the world. We are often involved in helping our clients with strategic projects and transactions, partnering with other organisations and bringing products to market and to scale – often across different jurisdictions. As a transactional and projects lawyer, I enjoy working with clients to bring the commercial, financing, regulatory and other legal elements together: it is an area of law that has a bit of everything! Continue reading “Rising stars: David Gibson – ‘There are so many great new technologies and medicines with potential to make a difference to populations and treatment pathways but key challenges remain in regulating them’”

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Life Sciences Yearbook 2024 – Editor’s letter

Welcome to the 2024 Life Sciences Yearbook from the Legal 500 and Legal Business, sponsored by Herbert Smith Freehills.

This yearly publication will offer insight into the issues facing life sciences companies in the wake of Brexit, as well as interviews with leading private practice lawyers in the sector and a data-driven snapshot of the top firms and practitioners from the Legal 500. Continue reading “Life Sciences Yearbook 2024 – Editor’s letter”

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Life Sciences Yearbook 2024: Sponsored foreword – Herbert Smith Freehills

Herbert Smith Freehills

‘Economic and geopolitical pressures continued throughout 2023, making the global business landscape a volatile one. It might even be asked whether disruption is simply the new business norm.’

Global themes in 2023 and outlook

The disruption felt globally at the end of 2022 continued to impact life sciences companies and investors in 2023. Continue reading “Life Sciences Yearbook 2024: Sponsored foreword – Herbert Smith Freehills”

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Sponsored thought leadership: China life sciences – Transaction insights and notable industry trends

China’s life sciences and healthcare (LS&H) industry underwent an unprecedented transformation in 2023 consisting of numerous challenges and opportunities. Within this year, BD transactions primarily included out-licensing of ex-China rights, China commercialisation partnering, asset acquisition and regaining drug product rights, which reflected the courage of China’s LS&H market players to proactively seek changes and rebuild corporate strategies in a quickly shifting market landscape.

Fangda Partners’ life sciences team remained active in advising on LS&H corporate transactions in 2023 and recent key deal highlights included (a) Hengrui Pharma (600276.SH)’s out-licensing partnership with Aiolos Bio to exploit the innovative anti-TSLP mAb (SHR-1905) outside of Greater China; (b) Kanghua Biological (300841.SZ)’s grant of exclusive rights to HilleVax for exploitation of recombinant hexavalent VLP norovirus vaccine outside of Greater China; (c) CStone Pharma (2616.HK)’s sale of the Tibsovo® (Ivosidenib) business, asset and goodwill thereof in Greater China and Singapore to Les Laboratoires Servier; and (d) a number of commercialisation arrangements entered into by multinational pharmaceutical companies with leading CSOs. Continue reading “Sponsored thought leadership: China life sciences – Transaction insights and notable industry trends”

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Sponsored Q&A: Fangda Partners

1. What are the current regulatory frameworks governing the life sciences industry in China, and how have they evolved in recent years?

Legislation wise, the Drug Administration Law and its implementation rules are pivotal to the pharmaceutical sector, overseeing the entire lifecycle of chemical and biological products. For medical devices (including in-vitro diagnostics), the Regulations for the Supervision and Administration of Medical Devices form a fundamental framework. Continue reading “Sponsored Q&A: Fangda Partners”

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Sponsored thought leadership: Healthcare and pharmaceutical regulation in Portugal

The health sector in Portugal, which encompasses the pharmaceutical market, is a prominent and fast-evolving sector that has undergone significant growth in recent decades.

Sérvulo & Associados law firm is proud to have a highly specialised, experienced and well-balanced team in the life sciences field. The team covers all the main legal matters of the health and pharmaceutical industry, acting and providing guidance on a broad range of issues. These include patent trademark litigation within the pharmaceutical sector, but also advice on regulatory matters, data privacy for clinical research, and patient support programmers, as well as distribution and supply agreements to the industry. Continue reading “Sponsored thought leadership: Healthcare and pharmaceutical regulation in Portugal”

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Baker McKenzie: One eye open

‘What defines Baker McKenzie over the last few years is the sheer amount of work that has gone into financial integration. This is a massive achievement but it has come at a cost. Now, establishing the differentiator to attract the next generation is important. It isn’t going to turn into Kirkland & Ellis, but what is going to drive that entrepreneurial aspect now Bakers looks more like other firms?’ So speaks one commentator of the quandary facing Baker McKenzie, a sentiment reprising a prevailing theme of our 2017 deep dive into the firm, ‘Waking the Giant’, which found a firm struggling to maintain its unique international selling point amid escalating globalisation of Big Law.

Then, the firm had just embarked on a new and ambitious phase, with the respected veteran intellectual property (IP) partner Paul Rawlinson instated as its first British chair in October 2016. The mandate? To implement the firm’s 2020 strategy, which focused on integrating Bakers across three profit pools, increasing profitability and growing the firm’s transactional practices in London, New York and China. Continue reading “Baker McKenzie: One eye open”

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Revolving doors: Moves in disputes and antitrust as Paul Weiss continues sweep of London recruits

Simpson Thacher begins this week’s lateral hire round-up with its recruitment of Legal 500 international arbitration leading individual David Edwards from Skadden. Edwards will co-lead the firm’s European disputes practice alongside Tyler Robinson.

The hire brings the London office to a total of five dispute partners: Edwards, Robinson, and antitrust specialists Antonio Bavasso, Ross Ferguson, and Étienne Renaudeau. All three antitrust partners are also listed as partners in the firm’s Brussels office, which opened in September 2021 and is headed by Bavasso and Renaudeau. Continue reading “Revolving doors: Moves in disputes and antitrust as Paul Weiss continues sweep of London recruits”

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King & Spalding takes another silk with hire of former director of public prosecutions

King & Spalding has hired Sir Max Hill KC (pictured) into its London office. Hill served as director of public prosecutions for England and Wales from November 2018 to October 2023. A barrister since 1987, he took silk in 2008 and was knighted after leaving the Crown Prosecution Service (CPS) in January 2024.

Hill’s addition brings the number of KCs in the firm’s London office to four, alongside disputes partner Ruth Byrne KC, arbitration partner John Savage KC, and office managing partner Tom Sprange KC. Continue reading “King & Spalding takes another silk with hire of former director of public prosecutions”

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How do you know when you have a brand advantage?

By Sholto Lindsay-Smith, founding partner and director of brand strategy at Industry, an international brand and business consultancy.

As the management mantra goes, ‘you can’t manage what you can’t measure’. Law firms often undertake evaluation of their brand in pockets throughout the organisation by teams in HR, customer experience, internal and external communications. What is often missing is a 360-view which can summarise the brand strategy, identify brand-blockers and determine where to invest efforts in building brand advantage. This article considers the importance in assimilating this information to build a lasting brand advantage. Continue reading “How do you know when you have a brand advantage?”

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‘The human cost’: Post Office Horizon fiasco throws scrutiny on litigators and shines light on litigation funding

The Post Office Horizon scandal saw over 700 subpostmasters convicted of fraud, theft, or false accounting. The victims were prosecuted for accounting shortfalls that were in fact the result of errors made by the Post Office’s Horizon accounting software.

At time of publication, fewer than 100 of those convictions have been overturned. Continue reading “‘The human cost’: Post Office Horizon fiasco throws scrutiny on litigators and shines light on litigation funding”

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Freshfields snaps up former FTC commissioner to bolster US antitrust offering

In a boost to its Washington DC presence, Freshfields has hired former Federal Trade Commissioner, Christine Wilson, as a senior adviser in its antitrust practice.

The firm has made a concerted effort to build out its antitrust offering in both the US and Europe over the last year. In October 2023, it appointed former senior director of mergers at the UK’s Competition and Markets Authority, Colin Raftery, to the firm’s London office. While in June 2023, antitrust litigators Heather Lamberg and Justina Sessions joined the firm’s Washington DC and Silicon Valley antitrust practices. Antitrust and foreign investment practitioner Charlotte Colin-Dubuisson also joined the firm’s Paris office in January 2024. Continue reading “Freshfields snaps up former FTC commissioner to bolster US antitrust offering”