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    Global Problem Solving from Covington: Deal with Complex Problems Anywhere in the World

    • Apr 08, 2021

Sarah Cowlishaw

Partner

London +44 20 7067 2043

  • About
  • Representative Matters
  • Credentials
  • About

     Advising clients on a broad range of life sciences matters, Sarah Cowlishaw supports innovative pharmaceutical, biotech, medical device, diagnostic and software technology companies on regulatory, compliance, transactional, and legislative matters.

    Sarah has particular expertise in advising on legal issues presented by digital health technologies, helping companies navigate regulatory frameworks while balancing challenges presented by the pace of technological change over legislative developments.

    Sarah is a co-chair of Covington’s multidisciplinary Digital Health Initiative, and is the Graduate Recruitment Partner for Covington’s London office.

    Sarah regularly advises on:

    • classification determinations for software medical devices, including on developments resulting from the implementation of the EU Medical Devices Regulation;
    • legal issues presented by digital health technologies including artificial intelligence;
    • general regulatory matters for the pharma and device industry, including borderline determinations, adverse event and other reporting obligations, manufacturing controls, and labeling and promotion;
    • the full range of agreements that span the product life-cycle in the life sciences sector, including collaborations and other strategic agreements, clinical trial agreements, and manufacturing and supply agreements; and
    • regulatory and commercial due diligence for life sciences transactions.

    Sarah’s pro bono work includes advising the Restoration of Appearance and Function Trust (RAFT) on the classification of a wound healing product containing human blood derivatives, and assisting in a project aimed at improving regulatory systems for clinical trials of drugs and vaccines for neglected diseases in developing countries.

    Sarah has been recognized as one of the UK’s Rising Stars by Law.com (2021), which lists 25 up and coming female lawyers in the UK. She was named among the Hot 100 by The Lawyer (2020) and was included in the 50 Movers & Shakers in BioBusiness 2019 for advancing legal thinking for digital health. 

    Sarah has undertaken several client secondments, including to the in-house legal department of a multinational pharmaceutical company.

    Areas of Expertise

  • Practices and Industries
  • Representative Matters
    • Represented various pharmaceutical companies on the negotiation of supply arrangements for COVID-19 vaccines and non-vaccine COVID-19 related products, including before the European Commission and the UK Government.
    • Provided numerous clients with strategic regulatory and practical solutions to bring innovative digital health products to market, including during the COVID-19 pandemic.
    • Advised (and continues to advise) clients on the new EU Medical Devices Regulation and In Vitro Diagnostics Medical Devices Regulation, that will come into force in May 2021 and May 2022, respectively, as well as the new UK-specific regulatory regime for medical devices, introduced in January 2021.
    • Advised Illumina on its partnership with Genomics England, to sequence up to 500,000 whole genomes for the NHS Genomic Medicine Service.
    • Advised Sensyne Health on regulatory matters in connection with its £60 million IPO on London’s AIM market.

    • Advised GSK on 23andMe Collaboration and $300M Investment.
    • Advised AstraZeneca on Strategic Collaboration with Circassia, a respiratory biopharmaceutical company, for the development and commercialisation of Tudorza and Duaklir (U.S. trademark to be confirmed) in the U.S.
    • Represented Humacyte in $800M Merger with Alpha Healthcare.

    Areas of Expertise

  • Credentials
    Education
    • BPP Law School, L.P.C., 2009
        • Distinction
        • Gamlen Law Prize
    • University of Bristol, B.Sc.
        • First class honours
        • Chemistry and Law
    Bar Admissions
    • Solicitor of the Senior Courts of England and Wales
    • Law Society of Ireland
    Pro Bono
    • Advising the Restoration of Appearance and Function Trust (RAFT) on the classification of a wound healing product containing human blood derivatives.
    • Assisting in a pro-bono project aimed at improving regulatory systems for clinical trials of drugs and vaccines for neglected diseases in developing countries.
    Accolades
    Previous Experience
    • Secondment to the in-house legal department of a multinational pharmaceutical company.
    • Secondment to the in-house legal department of an international pharmaceutical company, based in Germany.

    Areas of Expertise

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