Hannah Kerr-Peterson is an associate in Ropes & Gray’s life sciences regulatory and compliance team, based in London.

Hannah’s practice focusses on the regulation of pharmaceutical, medical device and digital health technologies in the UK and EU. She regularly advises clients on transactional, advisory, compliance, commercial and contentious matters, which often relate to product classification, research, early access, product approval, pricing and reimbursement, market access, manufacturing, advertising and promotion, distribution, and safety vigilance.

Having obtained a first-class degree in Pharmacology and Molecular Genetics, conducted scientific research at a leading London-based research institute, and undertaken a secondment at a market-leading pharmaceutical company, Hannah is quick to grasp complex technical issues and provide clients with practical advice tailored to the needs of their businesses.

Experience

Transactional matters

  • Advised Advent International and Warburg Pincus on their acquisition of Baxter International Inc.’s BioPharma Solutions business, a provider of sterile contract manufacturing solutions, parenteral delivery systems and customized support services to the pharma and biotech industries, for $4.25 billion
  • Advised Elliott Investment Management, Patient Square Capital, and Veritas Capital on their acquisition of Syneos Health, a fully integrated biopharmaceutical solutions organisation offering clinical research and commercialisation services, for $7.1 billion
  • Advised Partners Group on its investment in GHO Capital Partners’ portfolio company Sterling Pharma Solutions, a leading pharmaceutical development and manufacturing organisation
  • Advised Partners Group on its acquisition of a majority stake in FairJourney Biologics, a leading antibody discovery contract research organisation, from GHO Capital Partners
  • Advised Partners Group on its acquisition of Pharmathen, a contract development and manufacturing organisation specialised in advanced drug delivery technologies for complex generic pharmaceutical products, for €1.6 billion
  • Advised Jounce Therapeutics, Inc. on its proposed all share merger with UK-headquartered biotech company Redx Pharma plc
  • Advised Becton, Dickinson and Company on its acquisition of Edwards Lifesciences’ Critical Care business, a global leader in advanced monitoring solutions, for $4.2 billion
  • Advised Provention Bio, Inc., a biopharmaceutical company dedicated to intercepting and preventing immune-mediated diseases, in its sale to Sanofi for approximately $2.9 billion

Advisory matters

  • Advised a global biotechnology company on an application for an Innovation Passport under the UK’s Innovative Licensing and Access Pathway
  • Advised a clinical stage pharmaceutical company on how to position its developmental product as containing a new active substance
  • Advised a consumer healthcare company on the reclassification of its contraceptive pill from prescription-only to pharmacy
  • Advised various clients on borderline issues and the classification of their medical devices
  • Advised a major online retailer on the establishment of a platform from which regulated products could be sold, such as human and veterinary medicines, medical devices and optical appliances*

Compliance matters

  • Conducted an internal investigation for a major international pharmaceutical company into the use of unlawfully CE marked medical devices in it’s clinical trial
  • Conducted various compliance investigations for a major international pharmaceutical company, concerning issues such as sponsorship of external events, hiring practices, expenses and hospitality
  • Drafted a range of standard operating procedures/policies for various pharmaceutical companies concerning, for example, the engagement of HCPs, disease awareness campaigns and the delivery of virtual conferences
  • Assisted a number of senior employees of an international pharmaceutical company, who were the focus of a Serious Fraud Office investigation into bribery and corruption overseas*
  • Conducted an internal investigation for a biopharmaceutical company into allegations concerning the manipulation of prescribing software*

Commercial matters

  • Drafted and negotiated an NHS supply agreement which comprised an entirely novel drug pricing mechanism
  • Drafted and negotiated various clinical trial agreements, including those for investigator initiated trials, those involving contract research organisations and the gathering of real-world data/evidence
  • Drafted and negotiated, on a pro bono basis, a series of research grant agreements on behalf of a cancer charity
  • Drafted, on behalf of numerous clients, a range of templates including: master services agreements, speaker agreements, sponsorship agreements, MDR-compliant medical device import and distribution agreements, compounder agreements, collaboration agreements and distribution agreements

Contentious matters

  • Assisted a global pharmaceutical company in its challenge of the Medicines and Healthcare products Regulatory Agency’s decision to include certain information in the authorisation documentation of a generic version of our client’s medicinal product
  • Assisted various pharmaceutical companies with their defence of PMCPA complaints, related to allegations such as the promotion of prescription-only medicines on social media, the offer of inducements to healthcare professionals, and the publication of clinical trial results
  • Assisted a multinational pharmaceutical company with its provision of information to, and cooperation with, the Infected Blood Inquiry*
  • Assisted numerous clients with proceedings before the European Courts: T-33/17 Amicus Therapeutics UK Ltd; Amicus Therapeutics v European Medicines Agency; T-733/17 GMP-Orphan SA v European Commission and Appeal Case C-575/19P; T-337/18 Intercept Pharma Ltd, Intercept Pharmaceuticals Inc v European Medicines Agency*

*Experience prior to joining Ropes & Gray

Areas of Practice

    Disclaimer

    Ropes & Gray International LLP is a limited liability partnership registered in Delaware, United States of America and is a recognised body regulated by the Solicitors Regulation Authority (with registered number 521000).