Sidley Austin LLP

Food, Drug and Medical Device

Partner

MARIA ISABEL MANLEY leads Sidley’s Life Sciences team in London and is a distinguished thought leader and adviser on EU and UK regulatory law. She represents development-stage, specialty and established global life sciences companies in a broad spectrum of matters, both contentious and non-contentious, including bet-the-company regulatory matters, investigations and court challenges. Marie is experienced in advising on issues arising during the life cycle of medicinal products, including optimisation of IP regulatory rights, advertising, product liability, interaction between competition and regulatory law; as well as market access issues (namely representing and advising clients in their interaction with HTA bodies such as NICE and payors such as NHS England). Marie has an unprecedented track record of successfully advising clients on the best strategy to overcome the challenges of Health Technology Assessments, to present the best value proposition to payors, including reliance on RWE to address gaps in clinical trial data. Marie has successfully represented clients in their interaction with NICE as well as challenging unfavourable NICE decisions before the NICE appeal panel and the English courts. Marie has represented a number of the world’s leading pharmaceutical and life sciences companies in litigation before the European and English Courts, as well as before the regulatory authorities, including the European Commission, the European and UK medicines authorities (EMA and MHRA), including successfully representing pharma companies in the enforcement of their orphan-drug exclusivity.