Alexis Vaujany

Alexis’ recent experience includes advising:

Regulatory

• A leading European pharmaceutical industry association on various strategic legal and policy analyses of the EU framework regulating innovation in pharmaceutical product development, including in-depth assessments of personalized medicine, accelerated approval pathways, drug repurposing and unmet medical need, complex and virtual clinical trials, the SPC manufacturing waiver, ERA, and a variety of other cutting-edge issues that have inspired the EMA Regulatory Science Strategy and the European Commission’s Pharmaceutical Strategy
• A European professional medical organization on the practical challenges and complexities arising from the new In Vitro Diagnostic Medical Devices legislation
• A multinational computer technology company, which has expanded its product offering to the medical device sector, on strategic and high-profile regulatory issues related to the launch of its Electronic Health Record (EHR) product in the EU
• A multinational tobacco company on EU regulatory matters, as well as on its global expansion, particularly within the innovative realm of novel tobacco products
• An international biopharmaceutical company on EU and EU Member State regulations on pharmaceuticals, including on requirements related to advertising and promotion, in a standalone manner or potentially adverse to certain competitors
• A multinational health products company on the rebranding of its products, including medicines, medical devices, cosmetics, and consumer products
• A global pharmaceutical company on the development of a regulatory strategy concerning its labelling obligations following a referral before the European Medicines Agency (EMA), including advice on addressing potential challenges related to label warnings
• A global diagnostics company on EU advertising and compliance review of promotional materials
• A French Pharmaceutical Industry Association and its members on a range of strategic and cutting-edge regulatory topics impacting the entire European and French pharmaceutical industry, including assisting with the legal and gap analysis of the key provisions related to this complex framework and providing practical assessment with regard to the legal impact that these changes may have on pharmaceutical companies
• A leading global online retailer and e-commerce platform on numerous legal and enforcement risk assessments related to the online sale and advertising of an extensive variety of regulated products in key EU Member States, including the online sale of medicinal products (and related online pharmacy establishment requirements), diagnostic tests, medical devices, cosmetic products, food and beverages, as well as other regulated products*

Corporate

• Clario in the US$8.875 billion sale to Thermo Fisher Scientific
• Veracyte Inc., a leading cancer diagnostics company, in the context of the bankruptcy sale of the business of its French subsidiary, Veracyte SAS, to Helio Diagnostics SAS
• TA Associates in the sale of a majority stake in Solabia Group, a global biotechnology ingredient solutions provider, to Astorg
• Bain Capital in the acquisition of Softway Medical group, a France-based provider of hospital information systems and management software for healthcare professionals
• Nactarome in the acquisition of Plantex, a France-based specialist in plant extraction for the food, nutraceutical, animal feed, pharmaceutical, and cosmetic industries

*Matter handled prior to joining Latham