Women leaders in healthcare and life sciences: sharing practices for success

With nearly 30 years of experience advising clients in the pharmaceutical and medical device sectors, Ms. Walsh is widely recognized as a national authority on FDA enforcement, compliance, and regulatory strategy. Her practice centers on guiding companies through the most complex and high-stakes challenges at the intersection of FDA law and government investigations. Ms. Walsh advises clients in M&A transactions requiring FDA expertise. She leads teams of attorneys to conduct comprehensive FDA-related diligence, and to advise clients on making determinations concerning the deal and its valuation. She also regularly counsels clients on managing FDA inspections, responding to warning letters, and deciding when to submit mandatory reports or conduct recalls. She has specific expertise in matters involving alleged FDC Act violations, such as off-label promotion or inadequate manufacturing practices. Prior to joining HPM, Ms. Walsh served as Associate Chief Counsel with FDA’s Office of Chief Counsel.

Cecilia Stahlhut Espinosa represents life sciences and consumer products companies in Mexico, with a focus on health and consumer law matters. She works with clients throughout all stages of complex and innovative projects. Her years of experience as external counsel to many life sciences companies offer her unique insight into the industry. She has a wealth of experience in regulatory drug matters (pharmaceutical), medical devices, research and development, digital health, biotechnology, compliance of new product technologies, and general health regulatory compliance. Cecilia has particular experience in the regulation of cosmetics, food, alcohol, tobacco, high tech and innovative devices, and consumer products in Mexico. She has also participated in the planning and adoption of regulatory strategies for various companies, with respect to product advertising and labeling, post market safety, compliance with good manufacturing practices, and the launching of new products. She also advises clients on sophisticated regulatory structures and the restructuring of business models and operations, clinical research projects, approval and marketing authorization pathways, standards for regulated products, and challenging labeling and advertising issues Cecilia has advised clients on promotional activities and compliance of regulations regarding interactions with health care professionals and related organizations, and implementation of patient programs. Cecilia has seconded two major orphan drug companies to advise on regulatory framework applicable to orphan drugs as well as the ongoing business activities of the clients, including contracts, advertising, marketing, pharmacovigilance, and health-corporate governance. Representative experience: Advising top multinational companies in the planning and adoption of complex regulatory strategies in connection with business restructurings. Advising companies on approval and marketing authorization pathways and standards for regulated products and compliance with labeling. Reviewed advertising and promotion materials for an extensive range of products and advised clients on launching of innovative marketing campaigns. Reviewed advertising and promotion materials for various products; served on promotional review committees; advised clients on promotional activities.

Charlotte is an experienced intellectual property lawyer who supports clients with the protection and exploitation of the full range of intellectual property rights, with a particular interest in the life sciences. Charlotte trained and qualified into the IP team of a City law firm. She joined Stevens & Bolton’s IP practice in 2008 and became a partner in 2016. Charlotte completed a Postgraduate Diploma in Intellectual Property Law in 2006 and has gained valuable experience through secondments at both The Coca-Cola Company and a global biotechnology company. Charlotte’s practice focuses on advising global companies, start-ups and individuals on IP licensing, research and joint development agreements, IP restructuring and transactional work. Her extensive experience on contentious matters includes trade mark and passing off disputes, copyright and designs litigation and pharmaceutical patent litigation as well as actions involving breach of confidence and defamation. Charlotte has a particular interest in life sciences, and her technical background has assisted her with work in this sector over the past 20 years. As head of life sciences, Charlotte leads the firm’s work in this sector. Recent highlights include: * Supporting a global biotechnology company with IP licensing, including negotiating complex cross-border patent and know-how licence agreements with major pharmaceutical companies * Advising life sciences companies on various collaboration and IP agreements with academic institutions, and supporting clients with material transfer agreements, technology transfer agreements and research agreements * Advising on disputes relating to confidential licensed know-how and the payment of royalties under licenced IP for medicinal products * Advising an international pharmaceutical company on complex patent and SPC regulatory issues * Representing an international oil and gas client on a copyright infringement dispute in the English High Court Chambers UK lists Charlotte as a ‘Leading Individual’, and she is also recognised as a ‘Next Generation’ lawyer by The Legal 500 and as a leading practitioner by World Trademark Review. Charlotte writes regularly for a range of legal and industry publications including PLC, Journal of Intellectual Property Law & Practice, European Intellectual Property Review and leading industry publications such as The Pharma Letter, PharmaIQ, PharmaTimes and European Biopharmaceutical Review. She is a member of INTA, AIPPI, the BioIndustry Association and the Association of the British Pharmaceutical Industry.