HELEN MIDDLETON is a life sciences commercial, IP and regulatory lawyer with over 29 years’ experience in the sector. Her practice is multidisciplinary, with a particular focus on international IP licensing transactions, as well as collaboration and development agreements, clinical trials, manufacturing and distribution agreements and marketing. In addition, she advises on the procurement rules applicable to life sciences products.
Helen’s practice covers the pharmaceutical, medical device, medtech, biotechnology and cosmetics industries and is particularly underpinned by her broad regulatory experience across the entire product lifecycle gained from her time in private practice at law firms in London and Ireland, and a significant period in-house. She previously served as Principal Legal Adviser at a global pharmaceutical network of independent companies, where she led its international R&D group. Prior to qualifying as a lawyer, she worked as a senior hospital clinical pharmacist in teaching hospitals in London.
Helen has in depth knowledge of the requirements needed to develop and commercialize bio/pharmaceuticals and medical devices.
Key areas of focus include:
- Commercial/contractual regulatory: drafting and reviewing international licensing agreements, collaboration and development agreements (including evaluation and option, feasibility, data sharing and funding), formulation development, manufacturing and supply, packaging and storage, distribution, marketing (including co-marketing and co-promotion), procurement, intellectual property relevant to commercial agreements (including IP regulatory rights and patent).
- Clinical trials: pre-clinical, clinical trials worldwide and all aspects relating thereto e.g., consent, data protection, biogenetic testing, advertising and compliance.
- Regulatory: marketing authorizations (including strategy and maximization of IP regulatory rights (regulatory data protection and market protection, orphan marketing exclusivity, pediatrics), pharmacovigilance, GMP, GCP and GLP.
- Medical devices: medical devices legal framework, classification issues and borderline products, interaction with notified bodies and software.
- Market access: pricing and reimbursement in the UK, procurement and parallel imports.
- Compliance: anti-bribery, pharmaceutical codes of practice and data protection.