Expertise
A senior international lawyer with three decades’ extensive transactional and regulatory experience in the life sciences sector, serving as a trusted advisor and advocate for multinational life science companies coupled with prior managerial experience as managing partner in private practice. Excels at balancing practical legal and compliance advice to senior management with a strong commercial orientation.
Deep expertise in M&A, licensing and complex business transactions, advising on regulatory matters, competition law, data protection, risk management, healthcare compliance and anti-corruption reviews and ethics programs. Highly collaborative, performance-driven, equipped with excellent leadership and project management skills and passionate about mentoring, motivating and developing legal teams.
- Experience
Life Sciences Department Management
Leader of the Life Sciences practice at Stringer Saul and Fasken London (over 12 lawyers) and annual turnover (£10 million).
Mentor, coordinate and supervise a team of multi-industry transactional practice of 30 lawyers engaged in M&A, transactional, financing, regulatory, IP, antitrust, tax, employee benefits, compliance, and data protection representing pharma, medical device, food and cosmetic and technology companies.
Selected Corporate & Commercial Transactions
Leading and co-ordinating the progression of a one-asset UK company to a NASDAQ listed, multi-asset immunotherapy company via acquisition by a SPAC, including the acquisition of clinical assets from big pharma companies, equity investment by big pharma in client, appointment of entire senior management team, preparation of client for listing including insertion of off-shore entities into group, tax advice, acquisition and securities advice, follow-on PIPE investment, continuing commercial advice with respect to development, manufacture and clinical trials, etc.
Market leading (largest by "bio-dollars" at time of completion) licensing and collaboration agreements with Roche, Novartis and Medimmune/Astra Zeneca
M&A and Product Portfolio acquisitions and disposals, to include travel and defence vaccines, other immunology products, oncology products, mature, generic and "specials" products
Acquisition of Founding Technology by multiple early-stage companies from institutions such as
UCL, Kings College, Cancer Research UK, IP Group etc.
Multiple research collaboration between biotech and mid-pharma companies with CROs, clinical and/or educational institutions
Multiple development and manufacturing, marketing & distribution agreements.
Litigation, Compliance & Privacy
Interpretation of contractual rights and obligations, negotiation of settlement of contractual disputes
Assessment of regulatory compliance of drugs and devices, and their manufacture and movement, and advising on consequences of non-compliance
Managing relations with healthcare professionals, focusing on rules governing transfer of value, sponsorship of events and continuing professional development initiatives
Dealing with protection of personal health data and ensuring operational compliance with GDPR
Dealing with “whistleblowing” events, including conducting extensive review and assessment of compliance with all manufacturing, maintenance and safety processes.
R&D, AI & Digital Initiatives & Clinical Trials
R&D: assisting pharmaceutical companies and medical device manufacturers in the initial phase of product development (drafting feasibility and joint research and development agreements)
AI & Digital Initiatives: implementing new technologies by way of licensing and/or consultant contracting (artificial intelligence, digital therapies, telemedicine)
Clinical Trials: advising on the regulation and conduct of clinical trials (negotiating and drafting clinical trial agreements and protocols with CROs) and supporting companies in their interaction with competent regulatory authorities to obtain marketing authorizations or CE/UKCA marks