Meet the Team

Overview of Experience

I am a UK qualified solicitor with over 15 years working within the UK, EMEA, and Global life science sector, including consumer healthcare, medical devices, pharmaceuticals and animal health. I have held roles in both private practice and in-house for large multi-national pharma companies including Baker McKenzie LLP, Kyowa Kirin International Plc, Astellas Pharma Europe Ltd, Elanco Animal Health and Eli Lilly and Company Ltd

Areas of Expertise

I am experienced in advising businesses as well as leadership teams on a wide range of legal, regulatory and Code compliance issues as well as risk management at UK, EMEA and the Global level including:

• Commercial, marketing and promotional activity throughout a medicine’s lifecycle, from pre-licence, product launches through to late lifecycle management, including internal governance projects and Medical, Legal, Review support.
• Market Access, pricing and rebate schemes.
• Early access schemes.
• Data Privacy.
• Medical Affairs contracting and governance.
• Commercial and IP agreements.
• Intellectual Property matters.
• Distribution and Supply Chain.
• Competition Law.
• Regulatory inspection readiness, audit, investigations and challenges.
• Pharmacovigilance.
• Patient support programmes.
• Sponsorships, grants and donations.

 

Therapeutic Areas of Expertise

Regulatory Bodies of Expertise

• ABPI Code of Practice
• EFPIA Code of Practice
• IPHA Code of Practice

 

Track Record

I have extensive experience in the following areas:

Lead lawyer supporting commercial and marketing teams, on product launches across a wide range of therapy areas in the UK/ROI as well as at global level as part of global product steering committees.

Complex digital health initiatives, including acting as the lead legal support for the development and implementation of global digital platforms.

Patient Support Programmes in the UK/ROI and across EMEA, including structuring, implementation and governance of new programmes.

Market Access, pricing and rebates in the UK and across EMEA.

NICE reimbursement and reimbursement appeals in the UK, and implementation of new pricing schemes and complex rebate schemes in the animal health sector.

Complex medical affairs contracting projects including clinical trials transformation and collaborative research projects.

Early Access Schemes (rare diseases) across multiple jurisdictions, including implementation and amendment of schemes as well as internal governance.

Regulatory Compliance – campaigns and communications (e.g. broadcast, social media and digital) of multiple business stakeholders and have advised on interactions with HCPs and patient organisations.

Code Complaints, regulatory challenges, product liability and contractual disputes.

Internal governance, process improvement and launch readiness governance.