Associate, European and UK Patent Attorney, J A Kemp

Karen plays an active role in advising and managing patent portfolios for a wide variety of clients, from startups to large multinational corporations. In particular, she has experience of managing large, complex portfolios of patent families, including those covering clinical candidates and platform technologies. She has expertise across a wide range of disciplines, including cell and gene therapies, antibodies, vaccines, biomarkers, and diagnostics. Karen is based in J A Kemp’s Oxford office.

Business Transformation and CTR Lead, DLRC Ltd, DLRC Group

James’s journey with the EU CTR started in 2017, working at the EMA in the CTIS business team. Over the last seven years, he supported the development of the regulation and guidance, the development of CTIS, and has supported clients with CTR readiness and CTA submissions. He has supported numerous clients in getting them ready for the CTR Go-Live through training, redesign of operating models, and updates to processes and procedures. More recently, he supports clients with strategic direction for trials submitted under the CTR and helps to navigate EU CTR guidelines and ensure CTA document compliance with the regulation.