Wide range of experience in academia, the public sector and industry on the translation of early stage research into patient treatments. Focused on regulatory/product development requirements for innovator + established products and formulating efficient global strategies for novel products.

Working knowledge CMC, Non-Clinical and Clinical for ATMPs, biologics, novel drug delivery systems and complex generic products. Advanced knowledge of polymeric controlled release systems for the delivery of novel and established actives, including microneedles and Nanoparticles. Understanding of formulations utilising novel excipients at all stages of development.

Experienced in writing clinical protocols for trials in early development through to pivotal registration studies. Deep understanding of biomarker strategies focusing on In Vitro Diagnostics and digital solutions including those that are AI driven. Expert in the development of companion diagnostics for global drug development programs.

Wide experience of medical devices including clinical development, preparation of clinical protocols, and expert in the EU MDR and IVDR.

Strong understanding of vaccine development for therapeutic and traditional applications, including mRNA and sRNAi products.

Extensive experience of Scientific Advice procedures in the EU, UK and US. Further knowledge of innovation support schemes including CA Innovation Offices and the EMA Innovation Task Force.

Experience in supporting a wide range of academic research groups and spin-out companies at different stages in the commercialisation process.

Working knowledge of regulatory processes and strategies from early development in academia through to post-marketing maintenance of commercial products.