Kate Greenwood

Senior Improvement Delivery Manager, Health Research Authority (HRA)

Kate is Senior Improvement Delivery Manager at the Health Authority, working to shape the environment for research through work taken forward by the Government and partners in response to the Lord O’Shaughnessy report on clinical trials. Kate has been working in NHS R&D at both operational and strategic level since late 1999 and has a broad historical knowledge of research management in the NHS. Previous roles include manager of a Professional research network, The NHS R&D Forum, and 15 years as Research Manager at Portsmouth Hospitals NHS Trust leading the R&D office and Sponsorship functions. Kate currently co-leads work to improve the set-up of studies at site and chairs the HRA study set up advisory board. Kate also co-led the People-Centred Clinical Research project and supports the development of guidance for inclusion and diversity plans. 

Emily Merrell

Director of the Advanced Therapy Treatment Centre (ATTC), Cell and Gene Therapy Catapult

Emily Merrell has worked within the Healthcare sector for 25+ years with global development experience spanning Biotech, Pharma, CROs, and the NHS. In addition to roles in drug development, Emily has also worked as a consultant within The National Healthcare System (NHS) where she led the development and implementation of a virtual COVID hospital that resulted in improved outcomes for COVID-19 patients. She was also previously Head of the Catapults ATTC Network Coordination during phase 1 of the ATTC Programme focused on Clinical Adoption of ATMPs. Her clinical development experience spans all therapeutic areas and all stages of the clinical development lifecycle, from First In Human trials to Long-Term Follow-Up and Post Marketing surveillances. Prior to joining the Cell and Gene Therapy Catapult as current Director of the ATTC Network, she was Senior Director of Therapeutic Expertise and Head of the Centre for Cell & Gene Therapy at ICON driving the strategic & operational growth of the Centre’s capabilities which has so far supported the delivery of 170+ Cell and Gene Therapy Clinical Trials over the last 5 years across a diverse range of therapeutic areas, development phases and technologies. Emily has a passion for enabling new ways of working by challenging ‘traditional models’ and cultivating more integrative working within and across organizations as the driving force of improving health outcomes for patients worldwide.

James Pound

Interim Executive Director Innovation and Compliance, MHRA

James Pound joined the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) in 2008. He has worked in a variety of roles within the MHRA and is an executive leader within the Agency with responsibility for our Innovation Accelerator (the home of our innovative pathways for medicines and medical devices), the clinical investigations and trials group and the standards and compliance function which includes our Medicines GXP compliance teams, British Pharmacopoeia and medical devices audit and compliance. James led the cross-Agency response to clinical trial assessment delays in 2023 which were successfully eliminated in Autumn 2023 with sustained performance by the Agency since then.

He holds an honours degree in Chemistry and has previously worked in a variety of roles in development and manufacturing in the pharmaceutical industry.

Paul Smith

Vice President, Regulatory Affairs, Infinitopes

A senior regulatory affairs professional with 35 years of experience in drug development and over 25 years in Biotechnology Regulatory Affairs. Originally trained as a toxicologist at SmithKline Beecham before moving into Regulatory Affairs. With Amgen for 19 years until 2016 and has since then has been working in start up biotechnology companies (Tusk Therapeutics/Infinitopes Limited) or as a consultant.

Experience across all areas of drug development and has provided bespoke regulatory services to start up and established biotechnology companies for all aspects of product life cycle management. 

Focussed on developing successful regulatory strategies to maximise opportunities for accelerated product approval in UK, EU and US. Particular focus on oncology products (targeted therapies, immunotherapies) and cell and gene therapies.  Provides  senior level drug development experience to start up biotechnology companies at board and investor level. 

Currently Vice President, Regulatory Affairs, Infinitopes Cancer Vaccines, Oxford.