12pm – 12.45pm GMT, 6 November 2025 ‐ 45 mins
Panel discussion


Consultant Paediatrician & Director of Strategy, Research & Innovation, Imperial College Healthcare NHS Trust




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.
Consultant Paediatrician & Director of Strategy, Research & Innovation, Imperial College Healthcare NHS Trust
Professor Bob Klaber studied at the University of Cambridge and Bart's and The London School of Medicine, before completing his postgraduate training in paediatrics in hospitals across London. He has also trained as a medical educationalist in quality improvement and, through an MD at University College London, in mixed methods research. He is a professor of practice (population health) at the School of Public Health, Imperial College London, a member of the NHS Assembly and a trustee of the Nuffield Trust.
In his current executive director role, he is responsible for strategy, research, innovation and improvement across the Trust. This also involves clinical leadership around redevelopment, sustainability, improving population health, developing the Trust’s role as an anchor institution and improving health equity. He continues to work as a consultant paediatrician at the Trust and as part of Connecting Care for Children, an integrated child health programme in north west London. Bob is also one of the leaders of Kindness in Healthcare, a network of 1400 people from 34 different countries.

Life Sciences Industry Director , NIHR
Dr Maria Koufali is the Life Sciences Industry Director at the National Institute for Health and Care Research (NIHR), and formerly led the UK Vaccine Innovation Pathway as Head of the programme.
Maria Koufali, is an experienced senior leader in life sciences research and innovation, bringing over 20 years of cross-sector expertise in working with global pharmaceutical companies, digital health firms, diagnostics developers, and MedTech SMEs. She holds a PhD in Pharmacology and Neuroscience, an MBA (Distinction), and is the first NHS R&D Director nationally to be awarded the Nye Bevan Executive Health Leadership Award. Maria currently leads the UK Vaccine Innovation Pathway at NIHR/DHSC, a nationally mandated clinical trials accelerator. Maria currently serves as Trustee and Chair of the Industry Advisory Board at the BBSRC-funded Quadram Institute, where she shapes translational and commercial strategy. She brings to the new contract a proven ability to develop national infrastructure, deliver commercial growth, and work across government and industry to accelerate innovation that benefits patients and the UK economy.

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.

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.