Nina’s role is to ensure that patients have faster access to the most promising new treatments, taxpayers get better value for money in drug expenditure and the route to funding is speeded up for responsibly priced, promising drugs. This includes responsibility for the Innovative Medicines Fund, the Cancer Drugs Fund, industry relations, patient access schemes (PAS), the Blueteq prior approval system, dose banding and budget impact tests.

Nina has worked in the NHS since 2001, starting at the National Institute for Health and Care Excellence (NICE). Nina developed and improved the process for technology appraisal and redesigning how NICE choose the topics it produces guidance on. Follow a year’s secondment in 2015 to the Office for Life Sciences as a Senior Policy Lead working on the Accelerated Access Review, Nina returned to NICE to set up, launch and subsequently head up Office for Market Access before moving to NHS England in 2016

Dr. Katherine Donigan is currently a Senior Director of Science and Regulatory at BIO where she leads BIO’s regulatory policy efforts for cell and gene therapies and diagnostics, as well as BIO’s international regulatory work.  Prior to joining BIO, Dr. Donigan held various positions at the US Food and Drug Administration in the Center for Devices and Radiological Health and in the Center for Drug Evaluation and Research.  At US FDA, Dr. Donigan worked on developing regulatory policies to address challenges posed by emerging technologies in personalized medicine.  Dr. Donigan holds a PhD in Genetics from Yale University with a focus on DNA repair and oncology.  She completed postdoctoral training at the National Institute of Child Health and Human Development with a focus on DNA damage bypass mechanisms.

Dr Edison Bicudo is a sociologist and geographer studying the social and geographical implications of pharmaceuticals, advanced therapies, and healthcare-related technologies. His studies have covered topics such as international clinical trials, neuroimaging software, 3D bioprinting, and CAR-T cells. In 2012 he completed his PhD in International Politics at King’s College London. In 2019 he published Neuroimaging, software, and communication (Palgrave McMillan)

Ben is an accomplished leader in Learning & Development with over 20 years’ extensive experience operating at senior levels in large complex regulated organisations.

Working for leading brands such as easyJet, Marks & Spencer and British Airways Ben has supported significant growth and driven positive organisational change by creating and executing Skills, L&D and Talent frameworks and strategies aligned to business needs.

His retail and aviation experience means he balances low cost and high quality without compromise to high safety, customer and regulatory standards.

Ben currently works as Director of Skills Growth for the Cell & Gene Therapy Catapult applying his experience to coordinate and support the evolving skills agenda across the advanced therapy and medicines biomanufacturing sector

Dorothea is a pharmacist with more than 20 years of experience in research, development, manufacturing and supply of pharmaceutical products. She received her PhD from the University of the Saarland, Saarbrücken, Germany.

While with Novartis, she was leading manufacturing sites in Switzerland, Germany and
Ireland. A highlight in her career was the build-up and operational launch of the first
commercial Cell & Gene manufacturing facility for Novartis in Europe.

In 2020, Dorothea moved on to Tigen Pharma, a Swiss biotech company in the field of cell
therapies to cure cancer. Tigen is a disruptive catalyst, combining a unique culture with a
multidisciplinary set of clinical and technical capabilities and a long-term perspective to the
benefit of patients and society.

Dorothea is a firm believer in cross-cultural and -functional teams to go beyond the beaten
industry track.

Dr Lee Aiyegbusi is a Senior Research Fellow and a Deputy Director at the Centre for Patient-Reported Outcomes Research (CPROR), University of Birmingham, UK. He is a co-Lead for the PRO theme, Medical Research Council – National Institute for Health Research (MRC-NIHR) Trial Methodology Research Partnership (TMRP) Outcomes working group. His primary research interests are focused on the optimisation of patient-reported outcome assessments for clinical trials, routine clinical practice, and regulatory purposes; and the optimisation of patient public involvement and engagement (PPIE) in research. He has led research with the Midlands and Wales Advanced Therapy Treatment Centre, exploring information provision and the use of PROs and PPIE in advanced therapy medicinal products (ATMPs). He is the PPIE lead for the NIHR Oxford-Birmingham Blood and Transplant Research Unit in Precision Cellular Therapeutics.

Professor Melanie Calvert, PhD, is Professor of Outcomes Methodology at the University of Birmingham UK. She is Director of Birmingham Health Partners Centre for Regulatory Science and Innovation and Director of the Centre for Patient Reported Outcomes Research which aims to optimize the use of patient reported outcomes (PROs) in clinical trials and routine care, to improve service delivery, enhance patient care and outcomes and ensure that the patient perspective is at the heart of health research and healthcare decision-making. She has led PROs research with the Midlands and Wales Advanced Therapy Treatment Centre, the National Institute for Health and Care Research (NIHR) Birmingham Biomedical Research Centre and is the theme lead for PROs research within the NIHR Oxford-Birmingham Blood and Transplant Research Unit in Precision Cellular Therapeutics

Dr. Kai Pinkernell is the Chief Medical Officer at Glycostem Therapeutics, Oss, The Netherlands, and responsible for Clinical and Regulatory Affairs. Glycostem Therapeutics is a leading clinical-stage company focused on the development of therapeutic, allogeneic off-the-shelf Natural Killer (NK) cells.

Previously, until March 2021, Dr. Pinkernell was Chief Medical Officer, Chief Development officer and managing director at Medigene AG, a clinical stage biotechnology company in Munich, developing personalized T cell-based immunotherapies, where he was responsible for Clinical and Regulatory Affairs, QA and CMC. Prior to this, Dr Pinkernell was Global Head of Clinical Business at Miltenyi Biotec GmbH, Bergisch Gladbach, Germany, leading worldwide clinical marketing, sales and development. Before joining Miltenyi Biotec he was Senior Director of Regenerative Medicine at Cytori Therapeutics Inc., San Diego, USA. During his academic career, he researched cell therapy approaches at Tulane University, New Orleans, USA. and before pursued a residency/fellowship in internal medicine/cardiology at the German Heart Center and Klinikum Rechts der Isar, Technical University, in Munich, Germany. He received his medical degree from the Westfaelische-Wilhems University in Muenster, Germany, and a Master of Business Administration from the Marshall School of Business at the University of Southern California, Los Angeles, USA.

Since 2019, Francesca has been the Director of London Advanced Therapies, which grew to UK Advanced Therapies in 2021. Francesca is the Director of Skills & Training in the King’s/UCL Gene Therapies Hub and holds the position of Chief of Staff (Health &Life Sciences), at King’s College London.

Previously she was Director of Grants at Barts Charity and Head of Strategic Development at Barts and the London School of Medicine and Dentistry, Queen Mary University of London. Francesca also has commercial experience having worked for companies both in the UK and overseas. Her academic background includes a MRes degree in Industrial Chemistry, a PhD in Structural Biology, in addition to being an awardee of EMBO and EU Marie Curie research fellowships. Outside academia, Francesca is the Chair of Trustees of the British Fencing Charity.

London Advanced Therapies (LAT) brings together the London scientific community working in the field of cell and gene-based therapies. Funded by Research England, and led by King’s College London, Imperial College London and University College London, LAT aims to catalyse London’s capabilities and outputs in the area of Advanced Therapies, through fostering collaborative work, facilitating commercial partnerships and creating a microclimate for innovation. We aim at positioning London, and the UK, as a global leader in Advanced Therapies commercialisation, with sustainability embedded through the breadth of commercial partnerships.

Dr Catriona Crombie is responsible for LifeArc’s grant funding portfolio and the team that provide translational advice to other medical research funders. Catriona joined LifeArc early in 2018 to establish the LifeArc Philanthropic Fund; a new academic funding mechanism that is intended to support the development of therapeutics and diagnostics for rare diseases. Catriona also has responsibility for the services that LifeArc provides to the charity sectors.

Prior to joining LifeArc Catriona spent 10 years at the MRC where she was responsible for the delivery of translational medical research and industry engagement funding schemes. In particular, Catriona worked as Programme Manager on the Biomedical Catalyst: Developmental Pathway Funding Scheme. The role involved projects to develop different types of therapeutics for a range of diseases including rare diseases. Many of those projects have subsequently been incorporated into companies. Before joining the MRC, Catriona worked in charity research funding and in academic research.