Plenary lecture 1 – June 8 @ 09:15
Challenges for the development and delivery of Cell and Gen Therapies
Dr Jacqueline Barry, Chief clinical officer, Catapult, London, UK

Jacqueline Barry is the Chief Clinical Officer, responsible for Clinical Translation and Delivery activities and an Executive Director of the Cell and Gene Therapy Catapult. She has extensive experience in the development of advanced therapy medicinal products and leads a multi-disciplinary team of Nonclinical, Regulatory, Clinical Operations and Programme Management specialists. She also leads the coordination of the UK Advanced Therapy Treatment Centre Network and is a Director of the Global Alliance for iPSC Therapies.

She feels passionately about making advanced therapies available for patients and works closely with the MHRA and the NHS on the development of the ecosystems to support the adoption of these therapies.

Prior her time at Cell and Gene Therapy Catapult, Jacqueline worked at the Scottish National Blood Transfusion Service where amongst other activities she designed the regulatory strategy for the Cellular Therapies for the Blood Transfusion Service and acted as Qualified Person for their release. She has a PhD from the University of Aberdeen and did post-doctoral research in neurophysiology at the University of Edinburgh.

Plenary lecture 2 – June 8 @ 10:40
Pragmatic registry based randomized clinical trials – A new opportunity
Prof Stefan James, Department of medical sciences and Uppsala Clinical Research Center, Uppsala University, Uppsala University Hospital, Sweden

Stefan James is Professor of Cardiology and Scientific Director of Uppsala Clinical Research Center at Uppsala University. He is a Senior Interventional Cardiologist at Uppsala University Hospital Sweden.

His research has been published in over 450 peer-reviewed cardiology journals, and he is an associate editor of Circulation and an editorial board member for the European Heart Journal, and American Heart Journal.

Stefan James has served as PI on steering committees for numerous international trials in cardiology and has pioneered the concept of registry based randomized clinical trials. He has served as the chairman of the Swedish Coronary and Angioplasty registry of SWEDEHEART and the president of the Swedish Cardiac society. Stefan James has received numerous reseach prizes and awards. For several years, he has been named by Thomson Reuters as a ‘Highly Cited Researcher’, ranking him among the top 1% most cited in clinical medicine.

Plenary lecture 3 – June 8 @ 13:10
Current and future use of modelling and simulation in pharmaceutical development
Prof Amin Rostami, University of Manchester, Certara, UK

Amin Rostami is the Director of the Centre for Applied Pharmacokinetic Research (CAPKR) at the University of Manchester and a Professor of Systems Pharmacology with an active program of training PhD students in proteomics, PBPK, clinical PKPD and precision dosing.  Amin is also the Senior Vice President of Research & Development and Chief Scientific Officer at Certara, where he ensures that various pharmaceutical companies incorporate the latest scientific advances in the field of biosimulation into their drug development efforts.

Plenary lecture 4 – June 8 @ 14:20
Global Health – Improving Pharmaceutical Economics for All
Dr Niya Bowers, Bill & Melinda Gates Foundation, USA

Niya Bowers, Ph.D., Senior Program Officer, CMC/ Integrated Development, Global Health, Bill & Melinda Gates Foundation

Dr. Niya Bowers joined the Bill & Melinda Gates Foundation in 2015, as a Senior Program Officer in Chemistry, Manufacturing and Controls (Integrated Development). She works closely with foundation’s strategy teams and partners, and provides technical expertise and strategic guidance for therapeutic drug development in Global Health.

Dr. Bowers has over 25 years of experience in pharmaceutical product development, including the end-to-end development of drug substances, drug products, and analytical. She also has in-depth experience in Process Analytical Technology (PAT), regulatory, and project management. Prior to joining the Foundation, she was a managing partner of Garden State Pharmatech, LLC, a CMC consulting firm. From 2010 to 2014, she was an executive director in Merck’s Global Science Technology and Commercialization organization. She was responsible for late phase analytical development for both drug substance and drug product and the head of Merck’s Global Process Analytical Technology. Before Merck, she was a director of Oral and Specialty Product Development in Schering-Plough Research Institute. She led the development, filing and approval of over 15 commercial products at Schering-Plough and Merck. Niya received her Ph. D. in Analytical Chemistry from Seton Hall University, and B. S. in Chemistry from University of Science and Technology of China.

COVID vaccine panel discussion – June 8 @ 16:10

Camilla Foged, University of Copenhagen, Denmark

Margareta Ramström Jonsson, Swedish Medical Products Agency

Dr. Margareta Ramström Jonsson is a pharmaceutical assessor at the Swedish Medical Products Agency with expertise on biopharmaceuticals. She holds a PhD in Analytical Chemistry and is an Associate Professor in Proteomics. Dr. Ramström Jonsson has a long career in the field of mass spectrometry research, with focus on protein characterisation, proteomics and development of new analytical protocols.