Speakers
Lawrence Tallon
Chief Executive Officer, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Marwan Fathallah, MBA, MSc
DIA CEO, DIA, United States
Prior to joining DIA in 2023, Fathallah was the Operating Officer and EVP at Ortho Clinical Diagnostics, accountable for Operations, Post Market Product Science and Engineering, Regulatory, Quality, Medical, Clinical, Scientific Affairs, and Process Excellence. Before joining Ortho, he held Executive and Senior Leadership roles in Research and Development, Operations, and Regulatory Medical and Clinical Affairs at Avantor, Danaher, Pfizer, Hospira, and Abbott Laboratories. Fathallah holds a Master’s and Bachelor of Science degrees in Mechanical Engineering from the Univ. of Wisconsin-Madison and an MBA from the Kellogg School of Management at Northwestern University.
Maria Vassileva, PhD
Chief Science and Regulatory Officer, DIA, United States
Dr. Vassileva is the DIA Chief Science and Regulatory Officer and the lead for the Global Science team. She has decades of experience with managing complex multi-stakeholder biomedical research programs. She spent most of her career in the nonprofit sector, leading the Science Team at the Arthritis Foundation, and working at the Foundation for NIH and the American Association for the Advancement of Science. She was also on the leadership teams of two health research organizations, serving as project director on multiple government contracts. Her areas of expertise include musculoskeletal, metabolic, immunity and inflammation disorders, as well as patient engagement. She received her PhD in Biochemistry and Cell Biology from Johns Hopkins.
Rachel Bosworth
Director of Communications and Engagement, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Rosalind Way
Director of National Healthcare System Engagement, IQVIA UK & Ireland, United Kingdom
Virginia Acha
AVP, Science and Regulatory Policy, Merck & Co., Inc., United Kingdom
Virginia (Ginny) has worked in industry and academia throughout her career, combining interests in science policy research and innovation performance within and across organizations. She joined MSD in 2017 to lead regulatory policy ex-US for innovation that leads to better treatment for patients globally. Since 2020 this scope has expanded, and Ginny now leads the talented and experienced Science and Regulatory Policy team comprising Global Regulatory Policy, Clinical Research Policy, Data and Advanced Digital Technologies Policy and Evidence Policy. Her work has regularly focused on policy shocks that challenge innovation and access to novel therapies for patients, including global and industry-wide policy work for innovation.
Sunera Awan
Head of UK, Ireland, Israel, and Malta Regulatory Affairs cluster, Bayer, United Kingdom
Alison Cave
Chief Safety Officer, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Dr Alison Cave is Chief Safety Officer at the Medicines and Healthcare products Regulatory Agency (MHRA), with responsibility for the safety of medicines and medical devices in the UK. She holds a BSc (Hons) and PhD from the University of London and has extensive academic and regulatory experience, including roles at both the European Medicines Agency and at the MHRA. Her previous positions include Head of Cellular, Developmental and Physiological Sciences at the Wellcome Trust and an Industrial Strategy Challenge Fund Director at UK Research and Innovation.
Julian Beach, MBA
Interim Executive Director, Healthcare Quality and Access, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Julian oversees the portfolio that is designed to ensure the quality and access of products to the UK market - this includes scientific advice, licensing assessment, marketing authorisations for all innovative and established medicines. A committed professional with over 15 years of Director/Board level experience with a broad demonstrated history at Medicines Healthcare Products Regulatory Agency, Novartis, Pfizer and GSK in pharmaceuticals. Flexibly skilled in regulatory, compliance, quality, health and safety, operations with passion for people development with results and improvement focus. Quickly adaptable with strong links to industry and regulatory bodies with country, scientific, commercial and business focuses.
Jacob George
Chief Medical & Scientific Officer , MHRA, United Kingdom
Saira Ghafur
Lead for Digital Health - Institute of Global Health Innovation, Imperial College London, United Kingdom
Ed Middleton
Interim Director of Strategy, Medicines and Healthcare products Regulatory Agency, United Kingdom
Hannie De Munnik, MSc
Executive Director EUCAN Regulatory Affairs, Astrazeneca BV, Netherlands
Dan O'Connor
Executive Director Regulatory, The Association of the British Pharmaceutical Industry (ABPI), United Kingdom
Magda Papadaki
Vice President, Regulatory & Translational innovation, Flagship Pioneering, United States
James Pound
Interim Executive Director, Innovation and Compliance, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
James Pound joined the British Pharmacopoeia in 2008. He has worked in a variety of roles within the BP including responsibility for medicinal chemicals, digital & publications and veterinary medicines. In addition to this he initiated and has led the joint BP and MHRA AQbD feasibility study and working party. He was promoted to Group Manager British Pharmacopoeia & Laboratory Services in 2017. He holds an honours degree in Chemistry and has previously worked in a variety of roles focused on analytical chemistry for both multinational pharmaceutical manufacturers and independent UK analytical laboratories.
Jane Wall
Managing Director, BioIndustry Association (BIA), United Kingdom
Gina Weston
Head of Regulatory Affairs, UK & Ireland, Europe and Regional Liaison, GlaxoSmithKline (GSK), United Kingdom
Sahirzeeshan Ali
Founder and General Partner, Modi Ventures, United States
Sahir Ali is the founder of Modi Ventures, a venture capital firm at the forefront of investing in the convergence of biology and technology. With a focus on scientific superintelligence and the engineering of life, he has backed breakthrough companies advancing AI-driven drug discovery, diagnostics, and next-generation therapeutics. As a parallel entrepreneur, scientist, and innovator, Sahir has led transformative work across artificial intelligence, cloud computing, and precision medicine. Sahir is also the co-host of Membrane, a flagship gathering co-led with Sir Richard Branson that brings together global leaders in science, medicine, and technology.
Silvia Cerolini
Patient Representative, United Kingdom
Jennifer Dixon
CEO, The Health Foundation, United Kingdom
Session Chair Invited
, Switzerland
Cynthia L. Verst, PharmD, MS
President, R&D Solutions D&DI; 2023 President, IQVIA, United States
Dr. Verst is president, Design and Delivery Innovation, Research & Development Solutions at IQVIA. She is responsible for driving innovation and transformation throughout the trial lifecycle. Having previously served as president of both clinical operations and real world and late phase research for IQVIA, Dr. Verst brings a holistic and comprehensive view of clinical research, and champions the advanced use of real-world data, analytics and technology to advance therapies for patients. Recognized by Fierce Biotech as a top woman in biotech, and as a PharmaVoice 100 leader, she currently sits on the Board of Directors for the Association of Clinical Research Organizations and is the Chair of the DIA Board of Directors.
Julia Vitarello
Founder & CEO, Mila's Miracle Foundation, Inc., United States
Jonathan Benger
CEO, National Institute for Health and Care Excellence (NICE), United Kingdom
John F Crowley
President & CEO, Biotechnology Innovation Organization (BIO), United States
Alastair Denniston
Professor - Regulatory Science & Innovation and Hon. Consultant Ophthalmologist, University of Birmingham, United Kingdom
Lord David Willetts
Chair of Regulatory Innovation Office at Office for Life Sciences & President, Resolution Foundation, United Kingdom
Ricardo Baptista Leite
CEO, HealthAI (The Global Agency for Responsible AI in Health), Switzerland
Ricardo Baptista Leite is a medical doctor (ID-trained), a Member of the Portuguese National Parliament, VP of the Social Democratic Party Parliamentary Board, and National Spokesperson for Health of the Social Democratic Party. He is the Founder and President of ‘UNITE-Global Parliamentarians Network to End Infectious Diseases’, a platform of current and former policy makers; VP of the ‘Parliamentary Network on The World Bank & International Monetary Fund’; and Global Ambassador of the ‘G20 Health & Development Partnership’. One of the six people to be awarded globally as a ‘HCV Change Maker’ by ‘The Economist’ in acknowledgement of leadership in the field of hepatitis C, he is the Head of Public Health at Católica University of Portugal.
Sir John Bell
, United Kingdom
Alejandro F Frangi
Bicentenary Turing Chair-Computational Medicine, Manchester University & E.D., UK Centre of Excellence on InSilico Regulatory Science & Innovation (UK CEiRSI), United Kingdom
Melanie Ivarsson, PhD, MBA
CEO, Health Data Research Service (HDRS), United Kingdom
Tippi C. MacKenzie
Benioff UCSF Professor of Children’s Health & Professor of Surgery, University of California San Francisco, United States
James M Wilson, MD, PhD
President and CEO, Founder, GEMMABio (Gemma Biotherapeutics), United States
James M. Wilson, MD, PhD, is a Professor in the Perelman School of Medicine at the University of Pennsylvania where he has led an effort to develop the field of gene therapy. His research career spanning over 40 years has focused on rare diseases and ways to treat them by gene therapy. The Wilson lab identified a new type of vector based on novel isolates of adeno-associated viruses which have become best in class for gene therapy being used by over 29 companies. More recently Dr. Wilson’s laboratory has focused on improved vectors for gene therapy and clinical applications of genome editing and mRNA therapy.
Claire Booth
Professor - Gene Therapy and Consultant Paediatric Immunology, Great Ormond Street Hospital (GOSH) for Children - International & Private Care, United Kingdom
Sir Rory Collins
Professor of Medicine and Epidemiology, University of Oxford, United Kingdom
Michael Von Forstner, PhD, MPH, MSc
Managing Director, Head of Pharmacoepidemiology Practice, Mesa Laubela Consulting, Switzerland
Michael's main focus areas are the planning, development, implementation and evaluation of benefit-risk management solutions, as well as the optimization of processes around signal and benefit-risk management. He is engaged in developing and applying (benefit-) risk analysis and signal management methodologies in order to make RM planning more formally reproducible. Furthermore, he supports the development, implementation and evaluation of effectiveness of additional risk minimization and PV measures in the context of RMPs, as well as post-authorization studies to optimize the benefit-risk profiles of medicines.
Sir Martin Landray, PhD, FRCP
Chief Executive, Protas & Professor of Medicine & Epidemiology, University of Oxford, United Kingdom
Prof Sir Martin Landray is CEO of Protas, a non-profit company that focuses on advancing the design and delivery of highly efficient randomized trials of treatments for major health conditions. He is Professor of Medicine & Epidemiology at Oxford Population Health and has over 20 years’ experience leading large, randomized trials particularly in common cardiometabolic and kidney disease. He co-leads the RECOVERY trial, the world's largest and most successful trial of treatments for COVID-19, estimated to have prevented over 1 million deaths worldwide. He is a global thought leader in clinical trial policy and regulation, and led the Good Clinical Trials Collaborative. In June 2021, he was knighted for services to public health and science.
Nick Meade, MSc
CEO, Genetic Alliance UK, United Kingdom
Dame Kate Bingham
Managing Partner, SV Health Investors, United Kingdom
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