Steffen Thirstrup is a medical doctor and board certified specialist in clinical pharmacology and therapeutics. He holds a PhD in pharmacology and has a long background in clinical internal medicine. He is an adjunct professor at the Faculty of Health Sciences, University of Copenhagen. From 2004-9 ST worked at the Danish Medicines Agency acting as member of CHMP and additionally CAT at the European Medicines Agency. Following a short period involved in developing best practice guidelines for primary care ST rejoined the DKMA as Head of the Licensing. From 2013-22, Prof Thirstrup worked asdirector and strategic consultant for NDA Group AB. From June 2022 Prof Thistrup is the Chief Medical Officer of the European Medicines Agency.

Since October 2015, Julie has been coordinating of the Biosimilar Medicines Group, a sector group of Medicines for Europe. Before that, Julie was part of Medicines for Europe’s regulatory and scientific affairs team for 8 years, with responsibilities in the areas of Quality, Compliance, Environment, Health & Safety as well as Bioequivalence. MSc in Pharmacology by background, she previously worked for the pharmaceutical industry. Her work consists in the coordination of Biosimilar policy related activities and external liaison with policy makers, EU institutions, Medicines Agencies, International organisations, industry and professional associations as well as a broad range of stakeholders.

Aimad Torqui has been the Division Head at the Medicines Evaluation Board since September 2022. His role encompasses overseeing (national)policy and European affairs, regulatory science, representation in EU committees, promoting the better use of medicines and veterinary medicines.

Professor Arnold Vulto was trained as a pharmacist and pharmacologist and did a PhD at the Rudolf Magnus Institute for Neuroscience at Utrecht University (The Netherlands). He is currently responsible for teaching pharmacology & therapeutics for medical students at Erasmus University Rotterdam. He is head of the Unit Teaching, Research & Education, including clinical trial management of the ErasmusMC Hopsital Pharmacy. He is supervising 6 residents in hospital pharmacy.

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 efforts ex-US for innovation that leads to better treatment for patients globally. Since 2020 this scope has expanded, as Ginny now leads the talented and experienced Global Regulatory Policy and Intelligence team for MSD. 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 on BREXIT, COVID-19 and now the R&D impacts of the Inflation Reduction Act.

Ms Cooke is Executive Director of the EMA and Chair of ICMRA. Starting her mandate as ED in June 2020 amid a public health crisis of unprecedented scale she announced “My number one priority will be to drive forward EMA’s response to the pandemic and the work already ongoing to support the development and approval of safe and effective COVID-19 vaccines and treatments.” Doing precisely that has since earned her various accolades including an Honorary Doctorate for outstanding contribution to healthcare (RCSI - 2023) and the ‘European of the Year 2022’ title by European Movement Ireland. Ms Cooke obtained a degree in pharmacy and master’s degrees in both Science and Business Administration from Trinity College in Dublin, Ireland.

Sam Khalil is the worldwide head of Medical Affairs at Novartis (Basel, Switzerland) for the Immunology, Hepatology and Dermatology franchise. He has more than 12 years of professional experience in drug discovery, development and marketing of Biological Therapeutics. Sam Khalil holds a PhD in Immunology and a post-doc in inflammation, focused on antigen presentation, immunogenicity and development of monoclonal antibodies. He has authored 16 publications and over 40 scientific posters at conferences.

Per Troein has been with IMS for 18 years and is responsible for supplier and associations relationships. One of IMS’ priorities is to have the best understanding of those dynamics to secure the most appropriate data, to be the best partner with the different data partners, and to be able to support the industry and also when appropriate governments. He is a well known speaker in the field of distribution trends and pricing and is very active in consulting projects in the area. Prior to joining IMS, Per worked 13 years for Pharmacia. His last 6 years were spent in strategic development as a VP including several major mergers and acquisitions.He holds an MSc in engineering from Lund’s Institute of Technology and an MBA from INSEAD.

Dorthe Bartels is a strategic advisor in pharmaceuticals for Amgros (Amgros national procurement organization for Denmark). Dorthe is also a negotiator for new medicines and responsible for the national biosimilar task force, who supports the regions and medicine councils in handlings and implementations of biosimilars in Denmark. Dorthe has a MSc in Pharmacy and MSc in business and has extensive experience in the pharmaceutical industry and has been the head of procurement, tendering and logistics in Amgros for last 9 years.

Previously served as Senior Vice President and Managing Director for DIA Europe, Middle East, and Africa (EMEA) in addition to corporate international public affairs and as consultant for Amgen, Merck KGaA, and Biogen, working across market access, government affairs, public affairs, health policy, corporate communications, and patient advocacy to bring medicines to patients. Mr. Bols has held board positions for Europabio, the European Confederation of Pharmaceutical Entrepreneurs, and other associations, and chaired various regulatory and access working groups within the European Federation of Pharmaceutical Industries and Associations. Mr. Bols earned his post-graduate degree in European Law from the University of Amsterdam.

Paul CHAMBERLAIN is a biopharmaceutical product specialist who specializes in presenting immunogenicity risk assessments to European and North American regulatory agencies. He works with Sponsors to develop strategies for evaluating the probability that a product might induce an undesirable immune response, as well as preparing expert reports on signal interpretation to support regulatory submissions. He is a Member of the NDA Advisory Board (www.ndareg.com).

Dr. Leah Christl is Executive Director, Global Biosimilars Regulatory Affairs and Regulatory and R&D Policy at Amgen. She serves as head of the global regulatory affairs team within GRAAS with responsibility for development and execution of global regulatory strategy for Amgen’s biosimilars portfolio. Dr. Christl also leads the global biosimilars regulatory and R&D policy with responsibility to develop and advance Amgen’s policy positions. Prior to joining Amgen, Dr. Christl served as the Director of the Therapeutic Biologics and Biosimilars Staff at the US FDA. Dr. Christl received her PhD in Molecular and Cellular Biology and Pathobiology – Marine Biomedicine and Environmental Science from the Medical University of South Carolina.

FRSA. Chair: Access Matters, Midstream. Board Member: European Forum for Good Clinical Practice (EFGCP), International Foundation for Integrated Care (IFIC), Health Quality Improvement Forum (HQIP). Having had Rheumatoid Arthritis for nearly 60 years from the age of three, I have a wealth of experience as a user of health services. Since 1990 I have voluntarily represented people with disabilities & chronic conditions locally, nationally & internationally. “The people have the right & duty to participate individually & collectively in the planning & implementation of their healthcare” Alma Ata Declaration – Principle IV, 1978 World Health Organisation

MD PhD Kristin Kaasen Jørgensen is a senior consultant in Gastroenterology at Akershus University Hospital. She is engaged in research within the field of Hepatology and Inflammatory Bowel Diseases, served as the clinical coordinator for the Gastroenterology part of the NOR-SWITCH study and was one of the first authors in the publication of the study in the Lancet.

MBA, PhD/MD in Respiratory Medicine, author of >70 publications. He had many senior positions at Acambis, GlaxoSmithKline and Takeda in clinical development of novel anti-inflammatory agents, influenza vaccines and vedolizumab GEMINI global development programme. He was Medical Assessor in Biological Licensing Division at UK MHRA, and also Head of Global Development for Celltrion leading development efforts and regulatory approvals for biosimilar infliximab rituximab and trastuzumab. Since 2016 Dr Kudrin works as an independent biopharmaceutical consultant supporting industry in clinical development and regulatory strategies for biosimilar and novel products. Interests: in biosimilars, oncology, immunology, vaccines, emerging markets.

Thomas Lang is biostatistician by training. He spent eight years in academic research, followed by three years in clinical research in the pharmaceutical industry. He currently works as senior statistical assessor for the Austrian Agency for Health and Food Safety. For more than nine years he was a member of the Scientific Advice Working Party at EMA. In his current role of a member of the Biostatistics Working Party, Thomas acted as rapporteur for the EMA Reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development.

Christian Maasch is a Managing Consultant and certified project manager for Product Development and Regulatory Affairs at Xendo, a ProPharma Group. He has more than 15 years of professional experience in drug discovery and development of biologics and chemical entities. Having a broad analytical expertise, Christian Maasch is an acknowledged expert for regulatory compliant analytical methods from drug discovery and companion diagnostics to clinical testing. He is a frequently invited speaker on the challenges/new approaches in R&D and QC, authored 28 publications and book chapters and (co)invented of more than 10 filed lead compounds.

Inger has more than 25 years’ experience in Drug Development and more than 15 years Regulatory Affairs experience with global regulatory responsibility for a number of drug development projects. Inger is experienced in developing and leading regulatory strategy and implementation toward the NDA approval and life-cycle management and has in that capacity overseen a number of license application and approval projects with multiple agency interactions in several regions of the world including USA (incl. Advisory Committee preparations), EU, Japan, China, Canada, India, Latin America and Southeast Asia. Experience also includes the project leadership responsibility for conducting a CVOT interim analysis to support regulatory decisions.

Prof. Dr. Florian Turk is Global Head Commercial and member of the Executive Committee at Sandoz Biopharmaceuticals. He is Vice-Chair of the Market Access Committee–Biosimilar Medicines Group and Chair of the HTA Working Group, Medicine for Europe. He has more than 15 years of global pharmaceutical and generics industry experience. Florian held several roles responsible for business-to-business commercialization, market access, pricing, public affairs and health economics in Novartis Pharmaceuticals and GlaxoSmithKline. Florian also holds responsibilities as Honorary Professor at the Department for Management, University of Paderborn. Florian holds a MSc in Economics and a Doctorate in BA from the University of Trier in Germany.

Nurse practitioner at the Rheumatology outpatient clinic of Maasstad Hospital Rotterdam. Registered Prescribing Nurse , Master of Science in Nursing, Master Advanced Nursing Practice. Special interest in Patient participation and Patient Centred Care and Self-management. Wrote in 2004 1st guideline for rheumatology nurses in the Netherlands about how to advice, instruct and inform patients when a biological is prescribed. Nurse member of the CBG-MEB Practice Committee, where problems signed in practice are discussed with the MEB. The committee acts as a “voice from practice” for discussing problems with medicines in practice.

Dr. Hillel P. Cohen PhD is Executive Director of Scientific Affairs at Sandoz, helping explain the principles of biosimilars and biosimilar policies to the healthcare community, patient advocacy groups, and health authorities. He has published and given presentations in the areas of biosimilar education, switching, interchangeability, naming and safety. Dr. Cohen led Sandoz efforts for the first biosimilar presentation (Zarxio®) to an FDA advisory committee and participated in both BsUFA 2 and BsUFA3 negotiations on behalf of industry. Hillel is active on the Education Committees including the Biosimilars Council and the Biosimilars Forum. Dr. Cohen received a BA from New York University and a PhD in Biology from Dartmouth.

Mareike has extensive experience in the pharmaceutical industry. In over 17 years with Novartis, Mareike held different roles with increasing responsibility within the company as well as with external industry- and non-industry partners. Roles included Technical Marketing, Global Project Management R&D, Alliance Management R&D as well as Public Private Partnership and Stakeholder Management for Middle East and Africa. In her current role, she focusses on policy issues related to R&D across the Novartis Divisions, with specific focus on Biotherapeutics including Biosimilars, Cell and Gene Therapies, Orphan Diseases, IP and R&D incentives. Mareike holds a degree in Veterinary Medicine and a PhD in cellular immunology.

10+ years of Leadership and Management expertise at senior or very senior level in three separate Regulatory Authorities (MHRA – Medicines and Healthcare products Regulatory Agency, UK; Danish Medicines Agency, Denmark; PEI – Paul-Ehrlich-Institut, Germany). Memberships in Committees/Working Parties at the European Medicines Agency (EMA)

Dr Rana is an experienced pharmacist with more than 15 years of experience in Regulatory affairs, holding a master degree in pharmaceutical quality assurance. She joined JFDA in 2008 and held various positions, including head of new drugs registration section, head of biological and vaccine registration section. She was the Project lead for the installation of the eCTD system at JFDA and collaborated in the preparation and review of the “Guidance for Registration of Biosimilars in Jordan” from May 2015. Currently, Dr Rana is the head of Clinical Studies Department at JFDA, a member of the Clinical studies and of the national stem cells committee and the MOH clinical trials and access to innovation committee.

Gareth Powell is a BD Officer for the NIHR Clinical Research Network (CRN). Gareth facilitates key discussions between industry and the CRN and is a point of contact for the life sciences companies engaging with the CRN. Gareth is able to provide advice to companies on how they are able to tap into the CRN study support services to ensure clinical studies are set up efficiently and recruit to time and target. He previously worked within the Business Intelligence Team and the Research Delivery Directorate of the CRN. He was responsible for supporting interactions between the life sciences industry and NIHR National Specialty Groups across 7 therapeutic areas, providing operational support through feasibility, set up and patient recruitment.

Kirstine Moll Harboe is an MD, PhD and clinical pharmacologist with both clinical and regulatory experience. She is also part-time lecturer at the University of Copenhagen, Faculty of Health. She is currently working as a senior medical officer in the Danish Medicines Agency (DKMA) and has been involved in numerous scientific advices and discussions concerning biosimilar medicinal products. At the EMA, she is a member of the Pediatric Committee (PDCO) and Scientific Advice Working Party (SAWP) and engaged in the Biosimilar Medicinal Products Working Party (BMWP) as an additional assessor.

Graduated in Biochemical Pharmacy by the Federal University of Ouro Preto, Minas Gerais in 2002; Specialist in Health Law, by the Oswaldo Cruz Foundation, Brasília in 2013 and MBA in Project Management, by AngloAmericano College, Brasília in 2008. Specialist in Regulation and Health Surveillance at the Office of Evaluation of Biological Products of ANVISA and master's student in Pharmacology by the Federal University of Ceará, since 2017. Previous experience as Pharmaceutical and Technical Analyst of Social Policies; having worked with planning and management at the Audit Department and at the Department of Logistics in Public Health, at the Ministry of Health.