Alexander Natz is the Secretary General of the European Confederation of Pharmaceutical Entrepreneurs in Brussels and advises innovative pharmaceutical and biotech companies, including start-ups, in regulatory and pricing & reimbursement matters from the EU law and German law perspective. From 2008 to 2013, he was Head of the Brussels Office of Bundesverband der Pharmazeutischen Industrie e.V. Before, he has been a lawyer at Sträter Law Firm in Germany with a special focus on managed entry agreements & licensing of pharmaceuticals. He has also worked in the field of competition law with the EC & in the pharma industry. His doctorate was supervised by the former judge at the European Court of Justice, Prof. Dr. Dr. Ulrich Everling.

Maren von Fritschen is a recognized leader in Regulatory Affairs with 20+ years in Pharma and MedTech. With a PhD in Natural Sciences, she's now Head of Regulatory Policy Europe at Moderna, driving regulatory strategies for innovative technologies like mRNA. Maren built the regulatory arm at EUCOPE and was a foundational force behind PharmaLex, later founding AddOn Pharma as CEO. She's chaired DIA's Regional Advisory Council EMEA, contributed to TOPRA, and the STARS project. In the academic realm she is lecturing and mentoring master students at the University of Applied Sciences. Additionally, she has established a comprehensive scientific network across leading Universities in Brazil, focusing on medication in primary health care.

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.

Zina is an associate in the Life Sciences team at Sidley Austin. With an academic and research background in molecular biology, Zina has a deep understanding of and keen interest in developments in biotech and advanced therapies, often advising clients in this space on all aspects of lifecycle management – from the laboratory bench to market. She is currently involved in a number of matters on market access and digital health.

Anne brings 25 years of experience of tackling R&D, clinical & regulatory challenges to Orchard Therapeutics, a biopharma company developing ex vivo autologous gene therapy to address severe & life-threatening inherited disorders. Before joining ORTX, Anne was Executive VP at VCLS, where she was involved in the design & preparation of a high number of successful regulatory submissions at all stages of product dvt with FDA, EMA & local agencies. She assisted over 50 cell, tissue & gene therapies dvt programs. Bringing expertise in Advanced Therapies, Anne began her career as R&D Project Manager at Medtronic Sofamor-Danek after her PhD on biomaterials & artificial organs.

1980 – 1986: University Mainz, Biological Faculty; 1987 - 1991: Diploma and Doctoral Thesis at the Max Planck Institute for Brain Research, Frankfurt; 1992 – 1993: Postdoctoral Fellow at the Max Delbrück Centre for Molecular Medicine, Berlin; 1993 - 1996: Postdoctoral Fellow at the Paul Ehrlich Institute, Langen; 1996- 2006: Paul Ehrlich Institute, Langen: Section Viral vaccines; Since 2007: Paul Ehrlich Institute, Langen as Head of Section Advanced Therapy Medicinal Products, Tissue Preparations

Leo joined bluebird bio, a clinical-stage company committed to developing potentially transformative gene therapies for severe genetic diseases and T cell-based immunotherapies, in 2018 as the Head of Access, Value and Evidence Strategy in Europe. He is responsible for leading bluebird’s European preparation for successful access and reimbursement. He has been working in the market access field for over 15 years holding positions at Almirall, Novartis and Biogen.

Dr Hidalgo-Simon is currently head of Advanced Therapies in the European Medicines Agency (EMA). Previous positions include the head of the Specialised Scientific Disciplines Department, head of Signal Detection, and head of Risk Management, also at EMA. She has a degree in Medicine and Surgery from the University of the Basque Country, Spain, and a PhD from the University of London, UK. Additional qualifications include Health Economics (University of York) and Computing (University of Westminster).

Helen Knight is responsible for the Technology Appraisal & Highly Specialised Technologies programmes. With an academic background in biochemistry & health economics, she spent 6 years working as a health economist for a health outcomes consultancy before joining NICE in the Technology Appraisal Programme in 2007. She has gained extensive experience of health technology assessment over a wide range of disease areas. As Programme Director, she is now responsible for all aspects of the management and delivery of the Appraisal and Highly Specialised Technologies work programmes within the Centre for Health Technology Evaluation. Her role involves directing the work of the team that produces guidance for the NHS in England and Wales.

Marie Manley leads is Partner and Head of Sidley’s UK life sciences practice. She is a distinguished thought leader and adviser on EU and UK regulatory law and acts as Chairperson of the DIA Legal Affairs Community. Marie advises clients before both national and European courts and the regulatory agencies in the UK and across Europe. She represents leading pharmaceutical and life sciences companies in litigation before the EU and English Courts, as well as before the national and EU regulatory authorities. Marie features prominently in leading bar publications. She earned a LLM from Columbia University School of Law and from Lausanne University; and a Postgraduate Diploma on EU Competition Law from King’s College.

After working as a senior statistician in Pharma and UK medicines regulation, Karen Facey became the founding Chief Executive of the first national health technology assessment (HTA) agency in Scotland. For the past 15 years, Karen has been an independent consultant on health policy, HTA and patient involvement. She has a part-time role as Principal Investigator at the University of Edinburgh, leading a work package on appraisal of rare disease treatments in the EC H2020 funded IMPACT HTA project. Karen has facilitated the development of the multi-stakeholder initiative, RWE4ACCESS, under the leadership of the Belgian Payer, INAMI/RIZIV.

Dr Gabaldo has more than 20 years of experience in drug development spanning from chemicals up to ATMP. Currently Vice President ATMP Global Regulatory Affairs at EVOTEC. Master degree in Pharmaceutical Chemistry and Technology and Master degree in Regulatory Affairs & Market Access for Chemicals and Biopharmaceuticas. Winner of 2017 edition of TopRA Award in the Future category, Michela offers up to date knowledge of the most recent regulations in ATMPs and Orphans. Currently member of the IRDIRC Regulatory Scientific Committee.