Ania Mitan serves as the Senior Vice President & Managing Director, EMEA and India. She is former Executive Director of the commercial organization at Celgene, where she built the oncology business in the EMEA region with healthcare partners to shape quality delivery systems and new commercialization models in personalized medicine, specifically with novel cell and gene therapies. She began her career at Eli Lilly and Company, serving as Head of Commercial Development for EU mid-size countries, Head of Primary Care Business Unit for the UK and Ireland, and Head of Marketing for the Critical Care Unit. Ania earned her MBA from Simmons College and MSc in Pharmacy from Silesian Medical Academy (Poland).

Paolo leads European public affairs activities at ARM. He is a patient access, healthcare policy and investment professional with more than 20 years of experience in both assessing and supporting access to innovative healthcare technologies. Before joining ARM in 2017, Paolo worked for 5 years at Deerfield Management, a healthcare investment company. Prior to that, he worked at Merck Serono, Kyphon (which became Medtronic) and also spent several years with the Italian HTA Agency Agenas. Paolo’s interests and expertise are centered on cell and gene therapy value assessment, healthcare system modernization and financing healthcare innovation.

Sam is a EU Regulatory Affairs Manager at CSL Behring Innovation located in Marburg Germany. Currently, he is responsible for CSL Behring's gene therapy portfolio within the Region EU. Sam received his molecular biology diploma degree from the Saarland University with a major focus on Genetics/Epigenetics. He also holds a PhD in Biochemistry from the University of Regensburg, in which he focused on the field of gene regulation, and a master’s degree in Drug Regulatory Affairs (M.D.R.A) from the University of Bonn.

As global public affairs director for biomedical innovation, Martin Telko coordinates science policy for Novartis. Martin started at Novartis as a development lab head in 2009 and has since held various positions in development and technical operations at Novartis and Sandoz. Prior to Novartis, Martin worked at Merck Research Labs in the US. Martin has a chemical engineering degree from the Ohio State University, a Master’s degree in Engineering Management from Duke University, and a PhD in Pharmaceutical Sciences from the University of North Carolina.

Sara is currently Senior Manager, Scientific Programmes at DIA. In the EMEA region, she is responsible for engaging with external stakeholders and advancing the scientific content strategy by creating opportunities to integrate scientific and regulatory changes of interest in DIA initiatives. Additionally, she is responsible for the regional patient engagement and learning design initiatives, being the liason for the Middle East and SEE regions. Previously, she was Public Health Promotion Projects Manager at the Portuguese Pharmaceutical Society. Sara is a Master of Pharmacy since 2015 and a Soft skills Trainer since 2012, having delivered over 300h of Training internationally primarily focused on creating impactful interactions.

Dr. Keith Wonnacott has 20 years of regulatory experience in the field of cell and gene therapies. He joined Pfizer as an Executive Director of Regulatory Affairs in their Rare Diseases Unit in 2017. At Pfizer, Dr. Wonnacott has a combined role working on regulatory strategy and regulatory policy for gene therapy products. He is active in many professional societies and trade associations and is a recognized expert on regulatory issues related to cell and gene therapies. Dr. Wonnacott made the move to Pfizer after spending the previous 3 years with Novartis Pharmaceuticals as the US regCMC lead for Kymriah. Prior to Novartis, He spent 13 years at FDA, most of which were as the Branch Chief of the Cellular Therapies Branch in CBER.

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.

Constance (“Stanny”) Berghs-Clairmont, PhD, is Global Head of Early Development Regulatory Affairs at Novartis. She has been in the pharmaceutical industry for approximately 20 years, of which about 15 years in Regulatory Affairs. Stanny is located in Cambridge, Massachusetts, USA.

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).

Dr Jordi Llinares is currently the Head of Research and Innovation at the European Medicines Agency (EMA). At the Agency he has had different posiitons including Head of Orphan Medicines, Scientific Support Development and, and Scientific and regualtory management between 2009 and 2020. Dr Llinares graduated as a Medical Doctor from the University of Barcelona and specialised (MIR) as clinical pharmacologist at Hospital Vall d’Hebron. He has a Masters in Science in Epidemiology from the London School of Hygiene and Tropical Medicine (London). Before joining the Agency he worked as clinical pharmacologist at Hospital de Sant Pau (Barcelona) and was member of the Ethics Committee of the IAS (Institut d’Assistencia Sanitaria).

Núria Semis-Costa is a biochemist (Universitat Autònoma de Barcelona) with a MSc in Pharmacovigilance (Universitat de Barcelona). After working in the industry in the field of blood products, she joined the EMA as a Risk Management Specialist in 2015, where she works in the areas of rheumatology, immunology and advanced therapies. Núria is also involved in initiatives related to risk management of biosimilars and medicines in pregnancy, the maintenance of the RMP template and the update of GVP XVI.

Aron F Stein, PhD is currently the Vice President, Global Regulatory Affairs at Sangamo Therapeutic where he provides the vision, strategic direction and corporate regulatory approach for all gene and cell therapeutics. He has over 30 years of product development experience in pharmaceutical and biotechnology having responsibility for multiple drug approvals in both large and small companies. Aron earned his B.S. and PhD at Texas A&M University in toxicology and was a NIEHS postdoctoral fellow at University of Kansas Medical Center.

As Associate Director of Regulatory Policy and Intelligence at BMS, Jacquelyn is responsible for evaluating trends in the regulatory environment and working with stakeholders to advocate for policies supporting development of innovative medicines. She has been managing projects, leading initiatives, and designing processes to assess the impact of regulatory change on strategy, operations, and compliance in the pharmaceutical industry for 13+ years. Her current focus is on regulatory policies impacting ATMPs and supporting project teams in the Hematology & Oncology disease areas. Jacquelyn holds a degree in Cell Biology & Biochemistry from Bucknell University and a MSc from the London School of Economics and Political Science.

2000-2008: Research Assistant, Institute of Experimental Medicine ASCR, Department of Teratology, Czech Republic; 2008-2017: Clinical Trial Assessor, State Institute for Drug Control, Czech Republic; 2009-2017: Lecturer, 3rd Medical Faculty, Dpt. of Embryology and Teratology, Charles University, Prague, Czech Republic; 2017-present: Director of the Marketing Authorisation Section, State Institute for Drug Control, Czech Republic; Expertise in Regulatory Science, Histology and Embryology, Advanced Therapy Medicinal Products, Nanomedicines, Clinical Trials and GMO; Czech Alternate member of the Committee for Advanced Therapies (CAT) EMA; Czech representative of the EU Innovation Network; External member of the Czech Committee for GMO.

Dr. Sean Burns is Vice President of the Disease Biology and Pharmacology team at Intellia Therapeutics, a leading genome editing company based in Cambridge, MA. In addition, Sean is a practicing endocrinologist affiliated with Massachusetts General Hospital (MGH) and Nantucket Cottage Hospital. At Intellia, he leads the company’s efforts to identify novel in vivo applications of CRISPR to treat genetic disease. Sean previously served at Intellia as medical director, and as director of Hematology and New Therapeutic Areas. Before Intellia, Sean was a physician-scientist at MGH and the Broad Institute of Harvard and MIT. Sean received his B.S. from Cornell University and his M.D. with Honors from the New York University School of Medicine.

Nick is a Policy Advisor for Regulatory Strategy at EFPIA. Nick’s current focus is on the revision of the general pharmaceutcal legislation, regulatory aspects of the Innovative Health Initiative (IHI), and the interface between the drug, device and diagnostics legislative frameworks in the EU. Prior to working at EFPIA, Nick spent 25 years at Pfizer within their Global Regulatory Sciences team. His last role in Pfizer was as Head of Europe and International Regulatory Policy. In this role he was also Co-Chair of EFPIA's Regulatory Strategy Committee. During 2019 Nick was President of TOPRA and Chairman of TOPRA's Board of Directors. Nick has a graduate degree in Genetics/Microbiology and a master’s degree in Information Science

Dr Winburn has a medical background in Surgery with a special interest in Renal Transplantation. Previously, Dr Winburn practised clinically in both the UK and New Zealand and completed a PhD at the University of Otago that centered on novel drug discovery in the context of renal ischaemia reperfusion injury. In 2010, he started work for Pfizer in medical affairs within the field of Inflammation. Afterwards, Dr Winburn became the European Medical Team Lead for Haemophilia and Transplantation, and subsequently the Western European medical lead for Pfizer’s rare disease portfolio. Ian also has worked in Japan, leading the Japanese Rare disease medical team.

Miriam Fuchs is a Global Therapeutic Area Lead in Regulatory Affairs at Novartis. Passionate about bringing innovation to patients, over the past years she has focused on CAR-T therapies, including the development registration of Kymriah. Miriam has worked in Project Management and Regulatory Affairs at Novartis as well as other Pharma/Biotech companies for 20 years. She holds a PhD in Biology from the Max-Planck Institute and engaged in cancer research as a post-doctoral fellow at the Dana-Farber Cancer Institute, Harvard Medical School, Boston, USA prior to joining industry.

Yanni Hao is an Executive Director RWE and Data Science with Novartis, leading real world evidence activities worldwide for the Cell & Gene Business Unit.

Christian is a seasoned Market Access professional with over 20 years of experience in the International Biotech and Pharmaceutical industry. He has been involved in over 50 HTAs across Europe and has built up a strong network of key influencers including EU and national agencies. Prior to co-founding MAP in 2012, he led market access teams and submissions at InterMune, Gilead, Pfizer and Genzyme on a very broad range of products and disease areas from chronic disease to ultra-orphan indications. Christian is a member of the Board of EUCOPE (European Confederation of Pharmaceutical Entrepreneurs); he is also a member of the Steering Group of EMIG (Ethical Medicines Industry Group) in the UK and Ireland.

Global Director for Public, Private Partnerships at Novo Nordisk, Global Medical Affaris. Former Director of Data Analytics Centre at the Danish Medicines Agency and co-chair of HMA / EMA Big Data Steering Group. 20 years for life science experience in academia and industry. Been leading EU framework programme workpackages, IMI and TransCelerate Biopharma workstreams in the past. Currently active in development of FHIR for clinical research and use of AI/ML in life science.

Stuart has over 20 years’ experience in the field of gene and cell therapy. Following a post-doc and fellowship with Dr. Terry Flotte at the University of Florida and UMass Medical School, as the field of gene therapy has developed, Stuart has taken positions within industry, moving from research to clinical development of AAV-based programmes for metabolic, ophthalmological, and neurodegenerative disorders. Stuart is a Regulatory CMC Gene Therapy Clinical Lead for early phase programmes at Biogen. Biogen is a member of both EFPIA and ARM, the industry associations leading the advocacy towards ATMP exemption from EU GMO regulation.

Regulatory professional and leader with many years of pharmaceutical industry experience in drug development & regulatory affairs with increasing level of responsibility. Led change processes in various teams successfully by engaging the relevant stakeholders in the decision-making process. Collaborated and influenced product development teams’ development strategy in various therapeutic areas including virology, oncology, CNS, metabolism, rare diseases. Negotiated successfully with health authorities during scientific advices, paediatric investigation plans and approval processes e.g. new products labels and during issue management.

Bettina Ziegele is Liaison Officer and responsible for stakeholder cooperation and international affairs at the Paul-Ehrlich-Institut (PEI) - the German competent authority for vaccines and biomedicines. After establishing and heading the Innovation Office at the PEI she worked as an expert at the Federal Ministry of Health supporting the "pharma dialogue" to strengthen pharmaceutical development and in the section for biotechnolgical innovations. She then roounded off her knowledge at the Federal Joint Committee (G-BA) on HTA and the requirements of the benefit assessment of medicinal products. Bettina Ziegele is a member of the EU Innovation Network at EMA and Chair of the Drafting Group of the “Simultaneous National Scientifc Advice”.