EUHA Symposium

CEO, Vita-Salute San Raffaele University,  

Research Director, San Raffaele Hospital  

President, EUHA 

Anna Flavia d’Amelio Einaudi is CEO of Vita-Salute San Raffaele University, Research Director of the San Raffaele Research Hospital, General Manager of Centro San Raffaele Foundation and General Secretary of Gruppo San Donato Foundation. 

Graduated in Economics and Commerce, she began her career by dealing first with auditing and subsequently with consulting in Corporate Finance. 

In 2012 she obtained a Master in Health Management at the SDA Bocconi in Milan and collaborated with the Research Center on Health and Social Care Management (CeRGAS) of Bocconi University. 

During 2012 she also joined the San Raffaele Research Hospital, supporting the CEO in the restructuring and reorganization of the hospital following its acquisition by the San Donato Group. 

From 2015 to 2019 she held the position of Operations Director of the Research Area of the San Raffaele Research Hospital. 

Since 2015 she has combined management activities with teaching activities at the Vita-Salute San Raffaele University where she teaches "Research Organization" and "Health Management" courses. 

Secretary General, European University Hospital Alliance (EUHA) 

Professor Johan Van Eldere M.D., Ph.D., MHM, FESCMID, is emeritus professor of microbiology at the Catholic University of Leuven and the University of Hasselt. He is currently acting secretary-general of EUHA (European University Hospital Alliance).  

Johan Van Eldere did his medical studies and PhD research at the KULeuven and afterwards was a research fellow at Oxford University. After his return to Leuven, he specialised in medical microbiology and hospital management. He was head of the department of Laboratory Medicine and the department of Pathology at the University Hospital Leuven. In 2014 he became medical director and member of the governing board of the University Hospital Leuven. In 2018 he became steering committee member for EUHA. From October 2023 onwards, he is acting secretary-general of EUHA and president of the scientific advisory board of the Vall d’Hebron institute of Research in Barcelona. He was and is chairman of national and international organisations in microbiology, reviewer for international journals and author of over 150 scientific papers.

Paul-Ehrlich Institute, German Federal Institute for Vaccines and Biomedicines, 

Former Chair of the Committee for Advanced Therapies (CAT) of the European Medicines Agency’s (EMA) 

Martina Schuessler-Lenz M.D. graduated from medical school at Mainz University Hospital, Germany.  

She worked as clinician-scientist in Berlin, New York and Barcelona and completed her fellowship  

in Internal Medicine. In 1992 she joined the pharmaceutical industry and was responsible for several clinical drug development projects of anticancer agents. Since 2005 she is working as M.D.  

at the Paul-Ehrlich Institute in the Department Haematology, Cell and Gene Therapy, where she reviews Advanced Therapies in clinical trials and marketing authorizations, and provides advice to ATMP development and life cycle management. She has served as the elected Chair of the Committee  
for Advanced Therapies (CAT) of the European Medicines Agency's (EMA) since her appointment  
by the Paul-Ehrlich-Institut in February 2017. In accordance with the requirements of the European Commission, her mandate ended in February 2023 after two terms. 

Head of Unit, Italian Medicines Agency (AIFA)

Dr. Odoardo M. Olimpieri (MD) is a haematologist by training, with a particular interest in the treatment of non-Hodgkin lymphomas and multiple myeloma.  

In 2014, Dr. Olimpieri joined the Italian Medicines Agency (AIFA) as senior clinical assessor, contributing to the regulatory and HTA evaluations of haematological chemical/biological products and ATMPs.  

From 2014 to 2019, Dr. Olimpieri served as an alternate member of the Scientific Advice Working Party (SAWP) at the European Medicines Agency (EMA).  

Since 2022, he has been an active member of the EMA Oncology Working Party (ONCWP). 

Policy Officer, European Commission  

Directorate General for Health and Food Safety (DG SANTE), Unit D2 - Medical Products: Quality, Safety, and Innovation 

Paschalia Koufokotsiou is a Policy Officer at the European Commission in DG SANTE, where she specializes in regulatory frameworks for Advanced Therapy Medicinal Products (ATMPs). Her responsibilities include contributing to the revision of EU pharmaceutical legislation under the European Pharma Strategy and actively participating in Council Working Party negotiations. She oversees key studies and initiatives, such as the Hospital Exemption Study for ATMPs under the EU4Health program, GMO assessments for clinical trials and market authorizations, and harmonizing ATMPs within the SOHO (Substances of Human Origin) framework. Additionally, Paschalia serves as the EC representative in the Committee for Advanced Therapies (CAT), ensuring regulatory compliance for ATMPs across the EU. Her portfolio also covers environmental policy for pharmaceuticals, focusing on enhancing environmental risk assessments and addressing antimicrobial resistance as part of the revised pharmaceutical legislation.  

Paschalia previously held positions in DG Agriculture and DG Employment, Social Affairs, and Inclusion. She holds an MSc in Veterinary Epidemiology and Public Health from the Royal Veterinary College, University of London, and a Doctor of Veterinary Medicine degree  from the Aristotle University of Thessalonik. 

Vice President Atmp global regulatory affairs, EVOTEC 

Michela Gabaldo is Vice President ATMP Global Regulatory Affairs at EVOTEC International where she is responsible to support the teams working on new innovative allogeneic/autologous cells and gene therapies programs to enter the clinical validation. 

Michela brings more than 20 years' experience in drug development having worked for almost 10 years for GlaxoSmithKline (GSK) in Clinical Operations and CMC Regulatory Affairs areas for New Chemical Entities (NCE), before joining in 2011 Fondazione Telethon and San Raffaele Hospital (SR-TIGET) to help them in advancing the most important strategic partnerships with pharmaceutical industries. These programs were developed both internally and in partnership with relevant pharmaceutical industries or through start-ups. In her role she’s been actively involved in the development and patient access of the 1st ex-vivo gene therapy registered worldwide, Strimvelis in 2016 and Libmeldy in 2020.  

After graduation in Pharmaceutical Chemistry and Technology at the Padua University, she granted a Master Degree in "Regulatory Affairs and Market Access for new chemicals and Biopharmaceuticals" from the UPO University.  

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. She has been actively contributing to many international initiatives aimed as shaping the regulatory environment for ATMP in EU and she was proposing many initiatives through leading trade organisations to support timely cross-border patient access for ATMP targeting ultra-rare life-threatening conditions.  

She’s currently a member of the IRDIRC (International Rare Disease Reasearch Consortium) Regulatory Scientific Committee and of the ISSCR (International Society for Stem Cell Research) Regulatory Working Group. 

Head of Research and Development, Fondazione Telethon 

Celeste Scotti is Physician Scientist and R&D Leader with almost 20 years of experience at the interface between medicine, research, and drug development in a broad range of therapeutic areas (musculoskeletal, rheumatology, immunology, liver, rare disease, neuroscience).  

After working for 8 years in Industry in Translational Medicine and Clinical Development, he currently serves as Head of Research and Development at Fondazione Telethon, where he oversees the funding activities of the foundation and the development of the internal gene therapy pipeline at the Telethon Institutes (Tigem and Tiget). 

He holds an MD by the Vita-Salute University, a Board Certification in Orthopaedic Surgery by the University of Milan, and a PhD in Bioengineering by the University of Basel. 

Head of Division, Centro Investigaciones Energéticas, Medioambientales y Tecnológicas (CIEMAT)  

Former President of the European Society of Gene & Cell Therapy (ESGCT) 

Professor Juan Bueren is the Director of the Biomedical Innovation Unit from the CIEMAT and the Biomedical Research Centre on Rare Diseases, CIBERER, and coordinates the Advanced Therapies Unit  

from Fundación Jiménez Díaz/CIEMAT. Prof. Bueren has been the President of the European Society  

for Gene and Cell Therapy until October 25th 2024, and is a Consultant of Rocket Pharmaceuticals Inc.  

Professor, Vita-Salute San Raffaele University,  

Deputy director clinical research SR-Tiget San Raffaele Hospital  

Co-coordinator Join4ATMP project 

Professor Alessandro Aiuti M.D., Ph.D., Haematologist, is Deputy Director Clinical Research, and Head of Unit on Pathogenesis and Therapy of PID of the San Raffaele Telethon Institute for Gene Therapy (SR-Tiget) in Milan; full Professor of Pediatrics and Director of the Residency Program of Pediatrics, Vita-Salute San Raffaele University in Milan, Italy; Director of the Pediatric Immunohematology Unit, San Raffaele Hospital, Milan. He is author of more than 300 peer reviewed publications (total citations of 23595, h-index Scopus 71). His main research interests are in the field of pediatric hematology and immunology, particularly pathogenesis and treatment of primary immunodeficiency. He has pioneered the EU market approval of the first ex vivo gene therapy for a genetic disease and led successful clinical application of gene therapy with hematopoietic stem/progenitor cell engineered for the treatment of inherited diseases of the immune system, inborn errors of metabolism and other blood disorders. He has received in 2020 the Else Kroener Fresenius Prize for Medical Research 2020 for groundbreaking successes in the development of gene therapies. He has been a member of CAT EMA representing clinicians and since 2023 is member of the Italian National Committee on ATMP. He is co-chair of EU JOIN4ATMP representing partner OSR/UniSR. 

Professor, Vita-Salute San Raffaele  

University and Research Group Leader San Raffaele Hospital 

Professor Chiara Bonini, MD, is a full professor of Hematology at the Faculty of Medicine and Surgery, Vita-Salute San Raffaele University, and the Head of the Experimental Hematology Unit at San Raffaele Scientific Institute. 

Her research focuses on engineered T-cell therapy for cancer treatment. She has significantly contributed to the development of suicide gene therapy in the context of hematopoietic stem cell transplantation and more recently to the use of gene-editing technologies to redirect T-cell specificity against tumor antigens. 

Professor Bonini has received several prestigious awards, including the Young Investigator Award from the American Society of Gene and Cell Therapy (ASGCT, 2005), the Van Bekkum Award from the European Society of Bone Marrow Transplantation (EBMT, 2012, 2016) and the Outstanding Achievement Award from the European Society of Gene and Cell Therapy (ESGCT 2024). She has served on the executive committees of various scientific societies of cell and gene therapy, hematology and stem cell transplantation including ASGCT, ESGCT, EHA and EBMT. 

Professor, Erasmus Medical Center,  

Professor Reno Debets is a certified immunologist and Professor of 'T cell immunity and adoptive therapy of tumors' at Erasmus MC-Cancer Institute. Since 2000, he has chaired the Laboratory of Tumor Immunology at the Department of Medical Oncology, and his laboratory, currently 18 members strong, is focused on monitoring patient T-cell immunity, deciphering tumor-immune cell interactions, and advancing adoptive T-cell therapies. 

Professor Debets has a 20-year track record in adoptive T-cell therapy, leading pioneering clinical studies in Europe, including phase I/II trials in advanced renal cell cancer and melanoma carcinoma. He chairs the Academic Center of Expertise in Tumor Immunology and Immune Therapies, and the steering group on adoptive cellular therapies at Erasmus MC, overseeing clinical trials and ATMP production. Since 2021, he has served as Erasmus MC coordinator for the European Center for Gene and Cellular Therapies within the European University Hospital Alliance (EUHA) and, since 2024, as a consortium partner in the EU JOIN4ATMP initiative. In 2020, Professor Debets founded Pan Cancer T BV, a spin-out company from Erasmus MC to develop TCR T cell therapies for hard-to-treat solid tumors.  

Professor, Vita-Salute San Raffaele University  

Director, Cancer Center San Raffaele Hospital  

Professor Fabio Ciceri is Director of Hematology, Bone Marrow Transplantation Unit and Blood Bank at San Raffaele Hospital. He is full professor of Hematology at Vita-Salute San Raffaele University since 2018 and Director the School of Specialization in Hematology. He is also Director of Comprehensive Cancer Center of San Raffaele Hospital. 

His research has focused on advancing haploidentical transplantation as a therapeutic option for high-risk diseases. Since 1996, Professor Ciceri has led early clinical development in advanced cell therapy, gene therapy, and regenerative medicine, contributing to the first advanced cell therapy for blood cancer and HSC-based gene therapies for primary immunodeficiencies, metabolic diseases, and hemoglobinopathies. 

Professor Fabio Ciceri is member of several scientific organizations, past-President of  Italian Bone Marrow Transplantation Group (GITMO), current Scientific Chair of European Society for Blood and Marrow Transplantation (EBMT) and Joint Accreditation Committee ISCT-Europe & EBMT (JACIE). He is President of AISPO NGO leading implementation of Blood Banks and BMT Units in low-income countries.  

Professor, Charité – Universitätsmedizin Berlin 

Join4ATMP Coordinator 

Professor Dr. Annette Künkele is professor for CAR T cell therapies, head of the Berlin Center for Advanced Therapies (BeCAT) and senior attending physician at the Department of Pediatric Oncology and Hematology at Charité University Medicine Berlin. Prof. Künkele studied medicine at Heidelberg University and was a pediatric resident at both the University Children’s Hospital Essen and Charité Berlin, subsequently specializing in pediatric oncology and hematology. She focused early in her carreer on cellular therapies, and consequently worked for 3 years as a postdoc in the laboratory of Prof. Michael C. Jensen at Seattle Children’s Research Institute, to develop a CAR targeting neuroblastoma and initiate a first-in-human phase I/II trial using this CAR T cell product. Prof. Künkele’s current research focuses on identifying novel CAR targets as well as hurdles preventing CAR T cell success against solid tumors. In addition to her clinical duties, Prof. Künkele heads her own research team and is responsible for the pediatric immunotherapy program and the good manufacturing practice (GMP)-facilities of BeCAT. She is EU JOIN4ATMP consortium coordinator since 2024 and Charité coordinator for the European Center for Gene and Cellular Therapies in the European University Hospital Alliance (EUHA) since 2021.  

Scientific Director, San Raffaele Hospital  

Vice-Rector Vita-Salute San Raffaele University  

Professor Gianvito Martino is Scientific Director of the San Raffaele Research Hospital and Vice Rector for Research and Third Mission at the San Raffaele Vita-Salute University. He received his Medical Degree in 1987 from the Univ. of Pavia (Italy) and completed his residency in Neurology in 1991.  

He is full professor of Experimental Biology and was appointed Honorary Professor at Queen Mary Univ. of London from 2009 to 2017. He has been the Scientific Secretary (1998-2003) and the President (2009-2012) of the Italian Neuroimmunology Society (AINI). 

He is the founder and the Scientific Coordinator of the European School of Neuroimmunology (ESNI) and of the Global Schools of Neuroimmunology (GSNI). Within the International Society for Neuroimmunology (ISNI), he served as advisory board member (2002-2010), Vice President (2010-2012) and President (2012-2014). He has been a member of the scientific committee and reviewing panel of ECTRIMS, FISM, MSIF, INSERM; UK MS Society, Wellcome Trust's Peer Review College. From 2017 to 2019 he has been the President of the scientific council of the Fondazione Regionale per la Ricerca Biomedica (FRRB). From 2015 he serves as Panel Member of the European Research Council (ERC). He has co-authored more than 250 original articles and book chapters. His scientific interests range from the elucidation of the pathogenic mechanisms of immune-mediated central nervous system disorders to the development of gene and stem cell-based therapies for the treatment of these disorders.