Csilla Pozsgay
Director of the National Institute of Pharmacy and Nutrition, Budapest
Tamás Szolyák
Deputy Director of the National Institute of Pharmacy and Nutrition, Budapest
Philip Walson
Professor Clinical Pharmacology; University Medical Center Gottingen
Board Certified in Paediatrics, Clinical Pharmacology and Medical Toxicology
Visiting Professor, Institute for Clinical Chemistry, Department of Clinical Pharmacology, University Medical Center at Georg-August-Universität Göttingen
After his undergraduate studies in the University of California, Berkeley, USA, Professor Philip Walson obtained his MD at the University of California, School of Medicine (San Francisco, USA) in 1969. He trained in paediatrics in the Pritzker School of Medicine at the University of Chicago and afterwards returned to the University of California to complete a 2-year fellowship in clinical pharmacology at the Department of Internal Medicine, Cardiovascular Research Institute.
For 19 years (1981-2000) he was Professor of Paediatrics, Pharmacology and Pharmacy at the Ohio State University/Nationwide Children’s Hospital, Columbus, USA. During this time he was also co-founder, Medical Director and Chief Scientific Officer of Pediatric Clinical Trials International, a for-profit subsidiary of the hospital dedicated to the development of paediatric therapeutics.
He was the Medical Director of the Central Ohio Poison Control Center, Director of the Therapeutic Drug Monitoring (TDM) and Toxicology Laboratory and principal investigator of the National Institute of Child Health and Human Development (NICHD) supported Pediatric Pharmacology Research Unit (PPRU) and Pediatric Clinical Pharmacologist for the National Institute of Mental Health (NIMH) supported Research Unit for Pediatric Psychopharmacology (RUPP) in Columbus, USA.
In 2000, Professor Walson moved to Cincinnati, USA, to set up the Clinical Trials Office at the Cincinnati Children’s Hospital and was Director of the Clinical Pharmacology Division. He was also the co-principal investigator for the University of Cincinnati PPRU and taught clinical study design at the Colleges of Medicine and Pharmacy at the University of Cincinnati.
In August 2008, he retired from the University of Cincinnati to move to Europe where he continues as consultant to industry and government on paediatric clinical trial design.
Mark Turner
MCRN UK, Enpr – EMA
Senior Lecturer in Neonatal Medicine at the University of Liverpool
Director of Research and Development and Honorary Consultant Neonatologist to Liverpool Women’s NHS Foundation Trust (LWH)
Associate Director of NIHR Medicines for Children Research Network (European Affairs)
Chair, NIHR MCRN Clinical Studies Group in Neonatology
Chair, NICE Guideline Development Group: Antibiotics for the prevention and treatment of early onset neonatal bacterial infection.
Mark Turner is a Neonatal Consultant at Liverpool Women’s NHS Foundation Trust and Senior Lecturer in Neonatology at the University of Liverpool. He trained in Medicine at the University of St Andrews, Scotland and Manchester University, specialising in Paediatrics and Neonatology in the North West of England and his PhD is in placental physiology.
The professional achievements Mark is most proud of is delivering early phase studies in premature neonates (First-in-human; Phase 0 etc.) and his hopes are to improve the access to children and babies of high quality medicines through rational drug development based on assessment of how medicines are used through work on specific medicines for babies and by support generalisation of this work through research networks.
Mark believes that the most important and realistic goals that he and his colleagues’ current focus worldwide should include insight on what children need as well as meeting academic drivers and to do the work needed to bridge between curiosity-driven research and clinical application.
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Martine Dehlinger-Kremer
Chair Pediatric Working Group, EUCROF and Global Vice President Medical and Regulatory Affairs, SynteractHCR
Dr. Dehlinger-Kremer has more than 30 years of experience in the research industry, including more than 26 years of progressively higher levels of Regulatory and Medical Affairs leadership responsibility. For 21 years, she served as a Vice President of International and Global Regulatory and Medical Affairs at various CROs headquartered in the U.S.
Martine has contributed to the global development of numerous products, including orphan drugs and biosimilars. She has participated in 100+ NDAs/MAAs in local and CTD/eCTD/NeeS format, in the maintenance of products on the market, and in numerous clinical studies across all phases. She has also served as the chair of the Pediatric Working Group of EUCROF, and as lead member of the Pediatric Franchise at Research Pharmaceutical Services, a division of PRA International.
Dr. Dehlinger-Kremer holds a PhD from the University of J.W. Goethe in Frankfurt, Germany; a general academic studies degree in neurophysiology from the Louis Pasteur University in Strasbourg, France; and a Master of Sciences degree from the University Moulin de la Housse in Reims, France. She is also a registered member of The Organization for Professionals in Regulatory Affairs (TOPRA)
Christina Bucci-Rechtweg
MD, Global Head, Pediatric & Maternal Health Policy, Drug Regulatory Affairs, Novartis
Dr. Bucci-Rechtweg graduated with a MD from the University of Rochester School of Medicine & Dentistry and was Residency trained in Pediatrics and Fellowship trained in Pediatric Critical Care Medicine at the State University of New York @ Buffalo. She has more than 10 years of pharmaceutical industry experience with roles in Clinical Development & Medical Affairs as well as Drug Regulatory Affairs, including the oversight and registration of heavyweight global clinical development programs. In her career she has provided oversight for pediatric development programs in phase II and III, including those with pediatric regulatory obligations in the EU and US, and guidance for early development programs intending to target conditions requiring therapeutic interventions for use in pregnant mothers. Christina served for four years on the Novartis Pediatric Advisory Group, representing the Autoimmunity Clinical Science Unit. She is the Global Head for Pediatric and Maternal Health Policy at Novartis Pharmaceuticals.
Jaroslav Sterba
Brno Paediatric Hospital, EMA PDCO Member
Jaroslav STERBA, M.D., Ph.D., is professor of oncology and the Head of Pediatric Oncology Dpt., University Children’s Hospital Brno, Czech Republic since 1998. He is also the Vice-Dean, Faculty of Medicine, Masaryk University Brno, Cz
He is the chairman of the NHL committee of the International BFM group and a member the Children´s Oncology Group (COG) (international associate member) European Bone and Marrow Transplant Group (EBMT), and SIOP.
Pr Sterba is a pioner in metronomic chemotherapy in children and has published the first european pediatric trial (COMBAT) in 2006 and organized the first Workshop in Metronomic and differentiating therapies in children and AYA in Brno in 2008. He has since improved the COMBAT protocol and is still engaged in the development of metronomic chemotherapy in children.
Mette Theilade Thomsen
Managing Director, “PIP Adviser”
Mette is CEO of “PIP Adviser” which provides expert regulatory advice on PIPs and PSPs. Mette has a background from authorities and industry. In the Danish Medicines Agency (2000-2006), she was nonclinical assessor of MAAs and EU Scientific Advice. She was member of the SWP, Gene Therapy WP, Biosimilar WP, and PGWP, and was rapporteur for CHMP and ICH guidelines. As Scientific Officer in EMA (2007-2009), Mette handled PIP procedures with PDCO, was in the FDA-EMA paediatric cluster, and established the PDCO Nonclinical Expert Group. In Novo Nordisk (2009-2017), Mette lead all PIP/PSP procedures, was paediatric strategy advisor across the company, and was in the EFPIA Paediatric group. Mette spent a year as Senior Director in Shionogi, London, before founding “PIP Adviser”
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Judit Mária Molnár
Director of the Institute of Genomic Medicine and Rare Diseases, Semmelweis University, Budapest
MD, PhD, Professor of Neurology, Psychiatry, Clinical Genetics, and Clinico-pharmacology, Doctor of the Hungarian Academy of Sciences is the director of Semmelweis University’s Institute of Genomic Medicine and Rare Disorders. Among others president of the Hungarian Medical College of Clinical Genetics, past president of the Hungarian Society of Clinical Neurogenetics, secretary of the Hungarian Society of Personalized Medicine, board member of the Neurogenetic and Neuromuscular Committee of the European Academy of Neurology, president of the Advisory Board of the Hungarian Insurance Company for Rare Disorders. She was the vice-rector for Scientific Affairs at Semmelweis University (Budapest, Hungary) between 2012 and 2015, where she was also responsible for International Affairs. She has been adjunct professor at the Montreal Neurological Institute, McGill University between 1999 and 2012. Dr. Molnar is the Facilitator of a Challenge Group of the International Consortia of Personalized Medicine initiated by the European Commission. She has a country coordinator role in the European Rare Disease Joint Action Program (‘Promoting Implementation of Recommendations on Policy, Information and Data for Rare Diseases — RD-ACTION’). She is the leader of the WP for Education and Training of the European Reference Network (ERN) for Rare Neurological Diseases. She is the representative of Hungary in the Rare disease EJP established by the European Commission. She is the member of the steering committee of the Association of Academic Health Centres International.
Dr. Molnar is recognized as a leading experts on the diagnosis and treatment of rare neurological disorders. The Institute of Genomic Medicine and Rare Disorders lead by her offers a comprehensive state of the art, patient-centered care for patients with rare neurological disorders including genetic testing, neuropathological investigations and genetic counselling as well. Dr. Molnar’s research covers a broad range of basic and clinical studies on rare neurological disorders, utilizing a broad spectrum of technologies in the development of improved diagnostics and therapeutics using molecular approaches
She plays important role in the organization of rare disease management in Hungary and acts as an ambassador promoting the personalized healthcare.
She published 1 book, 20 book chapters, 137 papers with cumulative impact factors 175, Hirsch index: 19 and more than 1250 citations. She owns 2 patents.
Wouter Wijker
Managing Director of Auxiliis Pharma, Head of Biometrics Unit
Wouter Wijker started his career as a researcher in human electrophysiology at the University of Amsterdam. After achieving his doctoral degree, he took on a position as biostatistician at the Academic Medical Centre of the University of Amsterdam and was mainly involved in setting up and analysing clinical studies. With this experience he founded BwO Research BV, a clinical research organization assisting several large and international pharmaceutical companies in human drug research. He held the position of managing director of BwO Research BV for almost 15 years. In 2004 BwO merged with IATEC were he was the director of biostatistics, a member of the management team, and report writer. Currently he is managing director of Auxiliis Pharma since 2006 and a board member of the society for Pharmaceutical Statistics and Data Management (PSDM).
Sarah Barthold
Project Manager, GLATT Pharmaceutical Services
Sarah studied pharmaceutical sciences at the University of Regensburg and ETH Zurich before she finalized her education with a PhD in Pharmaceutical Technology at the Helmholtz-Institute of Pharmaceutical Research Saarland/ Saarland University.
From 2015 to 2017 she worked at the institute of Biopharmacy and Pharmaceutical Technology at Saarland University dealing with nanoparticulate dosage forms.
In 2017 she joined Glatt GmbH as project manager in the Pharmaceutical Development Division of Glatt Pharmaceutical Services Binzen / Germany.
Glatt Pharmaceutical Services activities include the pharmaceutical development of solid dosage forms with a focus on multiparticulate dosage forms and controlled release applications, formulation and process developpment incl. clinical trial material production and commercial manufacturing.
Cesare Spadoni
Senior Director Business Development, Auxiliis BV
Cesare has more than 20 years of experience in the drug development field, in both scientific and commercial roles. He is currently Senior Director of Business Development at Auxiliis, a contract research organisation specialised in paediatric clinical development. Prior to that he held senior positions at AMRI, Aptuit Laurus and ThalesNano. Cesare started his career as research scientist in a pharmaceutical company (Eisai London) and in academia (institute of Enzymology, Budapest).
Following the death of his first daughter Laura to cancer, Cesare set up aPODD Foundation, a London-based charity focused on accelerating paediatric oncology drug development. As aPODD’s chairman he is actively involved in drug repurposing projects and setting up drug development collaborations with other childhood cancer charities.
Cesare holds an MSc in Applied Molecular Biology and a PhD in Neurosciences from UCL, University of London, as well as an MBA from the Central European University, Budapest.
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Klaus Rose
Managing Director, Klausrose Consulting Ltd
Dr. med. Klaus Rose, CEO of Klausrose Consulting, Switzerland, advises on all aspects or pediatric drug development. His clients are pharmaceutical companies, academic institutions, and publishers. He first studied psychology and Latin languages, then medicine. After postgraduate clinical training in Germany and England he joined pharmaceutical industry in 1991, was Global Head Pediatrics at Novartis 2001 – 2005 and Global Head Pediatrics at Roche 2005 – 2009. Since 2011 he is independent. He is a frequent speaker at international conferences and publishes on a regular basis. He co-edited three textbooks in the area of pediatric drug development.
Married with two daughters, his private interests include Mediterranean cooking, wine, gardening, Latin languages, Hungarian, and classical guitar.
Evie Mengou
Regulatory Consultant. EV Consulting
Evie Mengou is a seasoned regulatory affairs professional, with over 20 years’ experience in pharmaceutical drug development spanning several therapeutic areas, involving small molecules and biologics, in diverse business and cultural settings. Her most recent pharma appointment focused on commercialisation and partnerships; previously she lead global regulatory strategy and operations. After such leadership positions in pharma, and several years consultancy experience in a CRO, Evie established her own consultancy to provide strategic regulatory and development advice. Following the introduction of Paediatric Regulation in Europe, she has been involved in leading the preparation, negotiation and execution of paediatric investigation plans and paediatric clinical trials. Evie’s exposure to the unmet needs of the paediatric population, particularly in oncology, has driven her wish to improve paediatric drug development through the work of aPODD. She holds an MSc in Biochemical Pharmacology from the University of Southampton, UK.
Éva Kőhegyi
Senior Director, Global Clinical Development, Neurospychiatry, Otsuka
Martin Graham
CEO; KinderPharm
Dr. Martin A Graham is a graduate of Leeds University, England where he earned his BSc in Pharmacology and Microbiology with Joint Honors in 1984. He went on to earn his PhD from the University of London at The Institute of Cancer Research, Royal Marsden Hospital, London UK in 1990. Dr. Graham conducted his post-doctoral research in anti-cancer drug development at the Beatson Institute at University of Glasgow before joining Sterling-Winthrop Pharmaceuticals, which later became Sanofi-Synthelabo, in both the UK and the US. Dr. Graham later served as Director of Pharmacokinetics at Centocor Corporation, a Johnson and Johnson Company; VP of Research and Development at Gemin X biotechnologies; and VP of Development and Regulatory Affairs at TetraLogic Pharmaceuticals.
Dr. Graham founded PKPD Bioscience in 2004 where he currently serves is President and CEO. A decade later he founded KinderPharm in 2014, a pediatric drug development company where Dr. Graham also serves as President and CEO. With his extensive R&D experience with both small molecules and protein therapeutics from IND to NDA/BLA, Dr. Graham has been involved in numerous regulatory filings in the U.S., Japan and Europe for a wide variety of products including Oxaliplatin, Rasburicase, Mitoguazone, Tirapazamine, Alfuzosin, Birinapant, Stelara and Remicade.
Dr. Graham is an Honorary Professor of Pharmacokinetics and Pharmacodynamics at the University of Bradford, Yorkshire, UK and is a specialist in PK/PD modeling clinical trial simulation. He is the author of a text book on the Pharmacokinetics of Cancer Chemotherapy and has substantial publication record in the area of pharmacokinetics, drug metabolism and clinical pharmacology.
Benoît Hébert
Vice President, Business Development & Licensing Pediapharm Inc
Benoît Hébert has been the Vice President, Business Development and Licensing of Pediapharm since September 2009. Mr. Hébert has more than 20 years of industry experience and has a rare blend of scientific expertise and business skills. Focusing on pharmaceutical business transactions since 2000, he worked at Axcan Pharma Inc. from July 2003 to November 2006. Mr. Hébert has lead international licensing transactions, participated actively in product acquisitions, managed international product development alliances and global supplier relationship. Mr. Hébert holds an MBA in Management of Bio industries from the Université du Québec à Montréal. Mr. Hébert also received a M.Sc. in Immunology and a Ph.D. in Virology from the Institut Armand Frappier. Before returning to Canada in 2000, he was a NSERC postdoctoral fellow in structural biology at Purdue University. He is past president and a director of the Canadian Healthcare Licensing Association (CHLA).
Early Bird Deadline: August 31