Adrian Hill is Professor of Human Genetics and Director of the Jenner Institute at Oxford University, one of the world’s largest non-profit vaccine institutes. As well as leading a research program on genetic susceptibility to major infectious diseases, he is well known for developing promising new malaria vaccine candidates. His group discovered the ability of heterologous prime-boost immunization to induce potent T cell responses pre-clinically and has developed this approach to phase II clinical trials in Africa. He has also pioneered the use of small rapid clinical trials to provide initial safety and immunogenicity with a range of novel vaccine concepts.
Akira Homma is the president of the Political and Strategic Council (PSC) of Bio-Manguinhos of the Oswaldo Cruz Foundation (Fiocruz) based in Brazil. The Political and Strategic Council features among its professional members recognized by the developed works and linked to important institutions related to Bio-Manguinhos activities and also representative of the society as a whole, as the Department of Science and Technology of the Ministry of Health, BNDES (The Brazilian Development Bank), ABIFINA (Brazilian Association of Fine Chemistry Industries, Biotechnology and its Specialties), Butantan Institute, as well as elected representatives of the community. Akira Homma is a Medical-Veterinary graduate of Faculty of Veterinary Medicine, Universidade Federal Niterói, Brazil. As Director of Bio-Manguinhos - 20 years in two terms - Dr. Homma was responsible to the activities related to the technology development of immunebiologicals and manufacturing activities at industrial scale, which was initiated in 1976 with only one product and 26 employees, and he left the direction with a portfolio of 17 products and 1.200 employees. He also organized the Profesional Master Course Degree at Bio-Manguinhos.
Ananda Bandyopadhyay is since 2012 Senior Program Officer at the Bill & Melinda Gates Foundation in Seattle, USA with responsibility to support global polio vaccine research and product development across multiple countries and geographies, including South Asia, Latin America, Africa and Europe. He grew up in India and qualified for his medical degree from the Calcutta National Medical College & Hospital in 2005. He received his Master of Public Health degree in Global Health from Harvard School of Public Health in 2010. In between he worked for the polio eradication initiative in five states in India as a Surveillance Medical Officer for polio and measles with WHO and contributed to the successful and historic polio eradication effort and measles surveillance initiatives in India. He worked as an infectious disease epidemiologist at Rhode Island State Department of Health, US, for two years, before joining the Bill and Melinda Gates Foundation. Ananda is a guest lecturer for advanced degree programs in public health and infectious diseases in several globally renowned teaching venues including the Harvard University.
Anja Seubert is Head Laboratory Research Immunology at GSK Siena. She obtained a Bachelor in Biology from the University of Bayreuth, Germany. She also gained a PhD in Natural Sciences at the University of Tubingen, Germany.
Anne-Marie Georges consults in regulatory affairs at Novartis Vaccines (now GSK Vaccines) and various biotechnology and vaccine companies (Eurytech, Crucell, GSK, Viropharma and Takeda), in particular regarding European pharmaceutical law and developinglicensing biological medicinal products in the EU and in the world. She also acts an expert at the WHO and occasionally for the Council of Europe.
Antoine Courgeon is Head of Bacterial Vaccine Patents at Novartis Vaccines and Diagnostics (now GSK Vaccines) also leading the patent team based in Siena, Italy. Antoine is a French and European Patent Attorney with patent and technical expertise, qualifications and research experience in the fields of Biochemistry and Molecular biology. He joined Novartis in March 2011 after spending 7 years working for a leading bio pharmaceutical US company as a senior patent attorney.
Dr. Audino Podda is Head, Clinical Development & Regulatory Affairs at Sclavo Behring Vaccines Institute For Global Health S.r.l., (formerly NVGH). He was previously Vice-President and Global Head of Clinical Research Development and Medical Affairs and subsequently of Global Regulatory Affairs at Novartis Vaccines. In the last 20 years, he has led various vaccine development programs resulting in the clinical testingand registration worldwide of several novel vaccine candidates. Also a contract Professor at the Department of Public Health of the University of Genoa, Italy, he has made significant contributions to the organization and implementation of a Master in Vaccinology and Pharmaceutical Clinical Development for MDs from developing countries in collaboration with the University of Siena, where he obtained his medical degree and subsequently a specialization in Pediatric Infectious Diseases.
Barbara Baudner is Head of the Formulation Science Unit and Head of the Needle Free Delivery platform in the Vaccine Chemistry and Formulation department at GSK, Italy. She has focused on research projects such as “Enhanced Efficacy of Influenza vaccines” and “Influenza Novel Delivery” following a PhD in Pharmaceutical Technology from Leiden/Amsterdam Center for Drug Research, University of Leiden, The Netherlands, where she worked on Mucosal Delivery of Vaccines. She added a State Certificate as Pharmacist to her MSc from the Department of Pharmacy at the Philipps University of Marburg, Germany.
Bernadette Hendrickx acquired her Medical Degree at the Catholic University of Louvain (UCL,Belgium) She worked as fellow in oncology at UCL and the Hopital de Jolimont (Belgium) in the cancerology field. In 1979 she joined the pharmaceutical industry where she also ended her carreer. She successufully worked for Duphar, Solvay, GSK Bio and Sanofi Pasteur. Her fields of expertise are Regulatory, Pharmacovigilance and Crisis Management. In 2015 she founded a consultancy . She is also Senior Medical Advisor at the Master in Vaccinology since the 3rd edition.
Bernardo D’errico is Head of Quality Operations, Supplier Audits, PW&D, GSK, Siena Italy. He started his Job experience in 1995 with a scholarship in the Immunology Department at the Research Centre of Biocine S.p.A., Siena. The Company became Chiron S.p.A one year later and he has been appointed Quality Assurance first and QA Documentation & Systems Manager and QA Operations Manager later. He was also Head, QA Operation Italy managing all QA Operation groups in charged in DR/BPR management and product Release activities, and pharmaceutical technical complaints. From May 2011 is Head, Quality Operation Systems & Services Italy in Novartis Vaccines. Awards: in 2008 for “outstanding work on the Rosia Fluvirin PAI Team”; in 2011 for “outstanding work on BD Black Particles Recall Assessment/PQIA Finalization” . He obtained his M.Sc.Biologics with laudem at University of Siena.
Birgit Weinberger is Professor of immunology division Institute for Biomedical Aging Research Innsbruck, Austria. She studied Biology at the University of Regensburg, Germany and the University of Boulder, CO, USA focusing on Genetics, Developmental Biology and Medical Microbiology. Her diploma thesis at the Institute for Medical Microbiology and Hygiene (University of Regensburg) was entitled “Interaction of cell/erythroid-specific transcription factors with the p6 promoter of human Parvovirus B19”. She holds a PhD from the Institute for Medical Microbiology and Hygiene of the University of Regensburg for her work “Epstein-Barr virus (EBV)-specific virological and immunological parameters in patients with EBV-related disease or under immunosuppression.” Birgit joined the Institute for Biomedical Aging Research in 2005 working on the role of chronic Cytomegalovirus infection (CMV) in immunosenescence and characterizing CMV-specific T cells in young and elderly adults.
Carole Cluchat is currently leading Sanofi Pasteur R&D Project management dept for Europe. She is executive secretary of different steering committees. She has over 20 years’ experience in vaccine development. As Clinical Research Associate and CRA manager, she implemented and monitored Phase I to Phase III trials for pediatric combos, Hepatitis A and HIV in Europe, Latin America and Africa. Within Clinical dept, she implemented planning and resource management tools & processes. She then joined R&D Project Management Office where she lead the implementation of standard project & portfolio management tools contributing to successful “time to market”. Carole has a master in Natural Sciences and is certified PMP (Project Management Professional).
Carolina Danovaro has recently joined the Department of Immunization, Vaccines and Biologicals at the World Health Organization (WHO) to work mainly on the analysis and interpretation of global immunization data and the development of methodologies and processes to improve routine immunization monitoring and data quality. For the last 11 years, Dr. Danovaro was responsible for immunization data quality and strategic information at the Pan American Health Organization (PAHO) in Washington DC; she also served as the editor of PAHO’s Immunization Newsletter. Before joining PAHO, she worked at the International Vaccine Institute (IVI), on typhoid and cholera vaccine demonstrations projects in Vietnam and India. Earlier in her career, Carolina was a fellow at the National Immunization Program of the US Centers for Disease Control and Prevention (CDC). She holds a medical degree from the Pontifical Catholic University of Chile and a Masters in Epidemiology from the London School of Hygiene and Tropical Medicine.
She is a developmental research psychologist turned epidemiologist. Following her degree in Neuropsychology from the Vrije Universiteit in Amsterdam, she obtained her PhD in Epidemiology at the University of Birmingham. Most of her academic research has focused on maternal and infant health. She has stayed in the maternal and infant health research theme since then, working in the field of infectious diseases and vaccine development and safety. Cassandra joined GSK (formerly Novartis) as Epidemiologist in 2013. She currently supports the maternal immunization and respiratory programs.
Cesar Rengifo is Vice President and General Manager at GlaxoSmithKline Pharmaceuticals Brazil. Born in the Colombian capital, Bogota, Cesar studied Business Administration and graduated in Marketing. He began his career in the pharmaceutical industry in 1996 at SmithKline Beecham, as Vaccines Unit Manager for Venezuela, Ecuador, Peru and Colombia. From 2001 to 2002, he assumed responsibility for the vaccines and HIV businesses in the Latina & Caribbean region. He was appointed GSK’s General Manager in Colombia in 2002. And from 2006 to 2008 he assumed the position of VP & General Manager Puerto Rico, a position that helped broaden his view of the Latina Region as a whole still further. In 2008, Cesar was appointed VP & GM for Pharma and Vaccines businesses in Brazil. Under his leadership the businesses have achieved a robust and sustainable growth performance along the years.
Christian W. Mandl is assoc. Professor Vienna medical University Austria. He was Clinical Franchise Head for Early Clinical Programs at Novartis Vaccines. In this role, he oversed exploratory development studies bridging preclinical with clinical research. Previously, he had been the US Research Head and Global Head for all viral vaccine research projects working on a range of viral targets including RSV, CMV, influenza and HIV, and technology platforms such as viral RNA vectors and novel adjuvants. He is a world-renowned expert in the molecular biology of flaviviruses, and is a co-inventor on several patents related to a marketed vaccine for tick borne encephalitis. He has authored more than 90 publications in the field of virology since obtaining a PhD and MD from University of Vienna, and a Master of Science (Biochemistry) from Pennsylvania State University. He earned his postdoctoral lecturer qualification (Habilitation) in Molecular Virology and was certified as a Medical Specialist in Virology by the Austrian Medical Association.
After Medicine School at the University of Nancy in France, I have been teaching at the University and practicing in clinics during approximately 4 years. I joined Industry almost 20 years ago in GSK vaccine division headquarters. Primarily in charge of pharmacovigilance, I have evolved in different positions or jobs that basically created such as Compliance, risk management and medical governance and professional development for physicians. I moved in Sanofi Pasteur end of 2010. I’m passionate about vaccines, public health and preventive medicines but before all I’m passionate about people development. During six years I also fulfilled the mandate of the Secretary General to the International Society of Pharmacovigilance (ISOP). During the last 3 years I had the chance to contribute to one of the last CIOMS Working Group which issued A Guidance for Active Safety Surveillance in LMIC . Education and professional training: Physician University of Nancy – France Clinical Pharmacologist – University Victor Segalen – Bordeaux – France Pharmacoepidemiologist - University Victor Segalen – Bordeaux – France
Cosima Tatiana Baldari is Chair of the Department of Life Sciences and member of the Academic Senate at the University of Siena. She obtained her degree in Biological Sciences from the University of Rome in 1976. She did a postdoctoral fellowship at the European Molecular Biology Laboratory (EMBL) in Heidelberg, Germany. She joined the University of Rome in 1981 as staff scientist, returning to EMBL as visiting scientist. Then she moved to the University of Siena, where she set up her research group and pursued her academic career first as Associate Professor and since 2000 as Full Professor. She is a member of the European Molecular Biology Organization (EMBO) and AcademiaNet. The activity of the lab is focused on the functional dissection of signal transduction pathways in lymphocyte activation and apoptosis and dysregulation of these processes in lymphoproliferative, immunodeficiency and pathogen-related diseases.
He has been a Program Coordinator at the Bill & Melinda Gates Foundation since 2012. He manages a portfolio of approximately $2.5 billion and 45 active grants for the foundation's Polio program. Aaron has experience writing grant proposals for a variety of nonprofit organizations, including the Foundation for Integrated Development and Education, the National Environmental Trust, the Washington Office on Latin America, and Global Visionaries. He has a Master in Public Administration, with a focus on nonprofit management from the University of Washington.
She has been working as a medical writer since 2004 when she joined Chiron Vaccines. At that time the main activities of the medical writing group consisted in the preparation of clinical study reports and briefing documents for meetings with health authorities. Subsequently, with the increase of the filing activities Albertina specialized in supporting the preparation of the clinical sections of licensure applications. In 2010 she became the head of Novartis Vaccines (now GSK Vaccines) submission medical writing group, the group of medical writers who is responsible for the preparation and coordination of the activities related to the writing of the clinical sections of regulatory submissions. Albertina got her University Degree with Honors in Biological Sciences at the University of Florence, Italy in 1993. She obtained a Postdoctoral Fellow in the Laboratory of Biochemistry and Metabolism, NIDDK, NIH, U.S.A in 1996 and a Ph.D. in Molecular & Cellular Biology and Pathology, University of Naples "Federico II", Naples, Italy in 2000. From 2002 to 2003 she was Fellow in the Division of Hematology and Transplantation, Department of Medicine and Immunological Sciences, University of Siena, Italy.
Dr. Tozzi is a pediatrician and an epidemiologist who manages a research area and the telemedicine unit at Bambino Gesù Children’s Hospital in Rome (Italy). He previously worked at the National Health Institute where he participated in the coordination of a large clinical trial on pertussis vaccines. Since then he has been involved in several surveillance and research activities on vaccine preventable diseases and he participated in the design of national immunization strategies. He is a member of the Expert Vaccine Advisory Group of the European Center for Disease Control. He participated in polio certification and safety activities as a temporary advisor for the WHO.
Currently Head Clinical Data Stewardship, Standards and Resource Strategy at GSK, Amsterdam, Netherlands. He joined Chiron Corporation in 2002 as SAS programmer and during the years covered important roles such as Manager CDM and Manager Bioanalysis. From 2007 to 2013 he was Head of Clinical Data Management at Novartis Vaccines. He got a Ph.D. at Université Laval Québec, Canada.
Prior to joining Sanofi Pasteur in 2004, Alena completed Epidemic Intelligence Service at the US Centers for Disease Control and Prevention in Immunization Safety Branch. She also worked as a medical epidemiologist on STDs, HIV/AIDS and Multidrug resistant tuberculosis in Moscow, Russia. Alena is trained as Internal Medicine physician in Belarus (MD degree from Gomel State Medical University). The current area of interest is in advanced epidemiologic methods used in vaccine safety and quantitative benefit-risk assessment of vaccines
Alessandra Anemona is Manager for Biostatistics & Clinical Data Management at Sclavo Behring Vaccines Institute For Global Health S.r.l., (formerly NVGH) Department of Clinical Research & Regulatory Affairs based in Siena, Italy. Previously she worked as a project statistician in its meningitis franchise, and as Head Statistician at the NIMR/AMREF/LSHTM Collaborative Research Projects in Mwanza, Tanzania. Following a degree in Statistical Sciences and Demographics from Rome, she started her career as a statistician in the Department of Infectious Diseases, Istituto Superiore di Sanità, Rome, Italy.
She is currently Global Medical Affairs Director GSK, Germany. Previously she was Associate Medical Director, Global Medical Affairs, Novartis Vaccines and Diagnostics, Marburg, Germanyand from 2011 to 2012 Medical Affairs Manager, Novartis Vaccines Vertriebs GmbH, Holzkirchen, Germany. She also covered the role of Medical Scientific Liaison Manager (Respiratory Diseases and Diabetology) and Project leader/Medical Advisor (Rheumatology, Osteoarthrosis and Pain Research) at Novartis Pharma GmbH, Nuremberg, Germany. From 2003 to 2005 Scientific and research associate; Institute of Pharmacology, Pharmacy and Toxicology, Department of Veterinary Medicine, Ludwig-Maximilians-University, Munich, Germany. She obtained a Degree as a doctor of veterinary medicine; Ludwig-Maximilians-University, Munich, Germany.
He is an Associate Professor and Director for the Centre for Tropical Clinical Pharmacology and Therapeutics at the University of Ghana Medical School and the Director of the WHO Collaborating Centre for Advocacy and Training in Pharmacovigilance. He obtained his first degree in Ghana and his MSc and PhD from King’s College London. He was the President of the Pharmaceutical Society of Ghana from 2008 to 2012 and the President of the International Society of Pharmacovigilance (ISoP) from 2009-2012 as well as he President of the Pharmacy Information Section of the International Pharmacy Federation (FIP) from 2008-2012. He is an active media practitioner writing regular columns for a weekly in Ghana and appearing on radio and TV regular.
He is Supervisory Statistician GSK, Cambridge, US. Over thirty-five years of experience in the Pharmaceutical and Biotech Industry at Syntex Research , Genentech, Inc., and Chiron Corp., with the last eight years at Novartis Vaccines as Senior Director, Biostatistics. Major recent vaccine accomplishments include approval of BLAs and sBLAs in the US and EU for MenACWY (Menveo), Optaflu (Flucelvax) and Agrippal (Agriflu); and the US IND for GBS Vaccine, in addition to submission packages for the Rabies (Rabipur) and TBE (Encepur) vaccines. Past projects have included approval of Menjugate, a MenC vaccine, in Europe and Canada, and Fluad, an adjuvanted flu vaccine, in Europe. Also was involved with the design and analysis of several large Phase III trials: Italian Efficacy Trial in Pertussis, IL-2 in HIV (SILCAAT), tifacogin alpha (TFPI) in severe sepsis, two double-blind, placebo-controlled trials of Chiron HSV vaccine in the prevention of genital HSV-2 acquisition. Supported rapid approval of interferon-gamma 1b (Actimmune) for prevention of serious infection in chronic granulomatous disease. Research interests and experience: clinical trials and experimental design, numerous FDA interactions, interim analysis and group sequential methods, survival analysis, design of vaccine efficacy and consistency lot trials, and statistical methods in AIDS.
Andrea Livi is Regulatory Affairs Senior Group Manager at GSK Siena. He was RA Manager CMC & Compliance at Novartis Vaccines in Siena, Italy, whit the responsibility of Marketing Registration Application of Meningitis Vaccines, submission-related activities, regulatory impact assessment, and managing of change requests and MOGM activities. Graduating with a degree in Chemistry and Pharmaceutical Technology from the University of Siena, he started his career as a Junior Project Engineer at CTP Tecnologie di Processo-Poggibonsi, Italy.
She got Medicine and Surgery Degree in 1998 and the specialization degree in Ophthalmology in 2002. Annalisa worked as Ophthalmologist for 6 years and she was involved in Clinical Research for retina and macula diseases until 2007 when she achieved her PhD in “Degenerative and neoplastic ophthalmological diseases” at Siena University. She started her career in the pharmaceutical industry in 2008 as Physician in Clinical Development and then as Responsible for Pharmacovigilance in a Swiss-Italian Biotech Company specialized in production and development of biopharmaceuticals for the treatment of angiogenesis-related disorders. Annalisa joined Novartis Vaccines in 2013 as Regional Physician (Italy) supporting the conduct of clinical trials. Responsible for medical related/safety aspects of the trial and responsible for interacting with investigators including study feasibility assessments. On March 2, 2015 GlaxoSmithKline announced the completion of the deal with Novartis. From January 2016 she joined GSK as SERM (Safety Evaluation and Risk Management) Safety Physician.
Anne has been Director of Scientific Writing & Regulatory Affairs Services at 4Clinics since 2006. She is a native English speaker and came to 4Clinics with nearly 20 years of experience in clinical research and regulatory affairs. She has extensive experience in preparing clinical trial documentation (protocols, investigator brochures, study reports) and regulatory submissions. She has also written or co-written peer-reviewed articles for pre-clinical and clinical studies.
Present Position GSK Vaccines GmbH, Marburg, Germany Head Clinical Laboratory Sciences since January 2012. Previous Positions at Novartis Vaccines and Diagnostics GmbH, Marburg as Head Clinical Serology; at Novartis Vaccines and Diagnostics GmbH, Marburg Lab as leader Clinical Serology; at Chiron Vaccines GmbH & Co KG, Marburg as Lab leader Physicochemical analytics & Formulation. Education Ph.D. in Pharmaceutical Technology, Philipps-University, Marburg; Approbation in Pharmacy, Philipps-University, Marburg; Diploma in Pharmacy, Philipps-University, Marburg; Studies of Pharmacy, Philipps-University, Marburg Pharmaceutical Technical Assistant, Fresenius, Wiesbaden.
She is Principal Scientist GSK, Marburg, Germany. She has previously held the position of Lab manager Bexsero, Lab leader Clinical Serology at Novartis Vaccines and Diagnostics GmbH, and worked for Georg August University Göttingen as Scientific Assistant. She also worked as Medical technical Assistant in different laboratories. She got a diploma in Biology at Göttingen, a Ph.D. in Biology at Georg-August-University in Göttingen, and Master of Arts (consulting program) at University of Kassel.
After my Pharmacist degree, in 2004 and PhD in Immunology in 2007, I joined Sanofi Pasteur Pharmacovigilance Department managing periodic safety update reports. I am currently the Global Safety Officer for trivalent influenza vaccine Vaxigrip® and its Chinese equivalent which means that I am the safety expert for these products. I am responsible for continuous monitoring of their safety profile, from the detection and evaluation of safety signals to evaluation of the benefit-risk ratio of these vaccines. I also lead and coordinate transversal teams preparing safety documents. Finally I am part of the chief medical office/R&D project teams developing influenza vaccines within Sanofi Pasteur, where I am responsible for safety activities in clinical and regulatory projects.
Silvia got her Science Degree in Pharmaceutical Chemistry and Technology at Università degli Studi di Palermo, Faculty of Pharmacy. From May 2013 to date she is Clinical Research Associate and Clinical Trial Manager at GVGH in Siena, Department of Clinical Development & Regulatory Affairs. Her tasks are related to monitoring and management of vaccine Phase I clinical trials. She previously worked in the same role at Zeta Research SRL (Contact Research Organization) in Trieste, Italy. She is co-author of many scientific publications.
Since 2012, VP, Head Clinical Development Takeda Vaccines Business Unit (VBU), responsible for global clinical development including overall clinical program strategy, CDP development, oversight of protocol and CDP approval, advancing early and pre-clinical stage projects. Responsibilities include also epidemiology, serology and assay strategy and pharmacovigilance. Previous experience include Clinical Development of meningococcal and influenza vaccines since 2000 at Chiron Vaccines and development and license of pre-pandemic and pandemic vaccines at GSK bio. Prior to joining Takeda VBU, at Novartis Vaccines role as Chief Medical Officer Europe and head of early clinical development for early viral and bacterial vaccine. Graduated from Medical Faculty of the Humboldt University, Berlin, Germany and obtained her Ph.D. in Immunology, followed by two years postgraduate studies at Mayo Clinic, Rochester, MN.
He is Bernard Fritzell is President of BFL councils Bordeaux France a consulting company focusing on vaccine development and vaccinology. Previously Vice President, International Scientific & Clinical Affairs for Pfizer Vaccines, Paris France, and before that Vice President, Clinical Research and Medical Affairs at Chiron Vaccines in Siena, Italy, and Head of Clinical Research, Vaccines at Pasteur-Mérieux Sérums et Vaccins, France, his work on vaccine development in Europe and the USA has focused on areas such as new adjuvants, pediatric and adult combination vaccines, pneumococcal conjugate, Hib conjugate, meningococcal A & C conjugate, typhoid fever, Hep B, varicella-zoster, measles, rabies, dengue and Japanese encephalitis. Formerly Chairman of the clinical working group of the European Vaccines Manufacturers, he has also held governmental positions at the Ministry of Health in Somalia and as Medical Attaché to the French Embassy in Beijing, China. He graduated in medicine and gained an additional diploma in Tropical Diseases, Health & Development, and Statistics applied to Epidemiology and Clinical Research at the University of Bordeaux and the University Pierre & Marie Curie, Paris.
She is a Scientist, Group Lead, Vaccines Assessment PQ HIS/EMP/RHT/PQ within the WHO Prequalification Program, Regulation of Medicines and other Health Technologies. A pharmacist specialized in microbiology, she has 25 years experience in the area of regulation of biologicals, including quality control of vaccines, blood products and recombinant products, and is author of several publications in the area. She participated in the revision of the Venezuelan regulations of Pharmaceutical and Biologicals, as well as coordination of activities for the Latin-American network, PAHO, in Washington, DC, and participated in assessment of National regulatory Authorities located in the Americas, Europe and Asia.
Master of Pharmacy Degree (MPharm). She is currently Senior Project Manager at Clinical Vaccines Management at GSK Vaccines Italy. She manages the clinical supply chain from end to end for the Meningitis program. She has worked as Hospital Pharmacist in UK, and later moved to the Pharmaceutical Industry in biotech R&D field. First at Genzyme in The Netherlands and later at Tigenix in Spain. She has over 10 years’ experience in biotech clinical supplies at international level with an emphasis on biotech drug development (vaccines, cell therapy, gene therapy) and project management. She obtained her degree in Pharmacy at University of Salamanca, Spain.
She is the Head of Vaccine Programs at Institut Pasteur, Paris, France, since July 2015. Before, Christiane held appointments at Sclavo Behring Vaccines Institute for Global Health (previously Novartis Vaccines Institute for Global Health). As Shigella Project Leader she led the development of a vaccine against shigellosis based on a novel technology, called GMMA, taking S. sonnei GMMA from the bench to first in human clinical studies. With this experience, Christiane then took responsibility to oversee and coordinate GMMA vaccine projects as Technology Platform Leader. She is still the Principle Investigator for the SBVGH Shigella project in the EU STOPENTERICS program. Christiane received her Ph.D. in Microbial Genetics in 1997 from the University of Tuebingen, Germany, and trained as postdoc at Stanford University, USA, with focus on host-pathogen interactions.
She is Senior Director Epidemiology Sanofi Pasteur in Lyon in charge of the nosocomial and innovation franchise, development and management of the Epidemiology strategy to support vaccines at the early stages of development measures of unmet medical needs, design and supervision of epidemiological studies; methodological advice. She got a medical degree in Lyon, France and a PhD in Tropical Health Epidemiology from the London School of Hygiene and Tropical Medicine, UK. From 1989 to 1990 she worked with Médecins Sans Frontières Humanitarian Medicine in Uganda & Thailand. After this experience she was for 8 years Clinical Epidemiologist in Thailand & Vietnam, at Wellcome Trust-Mahidol University-Oxford Tropical Medicine Research Programme; implementation of cohort studies for malaria research. She is author of 80 publications in peer-reviewed journals.
From 2009 he is Head of the Unit for national scientific-regulatory advice & knowledge Management at Federal Agency for Medicines and Healthcare Products (FAMHP) in Brussels, Belgium. He previously was chemical-pharmaceutical assessor at the same agency. From 1998 to 2004 he was Scientific Personnel (Research & Development) at Gent University in Belgium performing research activities in preparation of a PhD. thesis in Pharmaceutical Sciences. He got a Master and a PhD in Pharmaceutical Sciences both at Gent University. He has a big expertise in drug development, radiopharmaceuticals, nuclear medicine and molecular imaging, clinical trials, scientific-regulatory advice, management, early market access and health technology assessment (HTA), drug-device combination products (DDCP's) and author on many scientific publications.
Claudia is a graduate with a major in Biology from Universidade Santa Úrsula in Brazil. Additionally, she completed post-graduate work in Medical Management at CONCEMA Management Akademie in Germany and an extension program on Instructional Design and e-learning at IBDIn Brazil. She began her professional career by accumulating seven years of experience in the conduct of applied research in molecular biology. Subsequently, Claudia’s career path led her to Institut Virion, where she was involved in serological assay production. She then seized the opportunity to join the pharmaceutical industry, spending four years as a Clinical Research Associate with GSK, followed by her current tenure of nine years with Novartis Vaccines/GSK. Claudia has contributed in various areas including clinical monitoring, pharmacovigilance, and training. In 2010, she was appointed Training Manager for Region Latin America, which was followed by her relocation to Italy in June 2014 for her current appointment.
He is currently Medical Affairs manager, Region Europe, GSK, Basel, Switzerland. Dr. Claudius Malerczyk graduated from Johann-Wolfgang-Goethe-University School of Medicine, Frankfurt, Germany, in 1994 and completed his medical doctor thesis in 1995. After residency in internal medicine and clinical research, he held two post-doctoral positions at Georgetown University Washington, DC, and Philipps-University Marburg, Germany. Dr. Malerczyk received his board certification in the field of pharmacology and toxicology in 2001. In 2002 he joined pharmaceutical industry and became responsible for clinical research of rabies vaccines. Since then he held several positions in the Clinical and Medical Departments of Novartis Vaccines. In 2009 he became Head of Medical Affairs for region Middle East & Africa. Since January 2013 he is Head of Medical Affairs Region International VACS (Vaccine Cluster Services) including country clusters of Middle East, North Africa, Subsaharan Africa and South East Asia.
He is associate Vice President R&D strategy at Sanofi Pasteur Cambridge USA. Prior to this, he was Head, Medical Affairs and Immunization Policy, Region North America, Novartis Vaccines and Diagnostics. Clement has over 15 years of vaccines industry experience in a variety of marketing, scientific affairs and policy roles. He started his career in Vaccines at Merck Vaccines Division where he held a variety of domestic and international marketing positions contributing to the launch of Varivax® and the early marketing planning activities for Gardasil®, ProQuad®, Rotateq® and Zostavax®. He was also at Chiron Vaccines as Vice President Strategic Planning & Business Intelligence and then Vice President Government Affairs & Immunization Policy for the US. Prior to joining Novartis he was Vice President of Marketing, Policy and Strategy at Acambis responsible for Government Affairs. In addition to his experience in vaccines, Clem was at Bayer Pharmaceuticals as Director of Global Scientific Affairs for their anti-infective franchise.
Daniel Brasseur is bachelor of the European School in Brussels and was graduated as a licensed paediatrician (1981) after studying medicines at the Free University Brussels (ULB). After a 3 years stay in Central Africa and 2 years as a Medical Director in Industry, he moved to the University Children’s Hospital Queen Fabiola (Belgium) and specialised in nutrition. At the laboratory of Paediatrics and Metabolic Diseases, he built up a unit for Nutrition and Pharmacology. He studied the impact of diet and nutrition on several enzymatic systems and immune reactions. His interest in infantile research led him to chair since 1994 the Ethical Committee of his Institution (up to 2001) and to participate to the evaluation of new and innovative drugs. This naturally brought him to take part in his National Drug Commission as an evaluator and further (1997) as a co-ordinator of the team of medical assessors at the Federal Ministry of Public Health. He continued his activities and moved to the Federal Agency for Medicines and health products (FAMHP) when this body was created (January 2007). He joined CPMP in 1997 at the European Medicines Agency (EMA, London) and was elected chair in 2001 up to 2007. He was also the Chair of the CHMP-Paediatric Expert Group and a member of the CHMP-Vaccine Expert Group at the same Agency. Later in 2007 he became chair of the Paediatric Committee (PDCO) at the EMA and was re-elected in 2010. He is the author or co-author of more than 100 publications and communications in paediatrics, nutrition and infantile pharmacology.
He is RA Senior Group Manager at GSK Siena. He got a Degree in Pharmacy in 2003 at Università degli Studi di Siena, Italy. After that a MSc Health Economics, Policy and Management at the London School of Economics and Political Science (LSE) in 2004. He joined the company Chiron Vaccines in Siena in 2004 as Regulatory Affairs Specialist, from 20017 to 2008 he moved to Hoffmann-La Roche as International Regulatory Affairs Manager. Since 2008 he is in Novartis Vaccines and Diagnostics (now GSK) covering roles of increasing responsibilities: Regulatory Affairs Manager, Senior Manager Regulatory Affairs and now RA Senior Group Manager.
He has over 20 years of experience in the Pharmaceutical Industry, predominantly in the areas of Regulatory Affairs and Vaccines. Eddie has held positions in the Irish Medicines Board (now HPRA), Novartis Vaccines & Diagnostics and GSK Vaccines. Eddie lead the Regulatory CMC and Device group for the Sanofi Corporation. An Irish national, Eddie is a qualified pharmacist and has an advanced degree in Pharmaceutical Medicine. Earlier in his career, he has been a Pharmaceutical Assessor with the Irish Medicines Board (now the HPRA). Currently, Head of Global Regulatory Affairs for Sanofi-Genzyme, Cambridge, MA, USA.
Work Experience: Senior Manager Clinical Vaccines Management 2014 to present; Technical Development Senior Project Manager Meningitis & Sepsis Franchise 2012 to2014; Technical Operations Project Manager for MenB Franchise 2006 to 2012; Industrial Product Manager 2004 to 2006; Industrial Product Management Expert 2003 to 2004. Education: Master’s Degree in English Languages and Literatures, University of Siena, Italy, 1998; Bachelor’s Degree in Biological Sciences (expected), University of Siena, Italy.
Elisabetta is currently Sr Alliance Management at Vaccines Business Unit at GSK Basel, Switzerland. She graduated in Biological Sciences in Rome, University “La Sapienza”, with a thesis on Molecular Biology on the topology of the DNA. Following the graduation, in 1987 she was employed in the Research Center of Sclavo (the formerly research center of Novartis Vaccines Siena) as Researcher dealing with Transgenic Mice techniques and molecular biology topics. In 1991 she moved to the Clinical Department of the same company, as Clinical Research Associate involved in the clinical development of several Chiron vaccines: Acellular pertussis, Hepatitis A, Haemophilus influenzae type b, Flu. In 1994 she got the specialization on Biochemistry and Clinical Chemistry at Siena University. In May 1999 she was asked to establish the Clinical Quality Assurance department of Chiron Vaccines in Siena, with the title of Manager Clinical Quality Assurance. Her main task was the planning and management of GCP and GCLP audits in Italy, Europe, and USA for clinical trial, as well as of system audits and CRO qualification audits. In this position she acted as reference person for Regulatory Authorities inspections occurring in Italy. The revision of the study documents used in Clinical Trials was another activity supported by the CQA department, and at the same time Elisabetta acted as advisor on ICH GCP and on local requirements of the Clinical Department. She acted as “Training specialist”, in particular on Standard Operating Procedures, many of which she was the author and reviewer, to the Clinical Department staff and Clinical Site staff. As of 20 April 2006 Chiron Vaccines has become Novartis Vaccines and Diagnostics, and due to organizational changes Elisabetta’s title became Head of Clinical Quality Assurance, Novartis Vaccines (now GSK Vaccines), Siena, keeping the previous responsibilities with the addition of the coordination of the GLP studies for compliance.
He is currently Project Leader, GSK, Siena, Italy. Fabio Bagnoli is Project Leader at GSK Vaccines, Siena, Italy. He received a Master of Science degree in Molecular Biology from the University of Siena. The topic of his thesis was the study of the Helicobacter pylori proteome by two-dimensional electrophoresis. Fabio holds a Ph.D. in Molecular and Cellular Microbiology from the University of Padova. His doctoral research evaluated host-pathogen interactions, with a focus on the Type IV secretion apparatus of H. pylori. He received his post doctoral training at the University of Stanford on the role of CagA in altering host cell polarity, motility and invasiveness. This research was mainly focused on confocal and live microscopy studies as well as the transient and stable transfection of epithelial cell lines. He joined Novartis (now GSK) in 2006 as Associate Project Leader for Streptococcus pneumoniae vaccine discovery. In 2010 he was appointed as Project Leader for vaccine research on Staphylococcus aureus. Fabio started the project from scratch as visiting scientist at the University of Chicago from where he transferred to Novartis (now GSK) the knowhow on infection animal models, functional studies of virulence factors and basic methods of staphylococcal mutagenesis. He then created a team (18 full time employees) at Novartis (now GSK) that led to the identification of several potential vaccine targets, including several newly discovered antigens. In 2013 Fabio set up a new laboratory platform within the Immunology Unit with the aim of developing immunological correlates of protection on the basis of human skin equivalents and whole blood assays. The work of this platform was rewarded with the Novartis 3R award for its high innovative value and its potentials to replace animal models. Research activity of Fabio has been published in important peer-review journals including PNAS, FASEB, Biochemical Journal of, Journal of Infectious Disease, Molecular Microbiology, and Infection and Immunity. Furthermore, he is the editor of two books on vaccines, of one on protein export systems of Gram positive bacteria, and of one on Staphylococcus aureus, and he is associate editor of Frontiers Immunology journal.
Fabio Rigat is Head of Research Biostatistics at GSK, Siena, Italy. He was Head Preclinical Biostatistics Research Group at Novartis Vaccines, which covers a broad range of topics, ranging from the translation of preclinical experiments results into the design of phase I clinical trials, to understanding the variability of human responses to multi-component protein vaccines and to the assessment of predictive biomarkers for the development of glycoconjugate vaccines. His main research interest is the statistical modeling of biological processes, focusing on statistical immunology for vaccine development. Previously he was Assistant Professor of Statistics and Analytical Science at the University of Warwick, UK, where he worked as a postdoctoral research fellow. He also holds a BSc Economics, from Pavia, Italy, and an MSc and PhD in Statistics, from Duke, USA.
Fabrizio Tediosi is an economist specialized in public health and health systems and policy analysis. In Swiss TPH his current research interests focus on a) how to strengthen institutions to promote good governance of health systems and translating evidence to policy; b) developing and applying methods to evaluate and validate health interventions for delivering them at adequate levels of effective coverage. He is also Adjunct Professor and associate researcher at Bocconi University, Milan, Italy. He got a PhD in Epidemiology (Int. Public Health) at University of Basel, Switzerland (2009) a MSc in Health Economics at University of York (1996-07) and a BS in Economics and Business at University of Pavia, Italy (1990-95).
He is Clinical Research and Development Lead, Rixensart, Belgium. François is a medical doctor working as Director, Clinical Research and Translational Science (CR&TS) at GlaxoSmithKline Vaccines, where he leads the clinical development of Ebola and HIV vaccines. He completed an MD (1996) and a PhD degree (2006) from the Catholic University of Louvain, Belgium, and was trained as an infectious disease specialist. Before joining GlaxoSmithKline Vaccines, he worked as research fellow, then as head of the clinical virology unit at the Retrovirology Laboratory of Luxembourg (1999-2007). During that period, he focused his research on HIV-1 entry and entry inhibition and on the molecular epidemiology of chronic viral infections. He joined GlaxoSmithKline Vaccines in 2007 where he served as Senior Manager then Director in the clinical development of vaccine programs including Flu Seasonal and Pandemic, HIV, COPD, CMV and Ebola vaccines.
Frank Bretz is Global Head of the Statistical Methodology group at Novartis Pharma Basel, Switzerland. He has supported the methodological development in various areas of drug development, including dose-finding, multiple comparisons, and adaptive designs. He is an Adjunct Professor at the Hannover Medical School in Germany and the Shanghai University of Finance and Economics in China. He has held several roles at the International Biometric Society and is currently a member of the American Statistical Society (ASA) Committee on International Relations in Statistics. He currently serves as an Associated Editor for Biometrics, Statistics in Medicine, BMC Medical Research Methodology, and Journal of Biopharmaceutical Statistics. He has authored or co-authored more than 90 articles in peer-reviewed journals and four books.
Currently Head of Clinical Vaccines Management (CVM) at GlaxoSmithKline. The CVM team is responsible for managing all aspects of material supply for clinical vaccine trials and the Interactive Response System associated with patient randomization and supply management. She obtained a Bachelors Degree in Biology from Gettysburg College and a Masters in Education, Biology from Shippensburg University. She has 19 years experience within GSK and Novartis, specializing in manufacturing and quality operations, project and portfolio management, product development and technology transfer, and clinical supply. She has received two Novartis Operational Excellence awards.
Gaia got a Master’s Degree in Chemistry. She works within the company since 14 years and from January 2012 she is QA Clinical supplies specialist. Her main tasks: to ensure coordination and appropriate management of batch release workflow supporting specific issued before escalation to team manager; DR, CAPA, PTC Management and Recovery coordinator for clinical trial material; to ensure timely release of Investigational Medicinal products (prepare batch release documentation, approval of PSF, allignment with Regulatory Submission), including tox batch release; Manage study specific Clinical Supplies GMP related activities (labels review, 3° party secondary packaging BPR review, quality oversight of clinical supplies distribution and transport). Her previous experiences in the company: (March 2001 – May 2004) Clinical Quality Assurance GCP Officer; (May 2004 – June 2009) Clinical Quality Assurance Auditor I and II; (June 2009 – January 2012) Global CQA Manager, Vendor Qualification, CAPA Management.
Senior Group Manager, Regulatory Affairs Business Process Improvement, GSK Vaccines (previously NVD). Gary has over 20 years of experience in the pharmaceutical industry. Before moving to NVD, Siena in 2011, he worked in Vienna, Austria at Immuno AG and Baxter Innovations in Clinical Research and Regulatory Affairs. He is an industry representative on the Article 57(2) Implementation Working Group, collaborating with the European Medicines Agency to define processes to support the EudraVigilance XEVMPD and ISO IDMP standards.
Dr. Gary Dubin, MD is Senior Vice President and Head of the Global Medical Office in the Takeda Vaccine Business Unit (VBU). Dr Dubin joined Takeda in September of 2015 and leads the Medical Affairs and Policy functions for vaccines and is responsible for safety and medical governance. Dr Dubin also serves as the Global Program Leader for Takeda’s Zika vaccine development program Dr Dubin has more than 30 years of experience in vaccine research. Prior to joining Takeda, he spent 20 years at GlaxoSmithKline (GSK) Biologicals (now GSK Vaccines) where, since 2010 he held the role of Vice President and Head, Global Late Clinical Development. During his career at GSK, he led global teams responsible for the clinical development and licensure of a broad range of vaccines addressing important unmet medical needs, including seasonal influenza (Fluarix Quadravalent and FluLaval Quadravalent), pandemic influenza (Pandemrix and Aprepandrix), meningococcal meningitis (Menhibrix and Nimenrix); human papilloma virus (Cervarix), rotavirus (Rotarix), strep pneumonia (Synflorix and protein-based vaccine in phase II development), malaria (RTS,S vaccine; submitted for licensure), herpes zoster (phase III); measles/mumps/rubella (US development program, phase III); tuberculosis (phase II), and others. He also supported Medical Affairs activities for these development programs and served as a core member of all major medical governance committees at GSK, including their Vaccines Medical Governance Board and the Vaccines Safety Board. Dr Dubin holds a medical degree from the University of Pennsylvania and completed his Adult Internal Medicine residence training at the University of Colorado. He completed a fellowship in Clinical Infectious Disease and a postdoctoral research fellowship in Molecular Virology at the University of Pennsylvania. Prior to joining GSK, Dr Dubin served as Assistant Professor of Medicine in the Infectious Disease Division at the University of Pennsylvania and currently serves as Adjunct Associate Professor of Medicine at the same institution. He holds numerous patents in the vaccine filed and has co-authors more than 80 scientific publications.
From March 2015 she held the role of Quality and Operations Manager, GSK Vaccine Institute for Global Health, Siena. She had the same role at Novartis with these tasks: to develop and maintain the appropriate procedures in order to ensure that the NVGH (Novartis Vaccines Institute for Global Health) already developed processes, can be readily transitioned to GMP contract manufacturers; Responsible that GMP contract manufacturers involved with clinical trials, are at a standard that meets appropriate quality requirements. She was previously Analytical Compliance Manager and QC System Manager. She got a degree in Pharmaceutical Chemistry at University of Pisa in 2002 thesis in phytochemistry.
Her current role is QA Ecompliance Manager at GSK Vaccines Srl (previous Novartis Vaccines) from May 2011. Among her tasks: to define Validation Strategy and Compliance for Computer Systems (IT Application, Process Automation and Lab Systems, SCADA, desktop application, MES, Hybrid Systems, excel spreadsheet, Network Infrastructure), SW Supplier Auditor; to define compliance guidelines for review of data from Hybrid systems and Audit Trail; to define compliance guidelines to maintain Computer Systems into a validated status. From 2008 to 2011 she was QA Ecompliance Coordinator (QA CSA -qa computer system and applications) at Novartis Vaccines Srl. She also had a long experience, 5 years Bayer Biologicals s.r.l. in Sovicille (Siena) Gmp Compliance Expert, reporting to the Head of Operations. In 1999 she got a University Degree in Chemistry at University of Calabria, Arcavacata, Cosenza Italy and in 2002 a PhD in Chemical Science, XV Cycle, thesis title “Modification on protected sugars” at the same University.
Degree in Chemistry and Pharmaceutical Technology. Overall more than 15 years RA experience within Industry. Since 2004 working in vaccines mostly on development and licensure of Bexsero and combination and now Global Regulatory Leader for Meningococcal ABCWY, Specialties and early in RDC Italy within GSK currently, he is Regulatory Affairs Senior Group Manager at GSK Siena.
He is currently Group Lead, Technical Regulatory Affairs at Roche in Basel Area, Switzerland. He previously was Head of Regulatory Affairs at Novartis Influenza Vaccines Responsible for leading global Regulatory Affairs function within the Novartis Influenza Vaccines (NIV) Business and Head Regulatory Affairs, Influenza Franchise at Novartis Vaccines and Diagnostics Responsible for leading the global Franchise Regulatory Affairs team located across the Novartis Vaccines network. In Novartis he also covered the role of RA Senior Group Manager CMC and Regulatory Affairs Manager (from 2002 to 2012). He got a B.Sc. (Pharm), Pharmacy and a Postgraduate Diploma, Quality Improvement both at Trinity College, Dublin.
He is currently Global Medical Expert at Sanofi Pasteur, Lyon, France. Graduated Medical Doctor from Lille Catholic Medical University in 1982, followed by a Master degree in Clinical Pharmacology & Toxicology (Paris 1986) and Master in Pharmaco-Economics (Lyon 1999). Currently working within Global Medical Affairs team in Sanofi Pasteur headquarters as a Global Medical Expert since 2002. Most responsibilities are linked to yellow-fever vaccines, Japanese encephalitis new recombinant vaccine, rabies vaccines and immunoglobulins. Main activities are related to medical support and expertise for clinical development (ongoing and future vaccines), regulatory affairs, pharmacovigilance and commercial operations as well as scientific coordination for publications, training, meetings and symposia. Previously involved from 1985 to 2001 in Clinical research and Medical Affairs for different pharma companies mainly in the Central Nervous System area for related drugs: antipsychotics, antidepressants, anti- Parkinson and anti-Alzheimer compounds.
Her current role is LimmaTech - GSK Liaison Leader at R&D Center Siena, GSK Vaccines. From November 2013 to December 2015 she was Head Program Office and Process Improvement, leading Business Improvement initiatives within Clinical Development Clusters organization at Novartis Vaccines Srl in Siena. Ilaria previously worked as Senior Manager, SOPs and Process Governance in Clinical Development for 5 years. She started her career in pharmaceutical industry in Chiron, in 1996 as Clinical Research Associate and since then covered roles of increasing responsibility within Clinical Operations. Education: 1999: Post-graduate diploma in Microbiology and Virology (PhD), University of Siena; 1994: University Degree with Honours in Biology, University of Siena.
She is currently Project leader, Bacterial projects II at GSK Siena (formerly Novartis Vaccines), having previously led the Group A and Group B Streptococcus project. The genomic studies she started have led to the discovery of broad-coverage protein-based vaccines against Group A and Group B Streptococci and of covalently-linked pilus-like structures on the surface of these important human pathogens. She obtained her degree in Biology in Barcelona, Spain, and her PhD in Human Genetics from the University of Rome, Italy.
He is currently President of the Brighton Collaboration Foundation, an international not-for profit organization harmonizing, conducting, and promoting high quality vaccine safety research based in Basel, Switzerland. Assistant Professor of pediatric infectious diseases and vaccines at the University Children’s Hospital Basel, Switzerland. During the last 12 years of his work, he was instrumental in building-up the network and coordinating research at the Brighton Collaboration. He co-developed multiple internationally accepted vaccine safety research standards. This includes widely endorsed and used standard case definitions, terminologies, and ontologies, as well as frameworks of applied semantic logics for automated data classification. He also co-developed electronic tools facilitating online collaboration and data processing and has coordinated multinational epidemiologic studies investigating vaccine safety concerns. He has published over 40 peer-reviewed articles in Journals including BMJ, Lancet ID, CID, Pediatrics, Vaccine and PIDJ. Leading public health Organizations including WHO, CDC, ECDC, EC/DG Research, IMI, FDA, and Health Canada fund his work. His mission is to provide high quality scientific evidence through collaborative efforts for trusted and timely public and private decision making related to immunizations.
Jan Jacobs Medical doctor KU Leuven, (Belgium 1984), Clinical Pathologist (Belgium, 1989), Clinical Microbiologist (The Netherlands, 1991), PhD on invasive streptococci (“Streptococcus milleri", Maastricht University), Hospital Hygiene 1991. From 1990 to 2005, he was working at the University Hospital of Maastricht and involved in diagnostic microbiology, infection control and teaching. He received several teaching awards (Best Lecturer (2001, 2003) and Best Tutor (2005), Faculty teaching award in 2005). Since 2006, he is appointed at the Institute of Tropical Medicine (ITM) as Professor in Tropical Laboratory Medicine, since October 2014, he has a 10% appointment as Professor at the Department of Immunology and Microbiology, University of Leuven. Currently, Jan Jacobs is involved in patient care (part-time supervising the diagnostic laboratory of the travel clinic of ITM), teaching (Infection Control and Laboratory Practicals at ITM) and in oversea capacity building projects about laboratory quality management, microbiological surveillance of invasive diseases in resource limited settings and antibiotic resistance/infection control. He is (co)-promoter of ITM institutional projects in the Democratic Republic of the Congo, Burkina Faso and Cambodia. At KU Leuven, he coordinates the course “Biomedical Development Cooperation”. His current research focuses on tropical bacteriology, with projects addressing invasive salmonellosis, appropriate microbiological techniques and antibiotic resistance. As to Infection Control, Jan Jacobs is in charge of the lectures of “Infection Control in Resource Limited Settings” of the course “Tropical Medicine and International Health” at ITM, and he is coaching the Infection Control activities of the Cambodian ITM partner (Sihanouk Hospital Center of Hope, Phnom Penh). Jan Jacobs is member of the European Society of Clinical Microbiology and Infectious diseases as well as from the American Society for Microbiology and has been board member of the Belgian Society of Clinical Microbiology and Infectious Diseases (2008 – 2013). He is technical advisor for the World Health Organization’s Prequalification of Diagnostics Program (test product review, ISO 13485 manufacturing site inspections), chair of the Procurement and Supply Working Group on Diagnostics from Roll Back Malaria Partnership and member of the World Health Organization Global Task Force for Cholera Control. Jan Jacobs is (co)author of > 180 research papers in peer-reviewed international journals.
She is currently Senior Group Manager, Regulatory CMC, GSK Vaccine NL. Mrs Rahbek has a Master Degree from Copenhagen University (PHARMA) in Pharmaceutical Development. In addition a Master Degree in Human Biology (MEDICIN) also from Copenhagen University. Mrs. Rahbek has worked in the pharmaceutical industry for more than 20 years in Research and Development with ALK Abello, product development and project management with Genmab and for the last 4 years as manager of Regulatory CMC for Novartis now in transition to GSK. Mrs. Rahbek has achieved approvals of an animal model for desensbilisation of environmental allergies; she has contributed in approvals of a monoclonal antibody and late she has been the lead CMC for the approval of Bexsero.
Professor Heinz-Josef (Joe) Schmitt obtained his MD, PhD from Johannes Gutenberg-University, Mainz, Germany in 1980. Following a fellowship at the Infectious Diseases Service of the Memorial-Sloan-Kettering Cancer Center in New York, he passed board-certifications in microbiology, pediatrics and infectious diseases. Following a huge research plan on the clinical development of acellular pertussis vaccines and their combinations at the University in Mainz, he was appointed full lifetime Professor at the Christian-Albrechts-University, Kiel, Germany, in 1995. In the same year he was appointed as a member of the German NITEC (STIKO), and he became the chairmen of this governmental advisory board in 1998 until he stepped down from the position in 2007. Besides continuing vaccine research, in Kiel, the epidemiology of respiratory infections became a second topic of his work based on innovative development of molecular tools to detect respiratory viruses in clinical specimens. In summer 2000 Schmitt accepted an offer as Professor of Infectious Diseases and Vaccine Development at the Johannes Gutenberg-University, Mainz, where he still is a member of the faculty. Professor Schmitt served as an advisor to the World Health Organization from 2003 to 2007 in various committees, including the Strategic Advisory Group of Experts on Immunization (SAGE). He was General Secretary of the Society of Independent European Vaccination Experts (SIEVE; 2003–2007). In 2006, he received the Helmut Stickl Award from the German Academy of Pediatrics for outstanding work in promoting the use of vaccination to prevent infectious diseases. He joined industry 2007 and currently is a Senior Director medical and Scientific Affairs (Vaccines) with Pfizer International Developed Markets based in Paris. He is (co-) author of more than 100 scientific articles, has contributed to various chapters in scientific books, and has given numerous presentations around the globe.
He is Malaria and Ebola vaccine development Director, Clinical Research and Translational Science, GSK Vaccines. Johan Vekemans is a Belgian pediatrician with a strong interest in research relevant to global health, and more particularly to pediatric diseases in tropical areas. As a graduating young doctor and PhD student he conducted laboratory immunology research investigating early life vaccines, maternal and neonatal Chagas disease and tuberculosis antigens. He also trained as an epidemiologist at the London School of Hygiene and Tropical Medicine. He lived, and worked as a researcher, in The Gambia, Bolivia, Italy and Belgium. Since about 10 years, he worked on malaria vaccine development at GSK Vaccines, being involved in project strategy, study design, protocol development, analysis planning, clinical care in rural African hospitals, vaccine safety review, malaria immunology, research centre capacity strengthening, Independent Data Monitoring Committee interactions, ethics of research in resource poor countries, scientific publications. He was involved in Phase 1 to Phase 3 vaccine research in the context of public-private collaborations.
He is President and director of KeithVeitch Communication in Amsterdam, Netherlands. He has a BSc & PhD in Biochemistry. His long professional career includes: 12 years of Post-Doc academic research, 10 in Belgium; 5 years at GSK Biologicals as Publication Writer/Manager; 7 years at Sanofi Pasteur as Director of Publications; 5 years at NVD as Head of Global Publications. Moreover he is Board member of ISMPP and TIPPA and Co-author of GPP3, published August 2015.
He is Professor of Child Health & Vaccinology London Sc. of Hygiene & Tropical Medicine, London, UK. Kim is an Australian paediatrician with extensive experience in research leading to or evaluating the introduction of new vaccines in the developing world. Between 1989 and 1995 he lead the Hib vaccine research program in the Gambia, which involved three Phase 2 trials of Hib vaccine, a maternal immunization study and a large Phase 3 trial. The latter study formed the prototype for future pneumococcal vaccine trials. Between 1995 and 2000 he worked at WHO Geneva, where his work included assistance with the design and oversight of the Gambian and South African pneumococcal trials. He also established the Pneumonia Trialist Group that established standardized methods and definitions for pneumococcal carriage and radiological pneumonia in vaccine trials. Since 2000 he has worked in academic institutions in the UK (London School of Hygiene and tropical Medicine) and Australia (Menzies School of Health Research, Darwin and Murdoch Childrens Research Institute, Melbourne) where he conducts research programs in the Asian-pacific area.
Laura Lulli received her degree in Pharmaceutical Chemistry and Technologies in University of Milan (Italy) in 1997 and in addition she got a Master in Scientific Communication in the same University in 1998. She has been working in Clinical Research since 2000, starting as a CRA in a local CRO, OPIS. Her career continued at Novartis since 2004 with growing responsibility, taking on project and people management responsibilities as CRA Group Head in the areas of Diabetes, Hypertension, Neurosciences and Multiple Sclerosis. In 2011 she moved to Novartis Vaccines (now GSK Vaccines) where she has been working as Clinical Operation Manager and Country Head for Italy and Spain.
She is currently Principal Scientist GBS Clinical Laboratory Sciences, GSK, Siena Italy. Laura holds a degree in Biological Sciences at the University of Rome "La Sapienza" (Italy), a Ph.D. in Microbiology from the ETH Zürich (Switzerland), and a post-doctorate at the Laboratoire de Biologie Microbienne at the University of Lausanne (Switzerland). In 1998, she moved at the Department of Pathology and Microbiology, University of Bristol (UK) for a Research Associate position, in the group directed by Prof. Mumtaz Virji to investigate the virulence determinants involved in the pathogenesis of Neisseria meningitidis. In 2002, she moved to Chiron (Novartis Vaccines, now GSK), Siena (Italy), to be appointed as Research Investigator at the Research Centre to carry out a project on the functional characterization of Neisseria gonorrhoeae antigens, as potential vaccine candidates. In 2005, she became Project Leader at the Research Centre of Novartis Vaccines, Siena (Italy), managing a project on the development of a vaccine against pathogenic Escherichia coli. In 2013, she joined the Quality Control in Novartis on a 12-months job assignment as QC Immunology Head with the responsibility of serological and non-serological release testing for all vaccine produced in the Company. Since November 2014, she was appointed as the GBS Principal Scientist in the Clinical Laboratory Sciences department, Marburg (Germany). An active member of the scientific community, she has published over 30 papers and she is principal owner of more than 10 patents related to vaccine candidates for Neisseria and E. coli.
Laura got her University Degree in Pharmaceutical Chemistry and Technology in 2003 and one year after she obtained a Master diploma in Clinical Research, Regulatory Affairs and Marketing. She started working in Novartis Vaccines on Jan 2006 as Clinical Research Associate. Previously she worked at the same company as Clinical Trial Manager and Senior Regional Clinical Study Coordinator. Some of the projects she managed: III Influenza Vaccine, III Meningitidis 1, III Meningitis trial, II Meningitis trial, II Pandemic trial, Streptococcus trial etc. working with centers in Switzerland and Spain. She is currently Clinical trial Manager at GSK Vaccines SRL in Siena.
She is Global Regulatory Affairs Technical Director of facilities at GSK Rockville, USA. Responsible for management and leading of global team for submitting and communicating new vaccine product licensure and post-approval CMC/facility changes to the FDA, EMA, International health authorities for international biological vaccine sites. Lead several Type C meetings and discussions with FDA and review of scientific advice documents for EMA. Prior to this, within the same company, she was Associate Director Regulatory Affairs from 2005 to 2014 (as Responsible for submitting and communicating new vaccine product licensure and post-approval CMC/facility changes to the FDA for international biological vaccine sites. Discussions with Regulatory Authorities, including Type C meetings and GMP site inspections. Management of Global Regulatory Cross Product Team for post approval submissions worldwide. Previous experiences in Centocor as Sr QA Compliance Associate and as Sr Process Scientist. She got a Bachelor's Degree in Chemistry and a Master's degree, Quality Assurance/ Regulatory Affairs.
He is Clinical Operations Manager at PATH, Geneva (CH) working on Meningitis Vaccine Sustainability Project (MSP) and Pneumococcal Vaccine Project (PVP). His tasks: Clinical Operations Lead for the implementation of Phase I/II to Phase IV Clinical Studies following ICH-GCP and relevant epidemiological guidelines and development of Standard Operating Procedures and Quality Assurance processes for clinical studies. Lionel joined PATH in December 2005 as Clinical Assistant to provide administrative support to the MVP (Meningitis Vaccine Project) clinical team and since then covered roles of increasing responsibility such as Clinical Research Associate for the Meningitis Vaccine Project; Senior Clinical Research Associate and Clinical Operations Lead. Since December 2006, he has worked on the clinical operations aspect of MVP clinical trials in Africa and India. He contributes to the development of clinical protocols and study guidelines, trial site selection, and site training process. He manages activities with contract research organizations and the clinical sites. Prior to joining MVP, he worked for the United Nations Conference on Trade and Development in a technical and administrative support role for regional workshops in Africa and Asia on issues of trade, development, and competition. He has also worked for the United Nations Institute for Disarmament Research. Lionel Martellet has an MA in international relations from Sussex University, United Kingdom, a BA in business administration from Temple University in Philadelphia and a MSc in Statistical regression, Methods in health statistics, Methods and practices in epidemiology at Université Victor Segalen (Bordeaux II, France).
He is currently clinical trial leader at GSK Vaccines in Siena. Among his responsibilities: Overall accountability of multinational clinical studies; authoLead author of study documents e.g., Protocol/Amendments, Inform Consent Forms, Diary Card and lead authoLead author of study documents e.g., Protocol/Amendments, Inform Consent Forms etc.; Support Project Team in determining the overall clinical strategy and objectives of trials; ensure continuity and alignment with trial objectives overall clinical program throughout the trial. He got his degree in Pharmacy at University of Treviso, Italy in 2012 and two master’s degree one in Clinical Research obtained in Milan and another one in pharmaceutical chemistry and technologies at University of Padova.
He got a Diploma (M.Sc.), Study of chemistry at Friedrich Schiller University, Jena, Germany. Manfred is currently Head Development QA Clinical Laboratory Sciences at GSK since Sep 2014. He previously was Manager Development QA for Technology Development, later on for Clinical Laboratory Sciences and Manager Clinical Quality Assurance within the same company. From 1985 to 2002 he was Scientific Associate Director, first in Quality Department and later in Pharmaceutical and Analytical Development Department at Jenapharm GmbH, Jena, Germany (acquired by Schering AG in 1996). From 2002 to 2004 he was Head of Pharmaceutical and Analytical Development at TAD Pharma GmbH, Cuxhaven, Germany. Manfred is author of many publications Publications, Patents and Public Lectures in the fields of analytical and galenical development.
He is currently Director Technical Services Serum Institute of India, Washington DC, USA. Dr. LaForce completed his internal medicine and infectious disease training on the Harvard Service at Boston City Hospital. Dr. LaForce held research, clinical and senior administrative positions at the University of Colorado Rochester Schools of Medicine. From 1994 to 2001, he chaired the Steering Committee on Epidemiology and Field Research for WHO’s vaccine cluster. From 2001 to 2012 Dr. LaForce directed the Meningitis Vaccine Project, a partnership between PATH, WHO and the Serum Institute of India that led to the development and introduction of an affordable Group A meningococcal conjugate vaccine in Sub-Saharan Africa. In 2012 he joined the Serum Institute of India, Ltd. as Director, Technical Services.
He is Senior Cluster Physician, Bexero, Menjugate and New Generation Meningococcal Vaccines, GSK, Italy. As a Cluster Physician in Novartis Vaccines since the beginning of 2013, Marco contributes to the clinical strategy of the development of meningococcal vaccines and is the author of a number of clinical documents within the Meningitis B program. Marco graduated in Medicine at the University of Rome “La Sapienza”. Formerly a researcher at the Universities of Liverpool (Neuroscience), Barcelona (Experimental psychology) and Pompeu Fabra (Information technology) he has had a varied experience in academia. He worked in clinical trials as a co-investigator in several neurological conditions and has been working as a physician for the pharmaceutical industry since 2010.
She is Clinical Franchise Head, Pediatric and Specialties Vaccines and Geographic Expansion, GSK, Siena Italy. Maria is an MD by education, with PhD in Infectious Diseases and Vaccinology. She is actually Clinical Franchise Head for Pediatric and Specialties Vaccines and Geographic Expansion. From 1 Sep, 2015, she will be Head of Clinical R&D for the Siena R&D Center. From May 2012 to May 2013, she was the Cluster Head for the Pediatric and Specialties Cluster, and before that she worked as Senior Cluster Physician in the Influenza Cluster. Among her achievements, the licensure of the first cell culture-derived H1N1 influenza pandemic vaccine in Germany, Switzerland and Japan, and the licensure of the first cell-culture derived seasonal influenza vaccine (Flucelvax) in the US.
Marie-Hélène Grillet is a physician working in pharmacovigilance for 20 years. She has experience in various fields of pharmacovigilance, including vaccines; drugs for human and veterinary medicine, either in post marketing or in clinical development and over-the-counter products. In 2014, Marie-Hélène joined Sanofi Pasteur as a therapeutic area safety leader, working with a team of global safety officers dedicated to combination and traveler vaccines. Our job is to provide a correct vision of the safety profile of the vaccines, detect any new risk, assess the benefit risk balance of the vaccines and submit accurate data to Health Authorities during the all life of the vaccine (from the first administration in man until the withdrawal of the last license from the market).
She is currently Senior Statistician at Company GSK. Main tasks: provide statistical support and develop new statistical concepts in all the aspects of the development of a vaccine (drug substance, drug product and analytical/biological methods), regulatory submission and commercialization. She is working in GSK (former Chiron and Novartis) for almost 20 years in the role of statistician in several departments from research and development to quality control and manufacturing assuming roles of increasing responsibility. She obtained her degree in Economic and Statistical Science at the University of Siena. Her specialties are statistical aspects in the development and validation of biological assay and process characterization.
He is Head of Clinical Data Management and Patient Reported Outcomes for GSK Vaccines. He has been working in the pharmaceutical industry for 24 years after completing his studies in Physiology and Pharmacology at the University of Sheffield in the UK and Information Systems at the University of West London. He started his career at Boehringer Ingelheim where he worked for 8 years and was heavily involved in the implementation of standard practices across international drug development programs. He also worked at Novo Nordisk where he was Head of Data Management for 12 years managing a team of 30 data management personnel responsible for all aspects of the data management of Phase I to Phase IV clinical studies. He joined GSK Vaccines in February 2015 and is responsible for clinical data management and the implementation of eDiaries used to collect safety data directly from clinical trial subjects. He has spoken extensively at international conferences and is a Lecturer and External Advisor to the University of Cranfield’s MSc in Clinical Research. He has also published articles on benefits of the implementation of Electronic Data Capture in clinical research.
Dr. Steinhoff is Professor of Pediatrics and Director of the Children’s Global Health Center at Cincinnati Children’s Hospital in Ohio, USA. With colleagues, he is currently conducting a large antenatal influenza vaccine trial in Nepal with Gates Foundation support, and an NIH funded post-partum influenza vaccine trial in the United States. A pediatrician with infectious disease sub-specialty training, he has served as a consultant to CDC, NIH, FDA, USAID, NORAID, WHO, the Rockefeller Foundation, the Ford Foundation, and as an advisor to the Bill and Melinda Gates Foundation. He was a pediatric resident, chief resident, and pediatric infectious diseases fellow at University of Rochester, New York. He served on the faculty of the Department of Child Health, CMC Hospital in Vellore, India, has held faculty positions in the Departments of Public Health and Pediatrics at the University of Michigan, and serves as faculty at the School of Medicine, and the Bloomberg School of Public Health at Johns Hopkins University in Baltimore. He has carried out research projects in South and East Asia, China, Africa, South America, North America and Europe. He has authored over 170 peer-reviewed research papers, and over 20 textbook chapters in pediatric, tropical medicine, and epidemiology textbooks. He received his BA and MD from the University of Chicago.
He is currently Head, Glbl Clinical Program, Pandemic, GSK Vaccines (previously Novartis Vaccines), Cambridge, USA. Matt received an MD and PhD (Pharmacology and Physiology) from the University of Chicago, and was trained in Pediatrics at Boston Children’s Hospital (Harvard U.) and in Pediatric Infectious Diseases at the U. of Minnesota. After several years in academics conducting clinical trials on vaccines and infectious disease epidemiology, he moved in 1994 to vaccine companies to supervise clinical development programs globally. Those programs have included phase 1-4 trials for numerous bacterial and viral vaccines, at major vaccine companies (GSK, Novartis, and Wyeth/Pfizer) and smaller biotech in the US. Since 2003, he has been at GSK Vaccines, and responsible for pandemic vaccine programs for the past 2.5 years.
She is Consultant Clinical Research Affairs, will present this workshop. Currently she is working as a Consultant in Clinical Research Affairs: Advises small businesses on clinical projects; Trains all staff at a leading phase I unit, Trains investigators in many countries including the emerging markets, Specialises in in-house technical training, with an emphasis on a practical approach. Courses include: ICH GCP – for all levels from introduction to advanced for both industry personnel and study site staff, practical implementation of ICH GCP; GCP refresher courses including the European Clinical Trials Directive; Clinical Research training at all levels – including monitoring, project management and preparation for inspections; Clients include major pharmaceutical companies, medical device companies, CRO’s, SMO’s, Hospitals in Saudi Arabia, UK NHS Trusts, nutritional companies and the food industry.
She is currently Global Quality and Compliance Head at Sanofi Pasteur, Lyon, France. She is a pharmacist. At Sanofi Pasteur she is responsible for PV international activities, quality documentation & PV trainings, preparedness to PV Audits/Regulatory Inspections worldwide; compliance and quality activities (quality control of ICSRs, manufacturing investigations, product technical complaints linked to AEs). Her previous experience was in pharmacovigilance in Sanofi Pasteur MSD, a Joint venture in EU territory between SP and Merck, for 8 years with a role of QPPV deputy, in charge of MMR vaccines, EU affiliates and processes.
She is the Chief Medical and Clinical Officer (CMCO), Dengue at Sanofi Pasteur. She has the responsibility for Global Medical Affairs, Regulatory Affairs, Epidemiology, Pharmacovigilance and Clinical R&D for the Dengue program which is now in registration phase. Melanie obtained a medical degree from University College, London in 1993 and went on to specialize in virology, working as a clinical virologist at St Mary’s and the Hammersmith hospitals in London until 1998. She obtained a masters degree in Medical Virology in 1997 from the Royal Free Hospital Medical School. In 1998 she moved to the Health Protection Agency where she conducted research in the field of respiratory viruses and HSV. She has been working in vaccines clinical development since 2000 first working for Wyeth in the UK on a number of vaccine projects in phase I to III. In 2004, Melanie moved to Sanofi Pasteur in France where she led the clinical development of seasonal and pandemic influenza vaccines and Dengue vaccine program in phase II and preparation for the phase III efficacy studies, and more recently was the Head Clinical Development EU. Melanie took on the broad role of CMCO, Dengue in January 2013.
She is currently Professor Pharmaco-Epidemiology, ERASMUS Medical Center, Rotterdam, Netherlands. She has a PhD from the Faculty of Mathematics and Physics in Groningen (cum laude), a pharmacy degree and a Master in Epidemiology from the Harvard School of Public Health. Her research group focuses on knowledge discovery from data collected in routine health care. Her research interest is to study drug and vaccine safety in large populations through the creation of national and most importantly international networks of databases. Successful projects with respect to international datalinkage are EU-ADR, SOS, ARITMO, ARPEC, SAFEGUARD, EMIF, GRIP, ADVANCE, and the VAESCO European Vaccines Safety Datalink. She is past president of the International Society of Pharmacoepidemiology and holds advisory roles in several projects/organizations such as ENCePP, the Brighton Collaboration, FDA, EMA. Miriam Sturkenboom has published over 200 journal articles in peer-reviewed journal articles in the field of (pharmaco) epidemiology.
He is currently Head clinical regulatory Affairs labelling & non clinical excellence at GSK Vaccines. Nicholas Perombelon trained initially as a biochemist at Aberdeen University, UK and then as a clinical biochemist at University of Surrey, UK, while working as a Clinical Biochemist for 2 years in the Chemical Pathology Laboratory at St Thomas’ Hospital, London. Thereafter, he studied for 4 years lipoprotein (a) metabolism as a research scientist at MRC Lipoprotein Team, Hammersmith Hospital, London. Nicholas joined GSK in 2001 as a scientific writer, working on malaria vaccine and pneumococcal conjugate vaccine developments in Clinical R&D. He subsequently took on the role of Manager, Scientific Writing, Cervarix Business Unit, transferring to a clinical regulatory affairs role in 2006, with a secondment to US to support licensure of Cervarix. In 2010, he returned to Belgium as Head Clinical Regulatory & Labelling in the Streptococcus and Neisseria team and worked on the initial marketing authorization for Nimenrix to EMA as well as lifecycle activities for Synflorix. In 2012, Nicholas was appointed as the Global Regulatory Lead for Synflorix and Synflorix Next Generation, supporting the lifecycle management of Synflorix including licensure in Japan in 2015. Currently, he is Head of the Clinical RA, Labelling and Non-clinical RA Excellence group in GSK Vaccines.
He did Biologist studied at the University of Bonn, Germany. Moreover has a pHD at the German Research Center for Biotechnology (GBF) in Braunschweig, Germany Department of Natural Products Research, Molecular Biology of Myxobacteria. He hold Research Scientist and Senior Research Scientist positions in Biotech Industry in Cambridge UK and Cologne Germany. Since 2007 Lab Manager for Influenza and TBE at Clinical Laboratory Sciences, Novartis Vaccines Marburg. Since 2012 Head of Sample Management at Clinical Laboratory Sciences, Novartis Vaccines now GSK Vaccines Marburg.
Noemi has a scientific background (Bsc in Ecology and Biodiversity and MSC in Neurobiology), and experience in different therapeutic areas of clinical research: neurology, oncology, and vaccinology, in clinical trials from Phase I to Phase IV. She has been working in Clinical Research for almost 8 years, starting as junior CRA in Sanofi-Aventis working in Multiple Sclerosis trials , and then in Philogen, a Swiss-Italian biotech, where she worked as CRA of phases I/II in Radio-immunotherapy studies in Oncology in collaboration with Bayer-Schering. Noemi joined Novartis Vaccines (now GSK Vaccines) in 2011, here she managed a FDA post-commitment trial with Menveo and an Influenza trial with both responsibilities of CRA and Clinical Trial Manager. Noemi is currently working in the IT System Integration Program as Project Manager.
Nora Dellepiane she an independent consultant on quality and regulation of biological products. She hold the role of Coordinator of the WHO team responsible for strengthening regulatory capacity for medicines (including vaccines) globally. Previously the scientist responsible for the Vaccines Prequalification Program, which she led for 17 years, she has worked in the field of vaccine production, quality control and quality assurance for more than 30 years. She was the Head of the National Control Laboratory in Buenos Aires, Argentina, and also worked in applied research in the field of immunology and vaccines for five years, and published a number of scientific articles in international journals.
He has been leading the Global Vaccine Safety Group at the World Health Organization since September 2007. Dr. Zuber is an international expert on vaccines programs in developing countries. He is a graduate of Lausanne (Switzerland) University and Harvard School of Public Health. Before joining the Global Vaccine Safety Group, he worked for many years at the United States Centers for Disease Control and Prevention (CDC). In his last two positions he led the Poliomyelitis Eradication Country Support at CDC and then led the New and Under-utilized Vaccines Introduction seconded to WHO. He is also an associate physician with the Faculty of Medicine at Lausanne University. In his current work, his main focus is about developing global collaborative mechanisms in order to build and sustain capacity for vaccine pharmacovigilance in low- and middle-income countries. Through his role at the WHO, Dr. Zuber serves as the executive secretary to the Global Advisory Committee on Vaccine Safety.
Philippe Beutels is Associate Professor at the University of Antwerp, Belgium, where he heads the Center for Health Economics Research & Modeling Infectious Diseases (CHERMID and also Senior Visiting Fellow at the University of New South Wales, Sydney, Australia. He holds degrees in Commercial Engineering and Medical Sciences and has published 150 contributions in peer-reviewed journals and books and delivered over 100 lectures at scientific symposia, mainly on topics related to health economics, mathematical modeling, and epidemiology of infectious diseases.
She is currently Chief medical Officer, Monitoring Uppsala Center WHO, Uppsala, Sweden. She holds a medical degree from Basel University, a medical doctorate from Berne University (both Switzerland) and a postgraduate diploma in Pharmacovigilance from the University of Hertfordshire (UK). After her obtaining her medical degree she trained in internal medicine, surgery and anaesthesia in Switzerland and New Zealand and worked many years as a board certified anaesthesiology consultant in private hospitals. She joined the Swiss Regulatory Authority Swissmedic (former IKS) in 1999 as a clinical reviewer and headed the Unit Vigilance (pharmacovigilance of human and veterinary medical products as well as haemovigilance) from 2009 to 2012. Since 2013 she works at the Uppsala Monitoring Centre as Chief Medical Officer.
Dr Pieter Neels is a native of Belgium where he trained as an MD (University of Antwerp, 1985) and was boarded as a general practitioner. In 1994, his interest for medical research led him to work for a pharmaceutical company. In 1997, he joined the Belgian Ministry of Public Health as a senior evaluator of the clinical part of registration files in the field of cardiology, nephrology, endocrinology (diabetes), ... In 2001 he was appointed CPMP member. In 2002 he was asked to take over all Belgian central vaccine rapporteurships. During this year he became infected by the world of vaccines and until June 2013 he was the rapporteur of more than 15 vaccines. After being an observer for more than 5 years at the Vaccine Working Party, he was elected vice-chair of this CHMP Working Party for discussion on development and evaluation of registration files for vaccines until June 2013. The Belgian agency started a spearhead policy in 2007 and Dr Neels was appointed co-ordinator for the spearhead domain vaccines. EMA/CHMP has asked Dr Neels has be an observer at the SAGE/WHO meetings and to attend several scientific meetings on vaccines until June 2013. WHO has asked Dr Neels to attend many meetings on vaccine development all over the world in order to share the EU regulatory requirements/competence in vaccinology. Dr. Neels is also a member of the world wide network on vaccine promotion as he is asked to attend the ADVAC course (Foundation Mérieux) and the IABS conferences. In 2013 Dr. Neels was nominated associate Professor at the Namur University for a course in Vaccinology. In June 2013 Dr Neels stepped down from the CHMP and left the Belgian Federal Agency to start his own consultancy company “Vaccine-Advice” in order to be able to support vaccine development in a more efficacious way. In 2014 Dr Neels was elected board member of IABS-EU and in 2016 he accepted to chair the Human Vaccine Committee of IABS.
Raffaella Ravinetto was born on 8th July 1966. She graduated as Pharmacist at the University of Torino, Italy, in 1991. She holds a Postgraduate Diploma in Tropical Medical Biology from the Antwerp Institute of Tropical Medicine (ITM) (2002). She was employed as Clinical Research Scientist in the pharmaceutical industry (Glaxo, Glaxo Wellcome) from 1992 to 1999. In 1999, she moved to the humanitarian sector, and worked as pharmacist in humanitarian emergency and development programs in the Balkans and in Africa with two different NGOs, i.e. Pharmaciens Sans Frontières (PSF) and Cooperazione Internazionale (COOPI). In 2002, she joined Médecins Sans Frontières (MSF), where she followed various dossiers on access to essential medicines and on quality of medicines, while performing regular field assessments in sub-Saharan Africa and Latin America. Since November 2006 to date, she has been the head of the ITM Clinical Trials Unit (CTU), which provides methodological and scientific support to ITM researchers and to ITM partner institutions in the South, for designing and conducting non-commercial clinical research projects in the fields of malaria, tuberculosis, HIV-AIDS, viral hepatitis and neglected tropical diseases. She is also the coordinator of the ITM-hosted Switching the Poles Clinical Research Network, which aims at developing ethics- and GCP-compliant approaches to medical research carried out in research-limited contexts and in vulnerable communities; and a co-promoter of QUAMED, a North-South Network promoting evidence-based strategies for universal access to quality-ensured medicines. She teaches on subjects related to medicines and clinical research in developing countries, at ITM and at other academic institutions. She was president of the Italian branch of MSF (2007-2011). She’s a member of the MSF Ethics Review Board, an ethical reviewer for the EU 7th Framework Programme and for the European Research Council, and a member of the Editorial Board of the Indian Journal of Medical Ethics. She has done reviews for the BMC Ethics, BMC Public Health, BMJ, BMJ Open, Pharmaceutical Medicine, PLoS Neglected Tropical Diseases, Springer Plus, Tropical Medicine and International Health, and the WHO Bulletin.
Ralf Clemens, MD PhD, is currently a senior advisor to the Bill & Melinda Gates Foundation, senior advisor to General Director IVI and is board member of various scientific and vaccine policy institutions and biotech companies as Curevac, Valneva, CEPI, AREF and Aeras. Prior to this Dr Clemens was SVP Vaccines Development at Takeda Vaccines as well as VP and Head of Global Vaccine Development at GSK Biologicals and Novartis Vaccines. At GSK Biologicals, he was also in charge of developing country business strategies and of technology transfers to developing country manufacturers. During his close to 30 years career in vaccine industry Dr Clemens developed and brought to licensure over 25 different vaccines. He graduated in medicine and holds an executive degree in Management from the Wharton Business School. Ralf has over 200 publications and given more than 300 scientific presentations mainly on vaccines and immunization.
She is currently the Head of Clinical Data Management (CDM) Trial Operations at GSK Vaccines, based in Amsterdam. In her role she is heading the CDM Oversight team that is providing sponsor oversight to the data management activities of outsourced studies. She has been in this role for the last 2 years. Before that, she was in leading roles in the clinical data management team at Novartis Vaccines and Chiron since 1999. Next to providing data management deliverables for clinical trials during this period, she has participated in the implementation of many new elements in the data management process, like to introduction of Electronic Data Capture and CDISC implementation. She has a background in Food and Dietetics.
She is Vaccine Development Leader (VDL), Bexsero at GSK Siena. She was Head of Regulatory Operations at Novartis Vaccines, covering the Publishing, Document and Data Management, Procedures Management and Labeling areas. Previously a Regulatory Affairs Specialist at Chiron, she also served as a patent examiner at the European Patent Office in The Hague. Research fellowships at the Nuclear Medicine Department of San Raffaele Hospital in Milan and at the Research Center of Biocine in Siena followed graduation in Pharmaceutical Chemistry and Technology at the University of Siena, Italy.
Rosanna Cieri is Regulatory Affairs Senior Group Manager at GSK Siena (previously at Novartis Vaccines, Siena, Italy) and Professor of Courses for Professional Advancement at CTP, regulatory affairs and compliance, Poggibonsi, Italy. She previously occupied pharmaceutical industry posts with increasing responsibilities for regulatory affairs, international QA and compliance following a degree in Biological Science from the University of Siena.
He is Regulatory Affairs Senior Manager CMC and compliance at GSK Siena. Prior to this, he was Regulatory Affair Senior Specialist at Novartis Siena and Regulatory Affair Advisor at GE Healthcare srl, Milano. He got an Academic Degree in Chemistry and Pharmaceutical Technologies in 2001 at Università di Ferrara and Second Level Master in Drug Regulatory Activities in 2004 at Università di Chieti, Chieti.
Simone got his degree in Biology at “La Sapienza” University of Rome in 2006. He worked 6 years in preclinical research as laboratory scientist in Italy and abroad (Spain and USA) both at Universities and in Pharmaceutical Companies. He approached the clinical research in 2006 starting as CRA in a local Italian CRO and then in Novartis Vaccines in 2008. He progressed in his career in Clinical Development as Clinical Study Coordinator, CTM and senior CTM, moving afterwards to CRA Manager position for Italy and Spain last year. Currently he is covering ad interim the role of Country Head Italy & Spain Global Monitoring Organization. In March 2015 GSK acquired the non-flu part of Novartis Vaccines.
She is currently Head Safety Dengue at Sanofi Pasteur, Lyon, France since January 2014. Her tasks: Lead Dengue Vaccine Development Program Safety Evaluation Global Team; Global Pharmacovigilance; Clinical Development Pre & Post Launch Vaccine Safety Management. She was Deputy Director, Dengue Vaccine Program, Pharmacovigilance Clinical Leader at Sanofi Pasteur from January 2011 to December 2013 (3 years). Previously, always at Sanofi Pasteur, was Manager, Global Product Safety Officer, Safety Evaluation from September 2007 to December 2010 (3 years 4 months). In that role she was responsible for: Global pharmacovigilance, Japanese encephalitis vaccine: clinical development, licensure, Risk management Plan and post-launch management, Post-marketing surveillance (pediatric marketed vaccines portfolio): Safety profile monitoring including signal detection, potential or identified risks, PSURs, labeling and safety reports to Health Authorities; First Introduction of hemophilus influenza meningitis vaccine in Japan. Education: Université Claude Bernard Lyon 1 Pharmacy Doctorate (Pharm D), Pharmacologie et toxicologie, Graduated with first-class honours 1992 – 2002. Université Paris Descartes Master degree in Toxicology, Toxicologie 1999.
He is Director Vaccine Implementation at GAVI Alliance in Geneva, Switzerland with responsibility to provide leadership and coordination in the Secretariat and across the Alliance for the roll-out of GAVI’s portfolio of vaccines. He joined GAVI from Novartis Vaccines where as Director Global Policy he was responsible to represent the company with the main UN agencies and in the industry association IFPMA. Previously he served as Director Strategic Vaccine Supply at PATH where he was responsible for forecasting of vaccine demand and supply and member of various UNICEF procurement reference groups. In the starting years of his career, he worked in supply chain, finance, and strategic planning for Novartis Pharma and Baxter Healthcare. He earned a Master in Business Economics from Bocconi University, Milan, with specialization in System Dynamics and is currently completing a Master in Public Health at Johns Hopkins Bloomberg School of Public Health in Baltimore.
Steffen Glismann is a Medical Doctor by training and has specialized as a Public Health Physician with a particular interest in child health. He has spent most of his professional career as a clinician in various Danish Hospitals and also worked for two years as District Medical Officer under the Ministry of Health in Zambia and one year with Integrated Management of Childhood Illness for WHO in Uganda. From 1998 to 2011, Steffen Glismann was a senior public health physician at the Danish Statens Serum Institute with National responsibility of risk assessment and prevention of Vaccine Preventable Diseases and he was the National Immunization Manager. During the same period he also lectured in vaccinology at three Danish faculties and was an invited speaker about childhood vaccinations at international conferences. From his assignments and collaboration with WHO Europe, the EU commission and the European Centre for Prevention and Control of Infectious Diseases (ECDC), Steffen Glismann has gained a wide range of international experiences in vaccinology; in particular he was the founder of EUVAC.NET, a surveillance network of vaccine preventable diseases in Europe, which is now integrated with the ECDC infectious disease surveillance program in Europe. Steffen Glismann was appointed Regional Director Scientific Affairs & Public Health, Europe at GlaxoSmithKline Vaccines in 2011.
Stephen Senn is Head of the Competence Center for Methodology and Statistics at Luxembourg Institute of Health. Originally from Switzerland, Stephen Senn has worked as a statistician in the UK National Health Service and in the Swiss pharmaceutical industry but also as an academic in various positions in Scotland and England. He is currently head of the Competence Center for Methodology and Statistics at the Luxembourg Institute of Health. He is the author of the monographs Cross-over Trials in Clinical Research (1993, 2002), Statistical Issues in Drug Development (1997, 2007), Dicing with Death (2003). In 2001 he was awarded the George Challis Prize for biostatistics of the University of Florida and in 2009 the Bradford Hill Medal of the Royal Statistical Society. He is a fellow of the Royal Society of Edinburgh.
He is Vice President Vaccine Global RA at GlaxoSmithKline Vaccines in Belgium. Prior to this he was Vice President for Regulatory Affairs in the Asia Pacific area (based in Singapore) for GlaxoSmithKline with overall responsibility for all GSK regulatory activities in that region of the world. Dr Cook joined the pharmaceutical industry in 1986 working in the area of Active Pharmaceutical Ingredient (API) manufacture and Quality Assurance before moving into Regulatory Affairs in 1993. He is experienced in the registration of medicinal products and vaccines in Europe and has extensive first-hand experience of regulatory affairs across the International region (i.e. Asia, Africa, Central Eastern Europe, Latin America and the Middle East) for both pharmaceutical and biological products. Dr Cook is a graduate of the University of Strathclyde (Glasgow, UK) where he completed a BSc (Hons.) in Applied Chemistry and then an MSc followed by a PhD in Analytical Chemistry. He is a Member of the Royal Society of Chemistry and a Chartered Chemist. He was granted the designation of Chartered Scientist (CSci) in 2004 by the (UK) Science Council. He has been a Member of The Organisation of Professionals in Regulatory Affairs [previously the British Institute of Regulatory Affairs] since 1994. He has participated in various APEC LSIF activities, delivered training and lectures on ICH country regulatory requirements and presented at many conferences on subjects as diverse as the drug development process, quality control, electronic document management, BSE/TSE, batch release requirements for vaccines and the role of regulatory affairs in the pharmaceutical industry.
She is a Senior Director of Vaccine R&D at Glaxo Smith Kline (GSK, previously, Novartis Vaccines) with broad experience in vaccinology in the areas of antigen discovery, nucleic acid and vector deliveries, adjuvants, product development, as well as the preclinical and clinical evaluations of vaccine candidates. She currently heads the CMV and HIV vaccine programs in the Research group at the company’s Cambridge, MA, USA, R&D site. Dr. Barnett has led the HIV vaccine project at the company since 1998 and the CMV vaccine efforts since 2007. Dr. Barnett has recently led efforts to produce GMP HIV Envelope glycoproteins to be used with GSK’s adjuvants for future proof-of-concept clinical evaluations in South Africa by the “Pox Protein Public-Private Partnership” (P5). Dr. Barnett was one of the first investigators to explore DNA prime plus Env protein boost vaccines for HIV, and now she is part of a team that is pioneering a synthetic self-replicating mRNA vaccine approach for HIV and other disease targets. Dr. Barnett and her team have also advanced a novel CMV vaccine approach for future technical development in preparation for clinical evaluations.
Doctor in Veterinary medicine (DVM), she graduated from the French veterinary school located in Lyon. Her professional experiences include small animal medicine and surgery in private practices, medical devices testing in a CRO, telemedicine model for veterinarians, project coordination for veterinary vaccines development. Her longest and preferred experience started 6 years ago when she joined the Corporate pharmacovigilance group of Merial (animal health division of Sanofi) up to 2017 she was the QPPV (qualified person for pharmacovigilance) for Sanofi Pasteur and from there she is now Associate director, PV Process Excellence at UBC - An Express Scripts Company
She is Global Head Regulatory Affairs Vaccines Business division at Takeda Vaccines, Chicago USA helping build a new, global vaccine business for the US company. For the past 20 years, she has held positions in quality, technical, analytical, and regulatory development of the vaccine portfolios of Merck, GlaxoSmithKline, and Novartis. She has been involved in the approval of over 15 novel vaccines including live virus, recombinant, inactivated, and combination vaccines. She is involved in regulatory policy activities and, having held numerous elected positions at the trade organizations, is currently Co-Chair, BIO Manufacturing Committee, a member of the BIO Regulatory Affairs Committee and the PhRMA Regulatory Affairs Coordinating Committee, as well as having served on the FDA TSE Advisory Committee as the industry representative, appointed by the Secretary of HHS. She received her PhD in Biology from Dartmouth College, USA.
She has over 15 years’ experience in the Pharmaceutical Industry within the Development department, with strong expertise in the management of Clinical Trials Management Systems, system validation and compliance, including management of an international Team. From October 2006 – today’s date she is Clinical Systems Senior Manager at Legacy Novartis Vaccines/GSK - Siena – Italy. Tatiana joined Chiron Siena Italy in 1999 and covered different position, the last one before the current role was Clinical Operations Leader at Chiron from 2004 to 2006. She got a Degree in Philosophy in 1996 at University of Bologna and a MSc in Cognitive Science at The University of Birmingham (United Kingdom).
He is currently Head, policy and scientific affairs Takeda Vaccines, Cambridge, USA. He was Vice President, Scientific Affairs, GSK Vaccines (previously Novartis Vaccines), Cambridge, Massachusetts, USA. He was Medical microbiology fellow at the NIH Clinical Center and in the Division of Vector borne Viral Diseases, Ft. Collins, Colorado, as Chief of the Arboviral Diseases branch and Division Associate Director for Science. After retiring from the Public Health Service, he joined the vaccine industry in clinical development of experimental respiratory virus vaccines and in medical affairs on influenza and other vaccines. He was elected to the Alpha Omega Alpha honor medical society, and as a Fellow to the Infectious Diseases Society of America and to the American Academy of Microbiology. He trained as an EIS officer at the US Centers for Disease Control and served as Public Health Service medical officer in the Viral Special Pathogens department in Atlanta. He gained his MD from the University of Pennsylvania and has a Master of Public Health and residence in Pediatrics from the Johns Hopkins University School of Hygiene and Public Health.
He is Clinical Research Fellow, Adult Vaccinology Oxford Vaccine Group Oxford, UK. He is involved in designing and performing human challenge studies with Salmonella Typhi and S. Paratyphi to assess the protective efficacy of novel vaccines in addition to furthering our understanding of host-pathogen interactions. A clinician by training, specializing in infectious diseases and medical microbiology, he has a special interest in the clinical translation and application of basic research findings.
Graduated of University of Chicago in Chemistry, he got subsequently a Master, PhD and MD degrees. His career is from Associate Professor of Infectious Diseases at Saint Louis University Medical School (1995-2006) to, currently being Senior Director in Global Vaccine R&D GSK Vaccines following also the study “Provide clinical/scientific expertise the Herpes Simplex Virus, Cytomegalovirus and Epstein-Barr Virus Vaccine Development Programs”.
Valerio is currently Senior Research Scientist at VisMederi Srl in Siena, Italy. His main tasks: analysis of blood sera samples and quantification of specific antibodies through ELISA and SRH method, laboratory instrument maintenance and calibration. Previously he also worked at the University of Siena, department of physiopathology experimental medicine and public health as biological sample analyst. He was also research fellow at University of Bologna at department of Biology doing a research on functional characterization of an orphan response regulator in H. Pylori.
He is Director, Global Clinical Program Coordinator, Sanofi Pasteur, Marcy l’étoile, France, overseeing all clinical department activities deliveries for the Dengue Program (Clinical Development Plan, CTD, pre-Approval Inspection Preparedness). He got a Master degree in Health Engineering from the faculty of Pharmacy in Montpellier (Fr). He started in 1997 as a Clinical Research Associate (CRA) for Rhone Poulenc Rorer South Africa in Johannesburg and then as Affiliate Safety Officer in charge of Pharmacovigilance, medical information, and quality assurance for Rhone Poulenc Rorer and Pasteur Mérieux Connaught South Africa. After 2 years in France as International Clinical Trial Monitor in charge of vaccine clinical trials in Europe, South Africa and Asia, moved to Hong Kong, China as CRA manager in charge of the Asia Pacific region for Aventis Pasteur. Following the great development of the activity in the region, became Head of the Asia Pacific Study Management and Logistic Platform based in Bangkok, Thailand. Came back to France as Director, Study management and logistic, Global dengue program to oversee all Study Management and Logistics activities deliveries across countries and regions for the Dengue Program (41000 subjects, 23 studies, 17 countries in Asia Pacific and the Americas) including 3 efficacy studies.
She is registered pharmacist, with 10 years of experience in pharma and biotech industries covering different roles in research and regulatory affairs functions. Currently working in GSK in regulatory affairs in Labeling team, since last 6 years. Masters in pharmaceutical sciences and diploma in Business management with experience in handling different aspects of regulatory projects, process development in multicultural environment.
Vittal Mogasale is Head of Access at Development & Delivery at International Vaccine Institute (IVI) Seoul, South Korea. He was head of the Policy and Economic Research Center as a Research Scientist at the International Vaccine Institute, focusing on Health Economics and Policy Research to support evidence based decision making at global, regional and country levels. Previously he evaluated cost-effectiveness of selected immunization programs in Australia while working at Center for Burden of Disease and Cost-Effectiveness, University of Queensland. He has worked for the control of infectious diseases and immunization programs in several countries, initially as a public health physician on the control of STIs among marginalized populations in Southern and Western India before scaling up STI/HIV prevention intervention services across six Indian states for Family Health International. He also established HIV sentinel surveillance in Western India and polio surveillance in Eastern India where he spearheaded several polio mass vaccination campaigns for the WHO. He obtained his Medical degree from Manipal University, India, an international Master in Public Health from Hebrew University, Israel, and PhD from the University of Queensland, Australia.
She presently leads the Clinical Documentation Operations group at GlaxoSmithKline Pharmaceuticals R&D, accountable for the tactical implementation of a sustainable TMF delivery strategy. Vittoria transitioned from Novartis Vaccines R&D where she launched the division’s electronic Trial Master Files system and over the course of 7 years established new processes and standards in document management and archiving for quality and compliant clinical studies. She also led inspection readiness programs, clinical operational excellence initiatives and contributed to the DIA TMF Reference Model working group. Prior to that, Vittoria held operational and scientific roles in Clinical R&D, in the pharmaceutical and CRO industry beginning 2001. Vittoria holds a Master’s Degree in Molecular Biology from the University of Pisa, Italy, and had basic research experience in molecular genetics and immunology at the University of Gothenburg and Karolinska Institute of Stockholm, Sweden.
He is currently Principal Statistician TD Statistics & Mathematical Modelling, GSK, Marburg, Germany. He received a PhD in theoretical physics in 2002 at the Philipps University Marburg, Germany. After two postdoc contracts at the University of Arizona and the Philipps University Marburg Walter decided to join Novartis as a biostatistician in 2007. Until 2012 the main responsibilities were in manufacturing and QC support with focus on development of Optaflu 2nd generation, assay validation in QC as well as ad-hoc support and root-cause analyses. Walter became part of a global non-clinical statistics team in 2012. In this role he led a small team of statisticians with main responsibility in serological assay development and validation. In several global projects he collected experience with CBER interactions, both in written CBER communications and in face-to-face meetings.
Duccio Mattii is currently Quality Head GSK Siena, Italy. Formerly he was Quality Head at Novartis Vaccines and Diagnostics and Quality Head in Chiron (both in Siena, Italy) with close to 20 years of experience. During that period the site succesfully pass three FDA PAI's for three different products leading to three Manufacturing licences in US. He obtained his M.Sc, Chemistry at University of Florence Italy.
Elisabetta Traggiai is Senior Investigator I, Lab Head “B cell and antibody discovery Lab”, NBC/PPA, GSK, Basel, Switzerland. With 37 publications, she participates in Editorials of the Referee for European Journal of Immunology, Plos Journal, Journal of Immunology, Journal of Allergy and Clinical Immunology. She graduated in Biology at the University of Pisa and gained a PhD in Neurosciences at the University of Florence in Italy.
She is currently Head Clinical Operations in GSK Vaccines Institute for Global health in Siena, Italy. She previously was Head Clinical Operations & Training in NVGH in Siena. Elisa has more than 10 years experience in vaccine clinical development. Previous positions were: Research fellowship IRIS Research Centre Chiron Vaccines, Senior Clinical Trials Coordinator Chiron Vaccines, Clinical Operations Manager WHO/PATH Meningitis Vaccine Project (MVP). She got a Science degree in Molecular Biology at University Siena (IT) and a PhD at University of Genova (IT)
She is a Biostatistician at GSK Vaccines, Amsterdam, in the Netherlands. She joined the Novartis legacy company in November 2011, as part of the meningitis team, supporting their late phase clinical trials and regulatory submissions; and has since mid-2014 transitioned to the epidemiology team. Prior to joining the company, she had consulting and teaching roles at Cancer Research UK and the Institute of Public Health, at the University of Cambridge. She completed her PhD in Medical Statistics at the MRC Biostatistics Unit in Cambridge, working with Scottish health registration data; and also holds degrees from the University of Southampton and Imperial College London.
Emanuele Montomoli is Full Professor of Hygiene and Public Health at the University of Siena in Italy. He received his BSc and MSc in Life Sciences from University of Siena in Italy in 1995 and he earned his MBiochem in 2001. In 2008, he funded VisMederi srl, a private enterprise involved in management and serology for clinical trials and focussed studies with human viruses for pharmaceutical companies. Actually, he has a role of Chief Scientific Officer. His research interest is primarily in the field of influenza vaccines, and in particular in the study of correlates of protection. He is expert in development, standardization and validation of assays for antibody detection. He has conducted many clinical and laboratory research studies to evaluate immunogenicity and efficacy of traditional and new influenza vaccines. Recently he has participated in protocols for development and evaluation of new molecules as adjuvants. He has also undertaken planning and execution of European seroepidemiological studies for emerging infectious disease in collaboration with WHO Regional Office and eCDC. In 2015, he was Scientific Coordinator for one European Project IMI (Innovative Medicine Initiative) titled “Standardization and development of assays for assessment of influenza vaccine correlates of protection (FLUCOP)” (IMI-JU-10-2013-01, Grant Agreement No 115672). He has organized 1st, 2nd and 3rd edition of the Summer School on influenza in Siena with the support of ISIRV. Over the years, he has published almost 70 scientific papers and reviews, and written several chapters in textbooks.
Ennio de Gregorio is Global Head of Bacteriology since 2014 and Head of Research in GSK Vaccines, Italy since 2011. Prior to this position he was head of the Research Immunology Function (2008) and project leader of two research programs in GSK Vaccines Siena (2004-2008) (formerly Novartis Vaccines). Between 2000 and 2003 Dr. De Gregorio worked as a post-doctoral fellow of Human Frontier Science Program at the CNRS, Gif-sur-Yvette, France. Between 1996 and 2000, Dr De Gregorio performed his PhD work at the European Molecular Biology Laboratory (EMBL) Gene Expression Program in Heidelberg, Germany. Dr. De Gregorio received his degree on Molecular Biology from the University of Rome, Italy in 1994.
Enrico Malito is a protein crystallographer working at GSK Vaccines Siena (Italy). He started studying protein structure and function using X-ray crystallography in 2000, with Prof. Andrea Mattevi at the University of Pavia (Italy), where he obtained a master in molecular biology (2001) and a PhD in protein crystallography (2005). After his PhD, he worked as a postdoc (2005-2008) in the laboratories of Prof. Arnon Lavie at the University of Illinois at Chicago (USA), and in the group of Prof. Wei-Jen Tang at the University of Chicago (USA). In 2009, he joined Novartis at the Genomics Institute of the Novartis Research Foundation (GNF) in La Jolla, CA (USA), where he started working on structural vaccinology, and in 2011 he joined the newly established group of Structural Biology at Novartis Vaccines Siena.
Fabienne Willems is Professor at Institut d’Immunologie medicale, Faculty of Medicine, at Université Libre de Bruxelles. Fabienne teaches general immunology to Bachelors in Biomedical Sciences and Dentistry. The objective of her research is to decipher the innate immune signatures predicting the development of the adaptive immune response to vaccines in human. BSc in Zoology and PhD in Immunology. Current research interests: Innate immune response to adjuvant-based vaccines in human. One of the main challenges of modern vaccinology is the understanding of how the innate immune system controls the subsequent magnitude and quality of adaptive response. The innate and adaptive interaction is crucial to achieve optimal vaccination with robust immunogenicity. One of the current project is likely to generate new paradigms in vaccinology providing essential guidance for the selection of new adjuvants and the development of innovative vaccines with improved efficacy.
Francesco Berti is Head of Vaccine Chemistry and Formulation Research at GSK Vaccines (formerly Novartis Vaccines), Siena. Francesco earned his bachelor and PhD's (degrees in Physical Chemistry at the University of Siena. During his PhD course he worked on the physicochemical characterization of metal-peptide complexes by spectroscopic on the preparation and structural characterization of meningococcal ACW135Y polysaccharide-protein conjugate vaccines. In 2002 Francesco joined GSK Vaccines (formerly Novartis Vaccines; formerly Chiron Vaccines) as a young scientist and in the following 10 years was appointed Project Leaders, Lab Head and Unit Head. Francesco has also served as a visiting scientist at the Institute of Biological Sciences (National Research Council) in Ottawa (Canada) and at the Genomic Institute of Novartis Foundation (La Jolla, CA, US). In the last 15 years he has been working on research and development of several carbohydrate-based vaccines, particularly focusing on conjugates antigens against Neisseria meningitides ACW135YX, group B Streptococcus, group A Streptococcus, Staphylococcus aureus and Candida albicans diseases. Author and co-author of more than 50 published scientific papers and reviews and more than 20 patents.
Franco Laghi Pasini is Professor of Internal Medicine Dept. Of Clinical Medicine and Immunology Sciences at University of Siena. He obtained his degree cum laude in Medicine and Specialization in Cardiovascular Diseases both at University of Siena and Specialization in Internal at University of Parma. Research Fellow in the Dept. of Internal Medicine at Univ. Siena, 1974-1992. In 1973 and 1998 stage in the United States, respectively, at the Veterans' Administration Hospital in Buffalo, University of New York (Department of Cardiology) and at the Cleveland Clinic Foundation, Cleveland. He started his academic career ad Associated Professor of Internal Medicine at University of Siena and is Full Professor from 2000. He was Chief of the Clinical Immunology Unit of the Department of Clinical Medicine and Immunological Sciences. He was also coordinator of the PhD Course in Biomedicine and Immunological Sciences, related to the School Santa Chiara, and Coordinator of the School of Geriatrics. Member of the Regional Therapeutic Commission of Tuscany. More than 180 publications in international and Italian journals with "referee"; More than 350 communications at national and international congresses; 3 volumes; some books’ chapters.
Gianluca Breghi is CEO at Fondazione Achille Sclavo ONLUS/Sclavo Vaccines Association in Siena, Italy. In his role he manages two no-profit organizations active in the vaccine field for development of new vaccine technologies, and vaccines for neglected diseases. Responsible for the start-up of one of the two organization active in fostering development of vaccines for neglected diseases in Developing countries. Gianluca has more than 25 years’ professional experience in the Pharmaceutical and Biotechnology fields. Experienced in most pharma markets from biotech drugs to personal care products, in both business settings and no-profit organizations. Held top management positions in Business Development, Marketing, Chief of Staff, and Corporate Development in the biotech industry, Pharma and University setting, besides Independent Consulting position with Intercell AG and Novartis. Bachelors' in Business Administration at University of Pisa, Italy. MBA at Emory University, Goizueta School of Business, US.
Currently Head R&D Centre Italy, GSK, Siena, Italy. Prior to that, Giovanni Della Cioppa was Head of Clinical development Clusters (CDCL) from 2013 to 2015 and Head of Global Clinical DevelopmentCentral Functions (CDCF) from 2012 to 2013 at Novartis Vaccines and Diagnostics Srl. He had joined Novartis Vaccines in September 2007 from the Pharma Division, which he joined in 1990, holding positions of increasing responsibility in Switzerland, the US and the UK. Highlights of his career in therapeutics are the clinical development through regulatory approval and launch of the long-acting b2-agonist formoterol (Foradil®) in asthma and COPD, the first anti-IgE monoclonal antibody omalizumab ( Xolair®) in severe asthma and the development of the very long acting b2-agonist indacaterol in COPD. Giovanni has a keen interest in the methodology of clinical research. In 2007 he co-authored the book “Foundations of Clinical Research” (Springer) and he is author of 40 papers in peer-reviewed journals. He obtained his Post-Doctoral Degree in Pharmaceutical Medicine at the European Confederation of Upper Rhine Universities (EUCOR), while previously he had achieved a Post-Doctoral Specialist Degree in Internal Medicine delivering his thesis on the mortality for asthma. He obtained his degree in Medicine from the University of Naples, Italy.
Giuseppe Del Giudice is currently Global Head, Translational Medicine at GSK Siena. He is responsible of projects on vaccines development against several viral and bacterial pathogens as well as activities related to vaccine delivery. Giuseppe obtained his M.D. degree at the University of Milan and at the same University the Specialization in Infectious Diseases. He spent 12 years in Switzerland studying the immune response to malaria parasites first at the University of Geneva, then at the University of Lausanne. At the same time he became medical officer (staff member) of the World Health Organization, Division of Communicable Diseases. In 1996 he returned to Italy as Senior Research Director at the Research Center of Chiron Vaccines (now GSK Vaccines) in Siena (Tuscany). He is author and co-author of over 200 publications and member of several international societies and scientific boards.
Gloria Nino De Rivera is founder and general manager of Face-to-Face, a communications and public relations company based in Mexico City. Solutions-focused with international experience working for more than 18 years with multinational companies to effectively manage complex issues, support executive’s development and training, introduce social responsibility programs, develop and implement internal and external communication programs. For 12 years Gloria held Latin America region responsibilities for communications at GlaxoSmithKline, among her customers from the pharmaceutical industry are: Novartis, Takeda, Fidec, Stetens Serum Institute Novo Nordiks, Shire, the Bill & Melinda Gates Foundation.
Hans Bock is Chief Medical Officer, Region International, at Novartis Vaccines/Novartis Influenza Vaccines. He obtained his MD and doctorate from the Johannes Gutenberg University of Mainz, Germany in 1978. He conducted his postgraduate training in internal, family and tropical medicine. More recently, he completed advanced management programs at the Wharton Business School, University of Pennsylvania, USA. In 1985, he joined Behringwerke/Hoechst in Marburg, Germany, managing drug safety on a global scale, focusing on pharmacovigilance of vaccines and other biological products and remained in his field of interest after joining SmithKline Beecham in Munich, Germany. For 20 years he has redirected his focus on both vaccine development and medical affairs in the international area in particular Asia Pacific region. Dr Bock has authored over 200 original papers and has given more than 300 scientific presentations at national and international congresses and symposia worldwide.
Jane joined Novartis Vaccines (now GSK) in January 2014. She holds a medical degree from University College Dublin, Ireland, and worked initially in clinical medicine in Ireland and New Zealand before specializing in Public Health Medicine in Ireland. In 2009, she joined the European Programme for Interventional Epidemiology Training (EPIET), which brought her to the Netherlands where she worked at the Dutch National Institute of Public Health and the Environment (RIVM) and later at the Municipal Health Department in Amsterdam in the travel clinic and at the Department of Infectious Disease Control. She holds a PhD in infectious disease epidemiology from the Academic Medical Centre (University of Amsterdam) and her research has largely focused on the use of surveillance data for the control of vaccine preventable disease. She currently works on the meningitis vaccine portfolio in GSK.
In 2001, Stéphenne was raised into the Belgian nobility by King Albert II and given the noble title Baron for life. Jean, Baron Stéphenne, MSc, MBA served as the General Manager of GSK Biologicals. Baron Stéphenne served as the Chief Executive Officer and President of GlaxoSmithKline Biologicals S.A., since 1998 until April 2012. Baron Stéphenne served as the President of GlaxoSmithKline plc since May 2008. He began his career with SmithKline-Rit, where he moved up the ranks to become Chairman and Chief Executive Officer. He served as the President of UWE (Union Wallonne des Entreprises) and also served as its Chairman from 1997 to 2000. He served as Chairman and President of GSK Biologicals at GlaxoSmithKline plc from March 12, 2010 to April 2012. He serves as the Chairman of the Board of Directors of the Scientific Adventures Parc in Frameries. Baron Stéphenne serves as an Independent Chairman of BESIX Group S.A./N.V. He has been the Chairman of GSK Biologicals since March 12, 2010. He has been the Chairman of TiGenix N.V. since September 20, 2012. He serves as the Chairman of the Wallonia Foreign Trade and Investment Agency (B), Henogen S.A. (B), L'Union Wallonne des Entreprises (UWE) (B), Aseptic Technologies (B), IBA (B), Fortis Banque (B) and Société Belge des Bétons (B). He served as the Chairman of Glaxosmithkline Biologicals S.A until April 2012. He served as the Chairman of Ion Beam Applications, S.A. He serves as a Director of Vaxxilon AG and OncoDNA SA. He serves as a Director of CureVac AG and has been its Member of supervisory board since March 21, 2016. Baron Stéphenne serves as a Director of Nanocyl S.A. (B). He served as a Director of LFB S.A. He served as a Non-Executive Director of BNP Paribas Fortis SA/NV (a/k/a, Fortis Bank) from April 23, 2013 to April 23, 2015. He was instrumental in building one of the world’s leading vaccine companies and ultimately became the chairman of GSK Biologicals. During his forty-year tenure, his work spanned all critical functions from production to R&D to commercialization. He served as a Director of Groupe Bruxelles Lambert from 2003 to April 28, 2015. He served as a Non-Executive Independent Director of Ion Beam Applications, S.A. since May 2000. He served as an Independent Non-Executive Director of BNP Paribas Fortis SA/NV from April 26, 2001 to April 18, 2013. He served as an Independent Director of Besix Group sa. He is the Manager of the Year in 1996. He is a Chemical Engineer. He holds a degree in Chemical Engineering and Agronomy from the Agronomy College of Gembloux and a degree in Management from the Catholic University of Louvain (UCL).
Jochen Auerbach studied Veterinary Medicine in Germany. After a period of 4 years with virological diagnostics and research including his doctoral thesis, he joined Hoechst Roussel Vet as Regulatory Affairs Manager Vaccines. During the 8 years at Hoechst Roussel Vet Jochen was globally responsible for the RA aspects of the products and development program of Hoechst Roussel Vet at Behringwerke Marburg, Germany. In 2000 he moved to Chiron Vaccines (later Novartis Vaccines and Diagnostics) in Siena, Italy as RA Manager responsible for part of the Meningococcal development program and later as head of Regulatory Operations. After 5 years as RA Manager at Chiron / Novartis Vaccines, Jochen gained broad experiences in the area of technical operations and development by spending 5 years as project manager in Technical Operations and later as responsible for global planning and strategy in Technology Development at Novartis Vaccines and Diagnostics. In his current position Jochen is responsible for Regulatory Affairs of the GSK Vaccines Institute for Global Health, located in Siena Italy (previously Novartis Vaccines Institute for Global Health). The GSK Vaccines Institute for Global Health has the mission to develop effective and affordable vaccines for neglected infectious diseases of impoverished communities.
He is former Head of Microbial Molecular Biology at GSK Siena. He obtained a PhD in Molecular Biology from the University of Zurich and worked as a staff scientist at The European Molecular Biology Laboratory in Heidelberg, Germany before joining the Sclavo Research Center (ex Novartis Vaccines Research Center) in Siena, Italy in 1985. His major scientific interests over the last 25 years have been in research aimed at understanding bacterial pathogenesis and in particular the identification of vaccine candidates for diseases caused by Helicobacter pylori, Group B Streptococcus and Group A Streptococcus. Recent research has centered on the discovery of complex pilus-like structures in the streptococci and their role in host cell interaction and pathogenesis. From 2000 until 2008 he was Research Project Leader for Group B Streptococcus vaccines until the entry into the first clinical trials.
John Weil, MD is currently the Head of Epidemiology at Takeda Vaccines Business Unit, based in Zurich. In the thirty years since graduation from medical school I have worked in internal medicine (5 years), clinical epidemiology and public health (5 years). For the past twenty years I have busied myself applying epidemiological methods to the problems of drug and vaccine development with an emphasis on clinical trial planning and post-licensure observational safety and effectiveness study methodology for safety and effectiveness.
Jon Andrus is the Executive Vice President of the Sabin Vaccine Institute. He has more than three decades of experience as a global health leader with a well-documented record for fostering collaboration among national governments and partners to expand access to vaccines for the world’s poorest people. Since 2009, Dr. Andrus has served as Deputy Director of the Pan American Health Organization (PAHO) and, prior to that, was PAHO’s Lead Technical Advisor and Chief of the Immunization Unit, Family and Community Health. Before his tenure at PAHO, Dr. Andrus held senior positions at the U.S. Centers for Disease Control and Prevention (CDC), as Head, Vaccinology and Immunization Program at the Institute for Global Health at the Universities of California at San Francisco and Berkeley, and as Director of the Global Health MPH Program at The George Washington University (GWU). Dr. Andrus is a Professor in the Department of Global Health at GWU. He also holds adjunct faculty appointments at the University of California, San Francisco and Johns Hopkins Bloomberg School of Public Health.
She joined Novartis Vaccines (now GSK Vaccines) in April 2007. Her background is Pharmaceutical Chemistry and Technologies, a master degree she gained from the University of Siena in Italy. She holds the national accreditation for Pharmacist Profession. She recently submitted her Epidemiology Master of Science thesis at the London School of Hygiene & Tropical Medicine (final result is planned end November 2015). Her master project research mainly focuses on post-risk factors for GBS colonization in pregnant women in South Africa. She worked in Novartis from 2007 to 2011 as Clinical Research Scientist, managing flu clinical trials (pre pandemic, pandemic and seasonal). At present she is the senior manager of the Epidemiology operations team, leading activities of greater complexity (create procedures, templates, systems) across different functions to improve the quality of Epidemiology studies.
Lily Yin Weckx is an Associate Professor of Pediatric Infectious Diseases at Federal University of São Paulo, Brazil. She received her PhD degree in 1989 and since then has dedicated her academic activities in vaccinology. Professor Weckx coordinates the Reference Center for Special Immunobiologicals, a vaccine center focused on immunization of high risk patients and vaccine adverse events. Medical students, residents and post-graduate students from the University, and from other institutions, come for training and many academic projects and clinical trials are carried out in the service. She coordinates the post-graduation course on Immunization at Federal University of São Paulo. She has contributed to scientific papers in peer-reviewed journals as well as books in the area. Professor Weckx is a Member of the Technical Advisory Board on Immunization of the Brazilian Ministry of Health and a Member of the Permanent Advisory Board on Immunization of the Secretariat of Health of the State of São Paulo.
Lorenzo Tolleri is Senior Business Development Manager at Novartis Vaccines Srl in Siena (now part of GSK), where he deals mostly with search & evaluation of new and innovative technologies for in-licensing. Before joining the Business Development and Licensing group, he was Patent Associate in the Intellectual Property Department working on the various aspects of patent filing and prosecution. Lorenzo joined Chiron Vaccines (later acquired by Novartis) in 2002 as a post-doc at the Siena Research Center and holds a PhD in Molecular Genetics from the University of Pavia. Before joining Novartis, he was research fellow at the College of Medicine of the University of California, Irvine.
Lucia Ventura is currently Senior Principal Toxicologist, at GSK Vaccines and Diagnostics in Italy. Previously she worked as Senior Toxicologist and CNS project Team Leader at SienaBiotech and developing cardiovascular and anti-cancer drugs at Italfarmaco in Milan and Pharmacia & Upjohn Company. Following her qualification as a biologist she gained a PhD in Genetic and Applied Toxicology and spent eight years in academic toxicology research in France and Italy.
Maik W. Jornitz, CEO of G-CON Manufacturing Inc., is a technical expert with over 30 years of experience in bioprocesses, especially sterilizing grade filtration and single-use technologies, including regulatory requirements, integrity testing, systems design, and optimization. Jornitz has published 10 books, 15 book chapters and over 100 scientific papers. He is Chair of the PDA Science Advisory Board, task force member of Aging Facility and Post Approval Change Task Forces, as well as working member of BPOG, an advisory board member of the Biotechnology Industry Council, ICAV and multiple science journals. He recently has been recognized as one of the top ten global industry influencers. As a faculty member of multiple training activities, including PDA TRI, he trains members of the industry and regulatory authorities on a frequent basis. He received his M.Eng. in Bioengineering at the University of Applied Sciences in Hamburg, Germany and accomplished the PED program at IMD Business School in Lausanne, Switzerland
Mariagrazia Pizza is the Senior Project Leader for Bacteriology at GSK Vaccines. She began her career in 1986 as a Researcher at IRIS (Immunological Research Institute of Siena) and later became a Senior Scientist at IRIS. She has since worked as the Project Leader for a project aimed at the identification of a vaccine against Meningococcus B and in 2005 she served as the Head of the Molecular Immunology Unit for Chiron Vaccines. She received her degree in Chemistry and Pharmaceutical Technology from the University of Naples and was also a Postdoctoral fellow at the Institute of Biochemical Sciences in 2nd Medical School, Naples.
She has a PhD in infectious disease epidemiology from the London School of Hygiene and Tropical with experience in public health and industry. After 8 years at GSK Pharma supporting multiple therapy areas she moved to Novartis Vaccines (now GSK Vaccines) to support maternal immunization projects and then to lead the epidemiology group. In October, she moved back to the pharmaceuticals side of GSK and currently leads the epidemiological support for the infectious disease, oncology and pregnancy outcomes portfolios.
Marie-José Quentin-Millet contributes to Vaccine Research & Development since approximately 30 years, working a major portion of her career in Sanofi Pasteur and NIH. She has contributed to the development of Dengue vaccine, Acellular pertussis vaccines and combinations thereafter, to the Flu differentiation strategy including High Dose Flu, Intradermal Flu, Quadrivalent Flu and Pandemic Flu. She has held over the years several positions of increasing responsibilities and is currently VP of Product Conception & Development in Sanofi Pasteur RD where she leads some 600+ scientists and RD associates in Bioprocess RD, Analytical RD, Clinical Immunology, Clinical Supply and some key expert groups. She was trained as a biochemist and a microbiologist, and holds a PhD in Biochemistry.
Marzia Giuliani is currently Global Head of Bacterial Serology at GSK Siena. In the present position she directs Research Serology activities on the bacterial vaccine projects, responsible for scientific standards and quality standards for all serological assays related to bacterial vaccine supporting Research, Regulatory affairs, Clinical Serology, Technology Development and Toxicology. She received her degree in Biological Science at the University of Pisa. Senior scientist with expertise in molecular biology, microbiology and immunology, mainly focused on the characterization and measurement of antibody responses. More than 25 years of industry experience with more than 20 years in vaccines. In recent years her research focus has been bioassay development for preclinical and clinical trials, antigen characterization and evaluation of immune response to vaccines against Meningococcus B, Group B Streptococcus, Group A Streptococcus, Streptococcus pneumoniae, Staphylococcus aureus.
Massimo Bugnoli is OMV Operational Manager at GSK, Siena, Italy. He was from 2009 to 2011 Expert (SME) Manager , Bacterial Vaccines at Novartis Vaccines and Diagnostics in Siena, Italy. Previous job experience as Head of Bacterial Vaccines Manufacturing at NVD for more than 10 years. He started his career at Chiron Vaccines in Siena at the Research Centre. He holds a degree in Biological Science from Siena University, Italy.
Michèle obtained her PhD and MPH in Infectious Diseases and Immunity at the University of California, Berkeley. At GSK Vaccines and Diagnostics in Siena, Italy she works on the discovery and characterization and of Streptococcus pneumoniae pili and has published in numerous journals including Journal of Bacteriology, Molecular Microbiology, and PNAS.
Odile Leroy is the Executive Director of the European Vaccine Initiative, formerly European Malaria Vaccine Initiative (EMVI), which she joined in 2002 as Clinical and Regulatory Director, before heading the European and Developing Countries’ Clinical Trial Partnership as Executive Director. She has spent most of her career in vaccine development, as a scientist in Africa for nine years, followed by Corporate Clinical Director of airborne vaccines for 10 years at Pasteur Mérieux Connaught (Sanofi Pasteur). A member of the Science Board of the Brighton Collaboration, coordinator of the FP7 vaccine infrastructure project TRANSVAC, and a member of the WHO product development group for the measles aerosol project, she is a trained physician who has specialized in the areas of epidemiology, clinical pharmacology, and vaccinology.
Oretta Finco is Head B-cell Platform Unit at GSK Siena. The major interests of her group are now focusing on the human immunology of the B cell response after vaccination, both as immediate effector response and as long-term response by profiling the maintenance of antigen-specific memory B cells (MBC). She got her degree in Science at the University of Pavia, Italy and later a PhD degree in Genetics from the University of Pavia, compiling a thesis on the Role of C4 complement factor in the immune response. During this period, she spent two years in the laboratory of Prof. Michael Carroll in the Department of Pathology at Harvard Medical School, Boston USA, where she completed her research for the PhD thesis. She had a post-doctoral fellowship in the laboratory of Prof. Michael Carroll at Harvard Medical School, where she set up a transgenic mice laboratory focusing on the generation of several knock-out mouse lines for complement factors. In 1993 she joined Chiron Vaccines in Siena, with a post-doctoral fellowship in Immunology. In 1996 she was appointed as staff scientist in the Molecular Biology Department of Chiron Research Center in Siena. She has been Involved in several projects, mainly focusing in the study of the immune response in animal models following DNA vaccination and recombinant-protein immunisation. During this period she coordinated a research group involved in the identification of antigens candidates for a Chlamydia trachomatis vaccine by applying the reverse vaccinology approach.
He is Professor of Public Health at the Department of Public Health at University of Florence. He got a medical degree, cum laude, at University of genoa, Italy and after that a specialization in Hygiene. Paolo was professor in Epidemiology and Hygiene at University of Florence Faculty of Medicine for 8 years, his studies focused on Epidemiology and infectious diseases. From 1992 he is standing advisor of the Viral Hepatitis Prevention Board. He is author of many scientific articles published in 'Vaccine', ‘European Journal of Epidemiology’, ‘Journal of Epidemiology and Community Health’ e ‘Pediatric Infectious Disease Journal’.
Peter Dukes is Assistant Director for Researcher & Organisational Development in the MRC Africa Research Development Office (ARDO). Moreover he is seconded to the new Africa Research Excellence Fund (AREF), as Deputy to the Director, Professor Tumani Corrah. The AREF is a fund established by the Medical Research Foundation, a UK-registered charity. Through the ARDO, he works with MRC's two Africa-based research Units to help them build and sustain a strong learning and development environment. I have introduced Researcher Development Programmes to both Units. The programmes are based on the UK's Researcher Development Framework and are delivered with UK partners. As Deputy Director of the (AREF), he is responsible for creating new opportunities that meet the needs of talented early-career health and biomedical researchers across sub-Saharan Africa. He had a previous research management experience at the Medical Research Council, UK. Peter obtained a Microbiology BSc (with Honours) at the Cardiff University. Later he obtained a MSc, Medical Parasitology and a PhD, Medical Parasitology both at the London School of Hygiene and Tropical Medicine, UK.
He is Professor of Paediatric Infection and Immunity at the University of Oxford, Director of the Oxford Vaccine Group, James Martin Senior Fellow, Jenner Institute Investigator, Fellow of the Infectious Disease Society of America, Fellow of St Cross College and Honorary Consultant Paediatrician at the Children’s Hospital, Oxford, UK. He obtained his medical degree at St Bartholomew’s Hospital Medical School, University of London in 1989 and trained in Paediatrics at Birmingham Children’s Hospital, UK, specialising in Paediatric Infectious Diseases at St Mary’s Hospital, London, UK and at British Columbia Children’s Hospital, Vancouver, Canada. He obtained his PhD at St Mary’s Hospital, London, UK in 1999 studying immunity to Neisseria meningitidis in children and proceeded to work on anti-bacterial innate immune responses in children in Canada before returning to his current position at the University of Oxford, UK in 2001. He chaired the UK’s NICE meningitis guidelines development group, the NICE topic expert group developing quality standards for management of meningitis and meningococcal septicaemia. He chairs the UK Department of Health’s Joint Committee on Vaccination and Immunisation and the European Medicines Agency scientific advisory group on vaccines. His research includes the design, development and clinical evaluation of vaccines including those for meningococcal disease and enteric fever and leads studies using a human challenge model of (para)typhoid. He also runs surveillance for invasive bacterial diseases and studies the impact of pneumococcal vaccines in children in Nepal. He is the clinical lead for children for the Oxford Academic Health Science Network, the children’s lead for the NIHR Thames Valley Clinical Research Network and is the vaccines theme co-lead for the NIHR Oxford Biomedical Research Centre. His publications include over 300 manuscripts and books on various topics in paediatrics, infectious diseases, and high altitude medicine. He is leading a Wellcome Trust award to study enteric fever in Nepal, Bangladesh and Malawi which was initiated in April 2015.
He is a lecturer in mathematical modelling of in infectious diseases. His work involves the development and the analysis of mathematical models to investigate on the mechanisms that underlie the epidemiological dynamics of infectious diseases. From a statistical perspective, he is fitting mechanistic models to heterogeneous surveillance data in order to draw synergistic inference on key epidemiological drivers. More precisely, he is using statistical algorithms that have recently been developed to perform inference on partially observed Markov processes. He is currently contributing to the Ebola response of the London School of Hygiene and Tropical Medicine (LSHTM), funded by a 1-year Research for Health in Humanitarian Crises grant. This is in close collaboration with other groups at LSHTM, as well as the World Health Organization, Médecins Sans Frontières and Janssen. He is developing analytical tools for real time modelling and short term forecasting of the dynamics of the Ebola outbreak in West Africa in order to inform bed demands and to optimize the design of phase 3 vaccine trials. In parallel, he is also investigating the dynamics of seasonal influenza, funded by a 3-year Medical Research Council Career Development Award in Biostatistics. The aim of the project is to develop new mathematical modelling methods to improve our understanding of what governs the size and severity of seasonal influenza epidemics. This is a key public health priority for the design of effective intervention strategies, like vaccination. The work is done in collaboration with Princeton University (US), Nagasaki University (Japan) and Public Health England (UK).
He is currently Professor of Immunology and works at Welcome Trust Sanger Institute, Cambridge, UK. He was Head of Exploratory Programme at NVGH, professor of Vaccine Immunology at University of Birmingham, UK, consultant Immunologist at University Hospitals Birmingham, UK. Research interest: immunity to infectious diseases. Research Fellow 2004 -2007 in Blantyre at Malawi-Liverpool-Wellcome Trust Clinical Research Programme, University of Malawi. He directed projects exploring vaccines against nontyphoidal Salmonella, Shigella and Neisseria meningitidis.
Professor of Clinical Vaccine Immunology, Imperial College, London, UK. David Lewis trained in Cardiff Wales graduating MB BCh in 1983, followed by training in General Internal Medicine. He did a fulltime MSc in Medical Microbiology, and DTM&H at London School Of Hygiene & Tropical Medicine, followed by MD in mucosal vaccine research in HIV infection on MRC and Wellcome Trust fellowships at St George’s, London and Nairobi Kenya. He was appointed a Consultant Infectious Diseases Physician at St George’s Hospital in 1994, and as Professor of Clinical Vaccinology & Medicine led a research group in mucosal vaccines and immunology. In 2011 he moved to the Clinical Research Centre, University of Surrey, Guildford UK as Professor of Clinical Vaccine Immunology. Current research focuses on early stage development of vaccines, human mucosal immunology and translational immunology. Has conducted clinical trials using live oral GM bacterial vaccines, and injected, nasal, oral and vaginal vaccines particularly vaccines for poverty related diseases including HIV, TB, enteric and other infections. He is coordinator of the €30M Innovative Medicines Initiative project “BIOVACSAFE: biomarkers of vaccine immunosafety” involving over 20 partners from the vaccine pharmaceutical industry, academia, SMEs and NGOs.
Before joining Chatham House, David Salisbury was Director of Immunization at the Department of Health until 2013. He was responsible for the National Immunization Program and led the introduction of many new vaccines. He is the chair of the Global Certification Commission, chair of the European Certification Commission, member of the Eastern Mediterranean Commission and member of the South East Asian Commission on Poliomyelitis Eradication. He previously chaired the WHO’s Strategic Advisory Group of Experts on Immunization, the WHO committee that sets global immunization policy. He also served as co-chair of the Pandemic Influenza group of the G7 Global Health Security Initiative. David trained as a pediatrician in Oxford and London, and is a visiting professor at Imperial College, London and a fellow of the Academy of Medical Sciences. He continues to lecture and advise on vaccines and vaccination as well as undertaking ongoing work in polio, malaria and the development of new vaccines. He was made a Companion of the Order of the Bath in 2001.
Don de Savigny is Head of the Health Systems Research and Dynamic Modelling Unit of the Department of Public Health and Epidemiology at the Swiss Tropical and Public Health Institute, located in Basel, Switzerland. He has a PhD from the London School of Hygiene and Tropical Medicine and is an epidemiologist and public health specialist. He is also Professor of Epidemiology at the University of Basel and Honorary Professor at the London School of Hygiene and Tropical Medicine. Prior to this, he was Head of the Swiss Tropical Institute Field Laboratory in the United Republic of Tanzania (currently the Ifakara Health Institute) from 1984 to 1988 and Principal Health Specialist for the International Development Research Centre, Canada from 1988 to 1996. He has lived and worked for many years in Africa, most recently (1996-2003) as lead facilitator of the Tanzania Essential Health Interventions Program (TEHIP) for the United Republic of Tanzania Ministry of Health and Social Welfare.
He is Head of Translational Pediatrics and Infectious Diseases; Consultant physician in Paediatric Critical Care / Infectious Diseases; Hospital Clínico Universitario de Santiago de Compostela (Spain). Associate Professor in Pediatrics, University of Santiago. Born in Orense (Spain) in 1971, Federico Martinón-Torres currently is consultant in Pediatrics and head of Translational Pediatrics and Infectious Diseases at the Hospital Clínico Universitario de Santiago (Spain), nationally accredited as Professor in Pediatrics (ANECA) and Academic of the Royal Academy of Medicine and Surgery of Galicia. He graduated at the University of Santiago de Compostela and completed his medical training at the Hope Children’s Hospital of Chicago and at the Children’s Memorial Hospital of Chicago, before obtaining a PhD on the application of heliox in infants with bronchiolitis (awarded the national PhD prize). He has been granted over 25 prizes and awards to academic merits, including Best National Graduate in Medicine and Surgery (1995) and Best National Resident of all sub-specialities (2000). He has published over 300 articles (Impact factor > 400 JCR 2014), 6 books and 120 chapters in refereed journals and books. He has delivered more than 300 lectures in over 30 countries. His main research interests are: infectious diseases, vaccines, pneumococcal diseases, bronchiolitis, meningococcal disease and heliox therapy. He is directing or involved as coordinator or lead investigator in 25 ongoing international and multicentre clinical trials and research projects, including 2 FP7 (EUCLIDS and PREPARE) and 2 H2020 (PoC-ID and PERFORM) projects. Member of more than 15 national and international consultive and expert advisory boards on pneumococcal disease, RSV, meningococcal disease, heliox, rotavirus, flu and human papillomavirus, and of over 20 professional and academic international societies. He also collaborates with WHO-Europe. He currently coordinates the Genetics, Vaccines, Infections and Pediatrics Research Group (GENVIP www.genvip.org) of the Healthcare Research Institute of Santiago (IDIS), the Clinical Network of the EUCLIDS consortium (www.euclids-project.eu), the National Research Network on Meningococcal Disease (ESIGEM - www.esigem.org), the National Research Network on Respiratory Infections and genetics (GENDRES - www.gendres.org), and the Galician Pediatric Research Network (ReGALIP – www.regalip.com).
He is Head Global Public Policy & Stakeholder Management at Novartis International, Basel Switzerland. He was VP Head Global Policy GSK Cambridge USA and Vice President and Global Head of the Influenza Strategy Liaison for Novartis Vaccines in Boston, USA, where he coordinated cross-functional pandemic and prepandemic influenza vaccine activities, as well as driving influenza based interactions with national and international authorities. In 1991, he joined the World Health Organization. Until 2000, he worked in various teams in the Communicable Diseases Department, led the WHO efforts on global rabies and salmonellosis surveillance, and coordinated the WHO global activities on antimicrobials in the food chain. In 2001, he became coordinator of the WHO Global Influenza Program. In 2003, he led the WHO efforts on SARS virus discovery and epidemiological research. In 2006, he was made Special Advisor on Influenza Pandemic Vaccine Development for the WHO Initiative for Vaccine Research. Dr. Stöhr is a well-respected, internationally-recognized expert; since 1992 he has been invited to give over 165 scientific presentations, been co-author on more than 55 publications, and contributed with chapters to numerous books. Dr. Stöhr is an honorary Professor at the Freie University, Berlin, has won a number of scientific awards, and was included in the 2005 Scientific American 50 list of research and policy leaders.
Kate O’Brien is Professor in the Department of International Health at Johns Hopkins Bloomberg School of Public Health at Washington DC USA. She is a Canadian pediatric infectious disease physician, epidemiologist and a vaccinologist. She leads clinical vaccine trials for the Center for American Indian Health, and works on moving vaccine evidence into policy and access through her work as the Executive Director of the International Vaccine Access Center. Her particular areas of expertise are pneumococcal conjugate vaccine, Hib vaccine, vaccine impact evaluations, and the epidemiologic and policy analyses to support vaccine introduction and use. She earned her M.D. at McGill University and her MPH at Johns Hopkins University and, following residency and fellowship at Johns Hopkins, she joined the Respiratory Diseases Branch at the Centers for Disease Control and Prevention as an Epidemic Intelligence Officer before returning.
He is a Consultant in General Pediatrics and Vaccinology at the Oxford University Hospitals. NHS trust and an Honorary Senior Clinical Lecturer at the University of Oxford. After completing basic training in paediatrics at the Royal Children's Hospital, Melbourne, he worked in the paediatric intensive care unit at St. Mary's Hospital, London. While caring for children suffering overwhelming infections he developed an interest in the prevention of these illnesses by immunisation. This led him to the Oxford Vaccine Group, part of the University of Oxford, Department of Paediatrics, where he has undertaken paediatric clinical trials of meningococcal, pneumococcal, influenza and Hepatitis B vaccines. Dr Snape is partially funded by the Oxford Partnership Comprehensive Biomedical Research Centre.
Dr. Noni MacDonald is a Professor of Paediatrics (Infectious Diseases) at Dalhousie University and the IWK Health Centre in Halifax Canada. She is a former Dean of Medicine at Dalhousie University. Her two current major areas of interest are 1) Vaccines including vaccine safety, hesitancy, demand, pain mitigation, education and policy especially through her work with the World Health Organization, recently appointed to SAGE (the Strategic Advisory Group of Experts on immunization that provides advice to WHO on all aspect of vaccinology); and with the Canadian Centre for Vaccinology Health Policy and Translation Group ; 2) MicroResearch, building capacity in community focused research in developing countries and now also in Canada (www.microresearch-international.ca) to help interdisciplinary health professionals find local solutions for local maternal child health problems that fit the context, culture and resources. She is a Founder and Co-Director of the Centre for MicroResearch International. Dr MacDonald has published over 380 papers; was the founding Editor- in- Chief of Paediatrics & Child Health and Editor in Chief for 20 years, and a former Editor- in- Chief of CMAJ (Canadian Medical Association Journal). She has recently been appointed Editor for Child Health for new Oxford University Press publication called the Oxford Research Encyclopedia of Global Public Health . Dr. MacDonald has long been recognized in Canada and internationally, as an advocate for children and youth health and as a leader in paediatric infectious disease and global health.
He is Associate Professor of Hygiene and Preventive Medicine & Head of the Vaccine Preventable Disease Programme University of Bari & European Centre for Disease Prevention and Control (ECDC) Bari, Italy & Stockholm, Sweden. His research activity has been focused on infectious disease epidemiology and prevention. He is co-author of more than 100 scientific articles in peer-reviewed journals and several chapters in scientific textbooks.
Pierre Van Damme obtained his MD from the University of Antwerp, Belgium, in 1984. He received post-graduate degrees in health and economics, the evaluation of human corporal damage, and a master degree in occupational health. He obtained his PhD in epidemiology and social medicine in 1994 from the University of Antwerp. He is currently a full professor at the University of Antwerp in the Faculty of Medicine and Health Sciences where he chairs the Vaccine & Infectious Disease Institute (VAXINFECTIO, University of Antwerp); VAXINFECTIO is a consortium of three research units within the university: the Laboratory of Medical Microbiology (LMM), the Laboratory of Experimental Hematology (LEH), and the Centre for the Evaluation of Vaccination (CEV). It is recognized as ‘Centre of Excellence’ of the University of Antwerp and functions as WHO Collaborating Centre for the WHO European Region for the control and prevention of infectious diseases. The CEV was founded in 1994 by Pierre Van Damme. The centre conducts research in 5 main areas: (1) (sero-) epidemiology of infectious diseases; (2) economic evaluation of public health interventions and mathematical modelling of infectious diseases; (3) vaccine trial studies including assessment of safety, protective efficacy and immunogenicity of vaccines; (4) injection and diagnostic device research; (5) kinetics of vaccine-induced antibodies, including passive transfer of maternal antibodies and maternal immunization. Pierre Van Damme has authored more than 370 peer-reviewed papers and is on the editorial board of several scientific journals that focus on the study of vaccines and vaccine-preventable infectious diseases. Professor Van Damme was awarded with the Research Award of the University of Antwerp, and in 2000 with the Belgian Social Medicine Award ‘Jean Van Beneden’ for his work on the introduction of universal hepatitis B immunization programs. In May 2014, he was awarded with the prestigious Bill Marshall award of the ESPID society. Since 1994, he has served as the executive secretary of the Viral Hepatitis Prevention Board, a group of international experts dealing with topics on prevention and control of viral hepatitis. In 2016 he participated in the creation of a second expert board on HPV, the HPV control and prevention board. His current research projects at the University are focused on the epidemiology and prevention of vaccine-preventable infectious diseases, such as hepatitis A, hepatitis B, diphtheria, pertussis, varicella, rotavirus, measles, HSV, influenza, Ebola, Chikungunya, HPV and polio (in collaboration with the Bill & Melinda Gates Foundation). Since 1985 he has conducted more than 325 vaccine trials within the trial unit of the Centre for the Evaluation of Vaccination. He has been for more than 10 years a regular advisor for national and international organizations, including the Flemish Vaccination platform, the National Immunization Technical Advisory Group, and the World Health Organization (European Regional Office and Headquarters). He has been appointed as chairman of the European Technical Advisory Group of Experts on communicable diseases and vaccines for the WHO European Region (ETAGE) (2004-2014). He is a member of the Belgian Royal Academy of Medicine.
He is General Director of the Center for Vaccine Development – Mali (CVD Mali) and a Professor of Medicine at the University of Maryland School of Medicine. At the Center for Vaccine Development, Dr Sow heads the implementation of field and hospital-based epidemiological studies and clinical trials in the study of vaccine-preventable diseases. Previously, Dr Sow has served as the coordinator for WHO Multi-Center Field Trial on Leprosy Chemotherapy. He received his MD in Medicine from the National School of Medicine and Pharmacy of Mali and his MSc in epidemiology from the London School of Hygiene and Tropical Medicine. Dr Sow’s honors include the 2000 Paul Laviron Prize in Tropical Medicine from the University of Marseille, France. He was also named the Commemorative Fund Lecturer of the American Society of Tropical Medicine & Hygiene in 2006.
Steven Black is Professor of Pediatrics in the Center for Global Health at the University of Cincinnati Children's Hospital in Ohio, USA. He is a pediatric infectious disease specialist who has spent more than 20 years conducting clinical trials and safety studies of vaccines including being the principal investigator in five pivotal licensure trials and six phase for post marketing trials. He received his MD from the University of California San Diego and specialty training in pediatric infectious diseases at the University of California San Francisco.
He is Professor in Virology, Chief of Pediatric Infectious Disease at the Department of Pediatrics, Tampere University Hospital, Tampere, Finland. His group has worked on the development of non-live norovirus-rotavirus combination vaccine and he has conducted clinical trials of varicella and zoster vaccines, influenza vaccines, pneumococcal conjugate vaccine and meningococcal vaccines, and pediatric combination vaccines. He conducted the first clinical trials of live oral rotavirus vaccines in humans and, more recently, was the principal investigator of the first pediatric trials of Rotarix™ (GSK) vaccine and the lead investigator of the Merck’s RotaTeq™ vaccine trial REST. The published results of these pivotal trials were selected as Lancet’s Paper of the Year in 2007. He obtained his medical degree from the University of Helsinki and did postgraduate studies in New York at the Bellevue Hospital and the Roosevelt Hospital and has held several teaching positions at the University of Tampere, including Professor of Pediatrics
Rachid Marhaba is currently Serology Lab Manager at GSK Marburg Germany. He obtained a Bachelor of Sciences in Biochemistry at University of Nice in 1992 and three years later a Master in Pharmacology and Molecular Biology and a PhD in Immunology both at University of Nice as well. He was Postdoc fellow at Department of Tumor Progression and Immune Defense, Cancer Research Center, Heidelberg, Germany and after few years was appointed as group leader. Joined GSK Vaccines (formerly Novartis Vaccines) Marburg, Germany in 2008 as Lab Leader at Department of Clinical Serology.
Rahul Singhvi, ScD, MBA, is Chief Operating Officer of Takeda’s Global Vaccine Business Unit and is responsible for global supply of vaccines at the Takeda Pharmaceutical Company. Dr. Singhvi is a recognized business leader in the pharmaceutical industry and has deep experience in vaccine development and manufacturing. Before joining Takeda, Dr. Singhvi was President and CEO of Novavax, a Nasdaq-listed biotechnology company. In 2010, Novavax was named one of the ten most innovative companies in the biotechnology industry by Fast Company magazine. During his tenure at Novavax, Dr. Singhvi transformed the company from a specialty pharmaceutical business to a premier vaccine development company. Singhvi’s professional career began at Merck & Co in 1994, where he held several key positions in R&D and manufacturing. At Merck, he co-lead the varicella-zoster virus vaccine project team that oversaw the development of Varivax®III (chickenpox vaccine), ProQuad® (MMRV pediatric combination vaccine) and Zostavax® (Shingles vaccine). Dr. Singhvi graduated as the top ranked chemical engineer from IIT, Kanpur, India and obtained both his MS and ScD chemical engineering degrees from MIT. He received an MBA degree from the Wharton School of the University of Pennsylvania, where he graduated as a Palmer Scholar.
Rino Rappuoli is Chief Scientist at GSK Vaccines and is based in Siena, Italy. He earned his PhD in Biological Sciences at the University of Siena and has served as visiting scientist at Rockefeller University in New York and Harvard Medical School in Boston. Prior to the present position he was head R&D of Sclavo, and then head of vaccine research and Chief Scientific Officer of Chiron Corporation, and Global Head R&D at Novartis Vaccines. Several molecules he worked with became part, or are near to becoming, licensed vaccines. These include: CRM197 used in H.influenzae, N.meningitidis, and pneumococcus vaccines; an acellular vaccine against pertussis containing a genetically detoxified pertussis toxin; the first conjugate vaccine against meningococcus C and later against meningococcus ACYW; the MF59 used in a vaccine against pandemic influenza; and the genome-derived vaccine against meningococcus B, the first vaccine to provide broad coverage against meningococcal serogroup B. He was elected member of the US National Academy of Sciences and the European Molecular Biology Organization. Awards conferred include: Paul Ehrlich and Ludwig Darmstaedter Prize (1991), the Gold Medal by the Italian President (2005), the Albert B. Sabin Gold Medal (2009), the Lifetime Achievement Award from the Institute of Human Virology in Maryland (2010), and the Excellence Award from the European Society of Clinical Microbiology and Infectious Diseases (2011). In 2013 he was nominated third most influential person worldwide in the field of vaccines (Terrapin). In 2014 he was awarded the Prix Galeno Italy for the best pharmaceutical product.
Roberto Gasparini is a Full Professor of Preventive Medicine and Hygiene at the University of Genoa, Italy, and Director of the Inter- University Centre of Research on Influenza and Other Viral Infections. He is also the Principal of the Hygiene and Preventive Medicine Medical School of Genoa University. In 1986, he was appointed firstlevel permanent state professor (epidemiology) and became a Full Professor in the Faculty of Medicine and Surgery at Siena University, where he later became Director of the School of Hygiene and Preventive Medicine. Since 2000, Professor Gasparini has been involved in various research projects into whooping cough and disinfection, vaccines against influenza, human respiratory virus illnesses, epidemiology and vaccination policies. Between 2003 and 2005 he was Vice President of the Infectious Diseases Control and Prevention Section of the European Public Health Associations. He has published about 350 articles and since 1997 he has been Co-editor of the Journal of Preventive Medicine and Hygiene.
Sohail Ahmed is currently Global Head of Clinical Sciences at GSK Siena. Previously he was Head of Clinical Sciences Unit (Translational Medicine) at Novartis Vaccines and Diagnostics in Siena, Italy and in Cambridge, USA. He also worked as Assistant Professor of Medicine at the Boston University. He has strong skills and experience as practicing clinician in Medicine and Clinical Immunology, academic investigator in basic science research, and manager in industry (both Pharma and Vaccines) with emphasis on discovery, clinical profiling, proof-of-concept clinical trial design, and subject safety.
Stefania Salmaso is Director of the National Centre for Epidemiology, Prevention and Health Promotion Istituto Superiore di Sanità in Rome, Italy since 2004. She joined Istituto Superiore di Sanità in 1979 as Research Assistant at the Communicable Disease Unit in the Laboratory of Epidemiology and Biostatistics. Then she obtained the role of Senior researcher and research Director. Member of the Vaccine Working Party at EMA. Stefania holds a Degree with honours of Doctor in Biological Sciences after two year internship and discussion of a thesis in molecular biology, University “La Sapienza”, Rome, Italy. Later a Specialization in Medical Statistics, University “La Sapienza” - Rome, Italy and an extended Course in Medical Statistics at the London School of Hygiene and Tropical Medicine, London, UK. Since 1991 most of her activities have been focused on vaccinology, in particular with the plan, conduct and analysis of the NIH sponsored Italian Clinical Trial on Pertussis Vaccines, where she acted as the Principal Epidemiological Investigator. Author of more than 300 national and international Scientific Publications.
SShe is currently Professor of Pediatrics Infectious diseases, Head of the Institute for Global Health and Program Director of Master Programs at University of Siena. Sue Ann is also Professor and Head of the Clinical Department at Instituto Carlos Chagas, in Brazil and since 5 years is a Senior consultant for the Bill and Melinda Gates Foundation. She has over 20 years of experience in the pharmaceutical industry (GSK, Merck, Novartis) in different roles and increasing responsibility on clinical development, medical affairs, regulatory and medical governance. She has also been in charge of Continuous Medical Education as a member of the International Group at the Educational Commission for Foreign Medical Graduates (ECFMG- Philadelphia, USA). In 2006, Sue Ann founded the clinical/medical consulting company “GRID RIO – Global Research in Infectious Diseases” in Rio de Janeiro in partnership with GRID Switzerland in Zurich and GRID Germany in Munich and GRID Singapore in Singapore. Clients include prominent multinational pharmaceuticals as well as local private and public health companies.
After training in epidemiology at Stanford University, I have been working in public health and epidemiology for nearly 20 years with an emphasis on infectious disease. Initially I was a field-level epidemiologist conducting tuberculosis outbreak investigations in the New York City Department of Health. This was followed by several years with WHO and other international agencies where I worked largely on disease burden estimation and interpretation of surveillance data for policy and funding decisions. For the last five years I have been in the pharmaceutical industry first with Roche, then GSK Vaccines, and now Takeda where my current focus is on dengue.
Sylvie Bertholet is Vaccines Academy PhD Director and Unit Head Immunology at GSK in Siena, Italy. This second role focuses on the characterization, in animal models, of cellular immunological mechanisms of action and protection of prophylactic vaccines developed at NVD. Current projects include adjuvanted protein subunit-, and RNA-based vaccines against Influenza and Staphylococcus aureus.
Thierry Decelle is Senior Director, Enabling Sciences and Biologics Design, Sanofi Pasteur, Marcy L'Etoile, France. He is also the head of the R&D Animal Welfare and In vivo Support and is the corporate Animal Welfare & 3Rs Officer, Sanofi Pasteur. Dr. Decelle also holds a vet specialization Diploma in laboratory animal science and a National Diploma in toxicology. He belongs to several key European laboratory animal science organizations, including FELASA, AFSTAL, GIRCOR, ESLAV, EFPIA, as well as U.S. based organizations such as AALAS and APV. He currently serves as a member of the AAALAC International Council on Accreditation. He has been involved in several working groups with the European Commission to set up the new European Directive on the protection of animals used for scientific purposes.
Todd Ranheim completed his doctoral work at the Institute for Molecular Virology (St. Louis University Medical School) in the department of Cell and Molecular Biology, where his Ph.D. focused on the mechanisms adenoviruses use to evade the host immune response. Following a postdoctoral appointment at The Scripps Research Institute in the Department of Neurobiology, he joined Merck’s vaccine division and spent the next 13 years working in various roles. Todd was initially responsible for building and managing the analytical development group supporting the RotaTeq® vaccine from in-licensure to launch. Following the launch of RotaTeq®, he built and managed a group responsible for potency assays for all biologic programs in the Merck portfolio (vaccines, monoclonal antibodies, peptides, and siRNAs). Todd joined Novartis in 2010 to lead their Analytical Development group in Siena Italy where his primary focus was on the analytical assays and regulatory interactions leading to the licensure of Bexsero®. Since 2014, Todd has been the Head of the Analytical Development group at Takeda Vaccines responsible for the development of all CMC and Clinical assays to support Takeda’s vaccine pipeline.
Trent is the Vice President of Vaccine Technology and Engineering at Takeda Vaccines, where his responsibilities include technical operations, lifecycle management, and engineering for commercial vaccine manufacturing. Prior to Takeda, Trent held positions at Biologics Consulting Group, Life Technologies and Merck and Co. Trent was an adjunct faculty at University of Maryland and has taught as guest speaker in numerous courses on biologics manufacturing. Trent holds an MBA from the University of Virginia and a PhD from the University of California, Berkeley
Tumani Corrah is the MRC’s foundation Director of Africa Research Development and the first Emeritus Director of the MRC Unit, The Gambia. This provides Tumani with the ideal platform from which to work with partners to enhance research excellence by supporting talented researchers working on significant research challenges in west, central and eastern Africa. Tumani Corrahs’s role plays to his personal passion for growing a new generation of outstanding African researchers working in Africa. He is leading a new Charity (AREF) that gives much-needed support to bright, early postdoctoral African scientists at the most vulnerable point in their careers. The charity aims to provide the foundation for these young scientists to compete and win international grants, enabling them to continue their health research careers in Africa. Tumani has over 30 years of progressively senior-level experience in a leading research institution in Africa – the MRC Unit in The Gambia. There, he rose through the ranks to the position of Unit Director, a position he held through many challenges for ten years.
Ugo D'Oro is currently Head, In-vitro Immunological Assays Unit, Immunology Function at Novartis Vaccines and Diagnostics s.r.l. (a GSK company. Previously Senior Staff Scientist, Molecular Immunology Unit, Chiron Vaccines/Novartis Vaccines, Siena, Italy, and Fellow at Division of Experimental Immunology, Istituto Nazionale dei Tumori G.Pascale, Naples, he was also postdoc at the Laboratory of Immune Cell Biology, National Cancer Institute, NIH, Bethesda, USA. He obtained his MD and PhD in Cellular and Molecular Biology and Pathology from the University of Naples and a Medical Specialty Degree in Clinical Pathology from its Medical School.
Currently is Head of Biostatistics & Statistical Reporting Site Head Development Marburg GSK, Marburg, Germany. He has 27 years of experience in Biostatistics in the pharmaceutical industry in different roles. He graduated from the University of Trier with a Diploma in Mathematics focused on pairwise multiple comparisons and the closure test principle and completed his PhD in Medicine at Karolinska University Stockholm, Sweden, with a thesis on the quality of life of patients suffering from primary immunodeficiencies.
Vega Masignani is Project Leader of the Streptococcus pneumoniae vaccine project at GSK Siena. She got her PhD in Biotechnology with a thesis on the computational approach to the development of a novel Neisseria meningitides protein-based vaccine. At present, she continues to carry out research in the field of microbial pathogenesis in her role of project leader.
She joined Novartis Vaccines (now GSK Vaccines) in February 2014. Her background is Environmental Health Sciences, a degree she gained from the American University of Beirut (AUB) in Lebanon which operates under the charter issued by the Education Department of State of New York. She holds two masters degrees: one, in Public Health - MPH from the American University of Beirut and an MSc in Clinical Epidemiology from the University of Maastricht, the Netherlands. She recently submitted her PhD thesis at the department of Pharmacoepidemiology & Clinical Pharmacology - Utrecht University, the Netherlands (public defense is planned in January 2016). Her research mainly focuses on post-approval pharmacoepidemiological study methods using large electronic healthcare databases from the European countries. At present she is the lead of safety/pharmacovigilance of vaccines in the Epidemiology group at GSK Vaccines.
Vincent I Ahonkhai is currently consultant in Global Health encompassing the R&D of pharmaceuticals, vaccines and diagnostics for intervention against infectious diseases. He recently retired as Senior Advisor Global Health at the Bill & Melinda Gates Foundation, Seattle Washington. At the foundation he had founded and led the Regulatory Affairs team that collaborate with other teams to expedite the development and licensure of global health medical products for delivery to low-and middle-income countries. Dr. Ahonkhai has over 2 decades of experience in the biopharmaceutical industry where he rose to the Vice President position in Clinical Development, Medical Affairs, Regulatory Affairs and Product Safety and Pharmacovigilance. Pedvax-Hib, Augmentin, Levofloxacin are notable among the list of products for which his team was responsible in separate companies which were among the top 10 multinational companies worldwide. He is a board-certified Pediatrician and a specialist in adult and pediatric infectious disease. His medical training was at the University of Lagos Nigeria, and specialty training at the State University of New York at Brooklyn where he subsequently served as Assistant Professor. He also variously served as part time faculty at the Children’s Hospital of Philadelphia, member of the United States Institute of Medicine’s Forum on Emerging Infections, on the Advisory Committee to the Commissioner, US FDA, the Board of the Association of Scientists and Physicians of African Descent, and the Nigerian Academy of Science Forum on Evidence-Based Health Policymaking. He has presented in several infectious disease fora and published extensively in peer-reviewed journals.
She joined Novartis Vaccines in Amsterdam in March 2013. She was an epidemiologist of meningitis projects and supports pediatrics and specialty GPT and currently epidemiologist at GSK Amsterdam, NL. She obtained her MD in preventive medicine in China in 2004, MSc in International Health from Germany, Norway and France in 2007, and PhD in Epidemiology from University Medical Center Groningen, the Netherlands in 2012. Her PhD project focused on using new methodological / study design to predict the drug effect on hard renal outcomes using the short?term effect of a drug on multiple biomarkers. Yan started her career in Chinese Centers of Diseases Control and Prevention. Her responsibilities there included infectious diseases surveillance and monitoring and evaluating project implementation.
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