Deborah Ashby is Deputy Head of the School of Public Health at Imperial College. She sat on the Commission on Human Medicines and often advises the European Medicines Agency. Her research interests are in clinical trials, benefit-risk decision making for medicines, and the utility of Bayesian approaches in these areas. She leads the benefit-risk workstream of the IMI-funded PROTECT project, bringing together academic, pharmaceutical, regulatory and patient expertise to determine best practice, and innovate on both underpinning methods and communication of the benefits and risks of medicines. She has been awarded an OBE for services to medicine, appointed an NIHR Senior Investigator and elected to Fellowship of the Academy of Medical Sciences

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Alain Micaleff is a retired Senior Medical Safety Advisor for Merck Serono S.A., a company that combines its complementary expertise in new chemical entities (NCEs) and new biological entities (NBEs). Alain earned a Doctor of Medicine degree while studying in Rennes, France in 1975. He began his career at Beecham Pharma (now GSK) in 1984, with positions held at the French affiliate in Paris, then at the company’s headquarters in London, followed by the position of Head of Global Drug Safety at Serono S.A. in Geneva in 2001, and Vice President/Head of Global Drug Safety at Merck Serono in 2007. He served as an EFPIA representative at ICH E2B and ICH E2D Working Groups, and co-lead the IMI-PROTECT Benefit-Risk Group.  View Dr Alain Micaleff's profile

Steve Hobbiger has a BSc in Physiology and qualified in Medicine from the Middlesex Hospital, London University. After general medical training he joined the Wellcome Foundation Limited in 1989 and spent ten years at Wellcome and GlaxoWellcome working in Cardiovascular & Critical Care Clinical Research. Following a period as Director of Medical Research at Napp, Steve returned to the pharmaceutical company GlaxoSmithKline in 2001. He joined the department of Clinical Safety and Pharmacovigilance and in his current position he is the GSK EU Qualified Person for Pharmacovigilance. Steve has participated in CIOMS 9 and 10 and is a former Vice President of the UK Faculty of Pharmaceutical Medicine. He is the alternate co-lead the IMI-PROTECT Benefit-Risk Group.

Diana Hughes is a senior biopharmaceutical pharmacovigilance and risk management expert, is a Physician by training, and has a Master’s degree in Pharmaceutical Medicine. She has medical licenses with advanced certifications in both the UK and USA, and is fully trained as a General Practitioner with additional trauma and critical care experience (UK), and is a board certified Psychiatrist with a fellowship in Consultation-liaison Psychiatry (USA). Diana has 14 years of safety and risk management experience within Pfizer, with particular interest in risk minimization, risk communication and benefit risk assessment and communication. Diana has been a core member of the PhRMA Benefit Risk Assessment Team 2009-2012, Next Steps Benefit-Risk group, Benefit-Risk Task Force of the Centre for Innovation in Regulatory Science (CIRS), and IMI PROTECT Work Package 5 (participating in wave 1 and 2 case scenarios, and graphical representation sub team, and leading the Recommendations sub team). She is the alternate deputy co-lead the IMI-PROTECT Benefit-Risk Group.  View Diana Hughes's profile

Ioanna is a lecturer in Epidemiology, develops and applies new research methods for the analysis of large-scale data in chronic disease epidemiology. Dr Tzoulaki is also actively engaged in the development of several large population-based cohorts/biobanks. She is also the deputy co-lead of the IMI-PROTECT Benefit-Risk Group.  View Ioanna Tzoulaki's profile

Shahrul is a Senior Statistician at the Imperial Clinical Trials Unit, Imperial College London. His main area of work is in developing statistical methodologies to improve the process of safety monitoring and benefit-risk assessment of drugs and vaccines in Europe for pharmacovigilance. His other research interests include statistical computing and data management, decision sciences, data visualisations and Bayesian inference. He is the alternate deputy co-lead of the IMI-PROTECT Benefit-Risk Group.  View Shahrul Mt-Isa's profile

Gerry is a Biostatistics Senior Manager at Amgen Ltd (Cambridge, UK) and is a Regional Statistical Lead in the Immuno-Oncology therapeutic area. He also provides safety biostatistical support for multiple European post-authorization safety studies spanning products and indications. He is a member of the American Statistical Association (ASA) and served on the IMI-PROTECT Benefit-Risk Recommendations and graphical representations teams as well as co-leading the development and implementation of the Benefit-Risk Website.  View Gerry Downey's profile

Ian is currently a Senior Statistics Team Leader within AstraZeneca based in the US within the Inflammation, Neuroscience and Respiratory Therapeutic Area where he is responsible for Biometrics and Information Sciences support and input into various projects. Ian has a keen interest in structured Benefit-Risk assessments and is part of the core team responsible for implementation of structured Benefit-Risk within AstraZeneca as well as co-chair of the European Federation of Statisticians in the Pharmaceutical Industry Special Interest Group on Benefit-Risk.  View Ian Ian Hirsch's profile

Richard is an Associate Director, in the Statistical Methodology and Consulting Group in Novartis, Basel. His areas of interest are applying data-driven, evidence-based analyses to enable integrated, quantitative decision-making; Exploratory Analysis, Benefit-Risk methods; Health Economic modeling; Evidence synthesis and Bayesian Methods.  View Richard Nixon's profile

Kimberley leads the Patient and Public Involvement team in PROTECT Benefit-Risk. She is a Research Associate at Imperial College London and completed her Masters and PhD in Public Health at the same institution; her work focuses on how patients and the public can be meaningfully involved in the benefit-risk assessment of medicines. Her research interests include: investigating where PPI can be applied in clinical and regulatory decision-making processes, eliciting patient and public preferences on the benefits and risks of medicines with the use of formal methodologies, and developing a framework to guide the application, reporting and evaluation of patient and public involvement in benefit-risk assessment.  View Kimberley Hockley's profile

Ed Waddingham has played a key role in the PROTECT Benefit-Risk team as joint lead author of the group’s recommendations and a contributor to the ongoing work on patient and public involvement. His research focuses on the statistical aspects of benefit-risk assessment. He has an MSc in Modern Epidemiology from Imperial College London. http://uk.linkedin.com/pub/ed-waddingham/15/b2b/744/en  View Ed Waddingham's profile

Alesia Goginsky has worked in various pharmacovigilance-related areas in the pharmaceutical industry for the past 22 years and is currently a business process analyst for Worldwide Research and Development, Worldwide Safety and Regulatory at Pfizer. She holds a Ph.D. in Exercise and Sport Science/Sport Psychology from Penn State University. http://www.linkedin.com/pub/alesia-goginsky/7/a35/944/en  View Alesia Goginsky's profile

Christoph is a Senior Director at Bayer Pharma AG in the area of integrated analysis and life-cycle management statistics. Besides benefit-risk assessment his research interests include network meta-analysis and evaluation of observational data. He is a member of the German Region of the International Biometric Society (DR-IBS) as well as of the German Association for Medical Informatics, Biometry and Epidemiology (GMDS).

Dr. Metcalf is the Senior Director of Benefit Risk Evaluation at GlaxoSmithKline. She leads GSK’s efforts to assess and articulate the favorable v. unfavorable effects of medicines. Previously she led international Decision Sciences and Portfolio Management teams at GSK and Centocor, conducted health economics and quality of life studies for HIV and oncology therapies at GSK, and directed an NIH master contract for HIV vaccine research at Family Health International.  View Marilyn Metcalf 's profile

Dr. Lesley Wise is Vice President of Global PV Risk Management and Pharmacoepidemiology at Takeda, where she has responsibility for global risk management processes, benefit-risk assessment processes and implementation of risk management plans. She joined Takeda in 2010 after 9 years working at the UK medicines regulatory authority (MHRA) as manager of the Pharmacoepidemiology Research Unit in the Vigilance and Risk Management of Medicines Division. In her current role, Lesley works closely with Pharmacovigilance, Regulatory and Medical Affairs colleagues to ensure a “joined up” approach to Benefit - Risk Management.

Dr Lawrence Phillips is an Emeritus Professor of Decision Science at the London School of Economics, and a Director of Facilitations Limited. When he is not teaching on the LSE’s MSc in Decision Sciences, he works as a process consultant applying the ‘intellectual technology’ of facilitated workshops and quantitative modelling to help key players in organisations facing decisions that balance uncertainty and multiple conflicting objectives. His publications span behavioural decision theory, decision and risk analysis, Bayesian statistics, group processes, cultural differences in dealing with uncertainty, organisation theory, and the benefit-risk of medicinal products. In November 2005, the Decision Analysis Society of INFORMS awarded Dr Phillips its highest honour, the Frank P. Ramsey medal for distinguished contributions to decision analysis.  View Lawrence Phillips's profile  Personal website

Richard Hermann is a double-boarded physician in Rehabilitation Medicine and in Laboratory Medicine. He serves as a Safety Physician and is responsible for the global structured Benefit-Risk process at AstraZeneca. He served as one of the core members of the PhRMA BRAT team that created the BRAT Framework.

Dr. Luciani is the responsible of the Unit of Clinical Knowledge Engineering at the Mario Negri Institute in Milan. Therein, graphical models, Markov chain monte-carlo estimation techniques and knowledge acquisition methods are employed to provide medical knowledge with a formal and flexible probabilistic representation. Medical training, personalization and optimization of clinical decisions are the main targets of the developed models. They were applied to complex clinical problems, like the differential diagnosis of pulmonary embolism, the prognosis of patients with chronic heart failure and the discontinuation from mechanical ventilation in critical setting.

Alison is a Policy Manager at IAPO (the International Alliance of Patients Organizations), a unique global alliance representing patients of all nationalities across all disease areas and promoting patient-centered healthcare around the world. She manages and coordinates IAPO’s policy activities including policy development, communication and projects, engaging member organizations and representing their interests and needs when advocating at the global level and regional level. Projects like IMI-PROTECT are important to our work to improve clinical trials and research, and to increase the involvement of and benefit to patients.

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Andrea Beyer is an Epidemiologist with a Master's degree in Public Health from Emory University, Atlanta and PhD from University of Groningen. Dr. Beyer has worked in the field of Epidemiology, both in the US and in Europe, for several private and public organizations. For the past 4 years, under a collaborative agreement with the University of Groningen, the Netherlands and the European Medicines Agency, Dr. Beyer formed part of a small team of experts providing research support for the EMA Benefit-Risk Methodology project. Her research areas of interest are measuring individual differences in risk attitude, risk perception, and benefit-risk trade-offs among patients, regulators and healthcare professionals. With the support of the EMA, in 2011 Dr. Beyer completed a study on risk perception of medicinal drugs among medical assessors from nine European countries and will report during this conference the results of an EMA\UMCG supported study on capturing quantitative preferences for treatment outcomes among Multiple Sclerosis patients. Since January 2013 Dr. Beyer has also provided leadership for a study on extending benefit-risk methodologies to stakeholders under the Work Package 6 in the IMI-PROTECT project.  View Dr Andrea Beyer's profile

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Dr Torbjörn Callréus is a Chief Medical Officer at the Danish Health and Medicines Authority and an alternate member of the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency. He specialises in Clinical Pharmacology and obtained his MD and PhD degrees from Lund University in Sweden. In recent years, his work has focused on drug safety related issues in both the pre-approval and post-approval phases of development thus gaining experience from the pharmaceutical industry, academic research in pharmacoepidemiology and the European Union regulatory network

Dr. Edmond Chan is Director and Team Lead of Oncology Medical Safety Surveillance and Insight group at Janssen-Cilag. He was trained as nephrologist in London, has a Master’s degree in Medical Statistics, and a Doctor of Medicine Research degree in transplantation medicine. He has a keen interest in benefit-risk assessment of drug and was a member of the work package 5 team when he worked at the Imperial Clinical Trials Unit, Imperial College, London. He is currently a member of the Benefit Risk Evaluation team in Janssen-Cilag and the company lead in the IMI- EU Pharmacovigilance and Pharmacoepidemiology.  View Edmond Chan's profile

Dr Christine E Hallgreen has played a key role in the PROTECT Benefit-Risk group through review of BR methodologies and visual representation for BR communication and application of methods in case studies and the work on patient and public involvement. Christine has an MSc in Engineering from the Technical University of Denmark, and a Ph.D. degree within non-linear dynamics also from Technical University of Denmark.

Juhaeri Juhaeri, PhD, is Head of Pharmacoepidemiology at Sanofi and Adjunct Assistant Professor at the Gillings School of Global Public Health, University of North Carolina Chapel Hill, USA. Juhaeri is an Epidemiologist and Statistician with over 20 year experience in epidemiologic research in academia and in pharmaceutical industry. He is currently active in various public-private partnership projects of Pharmacovigilance, Epidemiology, and Benefit-Risk Assessment.  View Dr. Juhaeri's profile

Alfons Lieftucht is a decision scientist and is currently Director of Benefit-Risk Evaluation at GlaxoSmithKline in London, UK. Prior to this, he worked as an infectious disease outbreak investigator for Public Health England in London, UK, and for the World Health Organization in Geneva, Switzerland. He received his degree in veterinary medicine from Hannover Veterinary School, Germany, and his M.Sc. degree in health policy and management from Harvard University, Cambridge, Massachusetts, USA.  View Dr. Alfons Lieftucht's profile

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Andrew Thomson is a statistician at the European Medicines Agency, in the Human Medicines Evaluation Division. Prior to joining the EMA in 2014, he spent 7 years at the MHRA, initially as a Statistical Assessor in the Licensing Division, and subsequently heading the Epidemiology Unit in the Vigilance & Risk Management of Medicines Division.

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Emily worked as project manager for Imperial on PROTECT, managing all financial and adminstrative operations. Emily has extensive experience in Project Management and ensures that projects deliver on time and budget. In her other career stream Emily works in Emergency Management and Business Continuity.  View Emily Thompson's profile

Subhakanta is the Developer and Designer of the PROTECT Benefit-Risk Website. He is a motivated and enthusiastic IT professional with over 13+ years' experience gained at top tier organisations. Worked extensively in analysis, design, development of Java/J2EE application.  View Subhakanta Das's profile