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Swissôtel Le Plaza

Oct 24, 2019 9:00 AM - Oct 25, 2019 5:30 PM

Messeplatz 25, 4005 Basel, Switzerland

Future of Evidence Workshop

RWE and RCT as building blocks for transformative evidence generation


René  Allard, PhD

René Allard, PhD

Contractor, CTC, Germany

René Allard graduated from the University of the Witwatersrand in 1991 and completed reading for his doctorate at the Ruhr-University Bochum, Graduation College of Biogensis and Mechanism of Complex Cellular Functions, in 1995. Since 2012 René has been Public Disclosure Lead at Grünenthal after serving in various positions in Research and Development in the Pharmaceutical Industry in the past 20 years. Interests include trial designs, outcomes research, genetic biomarkers, data collection methods, and pharmaco-economics.

Frederik  Floether, PhD, MA, MSc

Frederik Floether, PhD, MA, MSc

Quantum Industry Consultant - Global Lead Life Sciences and Healthcare, IBM, Switzerland

Dr. Frederik Flöther is the Global Healthcare & Life Sciences Leader for IBM Q Consulting. He has deep expertise in quantum computing and artificial intelligence and works with clients to create tangible value based on these next-generation technologies. Frederik has a PhD in quantum physics from the University of Cambridge and has authored 10+ peer-reviewed publications, patents, and white papers.

Robert  Hemmings, MSc

Robert Hemmings, MSc

Partner , Critical Path Institute, United States

Rob is a partner at Consilium, a consultancy partnership between Rob Hemmings and Tomas Salmonson, both long-standing contributors to the EU regulatory network. Consilium supports companies in the design of clinical development programmes, the design, analysis and interpretation of clinical trials, regulatory strategy and regulatory interactions. Previously Rob worked at AstraZeneca and then for 19 years at the MHRA, during which time he served as CHMP member at EMA for 11 years and chaired the Scientific Advice Working Party at EMA. Rob has co-authored multiple regulatory guidance documents and continues to work on any and all aspects of evidence generation and regulatory policy in respect of medicine’s development.

Michael  Lees, MA

Michael Lees, MA

Chief Operating Officer and Head of Market Access Strategy, PHMR Ltd, United Kingdom

Michael is the Chief Operating Officer and Head of Market Access Strategy at PHMR. In this role, he is responsible for ensuring that the research delivered matches the strategic needs of our clients. Michael has extensive experience in the development of health economic models and indirect treatment comparisons, utility measurement and health valuation, strategies for collection and use of real-world data, and the development of dossiers to support HTA submission. He also has substantial experience in working with different stakeholders, including through the use of early scientific advice through HTA agencies, to lead the development of integrated evidence plans and allow for access needs to be incorporated from early in development.

Inger  Mollerup, MS, MSc

Inger Mollerup, MS, MSc

Consultant, Inger Mollerup Regulatory Consulting, Denmark

Inger has more than 25 years’ experience in Drug Development and more than 15 years Regulatory Affairs experience with global regulatory responsibility for a number of drug development projects. Inger is experienced in developing and leading regulatory strategy and implementation toward the NDA approval and life-cycle management and has in that capacity overseen a number of license application and approval projects with multiple agency interactions in several regions of the world including USA (incl. Advisory Committee preparations), EU, Japan, China, Canada, India, Latin America and Southeast Asia. Experience also includes the project leadership responsibility for conducting a CVOT interim analysis to support regulatory decisions.

Andre   Rausch

Andre Rausch

Strategic Account Executive Nordics, IBM Watson Health, Germany

André Rausch is a Strategic Account Executive within IBM Watson Health focusing on improving patients life through real word evidence and AI solutions. He worked for over 20 years globally as a consultant to the Life Sciences industry.

Duane  Schulthess, MBA

Duane Schulthess, MBA

Chief Executive Officer, Vital Transformation LLC, United States

Duane Schulthess is the CEO of Vital Transformation, an economics consultancy in Brussels, Belgium and Washington, DC. He is a member of the U.S. Congressional Health Care Task Force, and the Executive Producer of the Vital Health Podcast, ranked in the top 30 healthcare podcasts by traffic. Previously, he was the EMEA Head of Corporate Development of The Wall Street Journal. Duane has an MBA from KU Leuven's Vlerick Management School. He received a Leverhulme Trust Fellowship to study the French horn at London's Royal Academy of Music, and has a BA Magna Cum Laude from the University of the Pacific where he studied music and managerial economics, graduating Phi Kappa Phi. He is a senior associate of the UK's Royal Society of Medicine.

Michael  Seewald

Michael Seewald

Head Real World Evidence, Novartis Pharma AG, Switzerland

A biochemist by education, Michael Seewald built expertise in analytical disciplines (biophysics, bioinformatics, chemoinformatics) during his academic career, and authored/co-authored publications in leading journals such as Nature and EMBO J. Michael began his industry career in the area of bioinformatics, then moved through a number of positions of increasing responsibility in Finance, Strategy, Marketing, and Development. Since 2015, Michael is heading the Center of Excellence for Real World Evidence at Novartis.

Solène  Thieffry, MSc

Solène Thieffry, MSc

Global RWE Policy Lead, UCB, Belgium

Solène is the Global RWE Policy Lead for UCB in Brussels, Belgium. In this role, she is leading and coordinating the external engagement strategy that aims to advance acceptance of RWE by healthcare decision-makers from early clinical development through to in-market treatment options. Within this role, she is actively involved in different activities such as the IMI EHDEN project. Prior to this, she held various positions in access, pricing and health economics and outcomes research in Global Market Access mostly focusing on neurology solutions for patients.

Ian  Rentsch, JD

Ian Rentsch, JD

CCO & GM Pharma , CENTOGENE GmbH, Germany

Ian Rentsch has over 25 years’ experience in Multinational Corporate Affairs, Outsourcing Management & Clinical Research Development working in large multinational companies including large biopharma and Contract Research Organizations Globally and in Emerging Markets. Most recent roles include General Executive Management, Leadership of regional clinical teams, Business Operations and Strategic Business Development in the Contract Research Industry & Clinical Technology.

Nikolai Constantin Brun, MD

Nikolai Constantin Brun, MD

Co-Chair, EMA-MHA Big Data Task Force; Dir, Div for Medical Eval & Biostatistics, Danish Medicines Agency, Denmark

Background and experience in the clinical field and afterward in research and devel-opment of pharmaceuticals in the Biotech and Pharmaceutical Industry for 17 years with a long list of publications in high-impact journals. 4 years as Director of Division responsible for Medical Evaluation and Biostatistics – both Human and Veterinary Medical Evaluation, Danish Medicines Agency. As of 1st of January 2021 Director of Division responsible for Medical Strategy and Innovation, Danish Medicines Agency. Co-Chair of the joint HMA/EMA Big Data Steering Group. Member of the Board of Directors, Copenhagen Centre for Regulatory Science, University of Copenhagen Member of the Scientific Advisory Board, EHDEN, European Health Data Evidence Net

Lenka  Kellermann

Lenka Kellermann

Managing Director, OncologyInformationService, Germany

Peter  Mol, PharmD, PhD

Peter Mol, PharmD, PhD

CHMP member, NL, MEB, Netherlands

Peter Mol is the Dutch member of the Committee for Human Medicinal Products. He was a previous member (vice chair) of EMA’s Scientific Advice Working Party. He is co-chair of the EMA Cross-Committee Task force on Registries. He is also a professor of drug regulatory science at the University Medical Center Groningen. His research interest is in the area of regulatory science; from new tools to optimize regulatory decision-making (especially impact of personalised medicine and real world evidence), to improve knowledge transfer and with a specific interest in safety communication.

Bettina  Ryll

Bettina Ryll

Member of the First EU Cancer Mission Board, MPNE, Vision Zero Cancer, Sweden

Bettina Ryll, MD/PhD founded the Melanoma Patient Network Europe in 2013 and developed a special interest in patient-centric clinical research and drug development. Bettina’s current areas of focus are Adaptive Licensing/ MAPPS , innovative sustainable healthcare models and patient-centered risk/ benefit assessment tools. She lectures and advises on patient-centric drug development, member of ASCO and ISPOR and current chair of the ESMO Patient Advocacy Working Group.

Somnath  Sarkar, PhD

Somnath Sarkar, PhD

VP, Head of Quantitative Sciences , Flatiron Health, United States

Somnath Sarkar, PhD is vice president and head of quantitative sciences at Flatiron Health, where he leads a team of health economists, outcome researchers, biostatisticians, epidemiologists, and data scientists who focus on curation of high-quality real-world datasets, validation of real-world endpoints, and the development of various advanced analytics and analysis methods. In addition, Flatiron’s quantitative scientists collaborate with academic institutions and serve in a number of educational leadership positions to build industry-wide understanding of translating real-world data to potential real-world evidence for oncology research.

Christian  Stock

Christian Stock

Principal Statistician, Boehringer Ingelheim Pharma GmbH & Co. KG, Germany

Christian Stock is a Principal Statistician with Boehringer Ingelheim Pharma who is working in the fields of medical affairs and market access. He holds master’s degrees in biostatistics and health sciences, a doctorate in epidemiology, and a habilitation (second thesis) in biostatistics and epidemiology. Prior to joining Boehringer Ingelheim he worked at the Centre for Reviews and Dissemination in York (UK), the German Cancer Research Center (DKFZ) and the University of Heidelberg. His main interests for many years have been the design and analysis of studies for comparative effectiveness and safety research. He has worked extensively also with data sources such as electronic health records, disease and drug registries, and claims data.

Christian  Brasen, PhD, MSc

Christian Brasen, PhD, MSc

Project Manager, Biometrics, Lundbeck A/S, Denmark

Christian Brasen is project manager in Biometrics at H. Lundbeck A/S. He holds a Master of Science (2007), a PhD in biophysics (2010) and has experience as research group leader at the Technical University of Denmark and other positions in industry. In Lundbeck Biometrics Christian works within CNS focusing on remote assessment and prediction models.

Claudia  Cabrera

Claudia Cabrera

Senior Director Epidemiology & Evidence Excellence, AstraZeneca AB, Adj Researcher Karolinska Institute, Dept Epidemiology and Biostatistics, Sweden

Claudia Cabrera-Moksnes graduated from Tulane University School of Public Health with a master’s degree in Epidemiology. She completed her doctorate degree at Sahlgrenska Academy at Göteborg University, Department of Primary Health Care and she also holds a Licentiate in Medical Science, from 2005. Claudia has worked in Industry for 17 years across all therapy areas and patient safety, of late she has focused on the build of large global studies related to respiratory disease. In her most recent position, she leads studies in Patient Safety, China RWE development as part of the Global Evidence Hub, as well as leading Clinical Trial Diversity research.

Rachael  Higgins

Rachael Higgins

VP Account Management, Trinetx, United States

Nigel  Hughes, MSc

Nigel Hughes, MSc

Scientific Director, Observational Health Data Analytics/Epidemiology, Janssen Research and Development, Belgium

Nigel Hughes has a thirty-five year career spanning the NHS in the UK (16 years), NGOs and patient organisations (10 years) and within the pharmaceutical industry (17 years). He has worked clinically in HIV and viral hepatitis, liver disease, and in sales & marketing, medical affairs, market access and health economics, R&D, precision medicine, advanced diagnostics, health IT and Real World Data/Real World Medicine. His experience covers clinical, education, as an advisor, consulting, communications and lobbying over the years. Currently the Project Lead for the IMI2 European Health Data & Evidence Network, he was Platform Co-Lead for the IMI1 EMIF, as well as consulting on numerous projects and programmes in the domain of RWD/RWE

Jessica S. Scott, JD, MD

Jessica S. Scott, JD, MD

President, Legacy Health Strategies , United States

Jessica is a Patient Engagement leader who brings to Legacy Health Strategies a combined acumen of medicine and law, together with innovative thinking, to drive the culture change of increasing patient perspectives in medical product development to result in mutually beneficial outcomes for patients and industry. She is known as a credible and trusted thought-leader and collaborator, bringing novel solutions, digital strategies, and patient-centered approaches to biotech, med tech and pharmaceutical industries and across multi-stakeholder groups. She has deep knowledge of the pharmaceutical industry from leadership positions at GlaxoSmithKline and Takeda where she focused on building patient perspectives into the process of R&D.

Yoshiaki  Uyama, PhD, RPh

Yoshiaki Uyama, PhD, RPh

Associate Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Dr Yoshiaki Uyama is currently Associate Executive Director, Pharmaceuticals & Medical Devices Agency (PMDA) of Japan. He is responsible for regulatory science researches in the agency. He has many experiences in new drug evaluation and real world data utilization, including the ICH E15, E16 and E17 Expert Working Groups, and Pharmacoepidemiology Discussion Group. He is also served as a member of the DIA Council of Regulators and a board member of the international society for pharmacoepidemiology as well as a visiting professor in Chiba University, Nagoya University and Nagoya City University.

Elina  Asikanius

Elina Asikanius

Biostatistician, Finnish Medecines Agency Fimea, Finland

Elina Asikanius is a statistician at the Finnish Medicines Agency. She is also a member of the EMA Methodology Working Party and the EMA Scientific Advice Working Party. She joined FIMEA 2020 and before becoming a regulator she worked over 10 years in the pharmaceutical industry with broad responsibilities.

James  Black

James Black

Associate Group Director Epidemiologist, Personalised Healthcare Data Science, Roche/Genentech, Switzerland

James is an Associate Group Director in the Personalised Healthcare (PHC) group at Roche, a team focussed on enabling the Roche PHC vision by leveraging meaningful routine real world data at ever greater scale to generate insights on how to get the right drug to the right patient.

M. Khair  ElZarrad, PhD, MPH

M. Khair ElZarrad, PhD, MPH

Director, Office of Medical Policy, CDER, FDA, United States

Dr. ElZarrad is the Director of the Office of Medical Policy (OMP) at FDA’s Center for Drug Evaluation and Research (CDER), where he leads the development, coordination, and implementation of medical policy programs and strategic initiatives. Dr. ElZarrad currently leads multiple projects focused on exploring the potential utility of real-world evidence, innovative clinical trial designs, and the integration of technological advances in pharmaceutical development. He earned a doctoral degree in medical sciences with a focus on cancer metastases from the University of South Alabama, as well as a master’s degree in public health from the Johns Hopkins Bloomberg School of Public Health.

Andreas  Karabis

Andreas Karabis

Senior Principal RWAS, IQVIA, Netherlands

Andreas has been primarily focused on evidence synthesis, systematic literature reviews and decision-analytic models. He has been involved in numerous submissions to HTA and reimbursement authorities in Europe. Prior to joining IQVIA, he was most recently Director-Head of the Modelling & Evidence Synthesis service line at Mapi Group (now part of ICON). Since 2017, he has been appointed Honorary Senior Research Associate at the University College of London. Andreas has published over 20 articles in international peer-reviewed journals, over 50 conference abstracts and is serving as peer reviewer for several scientific journals. He holds a Bachelor’s in Mathematics, MSc and PhD in Applied Mathematics.

Rebecca  Li, PhD

Rebecca Li, PhD

Executive Director, Center for Global Clinical Research Data, Vivli , United States

Rebecca Li, PhD, is the Executive Director of Vivli and on faculty at the Center for Bioethics at the Harvard Medical School. Previous to her current role she was the Executive Director of the MRCT Center of Brigham and Women’s Hospital and Harvard for over 5 years and remains a Senior Advisor at the Center. She has over 25 years of experience spanning the entire drug development process with experience in Biotech, Pharma and CRO environments. She completed a Fellowship in 2013 in the Division of Medical Ethics at Harvard Medical School. She earned her PhD in Chemical and Biomolecular Engineering from Johns Hopkins University.

Anja  Schiel, PhD

Anja Schiel, PhD

Special Advisor, Lead Methodologist; Leader international HTA (iHTA) NoMA, Norwegian Medicines Agency (NoMA), Norway

Anja Schiel has studied Biology at the Johannes Gutenberg-University, Mainz, Germany. She received her PhD from the Free University in Amsterdam in 2006 and worked several years as Post-Doc before starting at the Norwegian Medicines Agency (NoMA) in 2012. At NoMA she is working as special adviser/Statistician/Methodologist both on regulatory (EMA) and HTA projects. She has been Chair of EMA’s Biostatistics Working Party 2017 - 2019 and just finished her 3-year term as Chair of the Scientific Advice Working Party (SAWP) at EMA. She continues currently as alternate member of the SAWP and is Member of the new Methodology Working Party (MWP) recently established at EMA. She also leads the international HTA team at NoMA.

Jan  Kimpen

Jan Kimpen

Global Chief Medical Officer , Philips , Netherlands

With a team with 40 clinicians and medical PhDs he drives advocacy, customer partnerships, clinical research and medical consulting, he is responsible for the annual publication of the Philips Future Health Index. He is a strategic advisor and participates in the WEF Global Future Council on Healthcare, the American Heart Association alliance and the Board of Sanara Ventures in Israel. Jan is president of COCIR, the European trade union for imaging, healthcare informatics and radiotherapy. Jan joined from the University Medical Center Utrecht – one of the largest healthcare organizations in the Netherlands – where he was a professor and chairman of Pediatrics before serving as CEO from 2009 to 2015.

Madis  Tiik

Madis Tiik

Senior Lecturer, Tallinn University of Technology, Estonia

He has been involved in eHealth development projects in Estonia from the beginning of 2005 and from 2007 to 2011 he was a Member of Management Board of Estonian eHealth Foundation where he formed a strong team of professionals around him. As medical doctor with strong knowledge in IT he provided professional expertise to ensure the new Estonian Electronic Health Record services being developed serve the best interests of medical staff and patients. In recent years, he has also counselled several foreign e-health related institutions and promoting Estonian experience world-wide.

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