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Future of Evidence Workshop

RWE and RCT as building blocks for transformative evidence generation


Speakers

  • René  Allard, PhD

    René Allard, PhD

    • Contractor
    • Self Employed, 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

    • IBM Q Industry Consultant - Global Lead Life Sciences & 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, MS, MSc

    Robert Hemmings, MS, MSc

    • Partner
    • Consilium Salmonson and Hemmings , United Kingdom

    Rob has been with MHRA for 16 years and heads up the team of statisticians and pharmacokineticists. Much of Rob’s time is spent educating colleagues in the importance and artistry of clinical trial statistics; their use in proof and in obfuscation. Rob is a co-opted member of the CHMP, chair of its Scientific Advice Working Party and has a number of other interests and responsibilities within the European regulatory network.

  • Michael  Lees

    Michael Lees

    • Head of Value, Evidence and Portfolio Strategy – EUCAN
    • Takeda Pharmaceuticals International GmbH, Switzerland

    Michael is the Head of Value, Evidence and Portfolio Strategy at Takeda EUCAN. He is responsible for ensuring that evidence generated in support of Takeda's medicines meets the needs of HTA and access decision makers in Europe and Canada, and therefore supports patient access to medicines. Prior to joining Takeda in September 2017, Michael led the HEOR Europe and Canada Oncology team at Bristol-Myers Squibb for seven years.

  • 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

    • CEO
    • Vital Transformation, Belgium

    Duane is the Managing Director of Vital Transformation which consults to national health authorities, blue chip multi-national organisations, governments, and stakeholder groups on healthcare policy and technology. He and his firm have developed many unique techniques and methods to harness Real World Evidence to evaluate new therapies, which are often discussed on their widely followed weekly Vital Health Podcast Series. Duane was formerly the EMEA Head of Corporate Development of The Wall Street Journal.

  • 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

    Solène Thieffry

    • 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

    • Chief Executive Officer
    • Clinerion, Switzerland

    Ian Rentsch has over 23 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

    Nikolai Constantin Brun

    • Director of Division for Medical Evaluation and Biostatistics
    • Danish Medicines Agency, Denmark

    MD, PhD Nikolai C. Brun Background and experience in the clinical field and afterward in research and development of pharmaceuticals in the Biotech and Pharmaceutical Industry for 17 years with a long list of publications in high-impact journals. 3 years as Medical Director responsible for Medical Evaluation and Biostatistics – both Human and Veterinary Medical Evaluation, Danish Medicines Agency. Chair of the HMA/EMA Joint Big Data Steering Group.

  • Lenka  Kellermann

    Lenka Kellermann

    • Managing Director
    • OncologyInformationService, Germany

  • Peter  Mol, PharmD, PhD

    Peter Mol, PharmD, PhD

    • Principal Clinical Assessor, University Medical Center Groningen; Member SAWP
    • CBG-MEB (Dutch Medicines Evaluation Board), Netherlands

    Peter Mol is a principal assessor at the Dutch Medicines Evaluation Board and a member (vice chair) of EMA’s Scientific Advice Working Party. He is chair of the EMA Cross-Committee Task force on Registries. He is also an assistant professor 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

    • Chair ESMO Patient Advocates Working Group (PAWG)
    • Melanoma Patients, 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

    Christian Brasen

    • 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, Sweden

    Claudia Cabrera graduated from Tulane University School of Public Health with a master’s degree in international public health and a concentration in Epidemiology and Biostatistics in 1994. She completed her doctorate degree in Epidemiology at the Nordic School of Public Health and Sahlgrenska Academy, Göteborg University. She also holds a Licentiate in Medical Science. Claudia has worked in the Pharmaceutical Industry for the past 14 years across all therapy areas and patient safety, lately she has focused on the build of large global studies related to respiratory disease. Her most recent position is in Real World Science and Digital.

  • Rachael  Higgins

    Rachael Higgins

    • VP Account Management
    • Trinetx, United States

  • Nigel  Hughes, RPh

    Nigel Hughes, RPh

    • 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

    • Head of R&D Patient Engagement Office
    • Takeda Pharmaceutical Company, United States

    Dr. Jessica Scott is the Head of R&D Patient Engagement at Takeda. Prior to Takeda, she was with Global Medical Organization, leading efforts related to clinical trial transparency, patient centricity initiatives, bioethical issues and the development of GSK’s approach to sharing aggregate results of clinical trial in plain language. Jessica received her MD from Tufts University School of Medicine, completing her residency in Family Medicine with the University of Virginia. She practiced Family Medicine in NC for more than a decade, leaving her medical practice to join GlaxoSmithKline. Jessica also attended Campbell University School of Law, graduating with honors with admittance to the NC Bar in 2010, where she is currently licensed.

  • Yoshiaki  Uyama, PhD

    Yoshiaki Uyama, PhD

    • Director, Office of Medical Informatics and Epidemiology
    • Pharmaceuticals and Medical Devices Agency (PMDA), Japan

    Yoshiaki Uyama, PhD, is Director, Office of Medical Informatics and Epidemiology, for the Pharmaceuticals & Medical Devices Agency (PMDA), Japan. His experience in the safety review and assessment of new drugs for PMDA includes serving as the Review Director; as International Conference on Harmonisation Technical Coordinator; as ICH E15 and E16 topic leader; as Division Director, Regulatory Science Research; as Division Director, Review Planning and Pharmaceutical Affairs Consultation; as Director, Division of Epidemiology; and as Rapporteur of the International Conference on Harmonisation E17 Expert Working Group. Dr. Uyama earned his PhD from Nagoya City University and his post-doctoral research focused on promoting science within Japan.

  • Elina  Asikanius

    Elina Asikanius

    • Statistician
    • F. Hoffmann-La Roche Ltd., Switzerland

    Elina Asikanius is a statistician at Roche in Basel. She joined Roche in 2009 and has worked in oncology clinical trials from phase I to phase III in lymphoma and breast cancer. In the recent years, her focus has been in rare diseases, in particular in hemophilia and currently in developmental disorders. She is also supporting the use of external controls at Roche. She holds an MSc in Statistics from University of Turku, Finland.

  • 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

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

    Dr. ElZarrad is the Deputy 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
    • Vivli Center for Global Clinical Research Data, 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

    • Senior Adviser/Statistician, Unit for HTA and Reimbursement
    • Norwegian Medicines Agency (NoMA), Norway

    Anja Schiel is working as Senior Advisor and Statistician for Norwegian Medicines Agency (NoMA. She has studied Biology at the Johannes Gutenberg-University Mainz, holds a PhD from the Free University Amsterdam and has many years of experience in medical research. Since 2017, she is also the Chair for the Biostatistics Working Party at EMA. Her role within NoMA involves working at the intersection of regulatory and HTA work, a unique perspective due to the structure of the Norwegian Agency.

  • 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.