Charles Makin plays a dual role at Biogen, serving as both the Global Head of the HEOR, HTA and RWE team; and the Global Head of Value & Access for Biogen’s pipeline franchise. As the leader of the HEOR, HTA & RWE team, Charles leads the design, generation and application of innovative RWE and outcomes research spanning both prospective and retrospective methodologies; and leads the development of economic models to create compelling and quantitative value propositions. As the head of the pipeline team, he ensures that market access and HEOR strategies are progressively being incorporated earlier into the drug development phases, helping further align Biogen’s regulatory and clinical evidence strategies with the reimbursement strategy. Before joining Biogen, Mr. Makin served as the General Manager/Vice President for ICON’s RWE-Late Phase Research unit, comprised of several hundred biostatisticians, medical affairs personnel, project/program managers and data management professionals based in >40 countries – to the 2018 Late-Phase CRO Leadership Award. Prior to that, he held leadership positions in major drug commercialization research companies such as IQVIA and Optum, and prior to that work for large payers such as Anthem and Humana.
Luis Prieto currently works in Basel, Switzerland, as Global Real World Evidence Director in the Immunology, Hepatology, Dermatology franchise at Novartis. He began his career in 1990 at the Institut Hospital del Mar Investigacions Medicas in Barcelona conducting research on patient reported outcomes. Since then he has worked in various organizations, including the World Health Organization, Eli Lilly & Co., and the European Medicines Agency. Prior to joining Novartis, Luis worked as Vice President Outcomes Research and Development at the International Consortium for Health Outcomes Measurement. Since 2007 Luis is associated with the Faculty of Public Health and Policy at the London School of Hygiene and Tropical Medicine. Since 2017 he is an Editorial Board Member of the journal BMC Public Health. Luis has a PhD in Epidemiology and a master's degree in Public Health (UAB, Spain), an MBA (ESADE, Spain), and a PGDip in Health Economics (University of York, UK).
Eliza is a biotech Director, responsible for developing and executing global HEOR strategy at Ultragenyx across all rare disease and clinical programs from pre-clinical through to commercialization. Eliza has 9 years of academic, consulting and industry experience, focused on health economics and outcomes research (HEOR) evidence generation, value messaging, publication and economic modelling. Expertise varies across a variety of disease areas including rare diseases, diabetes and infectious diseases, and globally, with extensive experience in North America, Europe and Asia-Pacific.
Charles Makin plays a dual role at Biogen, serving as both the Global Head of the HEOR, HTA and RWE team; and the Global Head of Value & Access for Biogen’s pipeline franchise. As the leader of the HEOR, HTA & RWE team, Charles leads the design, generation and application of innovative RWE and outcomes research spanning both prospective and retrospective methodologies; and leads the development of economic models to create compelling and quantitative value propositions. As the head of the pipeline team, he ensures that market access and HEOR strategies are progressively being incorporated earlier into the drug development phases, helping further align Biogen’s regulatory and clinical evidence strategies with the reimbursement strategy. Before joining Biogen, Mr. Makin served as the General Manager/Vice President for ICON’s RWE-Late Phase Research unit, comprised of several hundred biostatisticians, medical affairs personnel, project/program managers and data management professionals based in >40 countries – to the 2018 Late-Phase CRO Leadership Award. Prior to that, he held leadership positions in major drug commercialization research companies such as IQVIA and Optum, and prior to that work for large payers such as Anthem and Humana.
As founder and CEO of LynxCare, Georges De Feu is committed to increase the availability of actionable & precise data with the sole goal of improving patient outcomes
Nneka is founder and CEO of Pharmaceutical Economics Consultants of America (PEÇΛ). Dr. Onwudiwe’s areas of specialization are public health and health economics. Her work focuses on a variety of projects related to costs and cost-effectiveness, coverage, management, and payment methods for innovative technologies as well as compliance-related issues, including compliance with market-wide requirements of ACA, MHPAEA, and state laws. From 2012-2020, Dr. Onwudiwe was the Patient-reported outcomes (PRO) and Pharmacoeconomics (PE) Regulatory Review Officer at the Food and Drug Administration (FDA).
Dr. Onwudiwe holds a license in pharmacy and practices in the community providing medication therapy management (MTM) and other services.
Usha Periyanayagam, MD, MPH is a physician working at the intersection of data and medicine. She is currently the Head of RWE and Clinical Product at Komodo Health. In this role, she uses her clinical knowledge to translate data into actionable insights for life sciences companies, advocacy organizations, payers, and providers. She is also board certified in emergency medicine and continues to practice at Kaiser Hospital.
Previously, Dr. Periyanayagam was the medical lead at Agathos, where she explored EMR and claims data to highlight variation in clinical care. She was also an Instructor of Emergency Medicine at Harvard University, and she has extensive global health experience, including medical practice and epidemiological research in Uganda, South Sudan and Pakistan. Dr. Periyanayagam has been recognized by MedTech Boston’s list of “40 under 40 Healthcare Innovators” and by LinkedIn’s “Next Wave” in healthcare. She earned her MD, MPH in biostatistics, and BS in biomedical engineering from Northwestern University.
Global Outcomes Research at Shire, US Evidence Based Medicine at Sanofi, and Global Health Outcomes at Merck & Co. Tao led numerous real world data strategy, health technology assessment and research in real world evidence, HEOR & analytics across many countries worldwide, and authored numerous peer reviewed scientific articles, book chapters and abstracts at national and international scientific meetings.
Tanja Heidbrede is Head of Real World Data within the German Market Access department of UCB. Her team is focused on generating Real World data, tailored specifically to the needs of the German HTA assessments. With the increasing acceptance of Real World evidence for regulatory purposes and reimbursement decision making in Germany, she is continuously monitoring for new opportunities to bring in the real world view and she is very interested in exploring and understanding new ways of data generation and the potential of new data source, deriving from advances in technology.
Previous to that she held different positions in clinical research, medical affairs and market access on local as well as global levels.
Tanja is a pharmacist by profession and graduated from the University of Marburg, Germany.
Luis Prieto currently works in Basel, Switzerland, as Global Real World Evidence Director in the Immunology, Hepatology, Dermatology franchise at Novartis. He began his career in 1990 at the Institut Hospital del Mar Investigacions Medicas in Barcelona conducting research on patient reported outcomes. Since then he has worked in various organizations, including the World Health Organization, Eli Lilly & Co., and the European Medicines Agency. Prior to joining Novartis, Luis worked as Vice President Outcomes Research and Development at the International Consortium for Health Outcomes Measurement. Since 2007 Luis is associated with the Faculty of Public Health and Policy at the London School of Hygiene and Tropical Medicine. Since 2017 he is an Editorial Board Member of the journal BMC Public Health. Luis has a PhD in Epidemiology and a master's degree in Public Health (UAB, Spain), an MBA (ESADE, Spain), and a PGDip in Health Economics (University of York, UK).
Brian is the Executive Director, Health Economics & Outcomes Research (HEOR) Oncology, leads and manages the US HEOR Oncology organization at Bristol-Myers Squibb. In this role, he oversees all Health Economic & Outcomes Research team, works with external collaborative research partners, and focuses on value, access, and heath technology assessment needs for the portfolio.
He is an innovative, executive Real World Evidence and scientific evaluation leader with vision and extensive experience in directing clinical pharmacy programs and managing strategic business decisions. He has over 28 years of combined managed care, pharmacy benefit management (PBM), pharmaceutical market access/research (primary care products, biologics, and oncology agents), and senior healthcare executive experience. He has expert knowledge in health technology assessment and critical appraisal, evaluation and design of comparative effectiveness and observational studies, value assessment frameworks, and total cost-of-care management with an emphasis on patient-oriented outcomes. In 2013, Brian was named the No. 3 influencer in evidence development by HealthNetwork Communications.
Eliza is a biotech Director, responsible for developing and executing global HEOR strategy at Ultragenyx across all rare disease and clinical programs from pre-clinical through to commercialization. Eliza has 9 years of academic, consulting and industry experience, focused on health economics and outcomes research (HEOR) evidence generation, value messaging, publication and economic modelling. Expertise varies across a variety of disease areas including rare diseases, diabetes and infectious diseases, and globally, with extensive experience in North America, Europe and Asia-Pacific.
Lorenzo Sabatelli is a health economics and epidemiology expert, focusing on data-driven strategies to maximize impact and value of health interventions and policies. His professional experience encompasses roles in the biotech industry (at Incyte and at Amgen), consultancy services (at GLOBMOD Health, and in partnerships with other organizations), and academic research (at IHME- University of Washington, at the Fred Hutchinson Cancer Research Centre, and at the Epidemiology and Population Health department of the London School of Hygiene and Tropical Medicine).
He is currently responsible for building capabilities for and driving Europe-based HEOR and RWD generation at Incyte.
His interests include health, science and technology, environmental sustainability, and social dynamics.
He holds a PhD in physics from Trinity College, University of Dublin, and a master degree in physics from the University of Pisa.
Joel is currently responsible for the development of the value proposition of RNA therapies for Duchenne Muscular Dystrophies at Sarepta Therapeutics in Cambridge MA. His role includes generating HEOR evidence and market access strategies to support global access of the company’s RNA products. Prior to joining Sarepta Therapeutics, Joel was team leader and project manager at Mapi ICON. Joel also held various positions with increasing responsibilities at Johnson & Johnson in Switzerland where he developed, led and executed health economics and market access strategies. Joel started his career in the market access team at Sanofi Switzerland, where he contributed to HTA submissions to the Swiss health authorities.
Joel holds a PharmD, a PhD degree in Pharmaceutical Sciences and an MBA, both from the University of Geneva, Switzerland. He also holds a diploma in Health Economics from the University of York, UK.
