4th Annual MarketsandMarkets Real-World Data, Life Sciences Analytics and Market Access Virtual Conference (Time Zone - EST)

22nd - 23rd April, 2021
CONFERENCE SPEAKERS
Advisors
Charles Makin
Charles Makin
Global Head, Real World Evidence Strategy ,
Biogen


Charles Makin leads Biogen’s Real World Evidence Strategy team, overseeing RWE projects across all therapeutic areas for marketed and pipeline products.

Before joining Biogen, Mr. Makin served as the General manager/VP for ICON’s RWE-Late Phase Research unit, the world’s second-largest research group dedicated to prospective data collection; and led the team – 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 IMS, Mapi and Optum, including the roles of VP/Americas Head, Real-World Strategy and Analytics, Head of Observational Outcomes Research (Americas) and Global Head of Research Design and Proposal Development. He has also worked on the payer side (Anthem and Humana), where he led RWE initiatives, economic evaluations and health outcomes research studies.

In nearly two decades in RWE, HEOR and drug commercialization, Mr. Makin has developed and implemented drug value, safety and effectiveness roadmaps for most of the top 20 pharmaceutical companies to influence payers, clinicians and HTA bodies and positively impact market access. He has served as Principal Investigator on over a 100 retrospective database analyses (EMR, linked, claims), global registries, medical chart reviews, economic models, PRO studies, physician surveys, ITC/NMAs, SLRs and GVDs across every major therapeutic area. He has also developed >25 value development plans and product market profiles, and published on health policy. He has authored over 70 peer-reviewed manuscripts and scientific presentations, serves on the editorial board for multiple journals, and is an invited speaker at several conferences in the US and EU.

Mr. Makin holds a BS in Pharmacy from the University of Pune, an MS in Pharmacy Administration (major in outcomes research) from Purdue University, as well as an MBA (Marketing), summa cum laude, and a Master of Management, summa cum laude, both from Goldey-Beacom College. He has also completed a Pharmacoeconomics and Outcomes research Fellowship from Humana.


 Luis Prieto
Luis Prieto
Director Real World Evidence - Global Medical Affairs, Immunology, Hepatology & Dermatology,
Novartis


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 Kruger
Eliza Kruger
Associate Director, Global HEOR,
Ultragenyx Pharmaceuticals


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.


Speakers
Charles Makin
Charles Makin
Global Head, Real World Evidence Strategy ,
Biogen


Charles Makin leads Biogen’s Real World Evidence Strategy team, overseeing RWE projects across all therapeutic areas for marketed and pipeline products.

Before joining Biogen, Mr. Makin served as the General manager/VP for ICON’s RWE-Late Phase Research unit, the world’s second-largest research group dedicated to prospective data collection; and led the team – 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 IMS, Mapi and Optum, including the roles of VP/Americas Head, Real-World Strategy and Analytics, Head of Observational Outcomes Research (Americas) and Global Head of Research Design and Proposal Development. He has also worked on the payer side (Anthem and Humana), where he led RWE initiatives, economic evaluations and health outcomes research studies.

In nearly two decades in RWE, HEOR and drug commercialization, Mr. Makin has developed and implemented drug value, safety and effectiveness roadmaps for most of the top 20 pharmaceutical companies to influence payers, clinicians and HTA bodies and positively impact market access. He has served as Principal Investigator on over a 100 retrospective database analyses (EMR, linked, claims), global registries, medical chart reviews, economic models, PRO studies, physician surveys, ITC/NMAs, SLRs and GVDs across every major therapeutic area. He has also developed >25 value development plans and product market profiles, and published on health policy. He has authored over 70 peer-reviewed manuscripts and scientific presentations, serves on the editorial board for multiple journals, and is an invited speaker at several conferences in the US and EU.

Mr. Makin holds a BS in Pharmacy from the University of Pune, an MS in Pharmacy Administration (major in outcomes research) from Purdue University, as well as an MBA (Marketing), summa cum laude, and a Master of Management, summa cum laude, both from Goldey-Beacom College. He has also completed a Pharmacoeconomics and Outcomes research Fellowship from Humana.


Lucy Pan
Lucy Pan
Director and Strategy Lead, Global Evidence & Value Development,
EMD Serono



Nirosha Mahendraratnam Lederer
Nirosha Mahendraratnam Lederer
,



Georges De Feu
Georges De Feu
CEO ,
Lynxcare



Nneka Onwudiwe
Nneka Onwudiwe
Former PRO/PE Regulatory Review Officer,
FOOD AND DRUG ADMINISTRATION


Nneka C. Onwudiwe, PhD, PharmD, MBA received her doctorate in Pharmacy (PharmD) from the University of Maryland School of Pharmacy, PhD in Health Services Research with a specialization in Pharmacoeconomics from the University of Maryland School of Pharmacy, and an MBA (Honors) from the University of Baltimore. In addition, she received an honor of Rho Chi in Pharmacy in 2002 and an honor of Beta Gamma Sigma in Business Administration in 2012.

Dr. Onwudiwe 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 teaches Comparative Effectiveness Research (CER) & Pharmacoeconomics at the University of Maryland School of Pharmacy. Dr. Onwudiwe has received several awards and accolades over the years. She has received funding as a Principal Investigator from NIH/NHLBI. Dr. Onwudiwe served on the Food and Drug Law Institute’s (FDLI) Publications Peer Review Committee as well as a member of the ISPOR Value Assessment Frameworks Stakeholder Advisory Panel.

Dr. Onwudiwe has served on several ISPOR Scientific and Health Policy Working Groups (Task Forces and Special Interest Groups) that have developed products and tools used by decision makers and researchers around the world. She is currently serving on the Value Assessment of Medical Device Special Interest Group and Statistical Methods in Health Economics and Outcomes Research Special Interest Group. In addition to this work, Dr. Onwudiwe has presented at various professional conferences and published in several peer-reviewed journals such as Value in Health Regional Issues, PharmacoEconomics, Spine, Journal of the American Medical Association (JAMA), Obesity, Oncologist, Cancer Medicine, and Ethnicity and Disease.

Dr. Onwudiwe holds a license in pharmacy and practices in the community providing medication therapy management (MTM) and other services.


Myla Maloney
Myla Maloney
Vice President, Strategy and Commercial Operations,
Premier Applied Sciences



Usha Periyanayagam
Usha Periyanayagam
Director of Analytics,
Komodo Health



Tao Fan
Tao Fan
Senior Director, US HEOR US Medical Office ,
Takeda Pharmaceuticals


Dr. Tao Fan is Senior Director and TA head of US Health Economic and Outcomes Research at the Takeda Pharmaceuticals. Prior to that, he held various positions at 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
Tanja Heidbrede
Real-World Evidence Head,
UCB, Europe


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
Luis Prieto
Director Real World Evidence - Global Medical Affairs, Immunology, Hepatology & Dermatology,
Novartis


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 Sweet
Brian Sweet
Executive Director, Oncology, Real World Evidence ,
Bristol-Myers Squibb


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 Kruger
Eliza Kruger
Associate Director, Global HEOR,
Ultragenyx Pharmaceuticals


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.


Denise Globe
Denise Globe
Head of the HEOR COE,
Gilead, USA



Lorenzo Sabatelli
Lorenzo Sabatelli
Health Evidence and Innovation Leader,
Incyte


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 Iff
Joel Iff
Senior Director HEOR & Market Access,
Sarepta Therapeutics, USA


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.