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.
Nneka 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 a 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. She is a Patient-reported outcomes (PRO) and Pharmacoeconomics (PE) Regulatory Review Officer at the Food and Drug Administration (FDA). Dr. Onwudiwe is the technical expert and point of contact in the review of PRO, PE, and other type of claims in prescription drug promotion for the Division of Advertising and Promotion Review II (DAPR II) within the Office of Prescription Drug Promotion. 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. She is the founder and CEO of PEÇA, LLC, a healthcare consulting firm that provides regulatory and scientific advice, as well as a licensed pharmacist providing medication therapy management (MTM) and other services.
Dr. Vic Spain is Senior Real World Data Scientist in Genentech’s Personalized Healthcare Group. Vic’s role includes the evaluation of new or evolving data sources from routine clinical practice that can inform strategic decisions in Genentech’s development programs. Vic is an epidemiologist and veterinarian by training, having obtained his PhD in Epidemiology from Cornell University, NY, and Doctor of Veterinary Medicine degree from UC Davis. He has spent several years in the pharmaceutical industry, working at GSK and Merck in Health Economics and Outcomes Research. Prior to his work in the pharmaceutical industry, Vic was the Bioterrorism Epidemiologist for the Philadelphia Department of Public Health and an animal-welfare researcher at the American Society for the Prevention of Cruelty to Animals. When he is not working, Vic is often playing cello with his string quartet.
David P. Miller is the Global Head of Real World Evidence Methods, Analytics and Safety at UCB Biosciences. He is also an Adjunct Faculty member at the University of North Carolina Chapel Hill. Over the last nine years at UCB, his focus has been to evolve a Patient Safety team as a member of the Patient Safety Leadership team, build an Epidemiology team with a focus in delivering scientific relevant evidence, and most recently building a unified Real World Evidence practice with the accountability of setting the evidence standards meeting the current and future quality needs as defined by ISPE and other relevant societies. Prior to UCB, David has worked at GSK and in consulting environment (RTI Health Solutions and Ingenix).
Nirosha Mahendraratnam Lederer, PhD MSPH is a Managing Associate at the Duke-Margolis Center for Health Policy, where she helps lead the Center’s real-world evidence (RWE) portfolio. Immediately prior, she was a Subject Matter Expert in the Oncology Center of Excellence at FDA. While there, she helped implement patient-focused drug development in cancer products including clinical trial study design and product review, as well as foster consensus across US and ex-US healthcare stakeholders on best practices for patient-reported outcome capture, analysis, and communication.
Dr. Lederer has over a decade of pharmaceutical policy and health economics and outcomes research experiences including providing evidence-generation advisory services at Avalere Health, working in commercial and medical roles at Genentech and Bristol-Myers Squibb, respectively, and serving on Capitol Hill during the passage of the Affordable Care Act. She received her PhD in Health Outcomes and Policy from the UNC Chapel Hill with a focus on large database analyses and decision-sciences. She received her MSPH in Health Policy & Management from the Johns Hopkins Bloomberg School of Public Health and BA in Public Health from the Johns Hopkins University.
Alexander Cole is Executive Director and Global Head of the Epidemiology Department at Alexion Pharmaceuticals. Alexander established the Epidemiology Department at Alexion, where his team of epidemiologists provides leadership to Alexion-sponsored observational studies and disease registries, along with Pharmacovigilance/Risk Management and REMS assessment, Regulatory, Clinical Development, and Corporate Strategy initiatives. Alexander holds Doctoral and Masters degrees in epidemiology from Boston University. Alexander has specialty interests in methods to quantify assessment of bias and confounding in epidemiological studies, along with studies of pregnancy exposures and outcomes. Alexander has been in the field of epidemiology for 20 years and is a regular peer reviewer for the journal Pharmacoepidemiology and Drug Safety.
Sheryl Krevsky Elkin, PhD, is the Chief Scientific Officer at QIAGEN Digital Insights, a business division of QIAGEN. Dr. Elkin joined QIAGEN through the acquisition of N-of-One, and has led a team interpreting thousands of patient cases, establishing a rigorous process for analysis of scientific and clinical evidence and presentation of molecular and clinical evidence to physicians. Dr. Elkin played a lead role in the development of the N-of-One clinical interpretation methodology that supports clinicians in identifying therapeutic strategies for patients and has been a key player in the integration of N-of-One with the QIAGEN Clinical Insights software. Prior to joining N-of-One, Dr. Elkin completed her postdoctoral fellowship at the Massachusetts Institute of Technology’s Center for Cancer Research. She earned her doctorate in Biological and Biomedical Sciences from Harvard Medical School and an A.B. in Biology and Music from Amherst College, graduating Phi Beta Kappa and summa cum laude.
Dan Riskin, MD, MBA is Founder and CEO of Verantos, a leader in high-accuracy real world evidence generation. He is also Adjunct Professor of Surgery and Adjunct Professor of Biomedical Informatics Research at Stanford University. An expert in healthcare AI, he developed products that influence the care of millions of patients annually.
Susan M. Fish, MS is a biostatistician and Associate Director, Portfolio Data Strategy & Internal Collaborations, Strategic Evidence Integration & Collaborations for US Medical Affairs Hematology at Bristol Meyers Squibb (formerly Celgene Corporation). Prior to coming to Celgene in 2016, Susan was the BioOncology Programming Lead for several oncology registry programs during her 10-year tenure at Genentech. Ms. Fish is an experienced data analyst who is passionate about maximizing the potential of real world data and its usage in real world evidence generation.
Ms. Fish received her Bachelor of Science in Statistics and her Master of Science in Statistics degrees from North Carolina State University in Raleigh, NC
Tom Haskell is the Global Head of Innovation for Real-World Data & Analytics at Kantar Health. In this role, he engineers new data solutions, combining our industry-leading primary data collection infrastructure with current and emerging secondary data sources to provide unique offerings to our customers, including the award-winning Claritis™.
Tom has a deep background in providing innovative solutions to complex issues in the healthcare market. Previously, he worked for over 8 years at IMS Health (now IQVIA), leading the development of leading-edge cohort creation, analytics, and visualization tools for global real-world data. Previous to his 15+ years in the healthcare industry, he was one of the founders and lead architect of www.maquest.com, the first major online site to offer mapping and driving directions to the public. Tom is also a renowned speaker on Big Data and Healthcare. Industry conferences where he has spoken on the subject include ISPOR, PMSA, PBIRG, ARF (Patient Journey), ExL (Patient Experience), and Markets & Markets (RWE). Tom is a graduate of Harvard University, with a concentration in Applied Mathematics and Computer Science.
>14 years in the pharmaceutical industry with AstraZeneca. Expertise in real world and late phase projects and has worked closely with medical affairs teams to identify and build solutions to fulfill medical evidence gaps to ensure successful product launch. Strong oncology background and has supported the launch of some major medicines. Experience in phase I-IV studies across a variety of therapy areas. Join Syneos health 2 in 2018 and help customers define and execute their RWLP strategy.
Over 16 years of experience in biopharmaceutical development in Project management, director, customer relations, line management and strategy roles. Joined Syneos Health in 2015 and worked for 4 years in the oncology business unit in an Senior PD/ therapeutic advisor and strategy role, working exclusively with oncology customers across a broad spectrum of assets and indications, transforming industry trends and customer needs into robust clinical strategy and deliveries. Since moved into Real World and Late Phase with recent experience in EAP and Disease Registries. Prior to joining Syneos Health gained significant oncology management experience at other top 5 CRO’s. Global project delivery director for the pivotal trials leading to approval of the biosimilar HERZUMA® and the orphan approval of Xermelo®. Broad therapeutic experience including CNS, GI, Respiratory and Oncology with a strong interest in biosimilar development, immunotherapies and lung cancers. Based in Scotland, UK
Shaum Kabadi is Director of Epidemiology and Real-World Evidence at AstraZeneca. His experience includes leading teams and special projects, as well as strategic planning and implementation with collaboration across medical, commercial, and R&D. His experience includes medical oncology, hematology, rheumatology, nephrology, endocrinology, and cardiology.
He earned multiple individual performance awards at AstraZeneca, including a hematology US medical team launch award in 2018, and platinum award/2X silver award medal-winning abstracts at Academy of Managed Care Pharmacy meetings.
He earned a PhD in Epidemiology, MPH in Epidemiology and BA in Biochemistry. He has authored 20 manuscripts and approximately 50 abstracts.
Neurologist at Ramón y Cajal Hospital for 10 years, Ignacio’s CV includes several masters in health management, as well as being part of the Strategic Management Department of Ramón y Cajal Institute of Health Research. After graduating from Singularity University (Silicon Valley) in 2014, he founded two artificial intelligence in healthcare companies: Savana (electronic medical record processing), and Mendelian (diagnosis and treatment of rare diseases).In 2016 Ignacio was considered by the specialized medical media among the most influential people in health for his work promoting systemic changes in the sector through IT and big data. Moreover, in 2018 he was appointed “digital personality of the year” in Healthcare. He was awarded the Princess of Girona Foundation Award Company 2019 for "democratizing access to medical scientific information of millions of patients through artificial intelligence“.
Guru is associated with MC for over 15 years.
He has led a strategic and innovative transformation at MC from building various business models in content management, text mining, semantic analysis, pathways analysis, Natural Language Processing algorithms and now, Real World Evidence as well.
He comes with significant experience in working with the Top 5 Global pharmas, International Publishing houses, and US governmental organizations such as NIH and several regulatory bodies.
Guru, leads a team on Real world evidence consisting of Pharma experts and statisticians who work on Systematic reviews, meta-analysis, network meta-analysis, publication and medical writing, SEND data formats, pharmacovigilance and HEOR services, among others.
He has worked on Global Drug Discovery Informatics and digital programs across 8 therapy areas. He also owns a patent on pathway analytics and has co-authored several publications in some of the top journals.