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 led 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 >20 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.