5th Annual MarketsandMarkets Real-World Evidence and Life Sciences Analytics Conference

20th-21st October 2022 | Hilton Boston Logan Airport
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.


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


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.


Joel Iff
Joel Iff
Senior Director Global 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.


Melva Covington
Melva Covington
Senior Vice President, Research and Patient Outcomes,
Curio Digital Therapeutics


Dr. Covington is an executive leader at Curio Digital Therapeutics, Inc where she serves as Senior Vice President, Research and Patient Outcomes. Prior to this, she was VP of RWD at Ciox Health, a technology company. She is focused on developing patient-centered approaches for clinical and real-world evidence to inform health outcomes and disease prevention. Melva’s background is in public health outcomes research (HEOR) and strategic thinking. She has deep analytic RWE and market access experience gained across Pharma, therapeutic areas and product lifecycles. 

Melva has been a leader across multiple business functions, which include medical affairs, business development, clinical operations, health advocacy and field-based engagement. She is focused on developing, supporting and mentoring emerging leaders for global impact.  

Melva has led Global and US-based teams for Roche Labs, Eli Lilly, Sanofi, Pacira and Eversana. She is passionate about integrating data and consumer perceptions into knowledge documents and solutions that improve outcomes across diverse patient populations.

She has an A.B. in Politics/Economics from The Catholic University of America, MPH and Ph.D. from the University of North Carolina at Chapel Hill. She also holds a MBA from the Johnson School at Cornell University, has authored numerous publications, is patient advocate and impassioned public speaker.


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.


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


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.


Joel Iff
Joel Iff
Senior Director Global 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.


Melva Covington
Melva Covington
Senior Vice President, Research and Patient Outcomes,
Curio Digital Therapeutics


Dr. Covington is an executive leader at Curio Digital Therapeutics, Inc where she serves as Senior Vice President, Research and Patient Outcomes. Prior to this, she was VP of RWD at Ciox Health, a technology company. She is focused on developing patient-centered approaches for clinical and real-world evidence to inform health outcomes and disease prevention. Melva’s background is in public health outcomes research (HEOR) and strategic thinking. She has deep analytic RWE and market access experience gained across Pharma, therapeutic areas and product lifecycles. 

Melva has been a leader across multiple business functions, which include medical affairs, business development, clinical operations, health advocacy and field-based engagement. She is focused on developing, supporting and mentoring emerging leaders for global impact.  

Melva has led Global and US-based teams for Roche Labs, Eli Lilly, Sanofi, Pacira and Eversana. She is passionate about integrating data and consumer perceptions into knowledge documents and solutions that improve outcomes across diverse patient populations.

She has an A.B. in Politics/Economics from The Catholic University of America, MPH and Ph.D. from the University of North Carolina at Chapel Hill. She also holds a MBA from the Johnson School at Cornell University, has authored numerous publications, is patient advocate and impassioned public speaker.


Huan Huang
Huan Huang
Senior Director, Healh Economics & Outcomes Research (HEOR),
G1 Therapeutics, USA


Huan leads G1 Therapeutics’ HEOR team and oversees all Real-World Evidence (RWE) and HEOR projects. Her team is responsible for generating HEOR/RWE strategies, plans and studies to support marketed and pipeline products.  Prior to joining G1 Therapeutics,  Huan held various positions at Sunovion Pharmaceuticals, IQVIA, Boston Health Economics and Boston Scientific. 

Huan has a PhD degree in Chemistry/Pharmaceutical Sciences from University of Missouri-Kansas City, and a MS degree in Biostatistics from Harvard School of Public Health.  She has authored over 80 peer-reviewed manuscripts and scientific presentations.


Alex Mutebi
Alex Mutebi
Director, Centre for Outcomes Research, Real World Evidence and Epidemiology (CORE),
Genmab


Alex draws from a breadth of experiences to share his perspective on real-world evidence (RWE). Alex has over 15 years of combined experience in health care and the pharmaceutical industry. His work has involved frontline delivery of healthcare services in hospitals, research in health economics and outcomes research (HEOR) and RWE functions in industry. He has covered a number of therapeutic areas including psychiatry, inflammation, neuroscience, oncology, and hemoglobinopathies. 

Currently, Alex leads the General Medicine team within the RWE Center of Excellence (CoE) at Vertex Pharmaceuticals. Before that, he was a brand lead for marketed and pipeline products in thoracic oncology in the US HEOR team at Novartis Oncology. Prior to that he worked in the Global HEOR team at Amgen, and the Critical Path Institute’s Patient Reported Outcomes (PRO) Consortium. Alex has a BA in managing in health and social care organizations (Leeds Metropolitan University, UK), MSc in health economics and management (University of Sheffield, UK), and a PhD in pharmaceutical economics, policy, and outcomes (University of Arizona, USA). 

 


Sunil Dravida
Sunil Dravida
Global Head of RWD Center of Excellence,,
Takeda



Nathan Hill
Nathan Hill
Director, Real World Evidence Strategy and Innovations,
BMS



Prasun Mishra
Prasun Mishra
Founding Director, Chairman of the Board,
Agility Pharmaceuticals


Dr. Prasun Mishra is an investor, co-founder, advisor, and board member of a few US-based corporations; he has numerous publications/patents, several drugs in clinical trials, and has over 40 prestigious awards honors to his credit. He is the founder and CEO of Agility Pharmaceuticals, a technology-driven pharmaceutical company committed to revolutionizing drug discovery & development. Dr. Mishra is also the founding president and chair of the American Association for Precision Medicine and the AAPM Innovation Center, where he is leading research efforts focused on preventing & curing chronic diseases, treating the sick, and providing knowledge/tools to individuals to live longer, healthier lives.

He is a serial entrepreneur who founded his first company after graduating high school and his second company during his Ph.D. Since then, he has accumulated a wealth of experience by building, investing, and advising numerous other companies. He is also a General Partner in the Global Health Impact Network and Fund, a healthcare-focused investment fund based in Silicon Valley, CA. He is also a founding chair of WISE: World Investors and Entrepreneurs Society, an investment collective with a global investment footprint. He is a founding investor and advisor to Barcelona Ventures and an advisor to a $100M private equity fund.

He served as a Scientist and Principal Investigator at the pharma giant Genentech, Roche. Where he participated in several drug discovery project teams; moreover, his passion for drug development and precision medicine has led to the identification of new drug targets, biomarkers, companion diagnostics, and several drugs/ combinations in the clinic.


Eric James
Eric James
Associate Director Access & Reimbursement,
Novartis



Xiaoyun (Lucy) Pan
Xiaoyun (Lucy) Pan
Senior Director,
Bayer



Jessica Paulus
Jessica Paulus
Senior Director, Epidemiology,
OM1,Inc



Kristen Hahn
Kristen Hahn
PhD, MPH Head of RWE Research,
Picnic Health


Kristen Hahn is the Head of RWE Research at PicnicHealth where she manages a team of epidemiologists and biostatisticians who are responsible for generating RWE for use cases in the life sciences industry. She has significant experience designing observational and minimally interventional studies including those studying the natural history of disease, patient registries, and comparative safety and effectiveness of medical treatments. She is a reproductive epidemiology subject matter expert with extensive experience in pregnancy studies. She also has substantial knowledge of cardiovascular, neurologic, gastrointestinal, and rare disease indications as well as PASS, pragmatic RCT, and external comparator arms. Kristen completed her doctoral and postdoctoral training at Boston University School of Public Health where she was a pre-doctoral Reproductive, Pediatric, and Perinatal Epidemiology fellow and a postdoctoral MIT IMPACT fellow.


Eric Sarpong
Eric Sarpong
Director, Real-World Data Analytics and Innovation, Centre for Observation and Real-World Evidence (CORE),
Merck



Jennifer Webster
Jennifer Webster
Senior Director, Precision Medicine RWE Lead,
Pfizer



Akshay Vashist
Akshay Vashist
Head of Medical and Real World Data Analytics,
Otsuka Pharmaceutical Companies