With nearly 25 years in HEOR, RWE and market access across biopharma, consulting and CROs, Mr. Makin brings unique expertise in integrating rigorous scientific methodology with business rationale to develop, demonstrate & disseminate product value and effectiveness. Mr. Makin currently leads the RWE & Epidemiology team at Boehringer Ingelheim US, planning and executing holistic evidence generation for the entirety of its portfolio. Previously, he served in a dual role at Biogen, serving as both the Global Head of the HEOR, RWE & HTA team across the entirety of Biogen’s portfolio of pipeline and marketed products; and the Global Head of Value & Access for Biogen’s pipeline franchise. Mr. Makin pioneered the Integrated Evidence Generation Process for Biogen, turning multiple siloed workstreams into a unified, efficient, enterprise-wide process for the planning, execution and quality control of evidence generation across the organization. Before joining Biogen, Mr. Makin served as the General Manager/Vice President for ICON plc’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 medical affairs professionals, RWE scientists, biostatisticians, program managers and data management professionals based in >40 countries – to the 2018 Late-Phase CRO Leadership Award. Previously, he held leadership positions in major drug commercialization companies such as IQVIA and Optum; and earlier in his career worked at the large US payers Elevance Health and Humana, where he led RWE initiatives, economic evaluations and health outcomes research studies.
Mr. Makin has served as Principal Investigator on hundreds of retrospective database analyses, large global registries, economic models, PRO studies, patient/physician surveys, ITC/NMAs, SLRs and GVDs across every major therapeutic area; in addition to leading >25 value development plans and has published on health policy – resulting in >75 peer-reviewed manuscripts & scientific presentations, in addition to several invited speeches at HEOR and RWE conferences each year.
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 also completed a Pharmacoeconomics & Outcomes research Fellowship from Humana.
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 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.
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.
With nearly 25 years in HEOR, RWE and market access across biopharma, consulting and CROs, Mr. Makin brings unique expertise in integrating rigorous scientific methodology with business rationale to develop, demonstrate & disseminate product value and effectiveness. Mr. Makin currently leads the RWE & Epidemiology team at Boehringer Ingelheim US, planning and executing holistic evidence generation for the entirety of its portfolio. Previously, he served in a dual role at Biogen, serving as both the Global Head of the HEOR, RWE & HTA team across the entirety of Biogen’s portfolio of pipeline and marketed products; and the Global Head of Value & Access for Biogen’s pipeline franchise. Mr. Makin pioneered the Integrated Evidence Generation Process for Biogen, turning multiple siloed workstreams into a unified, efficient, enterprise-wide process for the planning, execution and quality control of evidence generation across the organization. Before joining Biogen, Mr. Makin served as the General Manager/Vice President for ICON plc’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 medical affairs professionals, RWE scientists, biostatisticians, program managers and data management professionals based in >40 countries – to the 2018 Late-Phase CRO Leadership Award. Previously, he held leadership positions in major drug commercialization companies such as IQVIA and Optum; and earlier in his career worked at the large US payers Elevance Health and Humana, where he led RWE initiatives, economic evaluations and health outcomes research studies.
Mr. Makin has served as Principal Investigator on hundreds of retrospective database analyses, large global registries, economic models, PRO studies, patient/physician surveys, ITC/NMAs, SLRs and GVDs across every major therapeutic area; in addition to leading >25 value development plans and has published on health policy – resulting in >75 peer-reviewed manuscripts & scientific presentations, in addition to several invited speeches at HEOR and RWE conferences each year.
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 also completed a Pharmacoeconomics & Outcomes research Fellowship from Humana.
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 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.
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 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.
Jen Webster has held roles in genomics research, healthcare utilization research and population health technology before joining Pfizer as the Precision Medicine RWE Lead. Jen leads a team that is responsible for enabling the use of real world precision medicine data across the asset lifecycle.
Sunil is the Global Head of Real-World Data Center of Excellence at Takeda Pharmaceuticals. He is an expert in developing fast translation of Real-World Data (RWD) into insights and evidence, including through use of advanced analytic solutions and tools. As an expert in RWD, he is constantly innovating internally and partnering with experts in the ecosystem to deliver cutting-edge Real-World Evidence to support various functions in the pharmaceutical landscape. He is a computer science engineer, with over 30 years of experience in data and digital transformation. Sunil has developed a new operating model to leverage RWD, implement analytics platforms for RWE, defined governance and designed new partnership models within the healthcare ecosystem. Sunil earned a B.S. in Electrical Engineering from Bombay University in Bombay, India and a M.S. in Computer Engineering from Villanova University. Sunil is also the lead author on a book Real-World Evidence in the Pharmaceutical Landscape.
Evidence (RWE) and advanced analytics (AA). Epidemiologist,
Software Engineer, Health economist, and applied medical,
mathematical modeler with over twenty years in healthcare
field. Director of RWE Strategy & Innovation at BMS-. Resulting
in expertise in the generation, collection, assessment, and use
of data using traditional and novel analytic methods. >100
peer-reviewed publications and international presentations
of data and research. Leading the delivery of multiple
concurrent work streams concerned with the assessment of
the impact on treatments
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.
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Xiaoyun(Lucy) Pan is the Real World Evidence franchise head at Bayer’s oncology business unit. Lucy and her team develop real-world evidence strategy and RWE generation to support company’s oncology products. Lucy holds a PhD in Pharmaceutical Socioeconomics from University of Iowa. She has strong expertise in global and US HEOR, value demonstration strategy, patient reported outcomes, and clinical trial design.
Jessica Paulus, is VP of Research at OM1 and provides scientific oversight regarding study design, analytic approaches, and study reporting. Prior to joining OM1, Jessica was faculty at Tufts Medical Center for over ten years, where she served as Research Director of the Tufts Predictive Analytics and Comparative Effectiveness Center and Associate Director of the Clinical and Translational Science MS/PhD Graduate Program.
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.
Andrew Stewart is currently the Head of Real-
World Evidence and Behavioral Science at Sanofi Consumer
Healthcare where he leads a team of subject matter experts
across real-world evidence, data and analytics, as well as
behavioral science. He has been leading real-world evidence
generation efforts for Sanofi Consumer Healthcare since the
beginning of 2019 and has worked in consumer healthcare
at Sanofi driving real-world evidence strategies since 2017.
Andrew has worked at Sanofi since 2013, originally developing
evidence strategies targeted at payers for rare diseases. This
gave him a diverse background in creating and implementing
targeted evidence generation strategies, as well as a myriad
of study designs to develop evidence that is meaningful to
payers and patients.
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Dr. Vishvas Garg is a Senior Director for Health Economics and Outcomes Research at AbbVie. In his current role, he leads the Dermatology franchise inclusive of multiple life-changing innovative therapies such as SKYRIZI and RINVOQ. Dr Garg has published 35+ peer-reviewed journal articles and have presented 100+ studies as abstracts, posters, and podiums at various national and international scientific congresses. Dr. Garg currently serves on the Editorial Boards of Expert Reviews of Pharmacoeconomics & Outcomes Research and Journal of Comparative Effectiveness Research. Over his tenure, his research has been instrumental in seeking novel regulatory label claims for various patient-centered outcomes, positive decisions from global health technology assessment agencies, and informing treatment guidelines
