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.
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.
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.
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.
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
Jyotsna is passionate about solving real-world problems in healthcare, and strives to enable data-driven decision-making using complex and diverse data sources. She is currently the Head of Real World Evidence (RWE) Statistics at Teva Pharmaceuticals.
With over 14 years of experience in the pharmaceutical industry across drug discovery, translational medicine and drug development, and an interdisciplinary educational background in Mathematics, Applied Statistics, Computer Science and Computational Biology, Jyotsna thrives in a cross-functional collaborative environment. She has a Ph.D. in Computer Science from Penn State University, M.S. in Computer Science and Engineering from SUNY at Buffalo, and an M.Stat. in Applied Statistics from the Indian Statistical Institute. Over her career, Jyotsna’s research has included building novel statistical and data mining methodologies and software tools for functional genomics and biomarker identification, various applications across drug discovery, randomization for animal studies, nonclinical data standards, and use of RWE across the drug development continuum.
Dr. Vic Spain is the Respiratory Real World Data Strategy Lead 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.
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.
Simon Andrews is Vice President, Operations for DRG’s Analytics division. Since joining DRG Simon has spent 9+ years leading research, data, and analytics projects for the full range of biopharmaceutical and medical device manufacturers.
Currently, Simon leads a global team of analysts, statisticians, and therapy-area experts to solve challenging problems through a combination of DRG’s real-world data assets, robust methodologies, and best-in-class research.
Simon’s completed a combined B. Arts and Sc and Mathematics degree at McMaster University and an MSc in Mathematics at the University of Toronto.
David is a health economist with 30+ years of experience in the health economics arena. Prior to joining Syneos Health, he held leadership positions at Quintiles (2012-2016), i3 Innovus/OptumInsight (2000-2012) and PAI (1988-2000). He is also a current committee member of the Clinical Trials Transformation Initiative (CTTI) in real-world evidence (RWE). His areas of expertise include work in economic modeling, retrospective database analysis, trial-based economic evaluations and patient reported outcomes.
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.
David P. Miller is the Executive Director of Epidemiology at Sarepta Therapeutics. He is also an Adjunct Faculty member at the University of North Carolina Chapel Hill. In the previous ten years, he was the Global Head of Real World Evidence Methods, Analytics and Safety at UCB Biosciences where 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).
Rachel Twardowski is the Director, IBD Business Insights at Takeda, leading the primary market research, competitive intelligence, data science and analytics teams for the Gastroenterology Business Unit, supporting the Inflammatory Bowel Disease Franchise. Over the last 2 years, Rachel has led her team to deliver a number of impactful business improvements including an integrated Promotional Marketing Mix Model, supporting pricing and distribution strategy, and developing robust analytics to prepare for competitive launches. Rachel’s team serves a diverse cross-functional team across the USBU, partnering with USMO and PVPS.
Prior to Takeda, Rachel worked in consulting and technology product development leading the real world evidence professional services group at SHYFT Analytics. During this time she supported many product launches, built end to end data warehouse and reporting solutions in multiple therapeutic areas and developed a software platform to perform virtual observational studies on real world data. Earlier in her career, Rachel worked at several start-up biotechnology companies in Engineering, Marketing and Logistics roles. Rachel holds Bachelors of Science and Masters of Science degrees in Biomedical Engineering from University of Rochester and Tufts University.
Hannah Ebben is the Marketing Analytics Specialist at Takeda, where she focuses on generating strategic insights from real-world data and leveraging her background in statistics and coding to produce robust analyses.
Hannah received a Masters in Biochemistry from the University of Colorado and worked in a computational chemistry research lab before realizing bench science was not the career path for her. She spent a year overseas teaching science courses at a university in Rwanda before beginning an MBA program at Northeastern University. While in Boston, Hannah worked at Biogen in a global insights function, gaining experience in market research, forecasting, and data analytics for a launching brand.
Kristen Coletto joined Aetion in 2018 and currently manages the development of real-world evidence focused products. She has 15 years’ experience in a variety of healthcare roles, spanning provider, payer and technology solutions. Before Aetion, Kristen was Vice President of Change Healthcare's provider financial counseling and revenue cycle business. She previously led concept incubation at Healthagen, a subsidiary of Aetna, and developed new start-up businesses focused on population health IT and services. Prior to joining Healthagen, Kristen was a member of Aetna’s Corporate Strategy team and managed strategy and planning for Aetna International to identify global growth opportunities. She also held positions at the Advisory Board Company and PA Consulting Group. Kristen has a Bachelor of Arts in Economics and Public Policy Studies from Duke University and a Master of Business Administration from the Wharton School of the University of Pennsylvania.
Throughout his career, Janak Joshi has been at the cutting edge of science, health and technology. As Chief Technology Officer and Head of Strategy at Life Image, he is focused on building industry-leading products for researchers, engineers and clinicians within a global footprint. He is a three-time entrepreneur successfully raising capital, and building and selling companies with the mission of leaving a legacy to prove that our generation did indeed fix healthcare in the U.S.
Janak’s entrepreneurial roots began as a Masters of Business Administration graduate student at Bentley when he was involved in his first start-up venture, CampusCareerCenter.com. Since then, he has been co-founder and CIO at Synestesi Technologies (also incubated at Bentley University and sold to Spry Media Group), CIO at Generation Health (sold to CVS Caremark), CEO at Type I Diabetes Exchange, before his current role at Life Image
Matthew A. Michela has been a healthcare industry executive for 30 years. He joined Life Image as CEO in 2015 with the mission of democratizing data to create an interoperable healthcare ecosystem that creates a connected view of a patient’s journey. By transforming the Life Image network into an innovative digital platform for the sharing of any and all clinical information including medical images, healthcare professionals can see data in a comprehensive way.
Throughout his career, Matthew has been at the intersection of providers, health plans, employers, and patients. He has a proven track record helping organizations create novel approaches to value generation. Matthew’s extensive experience includes senior positions at Harvard Pilgrim Health Care, and most recently, he served as COO at Healthways. He was also co-founder, president and COO at Care Management International, which offers solutions for healthcare clients in utilization management, radiology management, and case and condition management.
Elodie Baumfeld Andre is the Epidemiology Strategy Lead within the Worldwide Medical & Safety group at Pfizer. In this role, Elodie’s focus is on generating Real World Evidence (RWE) to support regulatory decision-making and driving continued innovation by implementing novel clinical designs and developing operating models. She is involved in discussions with global regulatory authorities, academics and focus groups to share learnings in this evolving space.
Elodie began her career at Pfizer Canada working in Health Economics & Outcomes Research, where she used Real-World Data (RWD) to develop the evidence value dossier and support reimbursement of cardiovascular drugs through a variety of observational research-related initiatives.
Following that, she spent almost four years in Medical Affairs and was accountable for scientific initiatives related to Pfizer’s cardiovascular, neuroscience & pain and inflammation portfolios. She worked cross-functionally to drive the development of strategies and tactics leveraging RWE to position Pfizer’s assets in the market.
Elodie has a Ph.D. in Pharmacoepidemiology from Université de Montréal in Canada, as well as a Master’s in Pharmacology and Bachelor’s degree in Physics from Université Toulon-Var in France.
Fred Francis is a results-driven businessman who brings over 15 years of experience leading medical imaging and image-guidance oncology companies. As Imagia’s CEO, Fred seeks innovation-driven growth, creating dynamic partnerships with global-leading pharma, medtech, hospitals, and research institutions. Prior to joining Imagia, Fred was CEO of Harmonic Medical, which developed next-generation ultrasound therapies for uterine fibroids and bone cancer metastasis. In 2000, he was founder and CEO of Resonant Medical, a leader in 3D ultrasound image-guidance for prostate and breast cancer radiotherapy. Resonant was successfully acquired by Elekta, a leading manufacturer of precision radiation medicine devices and software. Fred began his professional career co-founding Lateral Logic (now CM-Labs), which pioneered real-time rigid-body dynamics software for visual simulation and virtual prototyping. Their technology is still used today by major simulation and robotics companies, as well as academic research groups. He holds a BSc in Physics from McGill University.
Yizhou Ye is an epidemiologist at Takeda Pharmaceutical Company Limited in Cambridge, MA. He completed his Master’s degree in Statistics and PhD in pharmacoepidemiology at the University of Rhode Island. Yizhou has worked as an epidemiologist for several years in the pharmaceutical industry supporting early phase drug development and post-marketing studies using real-world data. He has been involved in various therapeutic areas including gastroenterology, metabolism disorders, and cardiovascular safety. He is a publishing author in the field of real-world data research methodology and application. Outside of work, Yizhou is an avid hiker and backpacker.
Dr. Reena Gollapudy is a Real-World Data Strategist and a SME in Drug Discovery & Clinical Development, with a passion to design and develop therapies for unmet medical needs and rare diseases. Reena leads the Real-World Data and Real-World Evidence Business Practice at Indegene. Prior to joining Indegene, Reena gained valuable Pharma industry and Real-World Evidence experience at Novartis Pharmaceuticals as well as exceptional innovation opportunities, in the Pharma Consulting and IT sectors.
A Biochemist and Molecular Biologist by training, Reena has over the last 20 years contributed significantly to designing and articulating Drug Discovery & Clinical R&D Solutions for the Pharma Industry. She has to her credit IP and awards for innovation in drug discovery and drug repurposing. Reena’s interests and capability building efforts have been directed towards design and implementation of targeted and precision medicine strategies to identify the right patient populations for innovative therapeutics.
Simon is an epidemiologist and health economist with expertise in evidence-based management of pain and musculoskeletal conditions.
He is currently a Director in the Global Center of Excellence for Real World Evidence at Vertex Pharmaceuticals, where he is leading RWE efforts related to pain and neurology,
Prior to Vertex, Simon worked in HEOR and RWE at Pacira Pharmaceuticals.
Anand Shewale, MS, PhD, is an Associate Director of Global Health Economics at Allergan, supporting neurology. Through this role, Anand has led the development of real-world evidence, PRO development and assessment, comparative effectiveness, and cost-effectiveness evaluations of acute and preventive treatments for migraine. Prior to Allergan, Anand completed a fellowship at the Arkansas Center for Health Improvement. Anand received his Master of Science and Doctor of Philosophy in Pharmaceutical Evaluation and Policy Research degrees from University of Arkansas for Medical Sciences in Little Rock, AR.
An Account Executive with over 25 years of experience spearheading and implementing clients’ solution needs in the Life Sciences Industry towards Dedalus' mission of digitizing the Life Sciences value chain of pioneering next generation solutions harnessing real world data, automation and advanced analytics. A progressive career within diverse business spheres including global service delivery, account development, project management, product development and architecture. Additional responsibilities include customer satisfaction, management of Life Sciences partnerships, projects and programs, relationship management and business development. In his previous role, Sharad was the Portfolio Director for DXC Life Sciences where he was responsible for the strategy and portfolio of the products and solutions. Sharad has a Bachelor of Computer Science degree from the University of Witwatersrand, South Africa and an MBA from Suffolk University in the United States. Sharad resides in New Jersey and is well connected with strong industry relationships.
