Mon 6 May
8:30 - 9:45
Plenary Session
Advancing Whole Health: How do We Know When We’re Succeeding?
Digital Conference Pass
While designing and implementing integrated interventions has been challenging, perhaps even more challenging has been evaluating whether the interventions are making a difference for the outcomes that matter most to people, families, and communities.
Whole person health requires a holistic approach that considers multiple factors that promote health or disease. While health care is one of the factors, the greatest impact on individual and population health is derived from health behaviors and social and environmental factors. Supporting whole health means reimagining how systems that have been traditionally siloed (e.g., health care, public health, social support services) work together in an integrated fashion to protect and improve health.
In this session, panelists will make the case for why HEOR needs to help drive innovation in whole person health by evaluating the effectiveness and value of interventions designed to support whole health. Panelists will discuss challenges and solutions to filling critical evaluation gaps, including:
Measuring and incentivizing what’s meaningful: How to develop and measure more meaningful outcomes (e.g., a “Whole Person Health Index”, electronic clinical quality measures)
The wrong pocket problem: How to account for value across sectors (e.g., modeling or health economic guidance for the cost-benefit analyses of Whole Person Health interventions)
Also, be the first to hear highlights from ISPOR's Strategic Plan 2030!
Moderators
Charlene Wong, MD, MSHP
Centers for Disease Control and Prevention, Atlanta, GA, USA
Charlene Wong, MD MSHP serves as the Senior Advisor for Health Strategy in the Office of the Director at the Centers for Disease Control and Prevention. In this role, she is coordinating a collaborative approach to protecting health that brings public health alongside efforts in health care and social supports. This work spans CDC’s priority areas of supporting young families, mental health and overdose, and readiness and response. She previously served as the inaugural Assistant Secretary for Children and Families and the Chief Health Policy Officer for COVID-19 in the North Carolina Department of Health and Human Services (NCDHHS). Dr. Wong was faculty at Duke University and served as the Executive Director of North Carolina Integrated Care for Kids (NC InCK), an innovative model serving ~100,000 Medicaid-insured children in central North Carolina. She is a primary care pediatrician, specializing in adolescent and young adult medicine. She completed her medical, research and policy training at Emory University, the Centers for Disease Control and Prevention, University of Washington, and University of Pennsylvania.
Speakers
Seth A. Berkowitz, MD, MPH
University of North Carolina at Chapel Hill, Chapel Hill, NC, USA
Dr. Berkowitz is an Associate Professor of Medicine at the University of North Carolina at Chapel Hill School of Medicine in the Division of General Medicine & Clinical Epidemiology. He is a general internist and primary care doctor. He studies the relationship between health-related social needs, such as food insecurity, and health outcomes. He is the author of the recent book Equal Care: Health Equity, Social Democracy, and the Egalitarian State, which examines how public policy can improve population health.
Eric C. Schneider, MD, MSc, FACP
National Committee for Quality Assurance (NCQA), Washington, DC, USA
Dr. Eric Schneider is executive vice president for quality measurement and research at the National Committee for Quality Assurance (NCQA) and an internationally known expert on health care quality. Prior to joining NCQA in 2022, Dr. Schneider was senior vice president at the Commonwealth Fund. He previously held the RAND Distinguished Chair in Health Care Quality at the RAND and was research faculty at Harvard Medical School and Harvard School of Public Health. He practiced primary care internal medicine at Brigham and Women’s Hospital. He is a fellow of the American College of Physicians and the National Academy of Social Insurance. He is a graduate of Columbia University (B.S.), the University of California, Berkeley (M.Sc.), and University of California, San Francisco (M.D.).
Denise Webb, .
The Partnership For Southern Equity, Atlanta, GA, USA
Denise Webb is a sophomore at Berry College, majoring in Biology and Conservation. Although her education is focused on conserving wildlife, she is not blind to the issues within her community. Since the age of 14, she has been engaged in the world of policy and change. A Senior Youth Staff at the Partnership for Southern Equity, Denise continues to work on issues ranging from racial inequities in healthcare to extreme heat in urban areas. Motivating audiences of all ages, she shares her advocacy efforts to address the disparities that directly impact her neighborhood. As Bonner Scholar, Youth Ambassador for Atlanta, and Senior Fellow at CoGenerate, she is in multiple communities volunteering, working, writing, and getting into “good trouble.” In 2023 Denise coauthored the book, “Why Aren’t We Doing This?- Collaborating With Minors In Major Ways” with Wendy Schaetzel Lesko. Despite these accolades, she is most proud of her 723 Duolingo streak
Tue 7 May
Missing Link for HEOR: A Path Forward for HEOR Data Integration
Digital Conference Pass
The integration and linkage of real-world data allows assembly of the whole picture of how patients feel by supporting incorporation of patient-generated health data with clinical data from electronic medical records and study-specific case report forms, and payer information through linkage of pharmacy and other health insurance claims. Data linkage may even extend beyond health care facilitates to include information about school attendance and other community data. In addition to incorporating patients’ experience to understand medical product safety, tolerability and effectiveness, linkage to health systems facilitates long term follow-up of medical products like cell and gene therapies and can also be used to evaluate delayed safety and risks. However, the process of linkage and integration is far from straight forward. Privacy constraints limit what and how much data can be shared, and the linkage process itself involves many assumptions to determine accurate matches from often-incomplete personal identifier information. We are about to learn a lot more about how well these linkages work since the FDA has asked to receive information establishing the accuracy of any linkage before linked data can be used for regulatory submissions. Come join this lively discussion with seasoned experts about the vision, key issues and reasons for optimism.
Moderators
Nancy Dreyer, MPH, PhD, FISPE
Dreyer Strategies LLC; University of North Carolina at Chapel Hill; Picnic Health, Newton, MA, USA
Nancy Dreyer is Adjunct Professor of Epidemiology at the University of North Carolina at Chapel Hill, Chief Scientific Advisor to Picnic Health, and a Trustee of Brandeis University. Prior to her switch from full-time employment to consultancy, she served as Chief Scientific Officer at IQVIA Real World Solutions, Global Chief of Scientific Affairs at Outcome Sciences Inc and Quintiles, and CEO of Epidemiology Resources Inc. She maintains an active career, teaching for the International Society of Pharmacoepidemiology (ISPE), participating in the ISPOR RWE leadership team, and publishing, and is a Fellow of both ISPE and the Drug Information Association.
One of her primary interests is advancing global use of real-world evidence by medical product regulators, clinicians and payers. Her current interests also include the role of patient-generated health data as well as data linkage and integration.
Speakers
Niall Brennan, MPP
CDC, Atlanta, GA, USA
Senior Advisor for Data Modernization, Centers for Disease Control and Prevention (CDC). Niall Brennan is the Senior Advisor for Data Strategy to the CDC Director. In this role, he provides guidance to the CDC Director on the multi-billion dollar CDC Data Modernization Initiative (DMI), as well as working directly with CDC Centers and Offices to accelerate implementation of the DMI. Prior to coming to CDC, Brennan was Chief Analytics and Privacy Officer at Clarify Health, where he led Clarify’s analytics and informatics strategy. He joined Clarify following his role as president and CEO of the Health Care Cost Institute, from 2017–2022, and previously served as the Chief Data Officer at the Centers for Medicare & Medicaid, from 2010–2017, where he led the Obama administration’s healthcare transparency efforts, built an advanced analytics enterprise, and played a key role in implementing numerous Affordable Care Act provisions, including the Qualified Entity Program and the Physician Payments Sunshine Act. Brennan is a graduate of Georgetown University’s MPP program and has an undergraduate degree from University College Dublin. He is married to Myra and has two children, Niamh (22) and Eoghan (17), who he inflicted difficult-to-pronounce Irish names upon. He is proud to be a native of Ireland, an immigrant, and a naturalized US Citizen.
Joe Franklin, JD, PhD
Verily, Washington, DC, USA
Joe Franklin leads the Strategic Affairs team at Verily and focuses on evidence generation strategy, including regulatory policy and health data privacy, at the intersection of clinical research and care. Before joining Verily in 2021, Joe held a variety of positions at FDA, including as senior advisor on data and evidence initiatives. Joe led the biosimilars policy staff in the Office of New Drugs and served as an attorney in the chief counsel’s office for multiple periods during his career at FDA. Joe has a PhD in cell biology from his early career as a bench scientist.
Keri Monda, PhD
Amgen Inc, Thousand Oaks, CA, USA
Keri Monda, PhD, is an Executive Director of Observational Research, and Clinical Development Epidemiology Head of the Data & Analytics Center within the Center for Observational Research (CfOR) at Amgen. In her role, she leads a team of epidemiologists and data scientists responsible for generating real-world evidence in support of programs from discovery through early and late development until launch, building and maintaining capabilities that make use of a large, integrated real-world data and analytics ecosystem. Prior to her time at Amgen, Keri was a genetic epidemiologist on faculty in the Department of Epidemiology at the University of North Carolina, Chapel Hill.
Wed 8 May
11:30 - 12:45
AI Enabling Whole Health: Opportunities and Challenges for HEOR and HTA
Digital Conference Pass
Artificial intelligence (AI) is transforming the life sciences and healthcare sectors, offering unprecedented possibilities for innovation, efficiency, and quality. How can we harness the power of AI while ensuring its ethical, reliable, and fair use? How can we leverage AI to generate and communicate evidence that supports health technology assessment (HTA) and health economic and outcomes research (HEOR)? And how can we prepare ourselves for the future of AI and its impact on Whole Health? Join us in this plenary session where we will explore these questions and more from different perspectives and domains. You will learn about:
The basics of AI and generative AI (GenAI), and how they differ from traditional data analysis and modelling techniques
The current and emerging applications of AI in life sciences and healthcare, and how they are driving innovation and value across
The challenges and opportunities of working with unstructured data sources, such as natural language, images, and real world evidence in the field of HEOR and HTA
The technical and methodological aspects of developing, validating, and interpreting AI models and outputs, and how to ensure their transparency, reproducibility, and accountability
The session will feature presentations from experts in AI, HEOR, and HTA, followed by an interactive panel discussion.
Moderators
Thomas Senderovitz, MD
NovoNordisk, Copenhagen, Denmark
Thomas Senderovitz is an M.D. from University of Copenhagen. He has more than 30 yrs experience from healthcare, pharmaceutical industry, biotech, CRO and regulatory authorities / governmental administration.
Since 2021 Senior Vice President Data Science at Novo Nordisk leading app 1100 data scientists across various domains and functions incl. Clinical Data Operations & Insights, Biostatistics/Statistical Programming, AI/ML & Real World Evidence, Pharmacometrics, Data Orchestration, External Affairs and Strategic and Digital Development. He recently joined the Board of Directors of Instem.
Previously CEO of the Danish Medicines Agency, Chair of Heads of Medicines Agencies Management Group and member of EMA Management Board. Member of executive management of PAREXEL, Grünenthal and VP Global Exploratory Development of UCB, VP Clinical R&D Ferring Pharmaceuticals a.o.
Speakers
Anirban Basu, PhD, MS
University of Seattle, Seattle, WA, USA
Anirban Basu is a Professor of Health Economics and the Stergachis Family Endowed Director of The CHOICE Institute at the University of Washington, Seattle. He holds joint appointments with the Departments of Health Systems & Population Health and Economics at UW, is a Faculty Research Fellow at the US National Bureau of Economic Research, and an elected Fellow of the American Statistical Association. His work sits at the intersection of microeconomics, statistics, and health policy. His research focuses on understanding the economic value of health care, generating causal evidence, and, lately, on the potential for discrimination with machine learning and artificial intelligence algorithms. He served on the Second Panel on Cost-effectiveness Analysis in Health and Medicine and serves on the Editorial Advisory Board for Value in Health Journal. He received his master's in Biostatistics from UNC-Chapel Hill and a PhD in Public Policy Studies from the University of Chicago.
Alexandra Berk, PhD
CVS Healthspire Life Sciences Solutions, Woonsocket, RI, USA
Alexa Berk leads Real World Evidence (RWE) for CVS Health®, serving as General Manager, CVS Healthspire™ Life Sciences Solutions - RWE. Alexa has 20 years of experience in observational and clinical research, starting her career at Memorial Sloan Kettering Cancer Center and moving into research leadership positions in life sciences, consulting, and startup environments. Alexa was most recently Medical Director for Digital Health and Data at Invitae, prior to joining CVS Health® in 2022 as Chief Scientific Officer for RWE. Alexa has co-authored manuscripts and abstracts in the research literature across indications, with a particular focus on oncology and rare diseases, and is a frequent speaker on the use of high-quality, patient-centric, and equitable research approaches. She is a graduate of Barnard College and the New School for Social Research.
Rachael Fleurence, PhD
NIH, Washington, DC, USA
Dr Fleurence is a Senior Advisor at the National Institutes of Health where she is working on launching a national initiative to eliminate Hepatitis C in the United-States. Dr Fleurence is also affiliated with the National Institute of Biomedical Imaging and Bioengineering where she works on advances in Artificial Intelligence and Machine Learning. Dr Fleurence currently co-leads the ISPOR Task Force on the suitability of EHR data for Health Technology Assessments. Previously, Dr Fleurence served as a senior health advisor in the Biden-Harris White House, Dr. Fleurence received a BA from Cambridge University (United Kingdom), an MA in business management from ESSEC-Paris (France), and an MSc and PhD in health economics from the University of York (UK).