Educational Symposia

* Program subject to change

Mon May 171:15 PM - 2:45 PMEducational SymposiumReal-world data and COVID-19: How will your evidence generation strategy change in a post-pandemic era?Live

The impacts of the COVID-19 pandemic on the healthcare system are undeniable. Disruptions in healthcare delivery stemming from the prioritization of COVID-19 cases have led to notable repercussions for both preventative and acute care. These shifts in utilization patterns have significant implications for real-world evidence generation, as data collected during the pandemic will require special considerations in order to deal with reactive changes to healthcare provision and accessibility during this period. Further, selected trends in care developed during the pandemic, such as the increased reliance on telehealth and expansion of community based care by large chain pharmacies may be incorporated into long-term care strategies moving forward. Lastly there is the potential to accelerate giving patients control over their health data, a trend that was emerging pre-covid which is a potential game-changer in both the clinical trials and RWE arenas. With the uncertainty that lies ahead, how can life sciences’ professionals continue leveraging real-world data to answer their organization’s most pressing research questions? Join experts from IBM Watson Health and Chiesi USA for a discussion on the impact of a pandemic on healthcare utilization, data collection, and real-world evidence generation. In this session, presenters will discuss:

The impact of the pandemic on overall healthcare utilization/cost trends, and the implication of these changing trends for your research
How and when your research approach may need to change
Potential longer term impacts of the COVID-19 pandemic, such as learnings related to healthcare accessibility and equity

SponsorIBM Watson HealthModerators

Tina Moen, PharmD

IBM Watson Health, Denver, CO, USA

Speakers

Brenna Brady, PhD

IBM Watson Health, Laurel, MD, USA

Martin Marciniak, RPh, PhD, MPP

Chiesi USA, Inc., Cary, NC, USA

Bill Saunders, MPH, PhD

Chiesi USA, Inc., Cary, USA

Joseph Tkacz, MS

IBM Watson Health, Bethesda, MD, USA

Beyond Cancer: Moving to High-Quality Real-World Data in Chronic Diseases

Despite representing a huge percentage of healthcare spend, chronic conditions receive significantly less focus on real-world data (RWD) development and usage than cancer. This two-part session explores how RWD is being developed and used in areas such as dermatology, rheumatology, cardiovascular and behavioral health. Panelists will explore:

Part 1: The evolution of registries to data networks, standards for quality, advances in machine learning and natural language processing (NLP).

Part 2: Use cases for accelerating research, measuring outcomes, and personalizing care.

SponsorOM1Moderators

Gary Curhan, MD, ScD

OM1, Boston, MA, USA

Speakers

Terrie Livingston, PharmD

EMD Serono, Wayland, MA, USA

Kathryn Starzyk, ScM

OM1, Boston, MA, USA

Marta Van Beek, MD, MPH

University of Iowa Hospitals and Clinics, Iowa City, IA, USA

Tue May 1811:45 AM - 1:15 PMGene Therapies: Reimbursement Challenges and Pricing Opportunities in the USLive

Economic evaluation studies may underestimate the value of innovative cell and gene therapies in rare diseases, impacting on Health Technology Assessment (HTA) frameworks, market access and pricing decisions. This symposium will explore the challenges faced by HTA and other reimbursement bodies, as they consider a wide range of cell and gene therapies. Panelists will discuss drug value evidence-based challenges, the coverage policies that global payers have used to address these challenges, and their impact on value assessment frameworks, contracting and affordability.

SponsorNovartis Gene TherapiesModerators

Omar Dabbous, MD, MPH

Novartis Gene Therapies, Bannockburn, IL, USA

Speakers

Michael Drummond, MCom, DPhil

University of York, York, YOR, United Kingdom

Michael Drummond, BSc, MCom, DPhil is professor of Health Economics and former Director of the Centre for Health Economics at the University of York. His particular field of interest is in the economic evaluation of health care treatments and programmes. He has undertaken evaluations in a wide range of medical fields including care of the elderly, neonatal intensive care, immunization programmes, services for people with AIDS, eye health care and pharmaceuticals. He is the author of two major textbooks and more than 650 scientific papers, and has acted as a consultant to the World Health Organization and the European Union. He has been President of the International Society of Technology Assessment in Health Care, and the International Society for Pharmacoeconomics and Outcomes Research. In October 2010 he was made a member of the National Academy of Medicine in the USA. He has advised several governments on the assessment of health technologies and chaired one of the Guideline Review Panels for the National Institute for Health and Care Excellence (NICE) in the UK. He is currently Co-Editor-in-Chief of Value in Health and has been awarded 3 honorary doctorates, from City University (London), Erasmus University (Rotterdam) and the University of Lisbon.

Lou Garrison, PhD

University of Washington,The Comparative Health Outcomes, Policy, and Economics Institute, Seattle, USA

Lou Garrison, PhD, is professor emeritus in The Comparative Health Outcomes, Policy, and Economics Institute in the School of Pharmacy at the University of Washington, where he joined the faculty in 2004. For the first 13 years of his career, Dr. Garrison worked in non-profit health policy at Battelle and then the Project HOPE Center for Health Affairs, where he was the Director from 1989-1992. Following this, he worked as an economist in the pharmaceutical industry for 12 years. From 2002-2004, he was vice president and head of Health Economics & Strategic Pricing in Roche Pharmaceuticals, based in Basel, Switzerland. Dr. Garrison received a BA in Economics from Indiana University, and a PhD in Economics from Stanford University. He has more than 150 publications in peer-reviewed journals. His research interests include national and international health policy issues related to personalized medicine, benefit-risk analysis, and other topics, as well as the economic evaluation of pharmaceuticals, diagnostics, and other technologies. Dr. Garrison was elected as ISPOR President for July 2016-June 2017, following other leadership roles since 2005. He recently co-chaired the ISPOR Special Task Force on US Value Frameworks. He was selected in 2017 by PharmaVOICE as being among “100 of the Most Inspiring People” in the industry. He recently received the PhRMA Foundation and Personalized Medicine Coalition 2018 Value Assessment Challenge First-Prize Award as lead author on a paper on “A Strategy to Support the Efficient Development and Use of Innovations in Personalized and Precision Medicine.”

Peter Neumann, ScD

Tufts Medical Center, Boston, MA, USA

Access to Oncology Combinations: the “Combination Challenge”Live

While combination therapies are not new in oncology, in recent years there have been significant advances in treatment with the introduction of targeted therapies and immunotherapies. Combinations of these new, innovative oncology therapies increasingly represent the preferred treatment option for many patients, delivering significant benefits and prolonged survival compared to monotherapies. However, access to branded combinations poses several challenges, particularly where each constituent is produced by different manufacturers and present in multiple indications. These difficulties ultimately lead to the “Combination Challenge”; where patients would benefit from the launch of better therapeutic options, manufacturers would see their volume increase and payers would value the combination however there may be barriers which prevent patients from having access to new combination. The session will explain the various Access challenges and discuss potential Policy solutions to address these.

SponsorMSDModerators

Duane Schulthess, BA, MBA

Vital Transformation, Wezembeek Oppem, VBR, Belgium

Speakers

Berit Eberhardt

International Kidney Cancer Coalition, Duivendrecht, NH, Netherlands

Christopher Henshall, PhD

Brunel University, London, United Kingdom

Luca Morlotti, ,

MSD, Lucerne, Switzerland

Tim Wilsdon, Msc

Charles Rivers Associates, London, United Kingdom

Wed May 19Delivering on Promises: Enhancing Patient Access to (Neo)adjuvant Cancer TreatmentsLive

This session’s focus will be on remaining unmet medical need in the fight against cancer; on the promises that (neo)adjuvant cancer treatments offer to patients, physicians, and societies; and on ways to overcome the challenges such treatments face in terms of value demonstration and appreciation. Four speakers - scientific leader, payer, regulator, and an industry representative - will offer their perspectives to get a better understanding of the value of early treatment. They will highlight the unmet medical needs and discuss the potential of (neo)adjuvant treatments to improve cancer treatment along the entire continuum of care (screening, treatment, social care). They will also dive-in on the hurdles to broad and rapid access of (neo)adjuvant treatments with a special view towards limitations around delivery, acceptance, matching of scientific evidence in HTA and P&R context. Finally, the discussion will focus on possible solutions for broader and more rapid access to early treatments such as evidence generation during authorization, innovative contracting, and multi-stakeholder collaboration.

SponsorMSDModerators

Duane Schulthess, BA, MBA

Vital Transformation, Wezembeek Oppem, VBR, Belgium

Speakers

Francis Arickx, .

,, Lucerne, Switzerland

Nadia Harbeck, MD, PhD

Brustzentrum der Universität München (LMU), Munich, BY, Germany

Milayna Subar, MD

Merck & Co., Kenilworth, NJ, USA

Sean Tunis, MD, MSc.

Rubix Health, Baltimore, MD, USA

Expedited Pathways to Decentralized Trials - The Transformation of the Regulatory Process and Increasing Dependence on RWELive

Precision medicine is redefining how we evaluate and treat disease. No longer is cancer defined by its organ of origin, tissue or cell type but rather its genotype. Over just a few decades lung cancer has been transformed from one disease affecting 100,000+ in the U.S. annually to dozens of cancers that each inflict just a few thousand. Conducting traditional 3-phased clinical trials in these orphan disease categories on a myriad of novel therapeutics while trying to expedite therapies from lab bench to bedside is forcing a transformation of both the clinical development and regulatory process. From cohort expansion to accelerated pathways to decentralized trials, this transformation has placed real-world evidence at the center of the approval process. We’ll explore how the traditional one-size-fits-all clinical development and regulatory approval paradigm has evolved to become an increasingly customizable process.

SponsorCardinal HealthModerators

Bruce Feinberg, DO

Cardinal Health Specialty Solutions, ATLANTA, GA, USA

Speakers

Jonathan Kish, PhD, MPH

Cardinal Health, Miami, FL, USA

Shibani Pokras, MPH

GlaxoSmithKline, Bryn mawr, PA, USA

Scott Swain, PhD, MPH

Cardinal Health Specialty Solutions, Dublin, OH, USA

Jacqueline Vanderpuye-Orgle, PhD

Parexel, LA VERNE, CA, USA

Virtual ISPOR 2021

May 17-20, 2021

Educational Symposia

The Professional Society for
Health Economics and Outcomes Research