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Thursday, June 18 • 5:00pm - 6:00pm
#527 OD: ON DEMAND - Patient Preferences in the Medical Product Lifecycle: Evolving Uses, Stakeholder Considerations, and Applications

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Component Type: Session
Level: Intermediate

Patient preference studies are an increasingly important means of assessing patient perspective on the benefit-risk trade-offs and the importance of properties of medical treatments. Regulator, industry, academic, health technology assessment, and patient –stakeholders are conducting these studies to inform development, regulatory, healthcare and reimbursement decisions across the medical product lifecycle. To enable well-designed studies and informative results, it is important to understand when patient preference studies best inform decision making and the needs and concerns of stakeholders using the results. Additionally, understanding methods of use with clinical trial data enables clear communication and appropriate application of results to inform decision making. This session will present a critical assessment of results from the first phase of PREFER, an Innovative Medicines Initiative (IMI) research project developing recommendations on how and when to use patient preference study for informing medical product development. It will describe three broad classes of approaches to applying patient preference results to clinical trials/data and key trade-offs between these approaches. The session will also demonstrate practical use of patient preferences in regulatory applications at FDA CBER, including roles in osteoarthritis, sickle cell anemia and type I diabetes islet cell transplant.

Learning Objectives

Identify where in the medical product lifecycle (MPLC) patient preference studies can best inform decision making and related stakeholder needs and concerns; Describe different approaches, with related advantages/disadvantages, for applying preference study results for informing MPLC decisions; Describe current and future FDA CBER regulatory applications for preference studies.


Kristin E Bullok, PhD


Critical Assessment of PREFER's First Phase Results: Methods and Challenges
Rosanne Janssens, MSc

Applications of Patent Preferences Studies in Drug Development: How Preference Data Can Inform Decisions
Bennett Levitan, MD, PhD

Capturing Patient Preferences to Inform Regulation of Medical Products
Telba Irony, PhD

avatar for Bennett Levitan

Bennett Levitan

Senior Director, Benefit-Risk Assessment, Global R&D Epidemiology, Janssen Research & Development, LLC
Bennett Levitan, MD-PhD is Senior Director, Global R&D Epidemiology at Janssen R&D. He introduced state of the art patient-focused benefit-risk assessment to Janssen and his team has led numerous clinical teams in benefit-risk assessments and patient preference studies. He co-led... Read More →
avatar for Kristin Bullok

Kristin Bullok

Benefit-Risk Management Scientist, Global Patient Safety, Eli Lilly and Company, United States
Kristin Bullok, PhD, is a research scientist in benefit-risk management at Eli Lilly and Company, Global Patient Safety. Since joining Lilly, she has years of combined experience in conducting structured benefit-risk assessments, consulting on patient preference trade-off studies... Read More →
avatar for Telba Irony

Telba Irony

Deputy Director, Office of Biostatistics and Epidemiology, CBER, FDA
Telba is Deputy Director of the Office of Biostatistics and Epidemiology at CBER. She joined FDA to implement the use of Bayesian statistics for the regulation of medical devices and led the Decision Analysis initiative including Bayesian statistics, benefit-risk determinations, and... Read More →
avatar for Rosanne Janssens

Rosanne Janssens

PhD Researcher, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven
Rosanne Janssens is a PhD researcher working on the PREFER project at the KU Leuven in Belgium, in the Regulatory Sciences & Pharmaco-Economics research unit. Her research aims at identifying multi-stakeholder challenges and solutions towards designing, conducting and using patient... Read More →

Thursday June 18, 2020 5:00pm - 6:00pm EDT
TBD Virtual Event Horsham, PA 19044