Registration will close October 11, 2023 at

Event Details

Overview

The meeting will consider the importance of patient-centric input into regulatory and HTA decision-making discussing the latest developments in the field and presenting industry examples. Speakers from EMA, the pharmaceutical industry, and those working with HTAs and patients will give their perspective on the importance and practical aspects of selecting relevant for patients outcomes in the evaluation of clinical trials.


Over the course of two half days we will have a range of speakers providing insight into the process of involving patients as research partners and how Patient Preference Studies can yield deeper understanding on patients' perspectives for decision-making in clinical trials. To set the stage, we will discuss the regulatory perspective, review published guidance and existing framework, and give overview of the logistical and methodological challenges faced by researchers and HTA bodies. We will present case studies assessing the importance to patients of improving symptoms in chronic obstructive pulmonary disease and fatigue in multiple sclerosis, both using discrete choice experiments. We will learn about a conceptual framework for addressing patient preferences in dose selection in the absence of full information on risks and benefits, also involving discrete choice experiments. The event will finish with a panel discussion, where experts will deliberate on the key takeaways and future directions as well as the role of the statistician in patient-focused drug development.


Who is this event intended for? Statisticians in the pharmaceutical industry, HTAs and regulatory bodies, working with registrational clinical trials.

What is the benefit of attending? Learn about latest developments in patient-focused drug development from various stakeholders' perspective.


Timings:- Please note, this event will be split over two consecutive afternoons, the timings for which are listed below.

Wednesday 18th October: 13:00-15:40 BST

Thursday 19th October: 13:30-16:10 BST

Oct 18 & 19, 2023 (GMT+1)

Speakers

  • Peter Mol (Professor of drug regulatory science at University Medical Center Groningen)

    Peter Mol

    Professor of drug regulatory science at University Medical Center Groningen

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  • Caroline Vass (Senior Economist in the Health Preference Assessment team at RTI Health Solutions)

    Caroline Vass

    Senior Economist in the Health Preference Assessment team at RTI Health Solutions

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  • Hannah Penton (Senior Scientist in the Patient-Centered Outcomes team at OPEN Health)

    Hannah Penton

    Senior Scientist in the Patient-Centered Outcomes team at OPEN Health

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  • Marco Boeri (Director of Preference Research at OPEN Health)

    Marco Boeri

    Director of Preference Research at OPEN Health

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  • Christine Sturchler (Director, Patient Engagement Scientific Excellence of Novartis)

    Christine Sturchler

    Director, Patient Engagement Scientific Excellence of Novartis

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  • Byron Jones (Biostatistician Specialising in Patient Preference Studies in the Patient Engagement Science group at Novartis)

    Byron Jones

    Biostatistician Specialising in Patient Preference Studies in the Patient Engagement Science group at Novartis

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  • Brett Hauber (Senior Director, Patient Preferences in Worldwide Medical and Safety of Pfizer)

    Brett Hauber

    Senior Director, Patient Preferences in Worldwide Medical and Safety of Pfizer

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  • Bennett Levitan (Senior Director, Benefit-risk Assessment, Department of Epidemiology at Johnson & Johnson)

    Bennett Levitan

    Senior Director, Benefit-risk Assessment, Department of Epidemiology at Johnson & Johnson

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