The RWE ROI Series: The Transformational Value of Real-World Data for Drug Development and Regulatory Decision-Making

The value of real-world data is clear. The acceptance of real-world evidence (RWE) is growing. But is this enough to propel RWE from being a nice-to-have to a must-have?

PicnicHealth is hosting a four-part webinar series to reframe the “ROI” for RWE generation and tackle the question: beyond the return on investment for RWE, what is the risk of inaction?

This webinar will explore relevant examples of how Data Science and Digital Health are accelerating pharmaceutical innovation and driving impact for patients. Bringing together global experts with diverse perspectives spanning regulatory, R&D and health tech, this conversation will highlight innovative, RWD-driven approaches to drug development and regulatory decision-making. Speakers will discuss the need for different types of data to construct a complete clinical picture – and how a data-driven approach can drive impact across both research and clinical practice.

Register today to learn more about the transformational value of real-world data for drug development and regulatory decision-making.

Speakers

Jesper Kjær, Director of The Data Analytics Centre at the Danish Medicines Agency, Co-Chair for HMA / EMA Big Data Steering Group

Jesper Kjær is Director of The Data Analytics Centre at the Danish Medicines Agency, and Co-Chair for HMA / EMA Big Data Steering Group. Jesper has 20+ years of experience in data management, analyses and data visualisation, having previously worked in academia and the pharmaceutical industry. He has headed up activities in EU Framework Programmes, TransCelerate Biopharma. Jesper is Co-PI of PHAIR: Pharmacovigilance by AI Real-time analyses, applying FHIR resources to healthcare data in DK for real-time safety surveillance. He is involved in EHDS pilot work and is an EMA DARWIN EU advisory board member.

Message Presenter

Najat Khan, Chief Data Science Officer and Global Head of Strategy & Operations, Janssen Research & Development

Najat Khan, PhD, is the Chief Data Science Officer and Global Head of Strategy & Operations for R&D at the Janssen Pharmaceutical Companies of Johnson & Johnson. In this combination of leadership roles — unique in the healthcare industry — Najat is responsible for overseeing the Janssen R&D strategy, pipeline and portfolio optimization and investment, and for fully integrating data science and digital health end-to-end across the pharmaceutical pipeline to drive transformational innovation for patients.

Message Presenter

Noga Leviner, Co-Founder & CEO, PicnicHealth

Noga Leviner is the Co-founder and CEO of PicnicHealth, a digital health company founded on the belief that empowering patients to gain control of their medical data is the critical first step to improving lives and health outcomes and driving scientific advances. PicnicHealth has pioneered the use of advanced human-in-the-loop machine learning algorithms to abstract key endpoints from medical records at scale with improved accuracy and efficiency. Noga is a vocal advocate for patients’ rights to control their own health data, having founded PicnicHealth in 2014 to help patients manage their medical records after personally facing the challenges of being a Crohn’s disease patient in the US medical system. She has spoken widely on the subject including at the White House.

Message Presenter

(Moderator) Evelyn Pyper, Evidence Strategist, PicnicHealth

Evelyn Pyper is Senior Evidence Strategy Manager at PicnicHealth, a patient-centric real-world data company. Her career in real-world evidence (RWE) spans the public and private sector as well as regional and global markets. Prior to PicnicHealth, she worked as Associate Director of Market Access at J&J Global Public Health, focused on securing access to HIV treatments in Sub-Saharan Africa; and as RWE Manager of a diverse portfolio of partnerships and research projects at Janssen Canada. Evelyn has a BHSc in health sciences with a minor in psychology from McMaster University and a Master of Public Health (MPH) degree from Queen’s University. Evelyn is currently completing her doctorate (DPhil) in evidence-based healthcare at the University of Oxford, with a focus on digital health.

Message Presenter