Enhancing Study Design with a Real World Evidence Tool
Sponsored by: Covance Market Access
Date: 30 November
Time: 3PM London/10AM New York
Explore our new tool for improved RWE decision making
In an effort to control rising drug development costs, our industry is under an enormous amount of pressure to find more efficient ways to design studies. While Real World Evidence (RWE) has the potential to transform research, there is a steep learning curve. What steps are needed in order to execute, develop and integrate RWE into existing processes?
Our educational webinar explores the issues and challenges in conducting RWE studies and development of a new tool that improves RWE study planning and execution. You’ll hear from specialists as they share how they developed this innovative tool for use in a team environment.
Learn how this new tool fills the missing gaps, captures a multi-step decision process and provides guidance on important elements such as regulatory standards, methodology and study types. The webinar will also describe how this tool can be used within the context of creating a coordinated plan or strategy for RWE.
Please join us as we explore how this tool was developed and how it can help with a variety of RWE studies and objectives. Register for our webinar today!
Vice President, Covance Market Access & Phase IV Solutions
Caroline helps biopharmaceutical and medical device clients navigate the complexities of global product planning, with a focus on health economics and outcomes research. She leads teams in multinational research to evaluate markets, formulate effective outcomes research strategies, and generate evidence pre- and post-approval to support product value. She has designed numerous RWE studies to assess disease burden and the impact of new therapies in routine clinical practice, as well as evaluations of patient-reported and health economic outcomes collected as part of clinical trials. Caroline brings over 25 years of experience working in the US and Europe across a number of therapeutic areas. She earned a BA in Economics and Political Science from Yale University and an MBA from Georgetown University / INSEAD.
Senior RWE Lead, Mundipharma International
Andrew currently leads RWE at Mundipharma International, part of a global network of independent associated companies. In his current role, he chairs a cross-functional working group responsible for coordinating and upskilling RWE across the network of companies. Previously, Andrew held roles in business development, pricing, market access, marketing, health economics, pre-clinical research and computer programming. He studied biochemistry and economics at Northwestern University and earned an Executive MBA from the University of Cambridge. He brings a global perspective from working and residing in China, Canada, across the US and Europe.
Agota Szende, MSc, PhD,
Associate Director, Covance Market Access & Phase IV Solutions
Dr. Agota Szende specializes in the design and implementation of RWE studies, health economic studies, health utility assessments, health-related quality-of-life studies, and research on how these data are used in drug regulatory and reimbursement decision-making processes. She has designed and conducted chart review studies in multiple countries to help inform burden of illness, economic modelling, and reimbursement dossiers. She has been published in multiple peer-reviewed journals and has presented her work at international conferences. Prior to joining Covance 14 years ago, Dr. Szende worked as a health economist for MEDTAP International and AstraZeneca. Dr. Szende received a PhD and a MSc in health economics at the University of York.
Senior Director, Covance Market Access & Phase IV Solutions
Elke is globally accountable for providing client-specific strategies for Phase IV observational studies and Phase IIIb/IV clinical trials execution, and to support RWE generation. Elke has over 20 years of experience holding various operational and strategic functions in medical affairs in the pharmaceutical and CRO industries, including Sanofi, Novo Nordisk, Menarini Group, Actelion, AbbVie and Covance. She is passionate about medical affairs and likes to define strategies and solutions that efficiently generate evidence and ultimately improve patient care and outcomes. Elke graduated from the University of Giessen with a BSc in Medical Documentation and completed a post graduate MSc in Pharmaceutical Medicine at the University Duisburg-Essen (Germany).
Key Learning Objectives
- Learn about how Real World Evidence (RWE) is transforming medical research
- Discuss the issues and challenges in RWE study design
- Explore how an innovative new RWE tool was created to support a coordinated plan for RWE
- Gain insights on how this tool can help your RWE decision-making
- Real World Evidence
- Data & Analytics
- Observational Research
- Health Economics and Outcomes Research
- Medical Affairs
- Regulatory Policy
- Market Access
- Clinical development
- Risk Management