The data characterizing the real-world clinical, economic and humanistic impact of innovative medical products are increasingly used across the broad spectrum of clinical and commercial development to support both regulatory approval and market access (with the former being a relatively new phenomenon since implementation of the 21st Century Cures Act). Despite an increasing number of sources of high-quality real-world data (RWD), there remain many situations in which a data-based solution has important strategic and/or scientific limitations. What are the strategic and scientific imperatives for prospectively generated real-world evidence (RWE)?
Join this webinar to explore the RWE/RWD landscape and the situations in which a prospective observational study or registry presents a more optimal solution, while also focusing on the unique operational factors that must be accommodated to maximize time- and cost-efficiency in the de novo generation of real-world evidence.
(Moderator) Jeff Trotter, Senior Vice President, Scientific Solutions, Real World Evidence, Worldwide Clinical Trials
Jeff Trotter, Senior Vice President for Worldwide Evidence™, supports clients with the critical transition from clinical development to commercialization. With more than three decades of experience and an MBA from Northwestern University, Jeff brings a pioneering spirit to the evolving real-world evidence research community. As an accomplished speaker and author with over 50 published articles and research papers, he prioritizes personalized client service, practical and strategic guidance based in experience, and candid communications grounded in mutual respect and cultural sensitivity through his role at Worldwide.
Mary Glenn Vreeland, Senior Director, Evidence Project Management – United States, Worldwide Clinical Trials
With 25 years experience in the life sciences arena, Mary Glenn has extensive knowledge of real-world research, industry trends and emerging digital health technologies. She establishes excellent relationships with clients and stakeholders, working harmoniously to design studies that are innovative, maximize value and address the competitive landscape. Mary Glenn has significant experience leading teams and ensuring they have the necessary resources and support to deliver customized solutions of the highest quality successfully and efficiently and in compliance with respective regulations. Her study experience spans all phases of research and numerous therapeutic areas. Throughout her career, Mary Glenn has held a variety of senior management positions within contract research organizations. Most recently, she was responsible for providing executive oversight on a portfolio of studies at the forefront of research, including a virtual COVID-19 study and the initiation of an inclusive research trial to broaden the understanding of multiple sclerosis disease biology among specific minorities. Mary Glenn has a Master of Health Administration from Washington University School of Medicine.
Florence Barkats, CCO and Digital Health & Technology Advisor, Cisiv Ltd.
Florence has 20 years’ experience in health informatics and real-world technology and methodology. Prior to working at Cisiv, she was Head of Clinical Services at Philips, held leadership roles at GE Healthcare Digital, Johnson & Johnson and was Head of Research for a digital health technology start-up. Florence also holds an advisory role with the UK NHS on digital transformation programmes and policy. She has a BSc degree from Johns Hopkins University and an MBA from London Business School.
Dilesh Doshi, PharmD, Vice President, Global Health Economics and Outcomes Research, Acadia Pharmaceuticals
Dilesh is the Vice President of Global Health Economics & Outcomes Research (HEOR) at Acadia Pharmaceuticals. His team is responsible for generating real-world evidence to guide appropriate treatments for patients with neuropsychiatric illness as well as children with rare disorders. The Global HEOR team also prepares for health technology and value assessment reviews conducted by governmental and non-governmental agencies.
Prior to joining Acadia, Dilesh was at Johnson & Johnson for 19 years. During his tenure at Janssen (J&J), Dilesh held various leadership roles, including Head of Real-World Evidence for a rare disease franchise, Founding Head of Population Health, Director of Translation Science and Director of Health Economics. He also spent several years in customer-facing payer liaison roles. Dilesh started his career at SmithKline Beecham within their health economics and pricing group.
Dilesh received his Bachelor of Science degree in Chemistry from Central Connecticut State University and a Doctor of Pharmacy from the University of California, San Francisco. He completed a two year post graduate fellowship at Thomas Jefferson School of Population Health in Philadelphia, PA. With over 80 podium presentations and peer reviewed publications including book chapters, manuscripts and posters, he is nationally recognized as a subject-matter expert and regularly invited as a conference speaker. He is a peer reviewer for scientific journals and has held a Faculty appointment for health economics and real-world evidence at the University of California, San Diego School of Pharmacy since 2009.
Who Should Attend?
- Medical Affairs and HEOR professionals charged with the responsibility of advancing and implementing real-world evidence (RWE) strategies
- Clinical Operations professionals seeking to better understand optimal approaches to leveraging RWE
- Product Managers and Market Access professionals seeking to utilize RWE for demonstrating (post-approval) product value to key stakeholders
What You Will Learn
In this webinar, attendees will:
- Understand the evolving real-world evidence (RWE) landscape and the importance of a portfolio approach to accessing and/or generating key data considering the full spectrum of product development and positioning
- Understand the situations meriting prospectively generated RWE and the limitations of certain retrospective real-world data (RWD)
- Understand critical operational components of prospective real-world studies to ensure they are as productive as possible
Worldwide Clinical Trials
Worldwide Clinical Trials is a global, midsize contract research organization (CRO) that provides top-performing bioanalytical and Phase I-IV clinical development services to the biotechnology and pharmaceutical industries.
Founded in 1986 by physicians committed to advancing medical science, our full-service clinical experience ranges from early phase and bioanalytical sciences through late phase studies, post approval, and real-world evidence. Major therapeutic areas of focus include cardiovascular, metabolic, neuroscience, oncology, and rare diseases. Operating in 60+ countries with offices in North and South America, Eastern and Western Europe, and Asia, Worldwide is powered by its more than 3,000 employee experts.