Register today to attend Real World Evidence Digital Week, our free-to-attend webcast series discussing the vital role of Real-world Evidence (RWE) and Real-world Data (RWD) in Clinical Development including focused insights on the role of big data processing, provider networks and chronic and rare diseases. To learn about sponsorship of future events, contact partners@informaconnectls.com
DAY 1 – FEBRUARY 28, 2022
Using Real-World Data from Clinical Development to the Clinic in Non-Oncologic Diseases
9am EST / 2pm GMT / 3pm CET
- The role of provider networks
- The role of big data processing, natural language processing, data linkage, and AI
- Use cases from clinical development, site selection, patient finding, patient journeys, comparative effectiveness and personalization in the clinic
Speaker:
Richard Gliklich, MD
CEO
OM1
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Natural History of Disease Studies as an Evidence Generation Tool and FDA’s Perspective
10am EST / 3pm GMT / 4pm CET
- The shift in regulatory outlook on RWE
- FDA’s approach to utilizing RWE for evidence generation
- FDA’s framework for RWE
- Industries view on RWE
- Adjustments needed within organizations
- Natural history of disease – FDAs definition
- The application of RWE in natural history studies
- Why bet on Natural History of Disease
- What makes a successful use of Natural History of disease submission (examples)
- Challenges
- Causal inference from observational data
- Target trials
Speaker:
Dr Shoshana Reshef
Director, Global Epidemiology & RWE
Teva
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DAY 2 – MARCH 1, 2022
Combining Patient-Centric Technologies and RWD for More Comprehensive Evidence
9am EST / 2pm GMT / 3pm CET
As research sponsors look for increasingly efficient models for procuring clinical data, significant focus has been placed on highly curated RWD to answer increasingly complex research questions as well as on adoption of digital technologies to conduct decentralized research. While the primary emphasis of the former has historically been on commercial applications and the latter on clinical trials, bringing the two together can be a powerful combination for the generation of RWE when secondary data alone are not sufficient to answer the research question. The objective of this session is to explore opportunities for pairing digital technologies and rich EMR to help researchers gather more data to support their RWE programs.
Speaker:
Joss Warren
Executive Director and Head of Strategy & Partnerships
THREAD Research
Brigham Hyde
President
Eversana
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The Importance of RWE Generation in Rare Diseases: Challenges and Future Trends
10am EST / 3pm GMT / 4pm CET
- RWD collection as an extension of rare disease clinical development
- Overcoming key challenges with RWE generation in rare diseases
- Current trends in RWE generation in rare diseases
- The future of rare disease RWE generation
- A case study in using ML to understand diagnostic challenges in a rare disease
Speaker:
Joseph D. Giuliano
Vice President, US & Global Medical Affairs
Amicus Therapeutics, Inc.
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