With the shift towards a patient-centric approach, we must measure the impact of biopharma products and devices in a real world setting
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Date Time 11:00 - 12:00
Location Webinar Timezone America/New York This webinar will discuss how real world evidence is playing a larger role across the entire product life cycle, with a focus on late phase regulatory discussions and payer decision-making.
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Overview
Payment models and federal reforms are increasingly focused on the real world impact of treatments and devices. Regulatory bodies are looking to real world evidence to close the gap between how a product performed in clinical trials and how a product performs in the clinical setting on a broader patient population.
As the capture and connectivity of health records and data continue to move towards digitization, the ability to assess and analyse these data increases in ease and efficiency.
Innovative late phase research approaches are benefitting from this move towards digitization, at the same time as more regulatory guidance is released in both the US and EU around the use of RWE to support and enhance submissions and product uptake. Combined, these two activities are making a high impact on the importance of assessing and realizing a real world evidence product strategy.
The increased interest in RWE not only lies with regulatory bodies, however, it also stands to make a large impact on how payers may cover a product based on the real world value it brings to the patient and the market. Understanding what evidence will best support a product’s value story is paramount for sponsors to ensure payers can make an informed decision about the product’s impact in a real world setting.
Key insights include:
- The broader role RWE is playing in decision making across the product life cycle due to technology advancements and RWD availability
- The current EU and US regulatory landscape and guidance around use of RWE for enhanced regulatory submissions
- How RWE can be used to support a product’s value story and uptake of RWE as a payer decision making tool
Key speakers
Alexander Gee
Alex has nearly 20 years of experience in pharmaceutical industry roles, with a focus on the commercialisation component of the drug life cycle. He has held positions at NHS, Novartis, Apreva, and GSK, and in CRO and consultancy organisations. His experience includes work involving respiratory, dermatology, and rare disease products, over a wide array of market access projects and disease areas, from early input into trial design to generic defense strategies.
Target audience
This webinar is intended for pharmaceutical professionals working in:
- Epidemiology
- Health Outcomes and Observational Research
- Market Access
- Pricing and Contracting
Real World Data insights
ICON's real world data (RWD) continues to drive healthcare and research discussions and decisions. Stay up to date with the latest information that regulators, payers and providers demand.