Real World Evidence Across the Product Lifecycle: Regulatory and Payer Landscape

Presented by

Jane Turner, Senior Principal, Real World Evidence, ICON

About this talk

The shift towards a value-based, patient-centric approach to health care continues to increase the need to measure the impact of biopharma products and devices in a real world setting. It’s now more important than ever for sponsors to understand how Real World Evidence (RWE) can play a role in developing a product’s value story across the development continuum. 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. Speakers: Jane Turner, Senior Principal, Real World Evidence, ICON & Alexander Gee, Lead Consultant, Principal, Pricing & Market Access, Commercialisation and Outcomes, ICON

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BioPharma companies and Medical Devices manufacturers face growing operational, regulatory and economic challenges when it comes to developing their drug or device. ICON provides analysis and key insights on these challenges, with practical advice and recommendations.