Real World Evidence Across the Product Life Cycle: Regulatory and Payer Landscape

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 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 real world evidence 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 real world evidence 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:

 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. Attendees will gain valuable insights on:

• The broader role real world evidence is playing in decision making across the product life cycle due to technology advancements and real world data availability
• The current EU and US regulatory landscape and guidance around use of real world evidence for enhanced regulatory submissions
• How real world evidence can be used to support a product’s value story and uptake of real world evidence as a payer decision making tool

Speakers

Jane Turner, Senior Principal, Real World Evidence, ICON

Jane has over 12 years of clinical research, project management and operations experience focused on late phase, real world evidence (RWE) and observational research. At ICON, she heads RWE strategy consulting in the EU to develop and deliver clients RWE-centric value propositions, and holistic RWE strategies, that draw from ICON’s full Commercialisation and Outcomes services offering. In her previous role at a global CRO, she was responsible for management of the European Late Phase team and implementation of fit for purpose process and technology for the delivery of observational research and real world evidence.

 Jane is a member of The Royal Pharmaceutical Society of Great Britain. She holds a Diploma in Clinical Science from the University of Wales and a BPharm from the University of Nottingham.

 

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Alexander Gee Lead Consultant, Principal, Pricing & Market Access, Commercialisation and Outcomes, ICON

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 defence strategies.

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