From First in Human to Proof of Value: Rethinking Early Clinical Development

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Description of event:

There is growing pressure on early clinical studies to evaluate more than just safety, tolerability and pharmacokinetics. Sponsors, their investors and development teams increasingly expect early evidence that supports confident decision-making and accelerates progression through the clinic.

This webinar, delivered by Richard Burrell (Celerion), explores how shifting expectations in early clinical development are not only reshaping Phase I study design, but also operational models, site requirements and need for partnerships. With a growing focus on demonstrating “Proof of Value”, whether through Proof of Mechanism, other translational insights or early signals of clinical efficacy, traditional Phase I units and classical clinical sites often lack the combination of capabilities required to deliver compact, cost-effective and information-rich studies.

The session will examine why closer integration between commercial Phase I units, academic medicine and publicly funded translational and clinical research initiatives is becoming essential. It will discuss how such models can reduce development risk, manage complexity, improve patient access, and help accelerate the path from First in Human to Proof of Value – supporting confident investment decision making.

Learning objectives

By attending this webinar, participants will be able to:

• Understand how evolving expectations in early clinical development are driving the move toward efficient demonstration of Proof of Value
• Identify the operational, regulatory and site-level challenges associated with demonstrating value earlier in development
• Explore how better integration between Phase I units, academic medicine and translational and clinical research initiatives can help accelerate development timelines, support patient recruitment, reduce costs and ultimately support decision making

Who should attend

This webinar is particularly relevant for:

• Clinical Development Directors and Heads of Early Development
• Clinical Operations and Study Management Leads
• Translational Medicine and Clinical Pharmacology Professionals
• Outsourcing, Vendor Management and Alliance Managers
• Medical Affairs and Scientific Strategy Leaders
• CRO Project Leaders and Operational Directors
• Biotech and pharma professionals involved in Phase I–II decision-making

Meet the speaker

Richard Burrell
Senior Director Business Development, Celerion

Richard has supported Celerion with Business Development activities across Europe since 2021. He has 25 years of experience in clinical pharmacology and early clinical development. For more than 20 years, Richard has pursued the use of Phase I capabilities to deliver more than just safety, tolerability, and pharmacokinetic studies in healthy participants. He is a passionate believer that the current and future needs of early clinical development are better served by revisiting how the Phase I industry, academic medicine, and clinical resources can work together in harmony.