Getting Trial Ready: Foundations for a Biotech’s Clinical Trial Journey

A Lunch & Learn for early-stage biotechs on the key processes, tools and regulatory responsibilities needed to start clinical trials.

About This Event

Getting Trial Ready is a clinical trials mini series providing practical guidance for early-stage biotech companies preparing to enter clinical trials.

This second Lunch & Learn, Foundational Processes and Tools for a Biotech’s Clinical Trial Journey, will help key staff at early-stage biotechs understand their legal and regulatory responsibilities when conducting clinical trials, and what must be in place to begin clinical activities as a compliant Sponsor.

The session will introduce and contextualise key clinical trial terminology — including GCP, SOPs, QMS and eQMS — and provide a high-level overview of the scope of activities required to establish robust clinical foundations. The speakers will also highlight the importance of getting this right early, helping attendees understand how to avoid critical inspection findings from regulators such as the MHRA, EMA, and FDA, which can lead to trial delays and marketing application rejections.

Who Should Attend

• Early-stage biotech and life science start-ups
• Academic founders and spinouts
• Senior and operational staff preparing for clinical trials
• Teams planning to act as a clinical trial Sponsor
• Anyone involved in building clinical operations infrastructure

What You’ll Learn / Key Takeaways

• Why early-stage biotechs have legal and regulatory responsibilities as Sponsors
• The foundational processes required to begin clinical trials compliantly
• Key clinical trial terminology and what it means in practice
• The scope of activities needed to establish robust clinical operations
• How early preparation can help avoid critical inspection findings

Speakers

Matt Hersch & Steve Crow
Co-Founders, BlueGreen Clinical

Matt and Steve are dedicated Clinical Operations professionals with extensive experience across all aspects of conducting clinical trials. They share over 18 years’ experience leading and developing a Clinical Operations department at a start-up biotech that grew from 40 people into a successful mid-sized pharma company of 4,000 employees.

During this time, they were instrumental in the development of two regulatory-approved medicines — Sativex and Epidiolex, one of which became a blockbuster with over $1B in annual sales — and are veterans of four MHRA and one FDA GCP inspections.

They now apply these experiences as co-founders of BlueGreen Clinical, a specialist Clinical Operations consultancy supporting biotech companies to start their clinical trial journey as compliant Sponsors.

About the BioEscalator

The BioEscalator is the University of Oxford’s biomedical innovation hub, supporting some of the UK’s highest-potential bioscience start-ups to translate world-leading science into real-world impact. Located on the University’s Old Road clinical campus in Headington, it provides an inspirational and supportive environment where fast-growing companies can thrive, supported by high-quality laboratory infrastructure, entrepreneurial training, and strong industry and investor networks.

Embedded within Oxford’s exceptional innovation ecosystem and working closely with the University, the NHS, and academic researchers, the BioEscalator accelerates the development of pioneering companies that enhance cutting-edge research and deliver meaningful advances in human health.

Find out more by visiting the BioEscalator website

Contact & Further Information

📧 bioescalator@medsci.ox.ac.uk

🌐 www.bioescalator.ox.ac.uk
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BioEscalator, Innovation Building, University of Oxford, Old Road Campus, Roosevelt Drive, Oxford, OX3 7FZ