CGT Oncology Trials: IRB/IBC Strategies, Trends and Operational Insights

Oncology cell and gene therapy (CGT) trials face persistent regulatory and operational challenges that can delay progress and impact outcomes. This session will move beyond high-level overviews to focus on common pain points, delivering actionable suggestions and information on successful tactics to best position trials from the regulatory, strategic and operational perspectives. Recognizing that most trials often get bogged down by red tape, regulatory confusion and operational bottlenecks, this webinar will focus on strategies to sidestep these challenges through IRB, IBC and operational approaches that not only meet regulatory requirements but also accelerate trials forward more efficiently and effectively.

The featured speakers will explore emerging trends disrupting the CGT oncology landscape — from adaptive trial designs and patient-centric approaches to next-level site readiness and capacity building. Attendees will understand how these trends translate into real operational wins that reduce startup delays, improve compliance and safeguard patient outcomes.

This session will also highlight how to coordinate IRB and IBC regulatory submissions into strategic advantages. Regulatory bodies and oversight committees aren’t obstacles — they’re partners, once their mechanics and processes are understood. This webinar will feature practical examples illustrating how top-performing teams leverage IRB/IBC relationships to expedite approvals without sacrificing integrity or safety.

By the end, attendees will hold a tactical playbook for elevating CGT oncology trials, one that goes beyond theory and delivers actionable strategies that could be the difference between a stalled trial and a success story. For professionals aiming to lead, innovate and advance CGT oncology, this webinar is essential.

Register for this webinar to learn how to drive efficiency and compliance in CGT oncology trials through integrated regulatory and operational strategies.

Speakers

Patrick Melvin, Vice President, Therapeutic Strategy & Innovation, Syneos Health

Patrick Melvin is a highly experienced Clinical Research Executive who has dedicated the last 20 years to leadership in hematology and oncology clinical drug development. This hematology and oncology experience includes oversight of programs ranging from first-in-human (FIH) studies through hybrid Phase I/II registration programs and significant Phase III registration programs, including extensive experience in the immuno-oncology and in advanced therapy medicinal products (ATMP) space. He has overseen more than 25 pivotal/registration programs, over a dozen of which have now resulted in US and global marketing authorizations, including marketing authorization for a “first-in-class” adoptive cell therapy. Patrick is a member of the American Society of Clinical Oncology (ASCO) and the European Hematology Association.

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Garry Coulson, Sr. Director, Regulatory & Quality, Sabai Global

Garry Coulson, PhD, RBP (ABSA) is a Registered Biosafety Professional with two decades of experience in research and regulatory compliance in academic, government and industry sectors. He holds a Master’s degree in Clinical Microbiology and a PhD degree in Infectious Diseases. Garry has reviewed hundreds of protocols throughout his career, many of which are specific to cell and gene therapy-based treatments. Prior to joining Sabai Global, he served as the Biosafety Officer at the University of North Carolina at Chapel Hill, where he managed biosafety and Institutional Biosafety Committee (IBC) operations. He is deeply passionate about public health and translational research that advances knowledge from the bench to the bedside.

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Michael Keens, CEO, Sabai Global

Mike is a seasoned leader with deep expertise in clinical trial operations and commercial strategy within the pharmaceutical development and services sector, with a strong focus on oncology. Mike serves as the CEO of Sabai IRB, a leading provider of Central Institutional Review Boards and Institutional Biosafety Committee services. Throughout his career, Mike has navigated both large CROs and niche service providers, balancing clinical trial operations with a strong focus on commercial strategy. His leadership has earned industry-wide recognition, including being named a PharmaVoice Top 100 Most Influential Person in Pharma (Patient Advocacy) and recognized as a Top 20 Innovator in Pharma Development by CenterWatch. Mike’s academic background includes a Bachelor of Science in Biology and Psychology from James Madison University and a Master’s in Public Health from the University of Virginia. Mike is a member of the American Society of Clinical Oncology (ASCO).

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