Global cell and gene therapy developers are looking beyond traditional trial geographies, and Saudi Arabia and the GCC are drawing attention for rare-disease populations, specialist hospitals, national genomics initiatives and fast-maturing research infrastructure. 

The region is moving quickly from ambition to execution, but the real question is a practical one.

Can a company or investigator actually run a trial here, can the region come first, and will the resulting data support global development?

Hosted by Phacilitate, this webinar brings together leading voices to explore:

Whether investigator-initiated trials (IITs) are possible in Saudi Arabia, and who can sponsor or submit one

When SFDA approval is required, and how registered vs. unregistered products change the pathway

Whether Saudi can be a first-in-human geography, and when prior FDA/EMA approval accelerates the route

What cell and gene therapy developers must prepare, including GMP, biosamples, genetic data and chain of identity

How the GCC compares, with Saudi, UAE and Qatar as distinct national pathways rather than one harmonised market

Andrew Lee, MD, PhD
Deputy Director, Guangdong-Hong Kong-Macau International Clinical Trial Center (BAY TRIAL)
Andrew is also Co-Founder and CEO of Spot Biosystems, where he is working with a China-based IIT model and considering how that evidence can support wider global development.

Sam Ringle, PhD
Advisory Board Member, European Genomic Medicine Consortium (EGMEDC)
Sam is a regulatory affairs consultant specialising in biologics and cell and gene therapies. His experience spans clinical trial applications, regulatory strategy and engagement with the EMA and FDA. He will bring a European perspective on what is required for early clinical evidence to support wider global development.

Dr Syed Osman Ahmed
Director, Adult CAR-T Program & Cancer Centre of Excellence, King Faisal Specialist Hospital and Research Center (KFSHRC)
Dr Ahmed acquired his qualifications in Neuroscience and Medicine from Imperial College, London, and trained in Medicine and Haematology in the London area. Since 2012, he has been a consultant at King Faisal Specialist Hospital in Riyadh, with a focus on AML and transplantation, and directs the hospital's Adult CAR-T program.

Join us on 20 August, as we map the practical regulatory pathway for advanced therapy trials in Saudi Arabia and the wider Gulf, ahead of Advanced Therapies World in Riyadh this December.

From IIT to IND: Can Saudi Arabia Become an Early Clinical Development Hub for Advanced Therapies?