Biotherapies and regenerative medicine trials are being explored for diseases in which there are no, or limited alternative treatment options. The Asia Pacific, Gulf Cooperation Council (GCC), and Latin American Countries (LATAM) are hubs for new emerging technologies and are growing at a compound annual growth rate above 65 % despite the pandemic. The biotherapy sector consisting of cell and gene therapies, and regenerative medicine markets in these regions are now outpacing the rest of the world.

In 2020, the largest proportion of trials in the region (58.1%) took place in China. The Middle East saw a 94% increase in the number of oncology trials and Israel saw the largest overall number of trials, at 62.5%. South and Central America saw a 58% increase in the number of trials, followed by Brazil, Argentina and Chile, at 41.1%, 23.3% and 12.3%, respectively. Critical factors for the shift are the ease of subject enrollment, diversity of subjects, and lower cost of conducing clinical trials.

The biggest challenges for this process are; what are the applicable regulations , how should the regulatory framework be incorporated, and on how can they be applied for clinical trials? There is clearly a need for creating awareness of these challenges and for training the multilingual, multinational teams to manage the Quality Management Systems in real time to optimize clinical outcomes.
This session will provide updates to regulations and guidance for biotherapies such as HCT/P (Human Cell therapy/Products), cord blood, adipose cell therapies and other products in Asia Pacific, GCC and LATAM countries.

The session will provide examples and case studies in order to implement these new regulations and guidelines and will provide knowledge to understand the similarities and differences about the regulatory framework. Tools (e.g. websites) to manage and operate the on-site and off-site Quality Management systems for clinical trials will be presented.

All relevant financial relationships have been mitigated.

Thomas Spitzer MD

Harvard Medical School, Massachusetts General Hospital

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