Guidelines for driving the pharmaceutical and vaccine industry - Advanced therapy

       Advanced therapy refers to medical therapy for human beings in which genes, cells, or living tissues are used as part of the therapy for diagnosing, treating, mitigating, or preventing a human disease.

       Advanced therapy technology is a new technology that has just begun to be used and developed in Thailand and has been promoted by the government to drive development under the BCG model strategy. It was found to be challenging in many areas, such as the research and development process, which requires high levels of capital and expertise. The creation of standards that will instill confidence in patients is another difficulty. Such developments must also focus on promoting the use of technology. Initially, the goal is to start using corneal stem cells for patients with limbal stem cell deficiency as a standard treatment in hospitals, and to provide treatment for leukemia with CD19 CAR-T cells.

Guidelines for developing advanced therapy under the BCG economic model are as follows:

• To support the development and advocacy of advanced therapy by piloting it in medical schools;
• To prepare to arrange a care process and supervise treatment standards throughout the process, in collaboration with regulatory agencies;
• To promote the establishment of a central facility with international standard certification for both production development and facility development, in order to help Thailand become a regional service hub;
• To consider the “freedom to operate/ intellectual property” (FTO/ IP) issue as a key issue for the feasibility of applying technology in the service model.

Source: National Science and Technology Development Agency (NSTDA)

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