9th DIA Cell and Gene Therapy Products Symposium in Japan

Development of Next-Generation Cell and Gene Products
- Issues in Development of Existing Products and Prospects for Practical Application of Next Generation Products -

Previous symposiums have discussed issues in research and development of cell and gene therapy products at various stages toward industrialization and implementation, sometimes anticipating and sometimes reflecting on the progress of regenerative medicine. Cell and gene therapy products have been increasingly recognized among treatment options with a steady increase in the number of marketing approved products in Japan. In addition, improvements in manufacturing technologies and efficiency in the product supply chain are being considered, and this aspect of industry is also expected to grow. Furthermore, research and development of products with new mechanisms of action and therapeutic concepts that are beyond the framework of existing product modalities are progressing, and there are high expectations for the practical application of new products that can be called as “next generation” products.

On the other hand, the spread of new therapies and products always comes with new challenges and issues: healthcare professionals are facing issues from their respective positions on how to use and handle them, companies are tackling issues in product development and manufacturing, and regulatory authorities are managing evaluation methods, regulatory science, and other matters.

This symposium will continue to provide a forum for sharing issues among industry, government, and academia, and for constructive discussions on solutions.

This year, we would like to deepen our discussions about the issues necessary to achieve further development of cell/gene therapy products as an industry, as well as initiatives to efficiently develop next-generation products. The following five sessions are planned.

• Consider the Price and Economics of Regenerative Medicinal Products
• Role of CMC Regulatory Affairs and Importance of CMC Regulatory Strategy
• Expectations and Challenges for Extracellular Vesicle
• Issues in Clinical Use of Out-of-Specification Autologous Cell Products
• New Technologies and Challenges of Adeno-Associated Viral Vector Products

Keynote lectures and other presentations will deliver the latest topics from academic researchers who are pursuing the practical application of next-generation products, and from government and regulatory authorities who support development of cell and gene therapy products.

To make this symposium useful according to the needs and convenience of everyone, this symposium will be held in a hybrid format. Presentation materials and lecture videos will be distributed after the symposium*. Our annual networking event will be held on the evening of Day 1 for participants to freely exchange opinions.

We look forward to seeing many participants this year.

* Please note that there may be restrictions on recording and sharing materials based on the content and nature of each session or lecture.

View Program