DECEMBER 20239autologous immunotherapies take off when scientists armed patient white blood cells with Chimeric Antigen Receptors (CAR) ex-vivo to allow these gene-modified T cells to recognize their tumor antigens, a therapy widely known as CAR-T cell therapy. The high manufacturing complexity drives the exploration in the development of allogenic cell therapy and in vivo genomic modification. The risks of bringing the new immunotherapy to market are high but can be mitigated by working with industry advocate groups who are defining the regulatory paths necessary for such a task.3. Which are a few technological trends influencing Immunotherapy today? What are some of the best practices businesses should adopt today to steer ahead of competitors? For small molecule and biologics developers, the availability of on-body injections opens up a new route of administration and may be desirable to maturing checkpoint inhibitors that can benefit from slowing down its pharmacokinetics. For the advanced therapy developers, many will seek to manipulate the expression of genes or alter the biological properties of living cells. FDA guidance for industry document on Chemistry, Manufacturing, and Controls (CMC) for Human Gene Therapy investigational new drugs (INDs) should be taken into considerations as soon as IND filing is in sight.For cell therapies, the technological trends are still developing but remain adhered to improvements in unit processes that can be modified without changing the entire manufacturing setup. Process intensification is another hot topic within advanced therapies as time in production ultimately influences cell therapy efficacy. Again, I stress the interaction between therapy developers and technology developers to ideate industry-wide solutions and to mitigate potential risks as they occur. Everyone in the industry has a high demand for current knowledge, so staying current is the best way to stay ahead of competitors. 4. Do you have any advice for industry veterans or budding entrepreneurs from the Immunotherapy space?Immunotherapy, whether it's in the form of checkpoint inhibitor or advanced therapy, is evolving to the point where combination of multiple technical competencies becomes necessary. While the drug developer needs to focus on showing efficacy and safety in the clinical trial, it may be much easier operationally to achieve the goal by business alliance. Especially because the immunotherapy clinical endpoints may have a shorter timeline, it does not hurt to consider late-stage development and scale up sooner. The best, and hardest, path to success is hiring the right leadership and attaining the right knowledge. Advanced therapies, such as immunotherapies, require knowledge to be translated to products quickly and effectively while supporting the very needs of the industry. To do so requires deep industry knowledge, expertise, and vision to help all patients ultimately win their battle with cancer. Li ChenFor cell therapies, the technological trends are still developing but remain adhered to improvements in unit processes that can be modified without changing the entire manufacturing setup
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