Scaling Platform Delivery of Gene Therapies: An Interview with NewBiologix's
CEO Igor Fisch
NewBiologix’s CEO Igor Fisch was featured in a recent episode of Supplier Horizons, hosted by Tom von Gunden, Chief Editor & Community Director at Drug Delivery Leader. The episode discussed the current landscape of cell and gene therapies, the advancements in manufacturing platforms (particularly, for production of AAV particles for gene delivery), current and future therapeutic areas, and what it would take to bringdown the cost of gene therapies to make personalized medicines more widely available.
“Today, cell and gene therapies have made huge progress,” says Igor. He sees cell and gene therapies as a revolutionary approach to medicine that will be able to cure the root of the disease and not only the symptoms. However, the cost of these treatments, which target rare genetic diseases, remains prohibitive for many patients, and the industry still has work to do on the technology development front. “NewBiologix is focusing on gene therapy and more specifically, on the production of AAV particles as a gene delivery tool to cure diseases.”
The main focus area for achieving that vision is reducing the cost of therapies by building more scalable AAV production platforms. Currently, the production of cell and gene therapies involves heterogeneous methods, including bacterial and mammalian cell biology components, which creates a suite of regulatory issues: “What we are on a mission to do at NewBiologix is improve these platforms that ultimately will have a positive impact on the cost of goods for those life-saving therapies,” explains Igor.
Building on his experience as a co-founder of Selexis, a leading platform for stable cell line development, Igor intends to apply a similar model for NewBiologix: developing a comprehensive platform for production of highest-quality AAV particles in a stable and scalable way. This platform will enable biopharma companies and contract manufacturers to advance more gene therapies into clinical trials by removing the limitations associated with AAV manufacturing.
Igor also addressed expanding the disease areas where gene therapies can have an impact in the future. Today, most of the indications for gene therapies using AAV particles are around ocular, brain (such as Parkinson’s and Alzheimer’s diseases), and muscle diseases such as dystrophy.
“If we want gene therapies to one day be important, not only in those indications, but also in oncology, then we need to put in place a process by which you can produce them in a homogeneous way in very large volumes,” says Igor.
With all the research and innovation happening in the cell and gene therapies space, Igor is optimistic that cures for genetic diseases, and more, are on the horizon.
“In the future, with all these innovations, medicines will become personalized. My hope, and a reason I set up NewBiologix, is that gene therapies can help us cure patients at the root cause of their disease,” he said.
You can watch the full episode here
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