The more efficient, design-based development paradigm for cell and gene therapies, coupled with their therapeutic power, will dramatically reduce manufacturing and testing costs and timelines and significantly alter the regulatory dynamics, American Gene Technologies CEO Jeff Galvin maintained in his plenary presentation at the PDA annual meeting held virtually in late July.
Coming from the world of Silicon Valley and having participated in the microcomputer revolution, Galvin sees strong parallels in the development and manufacturing efficiencies that will flow from the ability to design CGTs versus the traditional trial-and-error pharmaceutical discovery model.
In his compelling analysis of the “revolutionary” development and approval paradigm for CGTs, Galvin addressed: ● their therapeutic power ● the economics of their development and value ● the implications of the design versus discovery paradigm on manufacturing, testing and the related regulatory interface, and ● the future potential of the field.
The AGT CEO explained how CGTs not only offer higher treatment value but are “cheaper to build.” The design learnings are cumulative and fungible, allowing for predictability and precision – increasing their therapeutic potential while decreasing the time and resources needed for extensive clinical and safety evaluations.
“It is not about discovery and tons and tons of testing to see whether you can get it to work and whether it is safe. No, it is about designing it. And the components mean that it is much more similar to the industry that I came from originally – software – where the capabilities of computers and software double every year, and the cost halves.”