By Stefanie Johns, PhD, Director of Regulatory Affairs, Kymanox Corporation

Drug delivery methods present considerable challenges to the development of gene therapies, including difficulties in accessing the therapeutic target, prevention of degradation, and facilitation of drug activity to achieve its intended purpose. Even one of the most popular delivery methods, adeno-associated virus (AAV)-based technology, poses serious risk to patient safety through severe adverse side effects.

Read More

Read Our Recent Blogs

The Factor Podcast: Navigating the Real-World Environment of Medical Products

The Factor is a global medical device podcast series sponsored by Agilis by Kymanox. In this episode, Rita Lin and Shannon Hoste share their experiences and journeys in the field of human factors engineering. Rita begins by recounting her path into hea...

The Factor Podcast: Factors to Consider in Support of Clinical Readiness

The Factor is a global medical device podcast series sponsored by Agilis by Kymanox. How do you know your combination product is ready for clinical trials? Will it pass the regulatory review for clinical approval to proceed? The complexities of har...

The Factor Podcast: The Role of Human Factors in Medical Product Development

The Factor is a global medical device podcast series sponsored by Agilis by Kymanox. In this episode, Shannon Hoste and Rita Lin delve into the importance of real-world evidence, collaboration, and education within the medical device and combinatio...
See More Blogs