In this episode of The Factor, Shannon continues her conversation with Stefanie Johns, PhD, Director of Regulatory Affairs at Kymanox (
part 1). They review how companies can a create a successful roadmap to bring their product from lab to clinic and commercialization. Reviewing the importance in understanding the therapeutic index, understanding users, how best to manage risk, and incorporating the right data safety monitoring.
Additionally, Stefanie and Shannon emphasize the importance of collaboration with regulatory authorities and leveraging risk management plans throughout the product development process. They stress that there is no one-size-fits-all approach to being clinically ready, and it depends on the specific stage of the clinical trial and the product's characteristics.
Dr. Stefanie Johns is the Director of Regulatory Affairs at
Kymanox.
About the Factor:
The Factor, your trusted podcast for the life sciences industry. Join us as we tackle the essential factors that drive successful commercial products. Our team interviews industry thought leaders to explore regulatory compliance, market trends, and innovation. Stay ahead in this dynamic industry.
About Kymanox:
Kymanox has proven, collaborative, end-to-end solutions that help bring life science products to the market – and keep them there. We are a global professional services organization that supports comprehensive drug development with integrated science, engineering, compliance (e.g., QA/RA), and technical project management. Our work across small and large molecules, medical devices, and combination products affords us a wholly unique advantage. With our diverse team of experts, Kymanox helps clients navigate commercialization challenges that arise throughout a product’s life cycle – from early development to post-market – with optimized safety, quality, efficacy, and accessibility. We strive to advance life science innovation through insightful solutions and collaboration…because patients deserve better. Kymanox was founded in 2004 and is headquartered in Morrisville, North Carolina USA. Kymanox is backed by WestView Capital Partners, a Boston-based growth equity firm. For more information, visit
https://www.kymanox.com/.
The Factor is edited and produced by
Earfluence.