Morrisville, North Carolina USA, and King of Prussia, Pennsylvania USA, Jan. 04, 2024 (GLOBE NEWSWIRE) -- Kymanox Corporation (“Kymanox”), a professional services company exclusively serving Life Sciences, announced today the rollout of its Product Design, Development, and Commercialization group. This strategic initiative reflects Kymanox's commitment to fostering seamless collaboration among specialized teams, with the primary goal of supporting the swift and successful commercialization of high-impact combination products (e.g., biologic in a drug delivery device) for clients.
Newly appointed Chief Technology Officer, Nicholas (Nick) Ciccarelli, PE, who will lead the new group, emphasized the importance of optimal transitions between groups for faster speed to market. Ciccarelli stated, "Our approach prioritizes the flow of information and ideas between teams, promoting efficiency at every stage. By doing so, we're confident in our ability to accelerate product development timelines and get innovative solutions to market faster." Ciccarelli joined Kymanox as part of the NEUMA acquisition in 2021 and spearheaded a successful, fast-paced integration. Leveraging his entrepreneurial experience as NEUMA’s President and Co-Founder, he was instrumental in combining the powers of both organizations into a unified offering.
The newly formed Product Design, Development, and Commercialization group is structured to enhance collaboration and to leverage expertise and knowledge across the entirety of Kymanox’s 300 global employees. Within this group, there are four distinct teams with engineered overlap:
- Design and Innovation led by Alexis Dechelette, PhD,
- Product Development led by Nicholas Schill, PhD,
- Device Development and Commercialization led by Jason Miller, and
- Kymanox EU led by Michael Gschwandtner, PhD, RAC (i.e., anteris by Kymanox).
These four teams are able to work across the product development lifecycle from early-stage conceptualization through regulatory submission and tech transfer – and also support post-market activities. Specifically, the group works together to provide integrated program leadership and development road mapping, technology landscape assessments, product and process requirements definition, product design and development, all flavors of engineering and technical documentation, turnkey Verification and Validation (V&V), and specialty thirty-party supplier management. A world-class CGxP laboratory in King of Prussia, Pennsylvania USA extends these capabilities, further enhances speed-to-market, and supports a variety of client needs across the development and commercialization continuum. Kymanox’s presence in Germany and Switzerland allows for tailored solutions in the European market and with the governing regulatory authority EMA, while closely tying it to Kymanox’s extensive expertise and experience with the US FDA.
Seamless collaboration with other integral areas inside of Kymanox further bolsters the capabilities of the group. These areas include Chemistry, Manufacturing, and Controls (CMC), Process Engineering, Technical Services, Regulatory and Clinical Affairs, Quality Control, Quality Assurance, Human Factors, and other technical functions that one would normally find at a mid-cap biopharma company, thus ensuring a comprehensive and holistic approach to product realization. Stephen M. Perry, CEO and Founder of Kymanox, adds, “the further alignment and integration of these teams underscores Kymanox’s ability to now support the rise of hyper-virtual companies, or sponsors with approximately 10 or fewer employees. Clients can now leverage our expansive menu of support services to save their precious time and focus, and ensure clear responsibility and accountability for outsourced activities.”
With the newly formed Product Design, Development, and Commercialization group, Kymanox aims to play a pivotal role in the accelerated deployment of products, because patients deserve better.
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/.
