Histogen CEO Speaks on Bringing Tissue Engineered Products from Lab to Market at MD&M Conference
November 15, 2007 - Gail Naughton, CEO of Histogen, Inc., a regenerative medicine company developing solutions based on the products of newborn fibroblasts, addressed attendees at the annual Medical Design & Manufacturing (MD&M) Conference, Minneapolis this October. Naughton utilized past experiences in bringing four cell-based products from concept to market, while at Advanced Tissue Sciences, to present the challenges and best practices for the development and approval of human cell-based regenerative medicine products. "Cell based regenerative medicine products offer great potential to address countless of patient unmet needs. The high cost of manufacturing these products, long clinical timelines, and challenges with reimbursement have tremendously hurt product development and investment in this important field," said Naughton. "Developing a robust product pipeline based on one cell type and one manufacturing system is key, and can reduce the cost of developing a new product indication by 75%. It is also critical to have products with short and midterm markets and those where reimbursement challenges do not exist. Histogen's business plan and products directly address each of these key issues."
In addition to presenting at MD&M Minneapolis, which took place on October 16-17, 2007, Naughton will revisit the topic at MD&M West in January 2008.
Gail Naughton has spent more than 15 years extensively researching the tissue engineering process, and holds more than 90 patents in the field. During her time with Advanced Tissue Sciences, Naughton raised $350 million from the public market and corporate partnerships, and oversaw the design and development of the world's first upscale manufacturing facility for tissue engineered products.
Histogen, launched in 2007, seeks to redefine regenerative medicine by developing a series of high value products without the use of embryonic stem cells or animal products. Through Histogen's proprietary bioreactors that mimic the embryonic environment, newborn fibroblasts are encouraged to naturally produce the vital proteins and growth factors from which the company has developed its rich product portfolio.
For more information about the upcoming MD&M West Conference, taking place between January 28-31, 2008 in Anaheim, visit www.devicelink.com/expo/west08
0 comment :
Thanks for your comments.