SAN FRANCISCO Feb. 18, 2010 TGen Drug Development (TD2) and Rondaxe Enterprises today announced a strategic alliance that will help emerging companies speed new high-quality treatments to cancer patients.
Rondaxe, a drug development consulting company in Syracuse, N.Y., helps emerging pharmaceutical and biotechnology companies navigate through all phases of the drug development and commercialization process. The company specializes in drug chemistry, manufacturing and controls (CMC), quality assurance and control, regulatory affairs and virtual business development.
TD2, a non-profit Scottsdale subsidiary of the Phoenix-based Translational Genomic Research Institute (TGen), specializes in guiding drug companies through the complexities of setting up and conducting clinical trials, and moving promising drug candidates through the federal review process of the U.S. Food and Drug Administration.
"We are excited to work with Rondaxe, since effective CMC management is key to the successful application and approval processes of the FDA, and moving new anti-cancer treatments to market where they can provide patient benefit," said Dr. Stephen Gately, President and Chief Science Officer at TD2.
Jeffrey M. Evans, Ph.D., co-founder and managing partner of Rondaxe, said, "Our clients will benefit measurably from the 'TD2 Solution' by receiving clear clinical and regulatory development path guidance and service support."
Today's announcement was made during InformexUSA, the world's leading fine and custom chemical industry trade show, which runs through Friday, Feb. 19, at the Moscone Convention Center in downtown San Francisco.
The TD2-Rondaxe alliance is designed to bridge a critical gap between chemistry and translational medicine. This blend of expertise will speed research discoveries through the regulatory process to bring new compounds to patients in a risk-reduced and cost-effective manner. TD2 and Rondaxe teams will focus on maximizing their clients' value proposition throughout the early stages of drug-development.
Rondaxe will provide drug development and manufacturing strategies with expertise in chemical, fermentation, drug product and analytical development, supply chain strategy, manufacturing operations, quality control, and quality assurance.
TD2 offers an integrated suite of tools that includes preclinical support, clinical trials and regulatory affairs, "The TD2 Solution."
|Contact: Steve Yozwiak|
The Translational Genomics Research Institute