FLAGSTAFF, Ariz. -- Jan. 26, 2011 -- TGen Drug Development (TD2) and Flagship Biosciences today announced a strategic alliance that should help speed new drugs safely into human testing and quickly benefit cancer patients.
TD2, based in Scottsdale, Ariz., provides drug development firms with expertise in moving promising laboratory discoveries through the pre-clinical, clinical and regulatory approval steps of getting new drugs to patients as quickly and safely as possible.
Flagship Biosciences, based in Flagstaff, Ariz., will greatly assist in this process by providing high-throughput, multiplexed immunohistochemistry expertise to support preclinical drug development and human clinical trials.
"Flagship's technology will significantly accelerate our ability to identify biomarkers that could help researchers predict which drug compounds will work best on specific patient cancers," said TD2 President Dr. Stephen Gately.
And because Flagship's affiliated laboratories are certified by the U.S. Food and Drug Administration, under the 1988 federal Clinical Laboratory Improvement Amendments (CLIA) law, these findings can be translated directly into clinical trials, where they can benefit patients as quickly as possible.
Specifically, Flagship provides computerized histopathology, the microscopic study of diseased tissue, which is a critical part of anatomical pathology and key to the accurate diagnosis of cancer and other diseases from sample tissues. Flagship also provides deep expertise in measuring epithelial-mesenchymal transition (EMT), the process in which tumor cells become highly invasive, migratory and resistance to therapy.
"The local tumor environment is key to understanding efficacy and toxicity of oncology compounds in both preclinical and clinical trials, and EMT is central to understanding stromal involvement and fibrosis in cancer patients," said Dr. Gately. "Working with Flagship Biosciences brings a wealth of pathology knowledge in pharmaceutical product development, experience in difficult histology analysis."
When combined with TD2's integrated suite of molecular analysis tools designed to reduce the uncertainty in the drug development process, the partnership with Flagship will provide emerging drug companies with the promise of quickly and safely getting their discoveries to market.
"TD2 is the world-leader in novel approaches to oncology and oncology clinical trials," said Dr. David Young, President of Flagship Biosciences. "It is exciting to be partnering with TD2, and combining our quantitative pathology with TD2's oncology and molecular tumor profiling expertise. TD2's leadership in novel approaches to oncology clinical trials is an exciting match for digital pathology techniques and the promise of quantitative and virtual pathology analysis of patients and tumor response."
"This partnership is a further demonstration of the emerging regional strength of Arizona for biotech product development," said Dr. Robert Kellar, a board member of Flagship Biosciences. "Arizona is a unique resource for pharma, biotech, and device clients looking for the rapid application of new technology in development and clinical trials."
About Flagship Biosciences
Flagship Biosciences is a pathologist-owned pharmaceutical services organization that uses digital pathology to deliver quantitative tissue assessment in pharma and device development. Backed by a combined 60 years of pharmaceutical pathology experience, Flagship has a world-class team of pathology, image analysis and companion diagnostics regulatory experts.
TGen Drug Development (TD2) provides innovative services for oncology-focused biopharmaceutical companies using a dedicated team of professionals with broad experience and understanding in drug development. TD2, based in Scottsdale, Arizona, is uniquely positioned to support the need for improved and accelerated development of new chemical entities (NCE's) for life-threatening diseases. TD2 uses a unique combination of experience gained through its contract research organization business, and an integrated suite of proprietary and non-proprietary tools, preclinical study execution, regulatory affairs assistance, clinical trial design and management, and drug development experts to successfully move therapeutics towards regulatory approval. TD2 is dedicated to reducing the risks and uncertainty inherent in the drug development process. TD2 integrates world-class clinical and regulatory expertise with "-omic" science and provides unique drug development services aimed at minimizing the risk for clients in the Oncology drug development industry. TD2 is a non-profit subsidiary of the Phoenix-based Translational Genomics Research Institute (TGen). For more information, visit: www.td2.org.