Kinexum and Pennington Biomedical Plan to Integrate Regulatory and Development Strategy and Clinical Trials to Accelerate Translational Research for Therapies in Diabetes, Obesity, and Chronic Metabolic Diseases
Baton Rouge, LA /PRNewswire/ -- Kinexum and Pennington Biomedical Research Center announced plans to establish an integrated approach for emerging companies and early stage therapies to achieve high value regulatory and early phase human clinical trials. The approach will focus on acceleration and efficiency for translational research of scientific discoveries and therapeutic development to achieve important regulatory requirements, proof-of-concept, and first-in-human studies. The collaboration will bring together unparalleled experience and capabilities in diabetes, obesity, and chronic metabolic diseases to address critical milestones essential to bringing innovative products to market faster and more cost effectively.
Kinexum has been advising global regulatory and development strategy and providing management support for emerging companies in diabetes, obesity, and metabolic syndrome for over a decade. "We have seen increasing challenges for innovative products and early stage companies to cost effectively meet the complex requirements that are critical to success in meeting regulatory, preclinical, clinical, and manufacturing milestones," stated Dr. Alexander Fleming, Founder and CEO of Kinexum. "The integrated approach with Pennington Biomedical's Phase 1 Research Unit fits our mission to advance innovative therapies quickly and cost effectively, mitigate risk, and accelerate commercialization of new healthcare products."
The Pennington Biomedical Research Center has a 25 year history of leading clinical research in nutrition, obesity and metabolism. Pennington Biomedical's fully integrated Phase 1 Research Unit, as part of its comprehensive Clinical Research program, involving both outpatient and inpatient services, has recently expanded capacity and includes state-of-the-art technology, proven expertise, and specialized metabolic assessment capabilities. Pennington Biomedical is located in Baton Rouge, Louisiana in the heart of one of the nation's highest prevalence regions for diabetes, obesity, and chronic metabolic disease. "This collaboration between Kinexum and Pennington Biomedical leverages the unique strengths and capabilities of both partners, and combines the expertise in regulatory and development strategies with a sophisticated and comprehensive research infrastructure. Collectively, this partnership will result in research efficiencies, enhanced translational research, and more rapid development of products that may prove beneficial for improving human health," says Dr. Cefalu, Associate Executive Director of Clinical Research.
With a global diabetes epidemic, huge healthcare costs, and very lean industry product pipelines, the importance of innovation has never been greater. Kinexum and Pennington Biomedical offer joint expertise to advance innovative products to first-in-human, proof-of-concept as well as Phase 2 clinical trials. A full range of strategy, management, and trial execution capabilities are available to meet the regulatory and technical challenges necessary for advancing therapeutic development through important milestones that mitigate risk and attract interest and value recognition from industry partners and investors.
Kinexum specializes in translational regulatory and development strategy for the global healthcare industry. Kinexum professionals bring decades of experience from the FDA and industry spanning regulatory, preclinical, clinical, and manufacturing solutions. Kinexum has helped more than 200 companies based in Europe, Asia, and North and South America over the past decade to achieve successful commercial-value milestones. www.kinexum.com
About the Pennington Biomedical Research Center
The Pennington Biomedical Research Center is at the forefront of medical discovery as it relates to understanding the causes of obesity, diabetes, cardiovascular disease, cancer and dementia. It is a campus of the Louisiana State University System and conducts basic, clinical and population research. The research enterprise at Pennington Biomedical includes approximately 80 faculty and more than 25 post-doctoral fellows who comprise a network of 50 laboratories supported by lab technicians, nurses, dieticians, and support personnel, and 17 highly specialized core service facilities. Pennington Biomedical's more than 500 employees perform research activities in state-of-the-art facilities on the 234-acre campus located in Baton Rouge, Louisiana. For more information, see www.pbrc.edu.
SOURCE: Kinexum and Pennington Biomedical Research CenterCopyright 2012 PR Newswire. All Rights Reserved