Development of regulated products, drugs and medical devices, for the clinical treatment of diabetes and obesity has been increasingly complex, costly, and risky. Dietary supplements do not require FDA review prior to marketing and almost never have long term evidence of safety and efficacy. But, the world needs effective solutions from all these product approaches to meet the metabesity crisis. Our challenge is to build the evidence that a given product is safe and effective.
“One important step in this holistic approach that we at Kinexum have taken,” stated Dr. Fleming, “is to establish a strategic relationship with Pennington Biomedical Research Center in Baton Rouge. PBRC is one of the premier metabolic research organizations in the world. Pennington’s early leadership in obesity research has extended into every area of and approach to metabesity. Working together, we are committed to catalyzing commercial, government, and academic efforts to bring forward much needed preventions and treatments.”
Dr. Fleming, as CEO of Kinexum and during his career at FDA responsible for landmark approvals of metabolic drugs like metformin and the first statin, has experienced firsthand the trials and tribulations of metabolic product development. “Kinexum was founded not to develop health products, but to make these products better and move forward faster to reach the market. We feel privileged to be joining with Pennington and other organizations to accelerate progress against metabesity.”
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 helpe
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