Kinexum guides, designs, and manages strategic and operational solutions to the regulatory, manufacturing, nonclinical, clinical development, and business challenges necessary to take scientific discoveries to proof of concept and through the product life cycle.
Kinexum teams supplement the strengths of large and small organizations to reach high-value milestones effectively and efficiently. Kinexum specializes in crafting creative but sound and integrated solutions across scientific disciplines, therapeutic areas, product modalities, and business stages. We respond to emergencies and as well as requests for problem prevention and complex long-range planning.
Introducing Healthy Skeptic – a website about the US healthcare system by Kevin Roche
Will 'metabesity' supercede 'diabesity' in metabolic syndrome marketing?
Spanning pharmaceuticals, biologics, and devices, we have supported over 250 clients during the past decade to achieve their goals. Kinexum uniquely brings together:
We specialize in chronic metabolic diseases including diabetes, obesity, oncology, immunology, cardiometabolic, neuropathy and their complications.
Kinexum has provided support over the past decade to many of the leading companies developing therapies for diabetes, obesity and metabolism and a growing list of oncology and cardiovascular companies. With high unmet needs and growing healthcare costs, innovative and personalized approaches for the treatment of chronic metabolic diseases are of high value and interest.
Today, translational research and development faces what has been called the “valley of death”—the precarious, day to day challenge of managing high costs and risks of early stage development with limited resources. Traversing this stage of health product development requires an integrated strategy for achieving regulatory, preclinical, CMC, and clinical objectives.
Efficient utilization of limited resources is required to create value that will maintain funding momentum. Kinexum professionals are experts in supplementing the technical, operational, and business needs of a small company.
Kinexum provides a personalized approach to understanding and meeting the challenges and obstacles faced by science-driven organizations.
Kinexum congratulates Rhythm, one of its oldest clients, on landmark FDA distinction
We at Kinexum are delighted that Rhythm has received a Breakthrough Therapy Designation from FDA. See http://www.prnewswire.com/news-releases/rhythm-receives-fda-breakthrough-therapy-designation-for-setmelanotide-for-treatment-of-pomc-deficiency-obesity-300200925.html
Zan Fleming, who was previously the senior endocrinologist at FDA, commented: “This is a landmark FDA decision, not just for the patients with this rare disorder, but for all patients with mechanism-defined, very high risk obesity. Developing drugs for obesity has been dauntingly difficult, but until now FDA has not reviewed data that fulfilled the criteria for awarding breakthrough or fast track designations to an anti-obesity therapy. This affirmation of setmelanotide’s potential will stimulate basic research and clinical development across the entire spectrum of obesity disorders. My former division has also not provided a Fast Track Designation for any other indication—including reversal of T1D, which represents one of the most important unmet clinical needs in medicine. The key to winning BTD and FT is having a pin-pointed mechanism of action and compelling clinical data—in some cases, in just one patient. Kinexum is committed to helping bring potential breakthrough therapies to FDA and to patients.
Metformin - associated lactic acidosis: Current perspectives on causes and risk Ralph DeFronzo, G. Alexander Fleming, Kim Chen, Thomas A. Bicsak