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.
“Wow or Yeow!?”
We are now in a new era of
therapeutic development and regulation
A January 20, 2017
Special Roundtable Discussion
Timothy Franson, M.D., Chief Medical Officer, Your Encore
David Fox, J.D., Partner, Hogan Lovells
Brian Harvey, M.D, PhD., Distinguished Advisor, Kinexum
Alexander Fleming, M.D., CEO, Kinexum
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Start at minute 9
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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.
The Need for Faster Insulin: Problem Solved?
Douglas B. Muchmore, MD1
Abstract Considerable progress in treatment of diabetes has been made in the nearly 100 years following the discovery of insulin, and advances in insulin therapy have improved convenience, quality of life, overall glycemic control (A1C), and risk of hypoglycemia. An unmet need remains for a mealtime insulin that can faithfully reproduce the metabolic profile that ensues following meal ingestion in healthy persons. A number of “ultra-fast” insulin programs have been initiated, and Afrezza® (insulin human; Inhalation Powder, MannKind Corporation, Danbury, CT) stands as the first such product to be approved by the US FDA. Afrezza is unique as an “ultra-ultra” fast insulin, faster than any other entrant except IV insulin. The benefits and limitations of the Afrezza profile are discussed in this analysis.
Metformin - associated lactic acidosis: Current perspectives on causes and risk Ralph DeFronzo, G. Alexander Fleming, Kim Chen, Thomas A. Bicsak