Translational Research & Strategic Services
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.
News and Upcoming Events
Kinexum executives and leading experts will attend the conferences in this section. Anyone interested in meeting with them, please contact This email address is being protected from spambots. You need JavaScript enabled to view it. .
If you missed our 2/6/19 webcast, a video of the presentation can be found at:
Kinexum-Hogan Lovells Webcast: Targeting Metabesity
Recent Articles
A Perspective on the Development of the Treatment of Our Next Epidemic - Brian Harvey, MD, Ph.D
Background
Nonalcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease in the industrialized world [1]. The phenotypes of the disease extend from nonalcoholic fatty liver (NAFL) to nonalcoholic steatohepatitis (NASH), the latter of which progresses to liver fibrosis and end-stage cirrhosis [2].
EVIDENTIARY STANDARDS IN THE ACCELERATED APPROVAL OF CANCER DRUGS Grant Williams, MD
Let’s pretend I am an cancer drug sponsor with an immune-stimulating drug (Drug A) for the treatment of a refractory cancer. I plan to study Drug A in combination with an approved immunotherapy drug (Drug B), such as a PD1 inhibitor.
A Crash Course on 510(k) Clearances - Michael Sharp, Ph.D
I still get asked this question 40 years after the Food, Drug and Cosmetic Act (FDCA) implemented the medical device amendment (MDA). Although the answer is more confusing than may be expected, it is important for understanding the regulatory status of medical devices.
Beyond the NIH - Other Federal Medical R&D - Dean E. Calcagni, M.D.
Not counting the NIH, the U.S. Federal government spends more than $1.5 billion each year on medical research and development.
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