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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

Please join our next webinar

Kinexum Webcast: PTSD–Associated Pathologies in the World of 2018

Thomas Hedberg, MSc, Ph.D, Executive Director International Medical Crisis Response Alliance, on causes, effects and treatment failure of PTSD.

Friday, 12.14.2018, at 11 a.m. ET

 



        

Tuesday, January 8th, 2019


 

If you missed our 10/26/2018 Kinexum Public Webinar, a recording is now available:

Using Metformin to Target Aging

 Featuring TAME trial co-PI's Nir Barzilai, MD, and Steve Kritchevsky, PhD



 

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]. 

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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. 

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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.

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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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Early on Commercial Planning Investments within the R&D Process: The Business Case - Martin Lafontaine

Commercial investments within the early phase of R&D generally rank very low on a company’s priority list.  To use a sports expression, commercial investments often don’t make the cut, and get relegated to the bench.

Early on Commercial Planning Investments within the R&D Process: The Business Case - Full Article