Regulatory and Business Strategy

Integration of regulatory and business strategy is the essence of translational development and essential for development timelines and cost projections.  Kinexum brings the experience and communication skills for success in the regulatory and business environments.

Pharmaceuticals and Biologics

Highly regulated drug development requires skilled expertise in multiple disciplines.  Kinexum's integrated team brings extensive knowledge and experience in regulatory, preclinical, CMC, & clinical for manufacturing, safety, and efficacy goals to advance to market.

Devices, Combinations, & More

Kinexum has diverse experience and knowledge of the spectrum of regulatory guidances, business strategies, and development plans to manage risk and cost in multiple product methodologies including cell therapies, medical devices, combinations, botanicals & medical foods.

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 Webinar - March 22, 2019

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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

Why Kinexum?

Spanning pharmaceuticals, biologics, and devices, we have supported over 250 clients during the past decade to achieve their goals.  Kinexum uniquely brings together:

  • Exceptional experience — Kinexum professionals have 25 years or more in their specialties.
  • Key knowledge — Kinexum professionals reached leadership positions in major regulatory organizations, pharmaceutical companies, and other business and government organizations.
  • High recognition and involvement — Kinexum professionals are thought leaders in their fields, frequent conference speakers, and associated with innovative initiatives.
  • Large asset of valuable, deployable relationships — Kinexum professionals have built a vast worldwide network of experts and resources across academia, government, and business.

Areas of Expertise

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.

Translational Development Services

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.

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Recent Articles

The Silent Epidemic of Diabetes in China by Tom Hedberg


There are frequently heavy prices to pay for cultures embracing the lifestyle of Western nations, particularly of the US. China’s rapid economic and social expansion during the past 30 years has led to unwanted and heretofore unknown health consequences. The first epidemiological investigation of diabetes in China in 1980 showed a diabetes prevalence of 1%. By 2009, however, that prevalence had grown to 10%, and diabetes has since become the third largest chronic disease in China after cancer and cardiovascular pathologies.1 According to the International Diabetes Federation, while diabetes is skyrocketing in China, the nation is still largely unprepared for the expected increase in diabetes-related comorbidities and complications. Fortunately, these complications have not yet become as widespread as the core disorder.


Early NDA Planning for Small to Mid-sized Companies by Susan Manley

The final phase 3 studies are ongoing with a planned completion in 12 to 18 months. Your board is looking to the submission date with great excitement. Your company has made it this far – is time to relax? No, not yet! Your company has not prepared a US NDA in several years or, even more concerning, has never prepared an NDA. What can you do now to ensure a smooth trip to the submission and beyond?  


Applications of Machine Learning in Healthcare: Scalable Treatment Solutions for Cancer Patients by Michael Cobb

A decade ago, Ms. Gitika Srivastava and Dr. Naresh Ramarajan learned that their close relatives had been diagnosed with cancer. In response, the two co-founded a company that uses machine learning to transform how patients make cancer treatment decisions. 

There are many barriers to democratize access to cancer care. Finding the right diagnosis, the best doctors, and the most applicable treatment is already a challenging task for patients with access to insurance and healthcare resources in developed countries. In developing countries, such as India, each of these tasks becomes exponentially more difficult.


Strategies to Approaching CMC New Product Development and Manufacturing Outsourcing Resources by David Bergstrom

If your company is developing a new product, your team will—at some point—have to consider a CMC (Chemistry, Manufacturing & Controls) and outsourcing strategy. How should your company develop such a strategy?

Business Model and Corporate Strategy



A Perspective on the Development of the Treatment of Our Next Epidemic - Brian Harvey, MD, Ph.D


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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