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

If you missed our 12/14/18 webcast, a video of the presentation can be found at:

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 PTS

Other Upcoming events

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

Kinexum executives and leading expert will attend the conferences in this section. Anyone interested in meeting them, please contact This email address is being protected from spambots. You need JavaScript enabled to view it. .

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.

Sign Up for Newsletter & Other Important News

Take a sneak peek

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.