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 next Public Webinar will be on Friday, 07/13/2018, at 11 am EDT to noon:

 "European Medicine Agency - Some Recent & Anticipated Changes"

Presenter: Dr. Bart Van der Schueren, IG Endocrinoligie UZ Leuzen, Belgian Representative on EMA

Click here  to see invitation

Please log in  or dial 888-601-3595

Our Charles Alexander will be attending the 2nd Annual Heart in diabetes (HiD) Medical Conference in Philadelphia from Friday 07/13/2018 till Sunday 07/15/2018.


Blazing Clinical Development & Regulatory Pathways for Healthspan Interventions - Dr. Fleming presents at the Nathan Shock Centers Summit & American Aging Association 47th Annual Meeting, June 27th, 2018, Philadelphia, PA

Kinexum Public Webinar is on Friday, 06/08/2018, at 11 am ET to noon:

Rob Claar of HekaBio KK will Present:

Fast Track Cell Therapy Opportunities Under Japanese Regulations 

Click here to see presentation on Youtube

Special Webcast interview is now available on audio 

and with slides

Dr. Lawrence Steinman: From Big Hammers to Lasers: 

Lessons learned in targeting the immune system to reverse or prevent disease

Interviewed by Dr. Alexander Fleming             

Kinexum Public Webinar from Friday, 04/27/2018, is now available on audio (please start at minute 11):

David Fox and Phil Katz of Hogan Lovells  will present - 

Regulatory Outlook under FDA Commissioner Scott Gottlieb and DHH Secretary Alex Azar 

Click here to see the invitation

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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

Beyond Hemoglobin A1C Consensus Conference - July 21, 2017 Charles M. Alexander, MD

Originally, diabetes was a symptomatic condition with either diabetic ketoacidosis (DKA) in type 1 diabetes or marked weight loss, muscle wasting, and inanition in type 2 diabetes.  Prognosis was dismal for both and the main difference was the rapidity of the patient’s demise.

Beyond Hemoglobin A1C Consensus Conference - July 21, 2017 - Full Article

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

Marketing Added Value - Arthur Santora MD, Ph.D

Fosamax was the first treatment for osteoporosis in postmenopausal women approved based phase 3 data demonstrating a reduction in the incidence of vertebral fractures. Marketing Added Value - Full Article