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


Thomas Seoh Interview in July 2017 Issue of World Korean Medical Journal






 Dear Colleagues, 

For those who missed our Friday webinar: 

Dr. G. Alexander ("Zan") Fleming, Executive Chairman of Kinexum:

Targeting Metabesity—Let’s Prevent and Reverse Metabolic Drivers of Chronic Diseases and Aging

Please follow the link to listen to the recording: Targeting Metabesity - 4/28/2017 Webinar



Alexander Fleming, M.D., Executive Chairman of Kinexum, will be a moderator at the 17th Annual Diabetes Technology Meeting on November 4, 2017 at the Bethesda North Marriot Hotel & Conference Center.


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 Opioid Epidemic: A Perfect Storm

The Opioid Epidemic: A Perfect Storm


I recently was asked to take part in a series of expert workshops supporting FDA’s efforts to reduce the growing epidemic of opioid abuse, dependence and overdose in the United States. The first workshop, focused on packaging innovations, sought to gather input from a multi-disciplinary team to identify key intervention points; examine data needs and guiding design principles for the development of packaging, storage and disposal solutions; and contemplate the intricacies of integrating such solutions into the current healthcare marketplace. With representatives from academia, manufacturing, patient and provider groups, payor organizations, and government – the conversation was rich yet circular. What became clear to me throughout the day was that this issue, with its layers upon layers of complexity, truly was the perfect storm of public health crises.

Unraveling the problem will require a thorough understanding of the intricacies of human behavior – especially those related to addiction. Starting with the patient who fills the prescription, unintentional non-adherence, driven by forgetfulness, health illiteracy or simple misunderstanding, makes this problem in certain limited ways no different than the general “medication adherence crisis” that has been recognized and studied. Non-adherence has been proven to cost the US healthcare system hundreds of billions of dollars annually and to lead to immeasurable and preventable negative health outcomes. For the last decade, we’ve been trying to figure the whole “why don’t people take their medication as directed” problem out – and to address it - to no avail. What we’ve learned is that the reasons people don’t take their medications correctly are as individual as the people themselves and thus, so are the solutions.

To this conundrum, we now add on the problems associated with the nature of these particular drugs themselves.  Opioids further confound the problem of non-adherence (which we have not been able to solve) in unbounded ways. Opioid’s psychoactive effects and the propensity for dependence development converts unintentional non-adherence to intentional non-adherence (although one could argue about the meaning of intentional activity in addictive behavior).  What I mean to say is that we are no longer dealing with patients forgetting or failing to understand – but rather - seeking. Intentional activity is a whole new ball game and one for which virtually none of the innovations designed to address forgetfulness and literacy will help. Combine that with provider prescribing practices and rules around pharmacy and hospital reimbursement, and you’ve added fuel to the fire. Whether on the part of the patient or a third party (through diversion or sharing), intentional non-adherence draws into the conversation topics associated with access limitation, SUD diagnosis and treatment, traceability, and criminality, among others. Furthermore, the problem has created cultural issues of stigma and shame which force open discussion and self needs identification underground.

-          And then there’s the money. Both legally and illegally, it’s a profitable industry - and I’ll leave it at that for purposes of this discussion.


-          And what about patients living in chronic pain? It was obvious in the room that the concept of limiting access struck fear in the hearts of those advocating for the rights of those living in chronic pain.


-          And what about our love of privacy? We Americans delude ourselves into thinking that we have some - and we are recalcitrant in giving any up - regardless of whether actual or perceived.


-          And what about the gateway issues? If limiting access to opioids will drive current misusers to illicit drugs – how does that help?


For every proposed solution, another convoluted problem rose its ugly head. At the end of the day, only a precious few bright lines were left on the drawing board.  First, the criticality of having all stakeholders engaged, connected and aligned in the development and deployment of potential solutions was obvious. Second, given the mind-blowing statistics around the speed and the pervasiveness of the epidemic we’d better get used to the fact that our current rules of play need to be off the table and we’d better get moving.  In the war against the opioid epidemic, perhaps Patton would be right in opining that a good plan violently executed right now is far better than a perfect plan executed next week.

Regenerative Medicine in the Trump Era

Presentation - Ed Allera, Esq. and Barbara Binzk Blumenfeld, Ph.D., M.A., Esq.