Our Approach to Product Development

Building on the Company’s laboratory, lab animal studies, and clinical trial experience a refined, innovative method for discovering and developing product candidates consists of:

Product Candidates

The defining signature of these inventions is that they are comprised of physiological levels of naturally-occurring molecules, such as DNA and proteins. These compounds are low-dose, even micro-dose, when compared with most current therapies. As demonstrated for patents and in pre-clinical and FDA-authorized clinical trial studies, side effects are placebo-level. Several formulations share an active component that permits the development of different platforms, thereby augmenting future R&D. Stemming from years of experience, the technology base is solid as evidenced by more than 30 patents licensed to a leading pharmaceutical company, a licensed nutraceutical product currently on the market, and strategic alliances with well-respected university and industry leaders, and regulatory and patent experts.

Development Strategy

Potential new products are evaluated in vivo early in the development cycle in order to determine if they justify the time and expense needed to bring them to a point ready for licensing. If a candidate formulation appears promising as a consequence of this early testing, then patent applications are prepared, Investigational New Drug (IND) applications submitted to the FDA, and proof-of-concept trials initiated. Parallel in vitro laboratory and lab animal model work are also conducted so that a complete package can be presented to potential licensees or partners.

Observational Medicine

Hallmarks of this research which lead to a number of new product candidates, includes:

• evaluating cellular and whole body responses;
• emphasis on naturally-occurring molecules;
• determining the physiological effects of active agents;
• involving physicians and scientists who are prepared to think “outside the box.”

Pilot Trials

Rigorous laboratory and pre-clinical research:

• increases the odds that successful science will yield successful medicines;
• provides timely, independent feedback from knowledgeable clinicians.

Specialized Teams

Utilizing the expertise and experience of professional collaborators, we are able to accelerate all phases of development by gaining:

• scientific understanding of mechanisms of action;
• pre-clinical evaluations in order to obtain useful data economically;
• clinical focus on the benefit and labeling claim with the shortest path to market.