Advanced In Vitro Solutions for Success
Advanced In Vitro Innovation for the Future

Advanced In Vitro, LLC (AIV) is dedicated to improving the pharmaceutical field by advancing drug testing methodologies in the preclinical development phase. The goal is to establish new in vitro technologies to lower drug development cost and improve chances for clinical success while reducing or eliminating unnecessary animal testing. AIV plans to achieve goals by integrating technologies and using predictive in vitro models that accurately eliminate poor drug candidates early in the development phase, prior to wasted investment of time and capitol on compounds doomed to failure. Currently, AIV offers licensing of various intellectual property to parties interested in developing advanced in vitro tissue culture systems.

New Technology Needed

It is known that over 90% of compounds fail in the clinic, with costs now often estimated at over $1 billion per approved drug.  Development costs have more than doubled in the last 10 years and the number of approved drugs is on a declining trend.  Further, it has been predicted that costs may rise to $2 billion or more per approved drug in the near future.

“The head of science and technology at Eli Lilly & Co. warned that the cost of producing a successful drug could top $2 billion by 2010 unless the pharma industry can identify new and better ways to improve efficiency and effectiveness of drug discovery and clinical trials.” 1

With ever increasing costs and high failure rates of drug development, explanations are sought to help explain the current trend.  It has been indicated that strategies used previously are no longer adequate for the drug development challenges in the 21st century.

“In many cases, developers have no choice but to use the tools and concepts of the last century to assess this century’s candidates.  As a result, the vast majority of investigational products that enter clinical trials fail…” 2

With current technologies considered outdated by many, the demand for innovative drug development strategies has soared.  However, it has been stated that a supply of successful approaches has not yet met this demand.  Key factors will establish how valuable the new strategies are in producing greater clinical success. 

“…Not enough applied scientific work has been done to create new tools to get fundamentally better answers about how the safety and effectiveness of new products can be demonstrated, in faster timeframes, with more certainty, and at lower costs.“ 2
                           
A
dvanced In Vitro Solutions

Having previous success with in vitro model development, the founder of AIV is determined to generate rapidly implemented, cost-effective in vitro solutions to advance the field of drug development.  Along with eliminating unnecessary animal testing and saving time, in vitro drug screening alternatives can impact cost savings significantly.

“The estimated cost per drug using an in vitro toxicity assay is $100,000 compared to $1,000,000 per drug using conventional toxicity studies.” 3

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1 Kevin Davies, Bio-IT World, Drug Costs Nearing $2 Billion, Warns Lilly Executive. August 11, 2006.

2 U.S. Food and Drug Administration. Innovation/Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products. March 2004.

3 Excerpt from NCI website: Research Paradigm (2006).


In Vitro
Significance



"The development costs increase significantly during preclinical animal testing for safety and in clinical trials.  The loss of a new drug candidate in these late stage tests due to unanticipated toxicity represents a major problem for the pharmaceutical industry."

Excerpt from James M. McKim Jr. et al., A Biochemical approach to In Vitro Toxicity Testing, Pharmaceutical Discovery, January 2005

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“Prediction of long-term toxicity of NCEs in key organs is of utmost importance. In vitro models for such applications have not been validated." 

Report ECVAM Workshop 45, ATLA 2003.

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"Assays that predict the correct biomarker/histological changes drugs make and in vivo MTDs in humans at physiologically relevant exposures are exactly what we need. Bone marrow, liver, and lung assays are among the most important for anticancer therapeutics."

NIH Roadmap ADMET Workshop, Bethesda, June 2004.