3-dimensional cell culture and replication of human metabolism in the liver enables highly accurate, reliable predictions of toxicity.
Solidus' mission for the pharmaceutical industry is to improve the process of new drug development by providing proprietary decision-enabling technology to enhance drug safety, efficiency, cost, and, thereby, productivity from investment in new drug research and development.
Solidus Biosciences, Inc., a Delaware registered company, was founded in August 2002 to commercialize the DataChip/MetaChip biocatalytic platform to profile chemical compound toxicity to enhance decision-making in of support new product development in the pharmaceutical, biotechnology, cosmetics, and agrichemical industries. The company's core competence is its extensive knowledge and understanding of and experience with biocatalysis, cell culture and materials science to produce analytical products to evaluate drug safety by emulating human biological functionality. These capabilities, in combination with those in automation, permit miniaturization of design and processes to enable efficient materials usage and resulting application in the early drug development stages.
Professors Douglas S. Clark and Jonathan S. Dordick founded the company. Drs. Dordick and Clark are leaders in the field of biocatalysis with particular expertise in drug discovery. Together they have nearly 40 years of biocatalysis, cell culture, bioengineering, and drug discovery related research experience. In a prior venture (EnzyMed, Inc.), Drs. Clark and Dordick successfully converted their academic research to commercial product development.
The Company is the exclusive licensee of the worldwide patent for the DataChip/MetaChip technology held by Rensselaer Polytechnic Institute and the University of California at Berkeley. It has been awarded nearly $4.0 million in SBIR/STTR grants from the National Institutes of Health and the National Science Foundation to assist development of its technology. The Company's offices and laboratories are located in San Francisco, California.
In the pharmaceutical industry, it is generally accepted that toxicity is the cause of failure for 40% of drugs in clinical trials. Such failures are and have been a primary contributor to the steep growth in the cost of developing new drugs to treat the maladies of an ever-increasing aged global population. The failures in drug development attributable to the toxic profiles of candidates drugs is the direct result of the current inability or lack of capacity of drug developers to analyze and measure drug toxicity in parallel with the analysis of drug efficacy in the early stages of development.
New drug development at best is a high risk, time consuming, and investment intensive process. The process begins with an assessment of millions of compounds against a target disease, generally reduces to 10,000 lead candidates (compounds showing potential efficacy against targeted diseases), only one of which is likely to be commercialized. Successful candidates brought to market generally take 10-15 years from their initial selection to complete development. The estimated, fully capitalized cost to develop an approved drug ranges from $1.5-$2.0 billion.
Since 2000, the pharmaceutical industry has experienced low productivity from its investment in research and development as fewer candidates progressed through the development cycle to become approved drugs. In 2009, for example, only 26 new drugs were launched. In 2010, the proportion of total prescription sales from drugs launched since 2005 was less than 7%. In the five-year period 2000-2005, the industry received 43% fewer approvals of new drugs than in the 1990's.
Therefore, an overwhelming majority of total prescription sales currently are coming from mature drugs - many of which losing patent protection and will become subject to the severe price cutting from generic alternatives, Existing and prospective revenue losses stemming from the drugs with expiring patents has stimulated industry efforts to raise productivity.
The business of Solidus Biosciences, Inc. offers a corrective solution for the pharmaceutical industry's revenue losses and low productivity in research and development through its high throughput, biocatalysis-based DataChip/MetaChip platform that enables comprehensive toxicological analysis at the discovery through pre-clinical phases of drug development. The DataChip/MetaChip platform includes a portfolio of products that profiles (1) direct and metabolic toxicity; (2) P450 inhibition; (3) metabolic stability and (4) enables optimization of lead compounds.
DataChip/MetaChip 2.0, designed to assess direct and metabolic stability, is currently available and in various stages of validation by potential users. The other capabilities cited above are in development and are expected to available for use within the next 12-24 months.