Partnership. Performance. Success.
At 21CM, we view each client as a partner and understand that our ongoing success is contingent upon our clients' ability to reach early and accurate decisions about their drug candidates' performance.
To that end, we’ve developed a technology platform that gives our clients’ more control over their own processes by expanding the length of time available in which to test viable kidney, liver and brain tissue. Our proprietary preservation research services and integrated protocols and solutions can seamlessly fit into any drug development or cell preservation effort.
For more information, please contact us toll-free at 866-889-1215.
The Benefits of Technology
Drug screening efforts currently rely on liver cells that are basically dead due to the difficulty of freezing liver tissue. In contrast, we’ve shown that we can bank both liver and brain tissue in viable condition for drug discovery and drug screening purposes, or ADME/Tox studies. This technology will also work on anti-aging drugs, intended to prevent or treat brain aging and which must first be screened for their effects on both brain cells and liver cells.
(As an example, see videos demonstrating normalcy of electrical responsiveness in vitrified/rewarmed brain slices here.)
The Benefits of Service
We serve all phases of drug protocol and testing from early experimental to final product phase. Our team consists of a dedicated project manager plus technical and executive account managers who facilitate each project's design, implementation, evaluation, and ultimate commercial deployment. We offer:
|
To support our client investigators, we provide interactive, comprehensive services, including:
|
Filling the Technology Gap
Chemical drug discovery and development is a continuum of steps beginning with lead identification and concluding with FDA approval. Drug discovery consists of designing, synthesizing, and analyzing chemical entities for biological activities against a given target. Repeating these steps leads to identification of lead compounds.
Drug development consists of defining and optimizing the pharmacological, pharmacokinetic, and toxicological properties of lead compounds identified in drug discovery. To facilitate this, lead compounds are characterized with respect to their absorption, distribution, metabolism, excretion, and toxicology.
ADME/Toxicology profiles thus define how a compound interacts with the rest of the body to cause activity and toxicity. To identify the ADME/Toxicology profile of a candidate drug, the industry traditionally employs any number of in vitro and in vivo model systems, first and foremost of which, is the liver slice model. This screening system is variable, poorly preserved, expensive, and not able to be kept in inventory.
An estimated $4 billion was spent on ADME/Toxicology studies by the pharmaceutical industry in 2006. Lack of workable in-vitro model of human liver function is recognized as a weak link in characterizing lead compounds with respect to their safety/toxicity profile. Poor ADME and hepatotoxicity are the principle reasons for failure of lead candidates to become new drugs.
Moreover, serious drug-induced liver injury is the leading single cause for withdrawal of drugs from the market. At least six drugs have been pulled from the market and many others have never been marketed in the U.S. due to liver toxicity. The FDA has imposed significant limitations on the use of some drugs due to post-marketing reports of rare but acute liver toxicity, and numerous unstipulated drugs have fallen out of clinical trials due to human hepatotoxicity. Drug-induced liver injury has now become the leading cause of liver failure in the U.S., exceeding all other causes combined.
Poor validation of lead compounds for ADMET and toxicology can mean that too many programs make it into clinical development. This can later have devastating effects on company performance through loss of lead candidates in clinical trials, delays in bringing new drugs to market, black box warning labels imposing significant limitations on FDA approved drugs, and withdrawal of approved drugs from the market.
Well-preserved liver slices that provide a reproducible and specific in vitro model that accurately reproduce in vivo human hepatic ADME/Toxicology function are therefore urgently needed for lead optimization when costs are low to help develop safe and effective lead compounds and decrease failure rates of compounds in clinical trials when costs are high. 21CM preservation technologies will allow liver slices from multiple species to be healthy, functional and available on demand. Our approach enables ADME/Toxicology studies to be performed more reliably and earlier in the drug discovery process when costs are lower.
As more success with bio artificial organs is achieved, it is expected that less expensive in vitro tissue systems would become available for application to the lead discovery stage of drug development. These also will need excellent preservation solutions specific to their needs. Additionally, the development of well preserved genotype-profiled cell sources will enable delivery of bioengineered polymorphic tissues that will be combined with sophisticated assays to enable investigation of toxicity mechanisms and toxic genomics / proteomics for the candidate selection stage of drug development.
Our resultant core competencies in preservation technology could then be leveraged into development of specific preservation techniques for other tissue types useful to the drug discovery process such as GI tract, blood-brain barrier, lung, kidney and cardiovascular.
Vitrified Liver Slices |
Enabling Technology |
|
|
|
|
|
|
|
|
