Early Human Insight means generating human data well in advance of clinical studies. This redefines the concept of “first in human.” The benefits include:
- Identify and focus resources on the most valuable compounds
- Calibrate predictivity of other in vitro or in vivo models
- Assess efficacy/safety on authentic human targets
- Generate quantitatively reliable data on potency and selectivity in humans
- Avoid translational challenges frequently encountered with animal models
Human tissue-based studies can be valuable at all stages of the drug development process. Pharmaceutical companies are leveraging AnaBios’ technologies to identify and advance the preclinical development of molecules with the desired activity in human tissue and cell-based studies. In addition, clinical stage programs that incur unexpected toxicities use AnaBios’ proprietary technology to de-convolute signals and generate risk mitigation strategies.
Samples from 1-3 donors are usually sufficient.
- The turnaround time for data depends on the complexity of the specific study. On average, studies can be completed in 1-6 weeks. AnaBios receives donor samples several times a week, which permits the execution of studies in a timely manner.
AnaBios procures human tissue samples exclusively from a US-based procurement network comprised of a large number of hospitals. All cases are ethically consented and comply with all regulations governing the procurement and use of human tissue for research. In addition, all samples are procured using rigorous protocols which employ proprietary methods and reagents that ensure tissue viability and consistency.
AnaBios offers human tissue-based models for a variety of therapeutic areas, including pain, itch, atrial fibrillation, heart failure, fibrosis and kidney disease.
AnaBios has developed a variety of tests that address the potential toxicity risks related to adverse cardiac effects, peripheral neurotoxicity and fibrosis.
Animal models have a high rate of failure when quantitatively predicting human responses. Without reliable human efficacy and safety data, there is a high risk that resources will be wasted on the wrong molecules.
AnaBios’ tissue procurement services and human-based experimental platforms offer unique capabilities in the industry. In addition, AnaBios can provide consultative expertise related to translational research and drug development.
The FDA has stated that “the use of human tissue avoids the interspecies differences” and encouraged the use of human cells, like liver hepatocytes, when available. Additionally, the use of human cell and tissue-based experiments are supported by regulators provided that all studies are conducted in adherence to rigorous ethical and scientific standards.
By calibrating animal models and/or identifying cross-species discordances using human ex vivo data, pharmaceutical scientists can avoid unnecessary animal testing and shorten the path to clinical candidate selection. .