Developing a drug is an extremely long and regulated process. It globally includes a drug discovery phase, during which drug candidates are identified, and a preclinical phase where drug candidates have to demonstrate their proof-of-concept.
During the preclinical phase, models will be used, optimized, or developed to understand the mechanism of action of the drug candidate. In vivo studies are used to understand the effect of the lead drug on living organisms. Such assays can be very long to optimize, and can, in certain cases, become the ultimate proof of concept required to move ahead in the development of the drug.
The molecules can be tested for their pharmacokinetic and pharmacological behavior in small animals (ADME). Optimizations can be performed by chemical modification (small molecule) or mutations for biomolecules.
Some of the testings is performed internally at drug development companies, however, it is very common that in vivo testing and ADME is outsourced to laboratories with the capacities and authorizations to perform such tests. It can be difficult to find the right service lab for these studies.
This is why Labtoo developed a tailor-made service to support Labs, Biotechs, Medtech, and Pharma companies in their research program outsourcing.
Labtoo can look for any type of in vivo services, for the development of new drugs and the development of diagnostics assays. We work with academia and service labs to look for the best models and testing facilities according to specific needs.
In vivo model tests are performed on animals. They may be part of the proof-of-concept validation or may be performed for the regulatory dossier. Typically, in vivo tests will study the physiological and behavioral aspects, as well as the toxicity of the molecules being studied.
Pharmacokinetics studies the fate of an active substance of a drug after its administration in an organism. It consists of four phases: absorption, distribution, metabolism, and excretion of the active ingredient (ADME). Different tests, in vitro and in vivo, exist to answer these pharmacokinetic questions.
ATMPs (Advanced Therapy Medicinal Products) are medicines based on genes, tissues or cells for human use. They offer revolutionary new possibilities for the treatment of diseases and injuries.
Perform a feasibility study by looking for existing expertise available within the network of partners
Set up a study protocol, financial quotation and preparing contracts with lab partners
Implement the study plan into a schedule, collect all needed materials and reagents and execute the service
Each drug development follows a unique process, in terms of drug candidate identification, validation and optimization, pre-clinical and clinical protocols and marketing. There are, however, some broad outlines in the drug development phases, which are described here.
Discovery - 2-4 years
Pre-clinical - 1-2 years
Measurement of ADME(Absorption, Distribution, Metabolism, and Elimination): potency tests, solubility, LogD, Caco-2 permeability, CYP inhibition, etc.
Measurement of pharmacokinetics and pharmacodynamics PK/PD
Structural optimization and synthesis (chemical or bioproduction)
Selection of candidates