In the fields of medicine, biotechnology and pharmacology despite advances in technology and ever-greater understanding of biological systems, the drug discovery process can too often be a lengthy, expensive, difficult, and inefficient process. Once a compound has shown its value in testing it will begin the process of drug development prior to clinical trials. Peira reduces the research and development costs associated with the drug discovery process.
Drug discovery and design requires the identification of candidates, synthesis, characterisation, screening, and assays for therapeutic efficacy. Peira’s expertise lets researchers move away from time-consuming manual procedures, towards greater automation of the research process. Our hardware and software solutions limit bias and increase the reliability of your experiments.
The five key steps of the drug discovery process:
1. Research & early development
This first phase of the drug development process is basic research. During this phase researchers try to understand the underlying mechanism or cause of a certain disease. Researchers look for new chemical or molecular entities that display promising activity against a particular biological target thought to be important for the disease. Other properties (including safety, toxicity, etc) and metabolic effects of the identified entities in humans are not focused on at this stage.
2. Preclinical research
Preclinical research must be completed before clinical trials (testing in humans) can start. During this stage important feasibility, iterative testing and safety data is collected. The main goal of preclinical study is to determine a product’s ultimate safety profile. Products may be new or iterated medical devices, drugs and gene therapy solutions. Each class of product may undergo different types of preclinical research. For instance, drugs may undergo pharmacodynamic, pharmacokinetic, ADME, and toxicity testing through animal testing. Typically, both in vitro and in vivo tests will be performed.
3. Chemical & pharmaceutical development
During the chemical and pharmaceutical development phase the aim is to design a quality product and its manufacturing process to consistently deliver the intended performance of the product. The information and knowledge gained from the studies and manufacturing experience provide scientific understanding to support the establishment of the design space, specifications, and manufacturing controls.
4. Clinical research
In this phase clinical trials are conducted to collect safety and efficacy data for new drugs. These trials can only take place once there is adequate information about the quality of the product, its non-clinical safety and once health authority approval has been granted. As positive safety and efficacy data are gathered, the number of patients is typically increased. Clinical trials can vary in size from a single centre in one country to multi-centre trials in multiple countries. After conclusion of the clinical trials the drug will be submitted for regulatory approval, for example with the Food and Drug Administration in the US or with the European Medicines Agency.
5. Chemical & pharmaceutical production
Once a new drug has been approved by the regulatory agencies such as the Food and Drug Administration in the US a full scale manufacturing plant will be built based on the scientific understanding gathered during the chemical and pharmaceutical development phase.