Department of Product Development and Operations
Product Development works closely with Research to identify and evaluate potential therapeutics to add to our pipeline. Due to the considerable time and financial investment needed to develop a therapeutic, numerous criteria must be met to move a research drug candidate into product development. Product Development itself is a complex multi-stage process that requires a wide variety of technical skills and knowledge. This process includes pre-clinical characterization of the candidate drug followed by human clinical trials. The first stages of product development are critical to increase the likelihood of a successful clinical trial.
Once a drug candidate has the desired characteristics it will undergo pre-clinical testing to determine its behavior as a drug in living organisms. Drugs that pass the pre-clinical stage will then be moved into human clinical trials. These trials and testing will be performed by top of the line contract service providers. As a small company, AlerGenetica SL is establishing a network of experienced contract servicers and manufacturers to allow us to bring drugs quickly to market without having to immediately establish a complete clinical development testing infrastructure. Management of the network to guide drugs through initial characterization, pre-clinical and clinical trials is one the primary goals of Product Development.
This network will allow us to reach our drug introduction goals with significant savings to the company. In Product Operations, AlerGenetica has established the critical assays needed to measure the biological effects of our drug candidates. These assays will be used to test the contract production runs of our therapeutics to insure consistency and quality.
As a part of the Product Operations, our Regulatory department will work with agencies in Europe and US as we move candidates through clinical trials. In the future as the company grows we intend to develop infrastructure for product testing, manufacturing, formulation and packaging as needed.
Overall, AlerGenetica has combined a genome bioinformatics and human immunology based drug discovery platform with highly evolved state of the art development and production to move effective allergy and fungal disease treatments to patients quickly and safely.