Product Development at Kedrion encompasses a number of departments and activities that operate from basic research to pre-clinical and clinical development through ongoing monitoring of product use and efficacy (Pharmacovigilance). At all levels our goal is to encourage innovation and to press for continual improvement in all of our processes and products.
- Research and Development. Our products are used to treat rare and often severe diseases like hemophilia and immune deficiency disorders. Plasma-derived medicines are also used in critical care for conditions such as shock, severe burns, sepsis and complex surgery and to prevent Rh factor complications in newborns. Kedrion is constantly seeking to create new products and improve existing ones, and we strive at all times to improve efficiency and capacity at all our sites.
- Clinical Operations. Developing and improving medicinal and pharmacological products requires careful and intense clinical studies, including observational studies.
- Medical Affairs. Our medical affairs department and medical science liaison are available to interact and communicate with the medical and scientific community, including healthcare professionals and researchers, as well as consumers as appropriate. Our outreach includes scientific and educational programs for healthcare professionals and support for investigator-initiated research. We support publications in disease states that our products treat and provide information about the broader use of our products within approved indications.
There are many diseases and disorders that are life-threatening or chronically debilitating but which affect very few people. Some of these are referred to as neglected or orphan diseases because there is little economic incentive to research and develop treatment for them. Drugs that are found or developed to treat these disorders have come to be known as orphan drugs.
Because our work at Kedrion is directed at providing relief from rare diseases and disorders such as hemophilia and primary immunodeficiencies, we take special interest in the development of orphan drugs. This commitment has recently resulted in a new product currently under investigation, Plasminogen Ophthalmic Solution, for treating ligneous conjunctivitis, an extremely rare condition, most often diagnosed in infants and children, that can lead to blindness. Plasminogen Ophthalmic Solution in the form of eye drops obtained Orphan Drug designation status by FDA.
Kedrion’s commitment to alleviating the pain and suffering of orphan disease has led to the establishment of a plant in Siena, Italy, dedicated to research and development of orphan drugs. The laboratory is part of a collaboration among Kedrion, the Regione Toscana and Toscana Life Sciences.