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. The people working in Clinical Operations plan, implement and manage these activities as well as non-clinical projects related to Kedrion products.
- Medical Affairs. It is essential that those involved in marketing and education at Kedrion be well-informed about the medical characteristics of all Kedrion products as well as the disorders they are associated with. It is especially important that they are aware of the regulatory framework surrounding those products. Kedrion is convening advisory boards of medical experts in each of the regulatory jurisdictions in which it operates to establish an interactive communication regarding these matters.
- Medical & Scientific Information. Kedrion supports its external marketing and sales network as well as collaborating healthcare operators with up-to-date scientific information.
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 two new products:
- Plasminogen Concentrate in the form of eye drops for treating ligneous conjunctivitis, an extremely rare condition that can lead to blindness, most often diagnosed in infants and children.
- Factor V Concentrate, for treating a rare bleeding disorder resulting from a deficiency of this protein.
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 laboratories are part of a collaboration among Kedrion, the Regione Toscana and Toscana Life Sciences.