Actelion’s focus of bringing innovative medicines to patients in areas with high unmet medical needs can only be realized with rigorous testing of the compounds in its pipeline and thorough analysis and interpretation of the data.
Our clinical development department aims to fully explore and comprehensively describe the benefits of our compounds for patients. At the same time, we continuously assess and monitor the potential risks of new drug candidates. The group works to efficiently develop and bring innovative pharmaceutical products with an excellent benefit–risk profile to patients worldwide.
Actelion’s clinical and pharmacological research comprises multiple functions: clinical science, pharmacology, biostatistics and data management, drug safety, drug regulatory affairs, life cycle management, and clinical operations functions.
Life cycle teams, formed from representatives of preclinical and clinical development functions, technical operations and business strategy and operations, ensure an efficient development of a new medicine. They steer the compounds from the definition of a target profile and entry-into-human studies through to submission of the dossier to health authorities and commercialization until loss of exclusivity of the medicine in the major markets and beyond. They also ensure that all appropriate measures are undertaken to optimize the value creation potential of each product.
The collection of innovative compounds in Actelion's pipeline, in combination with each compound's different phase of clinical development and the medicine's stage of commercialization, makes this work highly diverse and demanding, yet it also satisfies our expectations for speed and cost-effectivenessin bringing new therapies to the patient.
Actelion’s clinical development functions collectively manage clinical programs to the appropriate scientific, medical and operational standards to generate the information required by health authorities worldwide.