Development process

Actelion’s mission to bring innovative medicines to patients can only be realized with rigorous testing of the compounds in its pipeline and thorough analysis and interpretation of the data.

Actelion’s clinical development department aims to fully explore and describe the benefits 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, effective and well-tolerated pharmaceutical products to patients worldwide.

Our clinical and pharmacological research involves the close cooperation of 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 clinical development functions, preclinical and business strategy and operations ensure the timely development of a product. They guide the compounds from the definition of a target profile and entry-into-human studies through to submission of the dossier to health authorities and beyond, handling Phase IIIb / IV programs. 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, makes this work highly diverse and demanding, yet it also satisfies our expectations for speed and cost-effectiveness.

Actelion’s clinical development functions collectively manage these clinical programs to the appropriate scientific, medical and operational standards to generate the information required by health authorities worldwide.