The R&D department identifies new targets to treat neurological diseases, characterizes the mechanism of action of drug candidates, performs regulatory studies and regulatory writing, discovers biomarkers, and generates intellectual property.
Clinical Operations manages and executes the operational aspects of the clinical study program and the individual clinical studies contained within it.
From study design to market approval, Clinical Operations is an important part of the drug development process and coordination.
The Clinical Operations team works with independent clinical investigators to execute clinical studies: from overseeing study start-up activities, regulatory procedures, site contracting, payment management, site activations, patient recruitment and patient safety, clinical monitoring, and clinical supply logistics. clinical operations focus on the smooth running of the clinical trial in accordance with trial protocol, GCP and ICH guidelines. Clinical Operations also ensures that clinical data is delivered on time, to budget and meets the required data quality.
The ultimate goal of drug development is to bring a new compound with proven therapeutic effect to the market.
The Pharmaceutical Affairs team manages, and develops supply chain processes, quality systems and CMC (Chemistry, Manufacturing, and Controls) to contribute to patients’ health and support the company and product development.
Regulatory Affairs is involved in all stages of drug development and also after drug approval and commercialization. Its main role is to ensure that the data gathered throughout the discovery and development stages of a drug will support its registration and commercialization. Regulatory Affairs is the interface with Health Agencies and acts as a link between different departments in the company. Regulatory Affairs also ensures the maintenance of the marketing license and leads life cycle extension activities.
The Market Access team ensures that the medicines are funded, reimbursed and made available to patients who need them. Market access identifies the value of the product based on payer customer insights, enhances value creation through clinical and health economic outcomes and research (HEOR) data and communicates the value through value propositions and global value dossier. The market access process links requirements at global level to the needs at local country level. The function coordinates the local activities pertaining to funding, reimbursement and pricing.
Thinking of people with progressive forms of Multiple Sclerosis first and foremost is at the heart of Medical Affairs: patient advocacy, patient empowerment, patient support and healthcare provider relations and education.
Marketing supports customers that are healthcare providers, patients and their families. In marketing, we ensure we are getting the right products and services to the right people, in the right quantity, at the right place, at the right time, at the right price and with the right communications and promotions