Premier Neuroscience at the Heart of R&D

After our technically highly optimized drug candidates have completed the necessary preclinical vetting, we “let the molecules peak,” by employing a biomarker supported experimental medicine approach to delineate the potential of the drug candidates to influence human biology, disease processes and symptomatology in healthy volunteers and carefully selected patient groups. Only the most promising drug candidates are allowed to progress further into larger clinical studies, and only if they promise to deliver impactful medicines.

Over the past year, we have focused our efforts and expertise on four promising “clusters” of biology. We believe this will allow us to fully explore our expanded operating space and deliver impactful medicines for niche and rare brain diseases.

Each of these clusters contain exciting and broad opportunities to identify innovative drug targets with strong link to disease biologies of high relevance for our therapeutic focus. Many drug targets in those clusters offer robust technical feasibilities to identify high quality drug candidates, with associated biomarkers, that facilitate further drug development.

The most important part of our drug development programs is to ensure that we deliver impactful medicines that address patients’ needs. To do this, we need deep insight into what patients and caregivers see as most critical, guiding us to bring to the treatment solutions that meaningfully improve quality of life. We take that to heart and have our patients at the core of everything we do. By letting the patient speak is also about developing meaningful labels – ultimately in service to patients –reducing burdens in peoples’ lives and on healthcare systems.

After we have ‘let the molecule speak,’ it then enters the proof of concept phase. This is a pivotal moment in drug development; no longer are we trying to understand what the molecule is capable of, but we make a choice, based on patient insights, potential efficacy, safety and tolerability, whether it should be moved further into the pipeline and take the steps needed to make it available to patients.

At this stage, we commit significant time and resources towards full development. We seek to find the most efficient clinical pathways, powered by groundbreaking study designs and operational excellence, to speedily advance the most promising candidates further into our pipeline. The large phase III studies needed for regulatory approval and marketing authorization are initiated, we evaluate the drug candidates to larger number of patients, to evaluate the safety profile, and we collect additional data needed for payer value proposition and formulary negotiations.

By combining new approaches with existing scientific and innovative competencies of the R&D organization, we have a great potential for bringing improvements that can help us better address patients’ high unmet needs and move Lundbeck towards being #1 in Brain Health.