Drug discovery success rate across all therapeutic areas looks rather bleak but Johan Luthman, Executive Vice President at Lundbeck, urged the audience to remain optimistic. Despite the common perception that neuroscience is one of the most difficult therapeutic areas, it has ranked among the top three therapy areas for FDA and EMA approvals in recent years. Furthermore, it has outperformed fields such as infectious disease and dermatology.
Luthman outlined some of the challenges and strategies for improving R&D productivity in neuroscience. He covered factors such as pipeline volume, probability of success, decision quality, cost, value and cycle time in drug development. In Luthman’s viewpoint, value is one of the main laggers in the formula; value is subjective to measure and it takes years to find out whether value is delivered.
Drug discovery is also a numbers game, Luthman explained that having choice is a “positive problem” and having different programmes drives up quality and chances of success. Unfortunately, scientists and researchers sometimes cling to projects that are doomed to fail because they have no other programs in their pipelines.
To prevent this from happening, Luthman stressed the need to de-risk projects as early as possible. He explained that the growing interest in biomarkers over the last 15 years has assisted decision-making and prediction of patient response to treatments. Early proof-of-concept (PoC) studies are also key to upholding the “fail early, fail cheap” ideology. Biomarkers and early PoCs are essential to avoiding costly failures, particularly in Alzheimer’s and Parkinson’s.
Lecanemab is a medication approved for the treatment of early-stage Alzheimer’s disease. Luthman credited its success to the fact that the developers conduct PoCs early on and the use of Bayesian adaptive designs. Also, Luthman drew parallels between breakthroughs in oncology, especially immunotherapy and emerging opportunities in neuroscience, suggesting that advances in biomarkers and immunology are driving progress in brain diseases.
The presentation included examples of high-value drugs and the significant societal impact of successful treatments for mental and neurological disorders. Luthman stated that there are projections of rapid market growth in neuroscience and things are on the up. Pharma giants like AstraZeneca, GSK and Pfizer are returning to neuroscience. Luthman ended on a positive note and encouraged the audience to remain hopeful for the future of neuroscience.
