Autism Spectrum Disorder (ASD) is a common neurodevelopmental disorder which does not have an approved medication to address its core symptoms. The Janssen Autism Knowledge Engine (JAKE) was designed to advance the clinical research process for autism by integrating emerging technologies into traditional clinical trial processes.
Autism Spectrum Disorder (ASD) is a lifelong, debilitating disorder affecting approximately 1 percent of the global population, and 1 in 68 children in the United States. Despite being one of the most common neurodevelopmental disorders with increasing prevalence in recent years, there are no approved medications to address the core symptoms of ASD, in addition to current standard of care behavioral therapies. This necessitates the study and development of targeted therapies that effectively improve clinical outcomes and quality of life for individuals with ASD (including both the core and associated symptoms of ASD). The Janssen Autism Knowledge Engine (JAKE™) was developed to advance clinical research in autism by integrating emerging technologies into traditional clinical trial processes. JAKE™ is a new, first-of-its-kind, digital, integrated system of tools and technologies for facilitating data collection and advanced analytics in clinical trials. JAKE’s software is designed to enable advanced biomarker data collection with the ultimate goal of using the system to develop novel medicines to improve clinical outcomes for people living with ASD. The JAKE™ system consists of three components:
Three initial studies were conducted to test the components of JAKE, including two in healthy volunteers, and one in children and adults with ASD and their families. Using data from these studies, the full three-part system was finalized, and is now being tested in a large clinical validation study. Furthermore, collaboration and clinical data-sharing can enhance research progress, improve communication between stakeholders and ultimately speed the discovery of new disease biology including potential novel treatment targets. With this philosophy in mind, Janssen is partnering with clinical research institutions and technology experts to maximize the potential for using the JAKE™ system to detect clinical outcomes in ASD. Gahan Pandina is the Senior Director & Venture Leader at Janssen Research & Development
Phase III Trials Show Long-Term Efficacy of Cobenfy Treating Schizophrenia
November 1st 2024Cobenfy (xanomeline and trospium chloride) demonstrated sustained long-term efficacy, safety, and tolerability over 52 weeks in Phase III trials for adult schizophrenia patients, showing significant symptom improvement and quality of life benefits with minimal adverse effects.