Title : Challenges in translating science into medicine in the field of brain health
Abstract:
From dementia to depression to pain, neurological diseases affect almost everyone at some point in our lives. The medical research has advanced tremendously, thanks to the advanced technologies such as high-resolution imaging systems, genetic diagnostic tools, and high-throughput target engagement screenings. Despite of such advanced technologies, the drug development in the field of brain health still suffers from high failure rates. In addition, many drugs that are approved to treat brain health lead to addiction problem of its own further decreasing the treatment options available for the patients in need. To make the matter worse, two recent events, opioid crisis and the controversy in the Aduhelm approval created a dampen effect in the investor’s community creating a roadblock for the investments from getting into the brain health research activities. All those factors add to the reasons why we continue to face slow progress in drug development in the field of neurological diseases and brain health. In this presentation, I will provide an overview of the current challenges and potential solutions facing developing drugs to treat brain diseases. This presentation will contain four subsections as follows: (1) an overview of different types of drug classes that failed in clinical trials despite of promising scientific data, (2) latest FDA regulatory requirements that further complicates the clinical trial design, (3) challenges in lack of evidences linking the scientific data to the disease state measurement, and (4) several recommendations on what we can do to overcome the current challenges including the importance of multidisciplinary approaches in every step of research efforts. This presentation will end with suggestions on the next steps that can help promoting our collaboration effort so that more medicines can become available to help patients suffering from neurological disorders.
Audience Take Away Notes:
- Understanding of the key factors in correlating target engagement with therapeutic significance in brain health
- Overview of the latest Regulatory requirements in drug development that further complicates clinical trial designs
- Need to integrate multidisciplinary approaches in how we conduct research in brain health
- Continued limitation in the use of Artificial Intelligence (AI) despite of the extensive data available and how to overcome such challenge
- New ideas to incorporate the ‘End Goal’ in mind while conducting research (i.e., efficacy, quality of life, patient adherence, etc)
