H.M. Pharma Consultancy will present at the 1st European Drug Discovery for Neurodegeneration Conference, to be held in Budapest (Hungary) from May 15-17, 2016. This is an educational course on translational CNS drug research which is based on the Alzheimer Drug Discovery Foundation’s annual US-based Drug Discovery for Neurodegeneration conference.
We will be tweeting from the conference under the recommended hashtag, #CNSDrugCourse.
Details of the presentation are as follows:
- Presentation Type: Oral presentation
- Title: Case Study #3 – Lead Candidate to IND
- Date and Time: Tuesday, May 17, 10:20 CEST
- Presenter: Dr. Hermann Mucke
Once a lead compound has been earmarked for development as a drug candidate, it enters a standardized preclinical safety study program that has rigid prescriptions for the minimum set of animal and in vitro investigations to be conducted in support for a first-time-in-man trial application. However, doing more than the minimum in this earliest stage of compound development can offer extremely important insights into mechanisms of action, pharmacodynamic and metabolic properties, and required formulations. Among such non-mandatory investigations are molecular imaging approaches, assays of relevant blood and tissue biomarkers, and intricate behavioral observations. In addition, many questions of less immediate scientific nature need to be considered in synchrony at this stage. These include the careful design of an intellectual property strategy; approaching regulatory authorities for formal scientific advice or protocol assistance; securing orphan drug designation or other distinctive labels that could provide advantages for the drug candidate; drawing a roadmap for presentations at scientific congresses and submission of journal manuscripts; and securing financial support for subsequent advanced investigations. This presentation will walk the audience through an early-stage neuropsychiatric drug development project to illustrate this web of interlocked challenges in the “lead-to-IND” phase.