Science Medical Liaison Management to Promote Clinical Evaluation of Nanovesicular Therapeutics

The Science-Medical-Public Liaison program aims to promote the clinical evaluation of Nanovesicular Therapeutics (NVT) by building a bridge between patients’ needs, the opportunities offered by modern medicine, and the restrictions from legal requirements. The exploding interest in extracellular vesicles (EV) and other nanovesicular modalities as novel therapeutic entities underscores the need for increased pre-clinical and clinical investigations, standardization, and interdisciplinary coordination of NVT drug development efforts.

The LBI-NVPM network partners, Paracelsus Medical University (PMU) Salzburg, and the University Hospital Salzburg (SALK, Salzburger Landeskliniken GmbH – Universitätsklinikum der PMU), will provide a strong interface between LBI-NVPM preclinical research and clinical reality. Important contributions include knowledge of and access to Good Manufacturing Practice (GMP) for pharmaceutical manufacturing of novel nanovesicular drug candidates, thereby directly enabling their clinical testing. The activities further entail the preclinical and clinical evaluation of candidates for NVT that are carried out in accordance with the applicable regulations and requirements of Good Clinical Practice (GCP), as well as Good Distribution Practice (GDP) to ensure the safe transportation of new investigational medicinal products. In collaboration with PMU and SALK, LBI-NVPM further interfaces with legal authorities and stakeholders from the Regulatory Affairs sector and provides scientific guidance to the process of defining regulatory frameworks for NVT.

LBI-NVPM fully embraces Open Innovation in Science (OIS) concepts and is committed to actively involving the general public to improve our science through out-of-the-box thinking. Scientists, clinicians, patients, healthcare experts, patient-interest groups, and informed citizens are brought together to promote the sharing of ideas, resources, and knowledge with the aim to collectively address complex medical challenges and how they can be addressed with NVT. Ultimately, integrating such a 360° perspective into the research and development of nanovesicular therapeutics shall maximize the impact of this novel class of medicines as they become ready for prime time.