MUV - University Hospital AKH Wien & MedUni Wien

Medical University of Vienna Medical University of Vienna (MedUni Vienna) is one of the longest-established medical education and research facilities in Europe. With almost 8,000 students, it is currently the largest medical training centre in the German-speaking countries. With more than 6,000 employees, 30 departments and two clinical institutes, twelve medical theory centres and numerous highly specialised laboratories, it is one of Europe's leading research establishments in the biomedical sector. MedUni Vienna also has a medical history museum, the Josephinum.

AKH Wien At the University Hospital Vienna, which belongs to the Vienna Healthcare Group, around 60,000 patients are treated annually as in-patients. The out-patient and special out-patient wards at the AKH Wien are frequented by around a further 1.1 million people. Together with doctors of the MedUni Wien, a nursing staff of around 3,000, over 1,000 associates of medical, therapeutic and diagnostic health professions and many further employees from different professional groups are available for the care of our patients.

Role within JOIN4ATMP

As lead of Work Package 1 "How to increase the predictability of preclinical safety and efficacy data", the University Hospital AKH Wien & MedUni Wien will carry out a series of tasks destined to evaluate correlations between preclinical studies and their predictability or reproducibility in patients:

Establishing a database of preclinical and clinical ATMP evaluation results. This involves collecting and categorizing data from various sources based on parameters such as ATMP type, disease targeted, cell source, administration route, and gene transfer methods.
Evaluating the predictivity of current preclinical testing methods for clinical ATMP performance. Experts will be interviewed to identify hurdles in existing preclinical tests, and analysis will be conducted on unsuccessful trials to understand reasons for early termination or lack of progression.
Mapping innovative alternatives to animal models for preclinical testing. This task aims to identify novel in vitro assays and digital solutions that can replace or reduce animal testing. The effectiveness and predictivity of these alternatives will be assessed through literature review and expert interviews.
Achieving consensus on preclinical testing methods. This task consolidates findings from previous tasks to establish recommendations for preclinical testing tailored to different types of ATMPs. Special consideration will be given to assessing pharmacokinetics, pharmacodynamics, safety of gene editing, and variability in cell mixtures.

Overall, MUV's main tasks aim to improve the efficiency and reliability of preclinical evaluation for ATMPs, ultimately facilitating their successful translation into clinical trials.