Translational research in the fiT
Translational research is a necessary and mandatory scientific phase for the development of new biomedical or pharmaceutical approaches, which is being performed to progress basic research into a first clinical use in humans.
In contrast to basic research, which is focused on a single research result, translational research is directed towards a clearly defined therapeutic or diagnostic target based on a comprehensive set of performance criteria which need to be fulfilled to convert the basic research into a safe, effective and high-quality product for human use.
To promote and facilitate translational research in an academic environment, the fiT works towards closing the existing gap between basic research and translational research by supporting researchers with guidance and infrastructure through the translational research phase according to globally accepted safety as well as quality standards for first-in-human trials of new therapeutic developments.
Biomedical and pharmaceutical innovations comprise Medical Devices, In-vitro-Diagnostics, Drug products or Advanced Therapeutic Medicinal Products (ATMP) for which specific translational scientific research programs apply.
The translational science and research activities typically consist of the following programs in accordance with the current Good Laboratory Practice (cGLP) / Good manufacturing Practice (cGMP) regulations:
- Definition of the specific use or indication and the required non-clinical and clinical performance criteria of the prototype/product including stakeholders and their requirements
- A comprehensive set of preclinical safety assessment including literature research, in vitro and in vivo animal studies
- Prototype qualification through a product and process development program to consistently achieve the defined specification
- Complete documentation of the preclinical and prototype qualification research program including a risk mitigation plan
- Manufacturing of the prototype in a cGMP compliant facility and approval by a Qualified Person
Rechtlicher und regulatorischer Rahmen für Produkte der Gesundheitsversorgung zur Anwendung beim Menschen
Produkte der Gesundheitsversorgung für den menschlichen Gebrauch sind gesetzlich geregelte Produkte, die von Behörden wie der Europäischen Arzneimittelagentur (EMA), der Food and Drug Administration (FDA) oder anderen, von einer Behörde benannten Stellen, zugelassen sind. Solche Produkte können nur nach Zulassung oder Genehmigung durch eine jeweils zuständige Stelle am Menschen verwendet und vermarktet werden.
Bevor mit der Entwicklung eines Produkts für eine gesundheitliche Anwendung begonnen wird, muss geklärt werden, welcher rechtliche und regulatorische Weg anzuwenden ist. Jedes Produkt unterliegt demnach einer der vier Regularien. In Europa sind dies:
- Medizinprodukteverordnung (MDR) (Verordnung EU/2017/745)
- Verordnung über In-vitro-Diagnostika (Verordnung EU/2017/746)
- Humanarzneimittel (Richtlinie 2001/83/EG und Richtlinie 2009/35/EG
- Fortgeschrittene therapeutische Arzneimittel (Verordnung EU/1394/2007)
You can find out how the translation of a clinical trial product in fiT would work in this exemplary project film.