M3 Klinische TranslationM3 Clinical Translation

Clinical Translation

Once results have been obtained from studies on tissue engineering and sold body implants they must be applied in the clinic. However, this is an immense challenge. The European Registration Procedure lays down a complex procedure consisting of laboratory studies and graduated clinical testing, in order to apply a medical device or a medical device with cellular components (ATMP) in man. In addition, the individual steps must comply with specific quality standards with respect to the investigations and facilities. This is very similar to drug registration. Thus an objective or qualitative error in the development of new implants can lead to years of development in the clinical implementation and make it necessary to repeat studies relevant to registration.

As tissue engineering and biofunctionalisation of sold body implants to avoid infection are rapidly developing and trendsetting procedures, there will be developments that are not even considered under the current conditions of registration. There are interfaces between the manufacture of medical devices and drugs or medical devices and ATMP. Totally new expertise must be developed to perform investigations for registration.

The BIOFABRICATION initiative is intended to perform research projects in the modules “Tissue Engineering” and “Implant-Associated Infections and Immune Reactions” under conditions that are relevant to registration from the start. These studies must be compliant with both national and international registrations, so that any commercial launch can cover as wide an area as possible. Each individual step must be compliant with the instructions of all registration authorities and direct contacts with these authorities must be developed. Moreover, timely contact must be made with the health authorities that are responsible for financing new services.

The research and development of highly innovative implants has only had a brief history, which is why there are only a few experts on issues relevant to registration. The few available experts are often self-taught and are qualified for a single application, without any overall knowledge of different products. In this context, BIOFABRICATION will first generate a group of specialists who can close this gap in the portfolio of many research facilities and between clinicians and industry. For this purpose, the project staff members in quality management, risk assessment, preclinical and clinical testing and approval of medical devices and ATMPs must establish and improve their qualifications. In parallel, they must organise regular training sessions for staff members, students and associated scientists from the other Hannover University sites on themes related to the registration drugs and medical devices and ATMPs, as well as other translation-specific themes, in order to accelerate the translation of research results into clinical use. In addition, staff members of cooperating industrial partners can be offered advanced training, so that the resulting group of experts becomes an established component of teaching at the NIFE. During the intended duration of BIOFABRICATION, companies will be added as cooperative partners to support the growing number of product developments. However, these will mostly concentrate on specific organs rather than specific procedures. The applicant therefore assumes that, in the long term, a scientist with specific training in translation will be responsible for the development line for each implant system - musculoskeletal, cardiovascular, dental, audioneurological, plastic surgical. The essential duties of this scientist will include the performance and planning of studies in R & D relevant to registration, setting up timely contacts to registration authorities, health insurance funds and other relevant institutions, as well as cooperation and identification of interested industry partners. The objective is to use these measures to drive the development and market launch of innovative implants.

Here are the staff of this module