Fifth Framework Programme - External Advisory Groups

	Medical Biotechnology to Clinical Practice
	Report of a Workshop organised under the aegis of the External Advisory Group (EAG) of the Cell Factory Key Action Brussels, 8-9 June 2000

The complete report is available as PDF-file: eag-gmo.pdf (430 Kb).
The overheads presented by the various speakers during the workshop are available as PDF-file: eag-gmo.pdf (3,8 Mb).

Rapporteurs:

Prof. Manuel Carrondo
Prof. Börge Diderichsen
Dr Alain Bernard
Dr Elisabetta Balzi

EXECUTIVE SUMMARY

In the field of biomedical Research and Development, the pace of discovery and development of new diagnostic products, bio-medicines and therapeutic strategies are rapidly increasing. The approach taken in the U.S.A. reflects strong pharmaceutical competencies. Europe has to develop systems to facilitate further the path leading from discovery and development towards phase I/II clinical trials. This goal can only be achieved through the establishment of a more integrated network and tighter links between bio-technologists and clinical practitioners, while creating a more supportive attitude to innovation in bio-medicine by regulators and policy makers, at earlier stages in the development of products. This report summarises the findings of the workshop "From Medical Biotechnology to Clinical Practice", conducted under the aegis of the Cell Factory External Advisory Group (EAG). The purpose was to identify the bottlenecks that exist at the interface between the nascent medical bio-technologies and clinical practice, and to explore the opportunities to strengthen the competitiveness of the European bio-medical-development sector and health care industry.

Experts from five different constituencies put forward their views and identified, in a consensual manner, the major European bottlenecks under three main headings. These experts represented large pharmaceutical industry, Small and Medium Enterprises (SME) and university / clinical departments, patient-organisations, medical bio-technologists, clinical practitioners and regulators.

1. Integrated training and education - there is a dearth of experts able to manage and integrate different disciplines involved at the interface, from concept and development of medical biotechnology products, to clinical practice. This is true for both the more scientific aspects, dealing for instance with labile molecules (e.g. proteins) and their delivery or with complex tissues and organs, as well as for the technological and managerial components involved in development, testing and regulation.
2. Common facilities - there is a lack of reference health institutes, large human tissue banks, centralised clinical data banks, GMP facilities for early development as well as clinical facilities for conducting GCP trials;
3. Regulatory harmonisation requirements - different, non-aligned country rules for all steps from development to clinical trial and unclear national agency regulatory frameworks render development of new bio-medicines and European - wide trials very hard to perform.

Drawing from the information on the recognised bottlenecks, opportunities have been identified by the group to enrich and promote the pipeline of new European bio-medicines, relying partly on support from stronger networks of the academic sector, clinical departments, industry and regulators and on a joint effort towards harmonisation of reference practices, facilities and rules. A short list of specific recommendations was drawn from the discussion, directed to each one of the areas of opportunity.

The workshop participants urge the industry leaders, researchers and clinical practitioners, with the collaboration of governments and the European Union institutions, to address and act upon the issues raised in the report. This action may require mechanisms additional to those already in existence, but such mechanisms would strengthen the European Research Area concept put forward by Commissioner P. Busquin.

External Advisory groups | Fifth Framework Programme | 19.12.2000