BioWorld International Correspondent

BRUSSELS, Belgium - The European Union's medicines agency in London plans to devote additional resources this year supporting innovative medicines and technologies.

Recently-released detailed plans for 2007 include intensified activity on evaluation and supervision of medicines, particularly providing pharma firms with scientific advice and early assistance in designing testing protocols. The agency has promised to focus on providing special support for small and medium-sized enterprises, and on contributing to pan-European initiatives for facilitating innovative research.

Its efforts will include continued backing for the EU orphan medicines policy. Protocol assistance will remain a priority area for the incentives offered under the scheme.

The agency has admitted in its 2007 workplan that emerging therapies and new technologies are presenting it with new challenges. The agency is already engaged in providing advice in early stage development of advanced therapy medicinal products - gene therapy, somatic cell-therapy and human tissue-engineered products, as well as other new technologies that will not fall within the scope of the upcoming EU regulation on advanced therapies.

It plans to promote early dialogue with sponsors of potential applications for advanced therapies and emerging products and technologies, and will widen its exchanges to academia and society at large, in a bid to identify expertise, expectations and bottlenecks relating to new treatments. One of the consequences during the year will be the drafting of a "Strategic plan for new technologies."

The agency's pharmacogenetics working party - which will meet five times during the year - will contribute to the scientific advice and protocol assistance on relevant pharmacogenetics and pharmacogenomic aspects, and will hold briefing meetings with applicants in response to specific requests.

It also will be finalizing new guidance for companies developing medicines in this field - on pharmacogenetic samples, testing and data handling, on pharmacogenetics and pharmacokinetics studies, on the use of genomics in clinical trials to explore treatment and genomic traits, and on pharmacogenomics in oncology.

The recently-established biosimilar medicines working party will also be developing new guidance, covering non-clinical and clinical issues on biosimilar medicinal products containing biotechnology-derived proteins, recombinant -Interferons, or low molecular weight heparins.

The agency also will be giving training to national assessors on evaluation of the quality, nonclinical and clinical aspects of biosimilars.

The gene therapy working party will review and update much of its current guidelines. It is revising its advice on quality, preclinical and clinical aspects of gene transfer medicines, on the scientific criteria for qualification as a gene therapy medicine, on genetically modified cells as gene therapy medicines, on nonclinical studies prior to clinical use of gene therapy medicines and on clinical monitoring of subjects treated with them.

Other areas under review will be pre-clinical and clinical experience on dose definition and dose ranging studies in gene therapy, and an update on long-term follow-up of participants in gene therapy clinical trials.

The agency currently is finalizing a series of definitions to avoid the risk of confusion in the rapidly emerging field of biomarkers. "The lack of consistently applied definitions to commonly used terminology raises the potential for conflicting use of terms in regulatory documentation and guidances or inconsistent interpretation by regulatory authorities, ethics committees and sponsor companies," it said.

A guideline now in preparation provides definitions for genomic biomarkers, pharmacogenomics, pharmacogenetics, genomic data and sample coding categories - "to facilitate the integration of the discipline of pharmacogenomics and pharmacogenetics into global drug development and approval processes."

According to the agency, the definition of what constitutes a genomic biomarker is key to understanding the definitions of pharmacogenomics and pharmacogenetics. It sets out clearly that a genomic biomarker is "a measurable DNA or RNA characteristic that is an indicator of normal biologic processes, pathogenic processes and/or response to therapeutic or other intervention."