This month, it is organizing intensive lobbying contacts between its membership and the key figures in the European Union institutions - senior diplomats, officials and members of parliament who are in a position to influence upcoming changes to EU rules on everything from research funding to clinical trials on advanced therapies...A government order implementing the law is expected to be issued this month.

Now, it said, it can start to provide testing services for clinical trials that are an important component of the collaboration...The tumor samples will originate from the multicenter brain cancer clinical trial conducted by the U.S.-based Radiation Therapy Oncology Group and the European Organization for Research and Treatment of Cancer, and supported by Schering-Plough...Herman Spolders, CEO of OncoMethylome Sciences, said, "I am happy that our cornerstone pharmacogenomics test is utilized in a

BioWorld International Correspondent BRUSSELS, Belgium - The European Medicines Agency has released draft guidance on virus safety evaluation of biotechnological medicines for clinical trials...The draft sets out criteria for viral safety evaluation studies, especially validation studies, required before and during clinical development...As soon as we have the necessary information, our reaction will be appropriate and proportionate," she said.

The guidelines offer principles and best practices for human genetic testing by encouraging high-quality laboratory practices in the collection and handling of samples and data, result reporting, education and training, and where possible, the clinical validity and use of the tests...They are intended to encourage quality assurance systems for human genetic and genomic testing, guarantee the international exchange of clinical samples and access to data on rare disease testing, and help meet OECD

The agency said last week there were major quality concerns and differences identified between Alpheon and the reference product, Roferon-A, in the quality and clinical comparability exercise...So far the scheme has delivered 22 approved therapies in the EU, and the products in the pipeline which have been designated as orphan medicines promise treatments for more than 200 conditions.

It aims to use the proceeds principally to boost clinical and preclinical studies...Clinical development programs include microplasmin, a proteolytic enzyme under evaluation for macular edema and diabetic retinopathy, and as a thrombolytic for acute stroke and peripheral arterial occlusive disease...Collen's laboratory was the first to produce tPA for clinical use

Another suggested improvement is to widen the "significant benefit" criterion for designation as an orphan, to include improvement of the quality of life alongside improved clinical safety and efficacy...When the European Medicines Agency requested additional safety and efficacy data in support of the application for an extension, the company decided to withdraw the current application and to resubmit an application when an ongoing clinical study is completed...It also has been widely remarked in

The rule will ensure high-quality research and due authorization for use in children, while improving available information without subjecting children to unnecessary clinical trials...Further calls for tender will be opened to other EU member states.

The agency stated that Orathecin (rubitecan) was being investigated in two main clinical studies of some 800 patients, assessing survival rates after receiving Orathecin in a comparison with standard medicines...The company informed the agency that at the time of the withdrawal all clinical trials in the European Union had been closed and there were no ongoing compassionate-use programs...But to reassure the EU public about the consequences of the withdrawal for patients, the agency statement added

A permanent gene therapy unit has been created in the agency, as it is expected that products in clinical development in the European Union shortly will be up for approval...The agency said that gathering knowledge from across a broad spectrum of European clinical use and preclinical development is necessary to support the development of the products with scientific advice and to evaluate their properties authoritatively...Industry anxieties have been intensified by formal Austrian statements, which

But while pharmacogenetics testing in clinical trials and large-scale epidemiological studies will be increasingly considered in pre- and post-approval development and assessment of medicines, the agency said, the use of genetic data for those purposes could raise new regulatory issues...So companies planning preliminary discussions with agency experts should provide at least four weeks in advance an outline of the key issues they wish to address with agency experts, linked to the relevant

To meet the particular challenges of evaluating new high-technology medicines, the creation of a cell therapy working party within the agency is envisaged, and actions already under way include discussion on preclinical and clinical issues in relation to the comparability of biotechnology products...Eric Gall, from Greenpeace's European affairs unit, said the EU's earlier safety assessments of 1507 were "superficial," and relied too much on data supplied by the companies.

At the same time, EBE is examining the draft EU guidelines on demonstrating significant benefit and clinical superiority for orphan medicines, which could erode the existing market exclusivity of orphans...And its member companies also are asking the European Parliament to keep in mind the interests of smaller biotechnology firms during the upcoming debates on the EU's draft regulation on clinical trials for pediatric medicines: They are urging for flexibility in the new rule, so that smaller firms

Gene therapy and cell therapy are to see new regulations, with guidance on quality, preclinical and clinical aspects of gene transfer medicines using lentiviral vectors and on assays for neutralizing antibodies...The agency will issue new guidance on potency testing for cell-based immunotherapy medicines, on production and control of biotechnological and biological medicines, on the quality aspects of similar products in which the active substances are biotechnology-derived proteins, on clinical

The draft guideline urged a case-by-case approach for the nonclinical/clinical data package, dependent on the state of the art of analytical procedures, the manufacturing processes employed, and clinical and regulatory experience...It has been created to standardize the approach to early clinical use of valuable medicines in development

It also had requested additional guidance on the types of preclinical or clinical data that could be considered as sufficient justification for the designation, with specific examples of diseases...Our sector has suffered too much from food scandals in the past to risk going against consumer opinion."

Such agreements are the life-blood of the biotech industry, since few biotech companies have the resources to undertake late-stage clinical trials and so are reliant on out-licensing to big pharma partners to see their products through to market," it said...The website also groups the individual voting patterns by nation, showing that members of parliament from Austria, Belgium, Denmark, Finland, France, Greece, Ireland, the Netherlands, Portugal, Sweden and Spain were largely in favor of tighter

The biotech medicines sector will be further affected by new rules on clinical trials and pediatric medicines...If the dam breaks, the logjam of products could turn into a flood," one senior European executive told BioWorld International.

He recognizes that the small biotech companies involved do not have the resources for large, long-term clinical trials to provide information on the cost-effectiveness of the treatment compared to conventional alternatives...One of the items on the agenda will be whether the EU should authorize BT11 corn - the latest challenger to the five-year-old informal EU moratorium on GM approvals.