SAFE-T Announcement: "Liver and Kidney Groups meet with the EMA and FDA!"


SAFE-T are delighted to announce that both the Liver and Kidney work packages have met with the regulatory authorities since the beginning of the year to seek advice and advocation of their biomarker selection and qualification plans for the exploratory phase of their projects. These important first meetings are in line with the overall consortium objective of interacting and liaising with the agencies early in study plans. "Being as transparent and upfront as possible with the EMA and FDA is instrumental to the consortium being successful and the last 6 months have demonstrated this very effectively for SAFE-T" commented Michael Merz, Novartis; the consortium co-ordinator.

On 1st March 2010, representatives of the Liver work package (led by Ina Schuppe-Koistinen in London and Michael Merz in Washington) met with the EMA and FDA in a joint briefing meeting to discuss the exploratory-phase plans of the team to qualify their novel candidate biomarkers for Drug Induced Liver Injury. Proposed patient populations defined in the qualification plan are to include healthy subjects, patients receiving chronic treatment with potentially hepatotoxic drugs, patients with non-drug-related liver diseases, and patients with systemic diseases with and without hepatic involvement. The exploratory phase qualification strategy was supported by the agencies with the recommendation to return for further discussions prior to the commencement of the confirmatory phase of the biomarker qualification. 

On 2nd June 2010, representatives of the Kidney work package (led by Joe Keenan & Frank Dieterle both in London) also met with the agencies in a joint briefing meeting to seek advisory input for the exploratory phase plans of the team. Explaining the rationale behind how the Kidney group selected their candidate biomarkers, nephrotoxic drugs and patient cohorts was important as the group sought regulatory comments on these processes. Like the Liver group the Kidney exploratory phase qualification strategy was supported by the agencies with some very useful and practical recommendations. The agencies added that they were keen to meet again prior to the full scale undertaking of the confirmatory phase of the plan. This is very much in line with what the SAFE-T kidney group would want.

In all, both meetings gave SAFE-T the opportunity to liaise and interact with the EMA and FDA to further the common goal of biomarker qualification. Michael Merz added "We are keenly awaiting the meeting of the Vascular group with the agencies in the autumn to complete the trio of work packages that make up SAFE-T".

Back to news list