How the bioanalytical scientist plays a key role in interdisciplinary project teams in the development of biotherapeutics - a reflection of the European Bioanalysis Forum.

The bioanalytical scientist plays a key role in the project team for the drug development of biotherapeutics from the discovery to the marketing phase. Information from the project team members is required for assay development and sample analysis during the discovery, preclinical and clinical phases of the project and input is needed from the bioanalytical scientist to help data interpretation. The European Bioanalysis Forum target team 20 discussed many of the gaps in information and communication between the bioanalytical scientist and project team members as a base for providing a perspective on the bioanalytical scientist's role and interactions within the project team.

Conference report: AAPS and US FDA Crystal City V meeting on Quantitative Bioanalytical Method Validation and Implementation: feedback from the EBF.

Crystal City V meeting on Quantitative Bioanalytical Method Validation and Implementation: 2013 Revised US FDA Guidance 3-5 December 2013, Hilton Baltimore, MD, USA The meeting provided an opportunity for Industry and regulators from the US FDA to discuss the recently published revised draft FDA Guidance for Industry on Bioanalytical Methods Validation during the 90 day review period. Key perspective and philosophical positions were shared leading to a healthy exchange of views and ideas on topics in the revised document. Discussions covered all aspects of bioanalytical method validation and method utilization.

2013 White Paper on recent issues in bioanalysis: 'hybrid'--the best of LBA and LCMS.

The 2013 7th Workshop on Recent Issues in Bioanalysis was held in Long Beach, California, USA, where close to 500 professionals from pharmaceutical and biopharmaceutical companies, CROs and regulatory agencies convened to discuss current topics of interest in bioanalysis. These 'hot' topics, which covered both small and large molecules, were the starting point for fruitful exchanges of knowledge, and sharing of ideas among speakers, panelists and attendees. The discussions led to specific recommendations pertinent to bioanalytical science.

The European Bioanalysis Forum community's evaluation, interpretation and implementation of the European Medicines Agency guideline on Bioanalytical Method Validation.

The European Medicines Agency's (EMA) 2011 guideline on bioanalytical method validation (BMV) was evaluated and subsequently intensely discussed by the European Bioanalysis Forum (EBF) during a 2-day workshop (EBF Workshop on the implementation of the EMA guideline on BMV, Château de Limelette, Limelette, Belgium, 15-16 March 2012). The goal of the evaluation and discussions was to come to a uniform interpretation of the guideline and thus to help facilitate a smooth implementation at our laboratories. Up front preparations for the workshop by dedicated teams concentrated on challenges on implementation: ambiguities, technical or operational challenges and issues in general.

Managing scientific, technical and regulatory innovation in regulated bioanalysis: a discussion paper from the European Bioanalysis Forum.

On 12-13 June 2012, the European Bioanalysis Forum hosted its third Focus Meeting in Brussels (Belgium). At the meeting, a panel discussion was held on the hurdles that the bioanalytical community encounters when adopting new technologies or managing regulated bioanalysis expectations around emerging technologies. Over the last few years, the industry has seen many new technologies maturing.

Conference Report: the 3rd EBF Focus Meeting: 'Hatching'--emerging technologies approaching the regulated bioanalysis laboratory. Brussels, Belgium, 12-13 June 2012.

One hundred and eighty scientists from industry and academia discussed the progress in emerging technologies approaching regulated bioanalysis, with a focus on what potential hurdles prevent them becoming broadly accepted by industry and regulators. The conference delegates agreed that moving innovative technologies forward can only be achieved by providing solid data to support the application. In addition, also establishing an open dialogue with health authorities is key for success.

'Less is More': defining modern bioanalysis.

The 4th Open Symposium of the European Bioanalytical Forum entitled 'Less is More' was held on 16-18 November 2011 at the Hesperia Tower Hotel, Barcelona, Spain. More than 50 interesting presentations were delivered covering areas with interest for the small- and large-molecule community - biomarker validation; regulations, including an update on new and emerging guidelines and on Global harmonization; technology updates; incurred sample stability; microdosing; dried blood spots and microsampling; challenges of 'free' and 'total' macromolecule quantification; stability issues in ligand binding assays or anomalous results. In excess of 450 delegates from more than 170 institutes and companies (industry, regulators and academia) from all global regions participated in the open and stimulating discussions.

From challenges to solutions. European Bioanalysis Forum 3rd Annual Open Symposium, Hesperia Towers, Barcelona, Spain, 1-3 December 2010.

The European Bioanalysis Forum is a bioanalytical nonprofit organization comprised of European pharmaceutical companies (27 members to date) and currently expanding to include CROs as well. The European Bioanalysis Forum provides a broad European bioanalytical network for the discussion of scientific, technological and regulatory topics of bioanalytical interest. The 3rd Annual Open Symposium was again much anticipated after the two previous successful meetings.

Incurred sample reproducibility: views and recommendations by the European Bioanalysis Forum.

Following intensive discussions, review, alignment of procedures and multiple surveys among their member companies, the European Bioanalysis Forum (EBF) is providing a recommendation on how to integrate incurred sample reproducibility (ISR) in the bioanalytical process. The recommendation aims to provide guidance throughout the lifecycle of a validated method, including the application of the method in study support. In its recommendation, the EBF considers both the internal discussions with EBF member companies, as well as the input provided in international meetings where ISR was discussed.