The 4th Workshop on
Recent Issues in Regulated Bioanalysis
Highlights of 4th Regulated Bioanalysis Workshop
Brian Booth (USA-FDA), CT Viswanathan (USA-FDA), Louise Mawer (UK-MHRA), Arthur Leonardo Lopes da Silva (Brazil-ANVISA), Jan Welink (Europe-EMA representative / Dutch Medicines Evaluation Board) and Eric Ormsby (Health Canada) will be engaged in a stimulating and interactive discussion on
Global Harmonization of Bioanalytical Method Validation Guidelines (BMV) and Sample Analysis
This worldwide important topic will be introduced by Surendra Bansal (Hoffmann-La Roche).
The above representatives from the agencies will also share Regulatory Perspectives to Support Submissions in North America, Europe and Latin America.
Christopher Evans (GSK) will lecture on the Use of Dried Blood Spots (DBS) in Regulated Bioanalysis: Practical considerations, applicability and progresses. Is the DBS technique the future of samples collection? Could DBS be used as replacement matrix to plasma for supporting drug development in clinical pharmacokinetic studies?
Chris Beaver (MDS and chair of the Ligand-Binding Assay Session), Joseph Marini (Johnson & Johnson), and Joleen White (Bristol-Myers Squibb) will focus on LBA Recent and old Challenges and Solutions: Validation of large molecules: specificity, selectivity and non linear calibration; LBA Free/Total; LBA new technologies available: pros and cons; Orthogonal methods to complement LBA for biotherapeutics and why do we need them? Neutralization assay: New White Paper.
Patrick Bedford (Health Canada) will lecture on Health Canada's Guidance for Subsequent Entry Biologics , and Louise Mawer (UK MHRA)will share the Agency considerations on follow-on biologics and biosimilars.
Steve Lowes (Advion) will lecture on technical challenges in providing quantitative analysis in a regulated environment for Biomarkers and on the development of a Regulatory Guidance able to meet the growing industry demand in this field.
Eric Woolf (Merck) will speak about "Bioanalytical Run Assessment - Factors to Consider Beyond the White Paper". Further discussing will be on evaluation of internal standard (IS) criteria; acceptance criteria for the variation of IS; trend analysis by using IS; Is calibration curve slope still important in LC-MS/MS bioanalysis?
Mario Rocci (ICON) and Robert Masse (Anapharm) will present "hot topics" on Incurred Samples Reanalysis (ISR): How to investigate ISR failure: Real case studies & lessons learnt; Real Case Examples in an Evolving Regulatory Landscape; What to do if the parent drug passed ISR but the metabolite failed; Hidden problems in the ISR "2/3 rule".
Mohammed Jemal (Bristol-Myers Squibb) will share his in-depth experience on Metabolites Quantification: what's new? Further discussions will cover the Purity for unstable metabolites reference standards (RSM).
Marc Lefebvre (Algorithme Pharma) will talk about the recent updates in Biostatistycal Analysis in Bioequivalence/PK studies.
Peter Vanamsterdam (Abbott and EBF representative) will also share the EBF input on global BMV harmonization.
Stephen Lowes (Advion), Peter van Amesterdam (Abbott), and Fabio Garofolo (Algorithme Pharma) will update you on the outcome and resolutions of the main 2009 Bioanalytical Conferences and Focus Groups (AAPS-BAFG; BSAT-APA; AAPS-NBC; 2nd EBF Open Forum; ASMS-RBIG.
