3D Tissue Models
4th annual Bioanalysis in Clinical Research
Olympia Conference Centre

London, UK
4th annual Bioanalysis in Clinical Research
Olympia Conference Centre

Schedule of Presentations:

Wednesday, February 11, 2009
08:30:00 Coffee and registration
09:00:00 Opening remarks from the chairperson Philip Timmerman
09:10:00 Keynote Address: Regulated bioanalysis - focus on support of clinical studies Philip Timmerman
09:10:00 Essential updates on the regulatory environment, standpoint and requirements
09:50:00 Keynote Address: GCP in bioanalysis: An overview of the history and the important components of a good study design Neelam Muizzuddin
10:30:00 Morning networking refreshments
11:10:00 Crucial information on small molecule drug metabolites, including MIST (metabolites in safety testing) Stefano Persiani,
11:40:00 Strategies for the analysis of therapeutic peptides in biofluids
12:10:00 Effectively working with the regulatory authorities - meeting essential requirements Marianne Groeneveld
12:40:00 Networking lunch
14:10:00 Spotlight Session
14:40:00 Real life examples of incurred sample analysis, repeat analysis: Demonstrating that your assay is reproducible Dirk Kasel
15:10:00 Afternoon networking refreshments
15:50:00 Latest directions in bioanalytical techniques
15:50:00 Latest updates on how mass spectrometry is being applied to large molecules
16:20:00 Emerging techniques in LC-MS and their role in reducing matrix effects Achille Cappiello
16:50:00 Gas chromatography-mass spectrometric analysis of F2- isoprostanes, biomarkers of oxidative stress, in vitro and in vivo
17:20:00 Examining the latest research into new electrochemical arrays coupled with magnetic separators for immunochemistry Marco Mascini
17:40:00 Closing remarks from the chairperson Philip Timmerman
17:50:00 End of conference day one
Thursday, February 12, 2009
08:30:00 Coffee and registration
09:00:00 Opening remarks from the chairperson Philip Timmerman
09:10:00 Keynote presentation by Jeffrey Sailstad: Co-organizer of the Crystal City III meeting, co-author of the meeting’s proceeding paper and a co-guest editor of the AAPS Journal themed issue dealing with bioanalytical method validation Jeffrey Sailstad
09:10:00 Indispensable advice on how to practically implement the Crystal City and AAPS findings
09:50:00 Practical guidance on the most vital bioanalysis issues
09:50:00 Global Bioanalysis in Virtual Pharma - Expectations for Successful CRO Relationships Richard Abbott
10:30:00 Morning networking refreshments
10:50:00 Optimizing Immunogenicity Screening Assays for Sensitivity and Reduction of Outliers
11:20:00 Regulatory requirements for incurred sample analysis Binodh DeSilva
11:50:00 Spotlight Session
12:20:00 Networking lunch
13:30:00 The importance of transferring bioananlytical techniques, such as flow cytometry and multiplex bioanalysis, from the research lab to a regulated environment for use in early clinical trial endpoints
14:00:00 Assessing and implementing quality in your bioanalytical studies: Should GLP, GCLP or another system be followed? • What are the GLP guidelines and is GLP suitable to follow? • How do GCLP guidelines differ from GLP, and will these be accepted as a standard? • Using available texts to develop your own system of practice • How to ensure that all laboratories used are up to a suitable standard if they are not accredited Brian A. Roberts, Sr. Life Scientist, Science Applications International Corporation (SAIC), USA Brian A. Roberts
14:30:00 Panel discussion: Coming to a consensus on evaluating the level of agreement between original and repeated results Hendrik Neubert
15:00:00 Afternoon networking refreshments
15:20:00 A practical implementation of MIST towards quantification of metabolites - SMART use of resources by applying a tiered approach
16:00:00 Common practice and challenges in biomarker data analysis
16:40:00 A practical example of in vitro, in vivo correlation: How to associate in vitro dissolution with in vivo data in bioequivalence studies Jean Michel Cardot
17:10:00 Closing remarks from the chairperson Philip Timmerman
17:20:00 End of conference day two
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