Anti-Infective Clinical Trials

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1 Anti-Infective Clinical Trials

2 The extensive clinical training and experience of our infectious disease staff places us in a unique position to fully appreciate the requirements of our clients conducting anti-infective clinical trials. In addition to our state-of-the-art technology, we provide global support and best practice/standard of care information during study set-up and advise and interact with our clients throughout the course of the clinical trial. Through a collaborative partnership we enhance and expedite quality delivery of accurate data that ultimately leads to the approval of new drugs which save lives and improve quality of life. Bacteriology, Parasitology & Mycology Clinical development programmes for anti-microbial compounds are becoming increasingly complex and necessitate a unique level of central laboratory support. As a global central laboratory dedicated exclusively to clinical trials, within the past 4 years we have supported over 90 bacteriology, parasitology and mycology studies ranging from Phase I to Phase IV, across 30 different disease indications, receiving study visits from in excess of 25,000 subjects. Our in-house capabilities in the US, Europe and Asia enable us to provide global consistency and quality data across all countries involved in your study. Excellence in Microbiology (EIM) Committee ICON has brought together world class experts with a combined 160 years of microbiology experience to create a committee dedicated to ensuring the success of your trial. Our EIM collaborates with your scientists to ensure the most appropriate protocol design and best in class analytical methods are chosen for your study. They will partner with your team from pre-award right through to database lock to ensure quality, timely and accurate result reporting and data transfers, in addition to providing ongoing expertise, advice and innovative solutions, to enable better, faster decision making. Review & discuss new protocols Review standard Advise and consider best practice Review & approve client specific Discuss global quality performance Review standard methods Collaboration with 3rd party laboratories Capabilities Culture, Identification & Susceptibility Customised MICs Testing all specimen types & isolates Semi-Quantitative &Quantitative cultures Species level identification Anaerobic chambers for culture & susceptibility tests Long term storage Custom assay transfer & validation Identification Systems Vitek Compact 2 API Conventional tests Spot Tests Special Stains Antibody & Antigen detection Operational Parameters 4-5 days TAT for a simple culture 6 days per week sample processing 7 day coverage for culture & susceptibility testing CLSI guidelines used (QC review, interpretation, result analysis) 20 day MIC validation for new studies Experience working with local & regional labs

3 Bacteriology, Parasitology & Mycology Customised Solutions Virology Tests, platforms, capabilities Virology EIM reviews all protocols Understanding of Microbiology testing regulatory requirements Extensive Microbiology expertise to optimise study design Ongoing availability of experts for consultation and support Viral loads are critical for assessing on-treatment anti-viral activity and treatment efficacy for anti-viral clinical trial programs. With so much importance placed on these data, it s critical that the central laboratory chosen to support your program has extensive experience and expertise in this field. In the past 4 years, ICON has successfully supported over 100 anti-viral studies across 14 disease indications, ranging from Phase I to Phase IV. We have received and tested samples from over 20,000 subjects at our global facilities from 42 countries worldwide. EIM and Client Collaboration ICON Technical Committee (ATC) Molecular Experts Precludes the need for additional testing Reduce time and financial wastage post regulatory submission Custom made procedure for testing to ensure regulatory and client specific requirements are met MIC panels are customised ICON s ITC brings together over 150 years of practical experience in collaborating with clients from protocol review right through to database lock. Our experts will advise on the benefits of specific assay utilization, protocol design and in-house custom assay transfers throughout the lifecycle of your anti-viral programme. Capabilities & Methodologies Testing Platforms Assays Include: Operational Parameters Real-time quantitative PCR Real-time qualitative PCR Reverse Transcription PCR Genotyping High speed automated immunoassays Manual EIAs Molecular Testing Abbott Diagnostics M2000 Roche Diagnostics COBAS TaqMan 48 Roche Diagnostics COBAS AmpliPrep/TaqMan Autoblot 3000H Immunoassays HIV 1&2 Ag/Ab CMIA Screen Hep A Ab IgM & Total Hep B Core Ab IgM & Total Hep B Surface Ab, Qualitative & Quantitative Hep B Surface Ag Qualitative & Quantitative Hep Be Antigen & Antibody Hep C Ab Screen CMV Ab EBV Ab Cellular Immunology Multi-colour Flow Cytometry CD4+ T Helper Cell quantitation Immunophenotyping (Lymphocyte subsets) Activation Markers Intracellular Cytokine Detection HBV Viral load HCV Qualitative HCV Viral Load HIV-1 Viral load CMV Viral load EBV Viral Load HBV Genotype HCV Genotype Abbott Diagnostics ARCHITECT i2000sr Ortho Clinical Diagnostics VITROS ECi Molecular Devices SpectraMax BD FACSCanto II BD FACSCalibur Consistency across testing locations Global SOPs EQA Interlab comparison Delta checks for false ve and false +ve results Contamination preventive measures Highly specific analytical methods to counter variation at genetic level Reflex evaluations Experience managing method to method differences between local/ regional labs and a central lab Innovative Data Solutions for Anti-virals ICONIK Hepatitis Package To assist in the rapid assessment and evaluation of the large volume of data generated during an anti-viral study, ICON have created an innovative data analytics package that is specifically designed to visually display the drug response of subjects as they progress through the treatment and post-treatment phases of hepatitis studies. Data can be stratified by genotype, liver function test results, countries, sites and multiple other subject parameters, and is available on an ongoing basis throughout the course of the study. Data can also be analysed at a program level, to rapidly visualize large data sets combined across protocols.

4 Virology Custom Flow Cytometry We have a dedicated Research and Development team who bring together over 100 years of experience in successfully developing and validating high complexity cell-based assays--from in-vitro diagnostic methods to fully customised, multi-parametric biomarker panels. Our global flow cytometry operations team executes these assays in our harmonised central labs around the world using state-of-the-art, standardised instrumentation; delivering consistent, timely high-quality results to inform your anti-viral programmes. Support Services In addition to the extensive anti-infective test menu, experience and expertise you ll find at ICON, we provide all of the necessary additional support services to ensure the successful execution of your clinical trial Safety and Supplementary Testing Logistics Data Management Project Management Site Support Study Materials and Instructional Support Quality Assurance Pre Optional (Sponsor-specific high complexity assays) 1 Week Transfer Receipt of project specific materials Performance of method transfer assays Review of results, additional actions Plan creation QC of plan Approval Performance of studies Data review, discussion with developer Additional studies if necessary Transfer Plan Creation Experments 2 Weeks 5-2 Weeks 4-8 Weeks Why ICON For Anti-Infectives Our state of the art technology, scientific expertise, experience and global reach make ICON the ideal partner for your anti-infective drug development program. Our scientific staff have authored or co-authored over 120 publications in peer reviewed journals, as well as serving on the committees of renowned anti-infective organisations and journals. Our dedicated support teams of Project Managers, Logistics Experts, Data Management teams, Quality Assurance and Site Support Personnel ensure that every aspect of your study is managed to the highest level of quality and satisfaction. Come and talk to us to find out more about what we can offer you. For more information contact: enquiries@iconplc.com ICONplc.com/labs Creation of draft QC, creation of final version Approval of validation report Report creation 4 Weeks Training Global Method Rollout

5 ICON plc Corporate Headquarters South County Business Park Leopardstown, Dublin 18 Ireland T: F: info@iconplc.com ICONplc.com/labs

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