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Semelhante a Java Clinical Research at the Research and Innovation Conference
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Java Clinical Research at the Research and Innovation Conference
- 1. Helping drug development with better data in early phase clinical trials Java Clinical Research Research & Innovation Conference 3rd March 2016
- 2. Who we are Java Clinical Research • Clinical Research Organisation since 1999. • A team of expert clinical research professionals • Manage Clinical Trials in the Pharmaceutical Industry • Deal with regulatory frameworks in multiple jurisdictions (EU, US, UK) • Develop and implement customised pharmacodynamic assays for clinical research 2
- 3. Better data in early phase clinical trials • Use modern technologies in clinical trials • Focussed, customised assays to measure drug-specific endpoints • Open, broad assays for biomarker discovery • Develop, streamline & validate methods to industry standards • Full documentation, implementation, training and support • Enable better decisions at critical phase I and phase II. 3
- 4. Case study: Clinical proof of concept in phase I study • Novel drug that has innovative characteristics • Startup needed to demonstrate USPs of drug early in clinical development • Java developed 3 customised assays for use in phase I • Delivered vital data for client: – detailed data on drug USP throughout phase I – close monitoring of ‘first in human’ study • Startup sold to top 10 Pharma
- 5. Case study: Clinical proof of concept - how we did it • Agility – Rapid development of customised bioassays • Capability – Put in place processes to implement complex assay measuring drug target – Developed novel sampling assay from scratch to target drug site of action – Researched & tailored established assay to measure specific markers • Partnership – Clinical trial sites – Other vendors
- 6. Case study 2: Platelet function testing • Brief – IC50 and drug interaction data • Activity – Assay testing 48 conditions developed – Procedure validation – Recruited and tested n=30 healthy volunteers • Results – Comprehensive data on 3 drug candidates – Study report compiled to support FDA submission
- 7. Research & Innovation Platelet proteomic assay dense granule – ADP & 5-HT a granule – proteins • Proteomics measures 1000s of biomarkers - unbiased • Platelets critical for targeted drug effects and off-target side-effects • Java has developed – standard methods for sampling and analysis – Computational techniques for analysis – Applied the technology in diagnostics, personalised medicine and clinical trial analysis • Supported by Enterprise Ireland and Irish Research Council
- 8. Effects of antiplatelet drugs, alone and in combination Research & Innovation Platelet proteomics Applications
- 9. 1.00E+08 1.00E+09 1.00E+10 1.00E+11 ALB FGA FGG PPBP THBS1 FGB PF4 CEP290 ACTB;ACTA1 HBB IGHG1 HBA1;HBA2 sp|P12345|SPIKE_HU… SPARC MMRN1 LTBP1 TF HP FLNA C3 VWF SERPINA1 APOA1 TLN1 IGKC CLEC12A A2M GSN FN1 NID1 MYH9 F5 PROS1 GP5 APP IGHA1 VCL TIMP1 IGHG3 IGLC2;IGLC3;IGLC6 TPM4 ACTA1;ACTC1;ACTG2;… TGFB1 HPX ACTN1 GAPDH IGHG2 GC CFH TUBA1B;TUBA1A LFQ Intensity LFQ intensity 5fmolStd LFQ intensity 10fmolStd LFQ intensity 20fmolStd Accurate, label-free quantification of proteins in clinical samples Research & Innovation Platelet proteomics Applications
- 10. Research & Innovation Platelet proteomics Applications Subtle effects of other drugs during and after treatment in phase I
- 11. Summary 11 Java Clinical Research www.javacr.com info@javacr.com @JavaClinical James McRedmond – Chief Scientific Officer • Java Clinical Research develops custom assays to tell you more about your drug – specific, focussed assays to prove your drug is working as expected – broad, open assays to find biomarkers, pathways or other effects you should be aware of
Notas do Editor
- management, quality, regulatory, clinical, scientific
- doing more in studies that are going on anyway
- Example of how we delivered more and better data for a client typical for startups that they are limited by budget – with us, do more in a single trial close monitoring of drug effects in 1st in human with customised lab processes - topical
- agility – small company, Quick results for safety/dosing of cohorts capability – CRO, scientific know-how, experience. 3 different types of capability – method/reg; de novo; mostly office research partnership – typical in industry to work with others, we do routinely, and also if for lab services we don’t know, we know someone who can, & have a can-do attitude+ here joint bid defense
- Doing R&D to improve and expand our service offering in lab NB EM is an innovative process we developed & implemented in phase I platelets – target of drugs to prevent heart attacks, also potential side effects can do proteomics in other cells also
- Replicate measurements – quantify hundreds of proteins Patterns of expression – effects of drugs, and combinations In clinical trials, effects pre-, mid-, and post- treatment. Coming soon – patient differences. Could be useful in trials
- Replicate measurements – quantify hundreds of proteins Patterns of expression – effects of drugs, and combinations In clinical trials, effects pre-, mid-, and post- treatment. Coming soon – patient differences. Could be useful in trials
- Replicate measurements – quantify hundreds of proteins Patterns of expression – effects of drugs, and combinations In clinical trials, effects pre-, mid-, and post- treatment. Coming soon – patient differences. Could be useful in trials