Java Clinical Research at the Research and Innovation Conference

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James McRedmond, Java's Chief Scientific Officer, gave a talk on our assay services in clinical trials which emphasised the two main applications of Java's laboratory assay.

Health & Medicine

Helping drug development with better
data in early phase clinical trials
Java Clinical Research
Research & Innovation
Conference
3rd March 2016

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

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

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

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

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

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

Effects of antiplatelet drugs, alone and in combination
Research & Innovation
Platelet proteomics
Applications

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

Research & Innovation
Platelet proteomics
Applications
Subtle effects of other
drugs during and after
treatment in phase I

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

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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

Editor's Notes

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

Java Clinical Research at the Research and Innovation Conference

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