Preclinical development in the current Pharmaceutical space
Transcript of Preclinical development in the current Pharmaceutical space
©2016 IDBS, Confidential
Preclinical Development
Dr. Paul Denny-GouldsonVP, Strategic SolutionsIDBS
©2016 IDBS, Confidential
Wherever you want to go,key drivers will influence your route…
Accelerated innovation – and more of it
Products to market faster Improved margins
©2016 IDBS, Confidential
CMC
A Strategic vision and SolutionIntegrated R&D&O Data, Process and Knowledge Management for Pharma
Process Chemistry
& Isotope
Production
Formulation
(GxP)
Analytical Dev
& Stab Testing
(GxP)BioAnalysis
(GLP)
Metabolite ID
Material
Sciences
Pharmacology &
Safety
PKPD
Pharmacokinetics
Drug Metabolism
Pilot
Manufacturing
QA/QCLead
Optimization
Target ID and
Mechanism
Lead ID and Med
Chem
DevelopmentManufacturing
Disease Pathways OperationsResearch
©2016 IDBS, Confidential
An IDBS Preclinical SolutionIntegrated preclinical development Data and Knowledge Management environment
Process
Chemistry &
Isotope
Production
Formulation
(GLP)
Analytical &
Stability
Testing (GLP)BioAnalysis
(GLP)
Metabolite
ID
Material
Sciences
Pharmacology
& Safety
PKPD
Pharmacokinetics
Drug
Metabolism
©2016 IDBS, Confidential
The goal is to build an R&D data value chain
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©2016 IDBS, Confidential
Master Request
List (Excel)
Drug Metabolism – Current State
Test Request
Sequence(Text)
Customer Assay Testing Lab
Instrument
Test RequestTest
RequestTest Request
Assay Setup (Excel)
Analysis(Stats
Package)
Summary(Excel)
Compound Details
Data Warehouse
Queries
Report
Report
ReportReport
Manual sequence creation
Copy & paste data; manual
analysis
Manually load data to
warehouse
Manually split data into separate reports
by project or customer
Communication done predominantly by email & sending files
Fetching compound
detailsOptimizing assay usage by
combining multiple requests
Manual Step: Copy & Paste or
©2016 IDBS, Confidential
Drug Metabolism – Streamlined Workflow
Test Request
Customer Assay Testing Lab
Instrument
Test RequestTest
RequestTest Request
IDBS Assay Record
(from template)
Compound Details
Data Warehouse
Queries
Report
Report
ReportReport
Automated data load and
analysis
Automated loading of results to warehouse
on publishing
Communication is orchestrated through task system: allowing alerts,
emails, scheduling and updates
Direct integration with inventory
Support for splitting or combining requests and assigning compounds to specific tests
Master Request Queue
Queries
Data reported by project/customer or other means
using queries and automated reports
Assay Parameters
Sequence
Data
Analysis & Results
Automated sequence creation
©2016 IDBS, Confidential
Some examples of what people already do
Class Assay/Workflow
Pharmacokinetics Study DesignDosing and Sample CollectionSolution/Standards PreparationWorklist and Instrument InterfacingNon-Compartmental AnalysisCassette StudiesTissue Uptake
Inhibition CYPTDI ScreenBCRPPGP MRP-2reversible/irreversible
Induction Hepatocytein vitro, ex vivoRGA/PXR
Stability Hepatocyteliver microsomesrCYP
Class Assay/Workflow
Metabolic ID Completein vitroIn vitro HTanimal ADMEhuman ADME
Transport/Uptake OATB-ClearCACOMDCK-PCRPKi determinationKm/Vmaxunidirection/bidirectional
Solubility
Protein Binding Covalent Bindingadduct formationEquilibrium dialysis
Blood:Plasma Ratio
©2016 IDBS, Confidential
Pharmacokinetics – Current State
Test Request
Study Plan (Word)
Test Request
Sample Collection
(Excel)
Sequence(Excel/Text)
CustomerAnimal
TechnicianStudy
Director Bio analyst
Mass Spec
Report (Word)
QA
Analysis is done by hand or copied to/from external
application
Manual sequence creation
Email EmailEmail
Communication done predominantly by email & sending files
Content in report must be traced back
to source records
Report is manually created from results file Analysis
(Excel/WNL)
Manual Step: Copy & Paste or
©2016 IDBS, Confidential
Pharmacokinetics – Streamlined Workflow
Test Request
Study Plan
Sample Collection Sequence
Customer Animal Technician
Study Director Bioanalyst
Mass Spec
AnalysisReport (Word)
QA
Data is imported and analysis is automatically
completed
Query
Optimized sequence is generated by query for
samples associated with study
Query
Tasks
Communication is orchestrated through task system: allowing alerts,
emails, scheduling and updates
Review is minimal as analysis and report are
system generated. Approval tracked using
task system
Word Report is generated automatically using
Export to Word features
Query
Optimized dosing and sampling schedule
automatically created after querying system
for study plan info
Test Request
©2016 IDBS, Confidential
PKPD Challenges
Results from different experiments/assays to be easily
queried and rapidly combined for meta analysis and/or trending
Coordinating PK and PD studies can be tough!
Merging datasets is time consuming and error prone
PKPD throughput is constrained
©2016 IDBS, Confidential
PKPD – Current StateEfficacy (PD) Study
Collect Samples
Bioanalysis (PK) Study
Import Sample Information
Collect Measurement
DataCollect PK Data
Send PK Request
Sample Info
Create ReportPK
ResultsCreate Report
Load data to warehouse
PKPD Modeler
Merge PD+PK data per sample
Massage data to load into modeling
tool (e.g. NONMEM)
Manual Step: Copy & Paste or
Requests are sent, typically via email, often with incomplete
information
Data are reported in multiple formats often
without full sample information
Summary reports are manually
created in Word, Excel or PPT Report
Manually load data to
warehouse
Merging the data and preparing it for analysis is by hand. Very time consuming
and error prone
©2016 IDBS, Confidential
Efficacy (PD) Study Bioanalysis (PK) Study
PKPD Modeler
PKPD – Streamlined Workflow
Collect Samples Import Sample Information
Collect Measurement
dataCollect PK data
Send PK Request
Sample Info
Create ReportPK
ResultsCreate Report
Merge PD+PK data per sample
Massage data to load into modeling
tool (e.g. NONMEM)
Test Requesting orchestrates requesting and scheduling
process
Data can be transmitted via the
database and retrieved using a query
Data can be easily merged with a query,
reducing errors
Summary reports can be automatically
generatedReport
Data can be analyzed/visualized within the system automatically, or
formatted ready for export
Key results can be automatically loaded to data
warehouse
Load data to warehouse
Load data to warehouse
©2016 IDBS, Confidential
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Bioanalysis - Going beyond the basics Insight into what else IDBS can provide as part of a BA solution
• Watson / No Watson?
• Reagents• Equipment• Deviation Management
©2016 IDBS, Confidential
Certificate of Analysis
Registration of critical COA related data.
pH Meter CalibrationpH Meter Calibration data
management.
Matrix LotRegistration of Matrices and
management of pooling information.
Standard and QC PrepTracking of relevant
information from preparation of Standards and QCs.
Common ReagentTracking of relevant
information from preparation of common
reagents.
Stock SolutionTracking of relevant
information from stock solution
creation.
Balance CheckProcess to ensure
balances function within expected limits.
Sample AnalysisCollection of analytical run
related data from production, method
validation, qualification or mandatory repeat runs.
Sample HandlingManage the logistics around registering
sample handling, sample shipment discrepancies and sample disposal.
Bioanalysis – the bit not in a LIMS
©2016 IDBS, Confidential
Formulations challenges Have we made this before – I cannot find any information on a given
formulation as all the data is in excel / local databases What was done to this formulation compared to another one – we want to
reduce the amount of repeat work and testing of known failed formulations Can we correlate the change in formulation with a change in property – link
downstream testing data with a formulation GLP and non GLP means I have to track everything and in paper it is really
difficult Sharing data with other groups – PK need to know stuff as do analytical but
I spend all my time writing reports and re-working data
©2016 IDBS, Confidential
An IDBS Preclinical SolutionIntegrated preclinical development Data and Knowledge Management environment
Process
Chemistry &
Isotope
Production
Formulation
(GLP)
Analytical &
Stability
Testing (GLP)BioAnalysis
(GLP)
Metabolite
ID
Material
Sciences
Pharmacology
& Safety
PKPD
Pharmacokinetics
Drug
Metabolism
©2016 IDBS, Confidential
But - What else is happening in the market Constant pressure on preclinical to be more efficient and
productive
Outsourcing / externalization of preclinical work is growing
But the requirements for accessible and good data is always there
©2016 IDBS, Confidential
CRO 1
CRO 2
CRO 3
CRO 4
Internal
InternalInternal
Internal
Internal
©2016 IDBS, Confidential
©2016 IDBS, Confidential
Why IDBS? Domain Experience
Company What we doUS Pharma IDBS (Global) PK,PD,BT,BA, Pre Formulations
Japanese Pharma IDBS (Global) PKUS Pharma IDBS (Global) PK,PD,BA
EU/US Pharma IDBS (Global) PD, DM, PK, BA, Pre Formulations, GLPUS Pharma IDBS PK
EU/US Pharma IDBS (Global) PD, DM, PK, BA, Pre Formulations, GLPEU Pharma IDBS (Global) PK, BA GLPEU Pharma IDBS BA GLP
US CRO IDBS BA, GLPUS Pharma Global Research and Pre ClinicalUS Pharma DM, PK
EU/US Pharma Oncology Vitro + VivoUS CRO IDBS (BioA, PK)
©2016 IDBS, Confidential
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