Capturing and managing that all-important data to make PK/PD analysis, in-vitro/in-vivo analysis and study reporting on demand whilst providing tangible benefits to each domain. IDBS has been delivering solutions into the preclinical development space for many years now. All of these solutions have delivered significant value to both the end user scientists and the organizations that employ them. The benefits come by increasing the time scientists can do their science by removing or drastically minimising non value add tasks – copy and pasting data from one application to another, writing reports, aggregating data from different studies etc. The business value to the organization is the greater opportunity to do more and improve the collaboration between the different business areas. These slides are part of a webinar series where we delve deep in pharmacology, drug metabolism, PK, bioanalysis or formulations. Watch this webinar here http://ow.ly/10fsRv

1. ©2016 IDBS, Confidential
Preclinical Development
Dr. Paul Denny-Gouldson
VP, Strategic Solutions
IDBS

2. ©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

3. ©2016 IDBS, Confidential
CMC
A Strategic vision and Solution
Integrated 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
Pharmacokinetics
Drug
Metabolism
Pilot
Manufacturing
Lead
Optimization
Target ID
and
Mechanism
Lead ID and Med
Chem
Development
Manufac
Disease
Pathways
OperationsResearch

4. ©2016 IDBS, Confidential
An IDBS Preclinical Solution
Integrated 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
Pharmacokinetics
Drug
Metabolism

5. ©2016 IDBS, Confidential
The goal is to build an R&D data value chain
5

6. ©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
Repor
t
Repor
t
Repor
tReport
Manual
sequence
creation
Copy & paste
data; manual
analysis
Manually load
data to
warehouse
Manually split data
into separate reports
by project or
customer
Email
Email
Communication done predominantly
by email & sending files
Fetching
compound
details
Optimizing assay usage by
combining multiple requests
Manual Step:
Copy & Paste
or Email

7. ©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
Repor
t
Repor
t
Repor
tReport
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

8. ©2016 IDBS, Confidential
Some examples of what people already do
Class Assay/Workflow
Pharmacokinetics Study Design
Dosing and Sample Collection
Solution/Standards Preparation
Worklist and Instrument Interfacing
Non-Compartmental Analysis
Cassette Studies
Tissue Uptake
Inhibition CYP
TDI Screen
BCRP
PGP
MRP-2
reversible/irreversible
Induction Hepatocyte
in vitro, ex vivo
RGA/PXR
Stability Hepatocyte
liver microsomes
rCYP
Class Assay/Workflow
Metabolic ID Complete
in vitro
In vitro HT
animal ADME
human ADME
Transport/Uptake OAT
B-Clear
CACO
MDCK-PCRP
Ki determination
Km/Vmax
unidirection/bidirectional
Solubility
Protein Binding Covalent Binding
adduct formation
Equilibrium dialysis
Blood:Plasma Ratio

9. ©2016 IDBS, Confidential
Pharmacokinetics – Current State
Test
Request
Study Plan
(Word)
Test
Request
Sample
Collection
(Excel)
Sequence
(Excel/Text)
Customer
Animal
Technician
Study
Director Bio analyst
Mass
Spec
Report
(Word)
QA
Analysis is done
by hand or copied
to/from external
application
Manual sequence
creation
Email
Email
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 Email

10. ©2016 IDBS, Confidential
Pharmacokinetics –
Streamlined Workflow
Test
Request
Study
Plan
Sample
Collection
Sequence
Customer
Animal
Technician
Study
Director
Bioanalyst
Mass
Spec
Analysis
Report
(Word)
QA
Data is imported
and analysis is
automatically
completed
Query
Optimized sequence is
generated by query for
samples associated
with study
Quer
y
Task
s
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
Quer
y
Optimized dosing and
sampling schedule
automatically created
after querying system
for study plan info
Test
Request

11. ©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

12. ©2016 IDBS, Confidential
PKPD – Current State
Efficacy (PD) Study
Collect Samples
Bioanalysis (PK) Study
Import Sample
Information
Collect
Measurement
Data
Collect PK Data
Send PK
Request
Sample
Info
Create Report
PK
Results
Create 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 Email
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

13. ©2016 IDBS, Confidential
Efficacy (PD) Study Bioanalysis (PK) Study
PKPD Modeler
PKPD – Streamlined Workflow
Collect Samples Import Sample
Information
Collect
Measurement
data
Collect PK data
Send PK
Request
Sample
Info
Create Report
PK
Results
Create 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
generated
Report
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

14. ©2016 IDBS, Confidential
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
14

15. ©2016 IDBS, Confidential
Certificate of
Analysis
Registration of critical
COA related data.
pH Meter Calibration
pH Meter Calibration data
management.
Matrix Lot
Registration of
Matrices and
management of
pooling information.
Standard and QC Prep
Tracking of relevant
information from preparation
of Standards and QCs.
Common Reagent
Tracking of relevant
information from
preparation of common
reagents.
Stock Solution
Tracking of relevant
information from
stock solution
creation.
Balance Check
Process to ensure
balances function within
expected limits.
Sample Analysis
Collection of analytical run
related data from
production, method
validation, qualification or
mandatory repeat runs.
Sample Handling
Manage the logistics
around registering sample
handling, sample
shipment discrepancies
and sample disposal.
Bioanalysis – the bit not in a LIMS

16. ©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

17. ©2016 IDBS, Confidential
An IDBS Preclinical Solution
Integrated 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
Pharmacokinetics
Drug
Metabolism

18. ©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

19. ©2016 IDBS, Confidential
CRO 1
CRO 2
CRO 3
CRO 4
Internal
Internal
Internal
Internal
Internal

20. ©2016 IDBS, Confidential

21. ©2016 IDBS, Confidential
Why IDBS? Domain Experience
Company What we do
US Pharma IDBS (Global) PK,PD,BT,BA, Pre Formulations
Japanese Pharma IDBS (Global) PK
US Pharma IDBS (Global) PK,PD,BA
EU/US Pharma IDBS (Global) PD, DM, PK, BA, Pre Formulations, GLP
US Pharma IDBS PK
EU/US Pharma IDBS (Global) PD, DM, PK, BA, Pre Formulations, GLP
EU Pharma IDBS (Global) PK, BA GLP
EU Pharma IDBS BA GLP
US CRO IDBS BA, GLP
US Pharma Global Research and Pre Clinical
US Pharma DM, PK
EU/US Pharma Oncology Vitro + Vivo
US CRO IDBS (BioA, PK)

22. ©2016 IDBS, Confidential
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