2008 Cpsa - Oral Presentation - Bioanalytical Manager R2

Improving Bioanalytical Communication, Sample Handling, Data Reporting and Decision Making with a Custom Informatics Tool John P. Walsh, Charles E. Taylor, Qiner Yang and Robyn A. Rourick

NON-CONFIDENTIAL October 28, 2008

1

Overview

The Workflow Problem

Bioanalytical Manager Release 1

Bioanalytical Manager Release 2

Delivering the Product

Delivering the Business

NON-CONFIDENTIAL October 28, 2008

2

The Workflow Problem The “Traditional” Method

– Bioanalytical Project Representatives – – –

Find out about ongoing studies Maybe find out about planned studies Incomplete study information (# samples, etc.)

– Study Sponsors – – –

E-mail Bioanalytical group leader about samples delivered Hallway conversations about the intent of the study No awareness of other strains on resources

NON-CONFIDENTIAL October 28, 2008

3

The Workflow Problem Inefficient Bioanalytical sample exchanges 1) Place samples in freezer 2) Write study on whiteboard –

Coded for shelf, study, plate type, project, etc.

3) Send email to Bioanalytical Group Leader (samples in freezer) 4) Conversation about urgency, number, type of samples [A few days later…] 5) Conversation about the timeline for analysis [A few days later…] 6) Send out results to PK and/or project leader and/or sponsor 7) Erase whiteboard 8) Samples placed in a rack for “old” samples

NON-CONFIDENTIAL October 28, 2008

4

The Workflow Problem Why this was difficult to manage

– Bioanalytical resourcing was hard to capture – –

Always busy, but how busy? What projects are putting a load on the system? – Number of studies – Number, type of samples

– Study histories were not organized – – – –

Bioanalytical Group Leader had some information Responsible Scientist had some information Study Sponsor had some information Past study reconstruction was difficult (read: stressful)

NON-CONFIDENTIAL October 28, 2008

5

Moving towards a solution… Bioanalytical Manager Release 1

NON-CONFIDENTIAL October 28, 2008

6

Position of Bioanalytical Research

NON-CONFIDENTIAL October 28, 2008

7

Bioanalytical Manager Release 1 Facilitating Open Communication

– Primarily, a project management problem – –

Scientific progress should not be altered Requires a more open communication standard

– Requirements of the system – – – –

Intuitive interface aligned with other company products Open architecture to evolve with further enhancements Centralized, comprehensive display – Everyone works from the same information Ability to track progress of studies RE and after bioanalytical

NON-CONFIDENTIAL October 28, 2008

8

Bioanalytical Manager Release 1 Bioanalytical Research Group Desires

– Assignment of responsibility to team members – Knowledge of all study relevant information – – – –

Number, sample matrices Study contact for questions Urgency of the results Dose administered or levels expected

– Track the historical context of the department – –

Reconstruct the competing interests on all studies at all times Assess bottlenecks for efficient planning

NON-CONFIDENTIAL October 28, 2008

9

Bioanalytical Manager Release 1 Sponsor, Project and Company Desires

– Association of all bioanalytical data to a study or project – Ability to mine data for SAR table generation – Notification of relevant parties for significant events – –

When it is being worked on, results available Any notes, comments or questions about the study

– Centralized location for study results –

Data was being held in multiple Excel tables in Outlook

– Notebook references for study progression NON-CONFIDENTIAL October 28, 2008

10

Bioanalytical Manager Release 1 –

Strategy The lifecycle of an in vivo study was broken up into several stages

–

Release 1 was a feasibility assessment – – –

Company-wide deployment of a Bioanalytical tool Refinement of the workflow tool prior to new functionality Will people use it???

–

Business rules were applied in order to make the system work

–

Adoption of the system was painless for user – –

Compromise on the deployment was essential Compliance is high; complaints are low

NON-CONFIDENTIAL October 28, 2008

11

Study Creation

NON-CONFIDENTIAL October 28, 2008

12

Study Creation

NON-CONFIDENTIAL October 28, 2008

13

Study Monitoring

NON-CONFIDENTIAL October 28, 2008

14

Study Monitoring Associate files with drag-and-drop functionality

File type independent

Indexing and back-up through company Windows directory

All study files attached!

NON-CONFIDENTIAL October 28, 2008

15

Stage Breakdown Every idea is entered regardless of feasibility Registered compounds are associated to the study (2-way association) Most study planning fields are entered (study name, dates, etc.)

Assessment of the studies value to the project and anticipated cost Protocol development for the in vivo portion of the study Approval of the relevant internal and external resources Ordering and quarantine of test subjects NON-CONFIDENTIAL October 28, 2008

16

Stage Breakdown Study is currently ongoing and being dosed or monitored In vivo study observations and notes are entered The expected sample drop-off time and date are input

Samples arrived in Bioanalytical Research freezers Responsible scientist is assigned when the work is about to begin Bioanalytical preparation and analysis of samples A detailed bioanalytical report is issued describing the prep and results NON-CONFIDENTIAL October 28, 2008

17

Stage Breakdown Interpretation of all study findings (i.e. PK, histopath, in vivo observations) Generation of pharmacokinetic parameters, if relevant Final study report issued with the conclusions of the study

Study Finalization – – –

Studies are finalized when the last report has been issued Studies are never deleted, only removed from viewing All reports are attached to the BA Manager item

NON-CONFIDENTIAL October 28, 2008

18

The Automation Solution Bioanalytical Manager Release 2

NON-CONFIDENTIAL October 28, 2008

19

Bioanalytical Manager Release 2 Defining the Scope –

All bioanalytical sample processes being done manually

–

Throughput requirements didn’t demand an HT solution – –

–

Importance placed on a high quality product – –

–

~345 samples / week (at time of assessment) ~5 studies / week (at time of assessment)

Automate routine work for PK plasma studies Hallway conversations about the intent of the study

Allow scientists to be scientists – –

Better methods for projects or compounds More information on compounds as they advance

NON-CONFIDENTIAL October 28, 2008

20

Bioanalytical Manager Release 2 Components of the System –

Plate registration system –

–

Implement a standard bar-coded plate for sample submission

Chain-of-Custody tracking of samples –

–

Integrate with a Freezer Management System

Automated sample preparation on a Tecan Evo –

–

Including the preparation of a standard curve

Integration with LC/MS systems –

Supply sample lists to the systems for analysis

–

Associate data to each sample from the processed output

NON-CONFIDENTIAL October 28, 2008

21

Schematic of the Design

NON-CONFIDENTIAL October 28, 2008

22

Plate Registration System – Excel tool for sample plate information entry – Multi-dimensional sample information entry

NON-CONFIDENTIAL October 28, 2008

23

Bioanalytical Manager Release 2 Tecan Sample Preparation

– Fully automated sample preparation for routine studies

– Each plate gets a customized sample preparation routine –

Based on the registered sample plate information

–

Tecan GEM file created, not a worklist

– Calibration curve spiking and dilution included in the prep –

Blanks, CS0 and solvents added to the plate

NON-CONFIDENTIAL October 28, 2008

24

Bioanalytical Manager Release 2 Tecan Sample Preparation

– Protein precipitation controlled with an internal standard

– ~42’ from thawed sample plate to LC/MS injection plate

– Simple registration of the injection plate –

Platemap is determined from sample platemap and GEM file

– Import the Tecan log file prior to injection –

Flag samples that may have had problems

NON-CONFIDENTIAL October 28, 2008

25

Release 2 Automation Options Centralized deployment of the automation tasks

Created files are automatically added to the BA Manager item

Laboratory tasks are logically laid out in order to minimize training

NON-CONFIDENTIAL October 28, 2008

26

Tecan Sample Prep File Generation

NON-CONFIDENTIAL October 28, 2008

27

Analyst File Generation

NON-CONFIDENTIAL October 28, 2008

28

Automated Preparation Results

NON-CONFIDENTIAL October 28, 2008

29

Automated Preparation Results

NON-CONFIDENTIAL October 28, 2008

30

Delivering the Product Wrapping quality to the deliverable

NON-CONFIDENTIAL October 28, 2008

31

Delivering the Product –

–

Desired product was always a quality Bioanalytical report –

Low barrier to authorship for scientists

–

Use all the data collected for the study

–

No more Excel tables with results only!!!

Utilize data from multiple sources to “put it all together” –

–

Use all the data collected for the study

Interface with SharePoint 2007 for storage of all final reports –

Use the XML backbone of Office 2007 applications

–

Route and E-sign documents to finalize

NON-CONFIDENTIAL October 28, 2008

32

Document Construction

NON-CONFIDENTIAL October 28, 2008

33

Document Construction

NON-CONFIDENTIAL October 28, 2008

34

Document Construction

NON-CONFIDENTIAL October 28, 2008

35

Report Publishing

NON-CONFIDENTIAL October 28, 2008

36

Delivering the Business Intelligently using all this information

NON-CONFIDENTIAL October 28, 2008

37

Delivering the Business - Conclusions –

Bioanalytical Manager has been extremely effective at Kalypsys

–

–

More focused discussions around bioanalytical work

–

Timeline and study management simplified

–

Prioritization of studies is transparent

–

Weekly queue prioritization meetings are F-A-S-T

Centralized data repository for study information –

Easily mined for IND, Due Diligence, etc.

–

Full study reconstruction is possible

–

Keeps the responsibility of the study de-centralized

NON-CONFIDENTIAL October 28, 2008

38

Metrics Analysis

NON-CONFIDENTIAL October 28, 2008

39

Delivering the Business - Conclusions –

–

–

Detailed metrics analysis allows the shaping of the business –

Accurate information on the output of the group

–

Ensure that projects are getting stage-relevant support

Automated sample preparation has potential in Discovery –

Allow scientists to focus on important issues

–

Capture and use as much info as possible for data integrity

Bioanalytical Research delivers a quality report with little effort

NON-CONFIDENTIAL October 28, 2008

40

Acknowledgements

NON-CONFIDENTIAL October 28, 2008

41

Thank You

NON-CONFIDENTIAL October 28, 2008

42