1. A Platform for Effective
in vivo Study Knowledge
Management at Genentech
Dana Caulder, PhD
Bio-IT World 2015, Boston
1
CGATAACGTA
GTT
0
1
0
0110111001D VOS

2. 2
Pre-clinical animal models are
essential to understanding
basic biology, and the
efficacy and safety
of potential therapeutics

3. 3
Pre-clinical animal models are
diverse, complex and
difficult to manage
in a structured way

4. • >12,000
Research
in
vivo
studies
• Studies
da4ng
back
to
1998
• Mul4ple
therapeu4c
areas
• In
house
and
CRO

5. 5
TECHNICAL APPROACH
PEOPLE
SUCCESSES

6. Technical approach lays the foundation
Strategy
Architecture
Development
6

7. Strategy
 Provide an all-purpose in vivo study tool
 Minimize data duplication
 Capture detailed and structured information
 Make (good) data entry as easy as possible
 Enable data reuse
7

8. Architecture
8
DIVOS
Drug IACUC
Cell
Lines
Solr apiapi
animal
mgmt
analysisstudy search
EAV
Web
RDBMS
Persistence
Near-real time
indexing
Clients

9. Development
 Create reusable components / widgets
 Combine these components in ways that make sense
for different customer groups  “Templates”
9
Oncology
Start date
Tumor Line
…
Tumor
Volumes
Neuroscience
Start date
Blinding
…
Behavioral
tests
Immunology
Start date
Immunology
Model
…
Ear thickness

10. 10
TECHNICAL APPROACH
PEOPLE
SUCCESSES

11. People are the key to change
Strategy
Tactics
Operations
11

12. Strategy: Steering Team
 Where are we headed?
 What is important for the business to succeed?
 Communication frequency:
 As a group, ~ bi-monthly
 One on one, as needed
12
Jason DeVoss (TI), Brent McKenzie (TI), Kimberly Scearce-Levie (TN), Kim Stark (TN),
Stephen Gould (TO), Maj Hedehus (BMI), Melissa Junttila (GEMMs), Michelle Schweiger
(IVS / SA), Geoff Ganem (SA), Jay Cowan (BCB), Erik Bierwagen (BCB), Bill Young (BCB),
Matt Brauer (BCB)

13. Tactical: DIVOS Gurus
 How are we going to get there?
 Are we overlooking critical needs for the folks on the
ground?
 Communication frequency:
 As a group, quarterly
 One on one, as needed
 Biweekly “office hours”
13
Josh Tanguay (TO), Bruno Alicke (TO), Jason Cheng (GEMM), Jason Long (GEMM), Sheila
Ulufatu (IVS), Maj Hedehus (BMI), Tiffany Wu (TN), Justin Lesch (TI), Donghong Yan (TI),
Meijuan Zhou (TI), Jing Zhu (CI), Janet Lau (CI), Ena Ladi (DI), Hans Brightbill (DI)

14. Operations: Development Team
 Making it happing
 Communication frequency:
 Daily
 Delivery frequency:
 Every 2 weeks
14
Jay Cowan, Gabe Becker, Bill Forrest, Oleg Mayba, Rafał Udziela, Artur Legan, Kuba
Zajkowski, Jakub Białek, Kamil Łomiński, Paweł Kaca, Joanna Musialak

15. 15
TECHNICAL APPROACH
PEOPLE
SUCCESSES

16. New capabilities are evidence of success
Study logistics
Collaboration
New
Perspectives
16

17. Study Logistics
 Rolling enrollment study designs are easier to manage
for Oncology studies*
  # of mice on study by 17-45%, depending on model
 Real time adjustments to animal standing orders are
possible for Oncology studies+
  # of mice ordered by 28%
17
* 2013 Roche 3R Awards Submission, Bruno Alicke
+ 2013 Roche 3R Awards Submission, Michelle Nannini, Janeko Bower, et al.

18. Collaboration
 Enabled electronic submission of small molecule
formulation requests
 Enabled submission of in vivo samples in barcoded
tubes to improve efficiencies in large molecule PK/PD
assay group
 Enabled consolidation and standardization of three
study request workstreams within Safety Assessment /
Toxicology group
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19. New Perspectives
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 Enables new insights using existing data
 Compare in vivo model performance over time
 Combine and reanalyze prior studies using different
grouping factors to investigate new sources of variabilitynull:
Raw and LME Fit Tumor Volume
Day
TumorVolume(mm3
)
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64
128
256
512
1024
2048
4096
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1.21478
Day
TumorVolume(mm3)
Nov 2011Mar 2012
May 2010 Nov 2010

20. 20
TECHNICAL APPROACH lays the foundation
PEOPLE are the key to change
New capabilities are the evidence of
SUCCESS

21. Patients are
our inspiration
21