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A Companywide ELN as the Enabler<br />
for a Recipe Data Warehouse<br />
Pascal Maes<br />
Janssen Research & Development<br />
Pharmaceutical Development & Manufacturing Sciences<br />
Strategic Operations
Pharmaceutical Research & Development<br />
Discovery<br />
&<br />
Screening<br />
Lead<br />
Pre-<br />
Clinical<br />
Pharmaceutical Development & Manufacturing Sciences (CMC)<br />
Clinical Development Submission<br />
Phase I Phase IIA/B Phase III Submission<br />
$ 1,000,000, 000 $270 $320 $310 $50<br />
~12 % 54% 34% 70% 91%<br />
8 years 1.5 y 2.0 y 3.0 y 1.5 y<br />
Industry Survey 2006-2010 Major Pharma Companies<br />
Phase<br />
IIIB IV<br />
A Companywide ELN as the Enabler for a Recipe Data Warehouse Pascal Maes 2
Trends in the Industry will result in…<br />
Patients<br />
Companion<br />
Diagnostic<br />
Responders<br />
Non<br />
Responders<br />
Treatment A<br />
Treatment B<br />
… twice the amount of products … in half the time<br />
A Companywide ELN as the Enabler for a Recipe Data Warehouse Pascal Maes 3
Goals and Vision<br />
To significantly improve time to market for new products, we<br />
need to implement a standard approach for all development<br />
activities, focused on:<br />
• Zero day release<br />
• Paperless tech transfer<br />
• Build-as-you-go regulatory filing<br />
• Convert data into knowledge<br />
A way forward:<br />
• Paperless execution<br />
• Use industry standards ISA S88/S95<br />
A Companywide ELN as the Enabler for a Recipe Data Warehouse Pascal Maes 4
ELN Roll out
Roll-out ELN at Janssen R&D<br />
Discovery &<br />
Screening<br />
1200<br />
1000<br />
800<br />
600<br />
400<br />
200<br />
0<br />
6<br />
50<br />
Pre-Clinical<br />
BCP DSSc<br />
66<br />
1<br />
11<br />
46<br />
Pharmaceutical Development & Manufacturing Sciences (CMC)<br />
88<br />
17<br />
Clinical Development Submission<br />
Number of Users Cumulative Totals<br />
73 78 63 90 104 146<br />
41 112<br />
#14341<br />
#405<br />
#16056<br />
Phase<br />
IIIB IV<br />
28 26 29 15<br />
A Companywide ELN as the Enabler for a Recipe Data Warehouse Pascal Maes 6
Janssen Research & Development<br />
Pharmaceutical Development & Manufacturing Sciences<br />
Springhouse<br />
Raritan<br />
Malvern<br />
Radnor<br />
Titusville<br />
Fremont<br />
St Louis<br />
Brazil<br />
Mumbai<br />
Xian<br />
Beerse<br />
Geel<br />
Schaffhausen<br />
Cork<br />
Leiden<br />
A Companywide ELN as the Enabler for a Recipe Data Warehouse<br />
Pascal Maes<br />
7
Team Commitment Level<br />
Strategic<br />
Operations<br />
75-100%<br />
US/EU<br />
Heavyweight<br />
Team<br />
50-75%<br />
Cross-<br />
Functional<br />
API(L)<br />
API(S)<br />
DPD(L)<br />
DPD(S)<br />
AD US<br />
AD EU<br />
AP<br />
Lightweight<br />
Team<br />
25-50%<br />
Cross-<br />
Functional<br />
Need Based<br />
Method<br />
Template<br />
System<br />
Interfacing<br />
S88 Workflow<br />
Change<br />
Management<br />
Superuser<br />
eLN Users<br />
10-25%<br />
Need Based<br />
Functional<br />
Rep<br />
Functional<br />
Rep<br />
Functional<br />
Rep<br />
Functional<br />
Rep<br />
End User<br />
eLN Users<br />
0-10%<br />
Need Based<br />
Up to 10 End<br />
Users<br />
Up to 10 end<br />
users<br />
Up to 10 End<br />
Users<br />
Up to 10 End<br />
Users<br />
A Companywide ELN as the Enabler for a Recipe Data Warehouse Pascal Maes 8
Pharmaceutical Development &<br />
Manufacturing Sciences ELN Users<br />
DPD<br />
Pharm Sciences<br />
HTS Automation<br />
Dissolution<br />
Characterization<br />
Particle Size<br />
Characterization<br />
Solid State<br />
Characterization<br />
Liquid &<br />
Parenterals<br />
DPD<br />
Formulations<br />
Preformulation<br />
Testing<br />
Solid Dosage<br />
AD<br />
AS & CoE<br />
AD<br />
SM&LM MD<br />
SM Characterisation Pilot Plant<br />
ID Testing<br />
Release<br />
Patient Pack<br />
LM Characterisation<br />
Investigations<br />
Material Testing<br />
Microbiology<br />
Spectroscopy<br />
Safety Test<br />
Prep ST<br />
API SM<br />
Process Dev<br />
PAT&Cleaning<br />
Process Dev<br />
Reference Standard<br />
Certification<br />
Method Validation<br />
Virology<br />
Method Development<br />
Tech Dev<br />
Cell Tech<br />
API LM<br />
Process Dev<br />
Process Dev<br />
AD Stability & Release SM<br />
Formulation<br />
Characterisation<br />
Clincal Release<br />
API SM<br />
CPA&C<br />
Stability<br />
Testing<br />
Process Control<br />
Lab Automation<br />
Process Science<br />
New Product<br />
ELN 6.4<br />
ELN 5.6<br />
LES<br />
#SN: 568<br />
#PN: 145<br />
#FN: 45<br />
#LES: 90<br />
A Companywide ELN as the Enabler for a Recipe Data Warehouse Pascal Maes 9
Mimetic Mode : Transformation Workshops<br />
Experimental Process<br />
Title<br />
Background<br />
Materials<br />
Equipment<br />
Forms<br />
Results<br />
Conclusion<br />
Reference<br />
Signature<br />
Workflow<br />
A Companywide ELN as the Enabler for a Recipe Data Warehouse Pascal Maes 10
Deployment PDMS Overview<br />
Month Users<br />
Jan-2010 0<br />
Feb-2010 51<br />
Mar-2010 40<br />
Apr-2010 0<br />
May-2010 55<br />
Jun-2010 59<br />
Jul-2010 7<br />
Aug-2010 84<br />
Sep-2010 39<br />
Oct-2010 89<br />
Nov-2010 98<br />
Dec-2010 46<br />
2010 568<br />
# of Experiments<br />
18000<br />
16000<br />
14000<br />
12000<br />
10000<br />
8000<br />
6000<br />
4000<br />
2000<br />
0<br />
ELN v6.4 PDMS Metrics<br />
Total Experiments<br />
Total Active Users<br />
Total Deployed Users<br />
Month<br />
1000<br />
900<br />
800<br />
700<br />
600<br />
500<br />
400<br />
300<br />
200<br />
100<br />
A Companywide ELN as the Enabler for a Recipe Data Warehouse Pascal Maes 11<br />
0<br />
# of Users
A Companywide ELN as the Enabler for a Recipe Data Warehouse Pascal Maes 12
Build Electronic Lab Environment<br />
Sharepoint<br />
Document<br />
Management<br />
Systems<br />
Project codes<br />
Training<br />
Isentris System ELE<br />
IM inventory<br />
control<br />
Werum<br />
PAS|X<br />
Nugenesis<br />
SDMS<br />
PIMS<br />
SAP<br />
Tiamo<br />
Unicorn<br />
LEA<br />
Print<br />
capture<br />
Maximo<br />
Department<br />
Location<br />
Balances &<br />
other RS232<br />
instruments<br />
LIMS<br />
Compound<br />
Structures<br />
Isentris<br />
CDS<br />
Empower<br />
Work<br />
Request<br />
System<br />
Symyx<br />
Metrology<br />
ECM<br />
CyberLAB<br />
Chemseek<br />
Discoveryg<br />
ate<br />
A Companywide ELN as the Enabler for a Recipe Data Warehouse Pascal Maes 13
A common recipe data warehouse
Building Knowledge Management<br />
Execute Store<br />
Analyse<br />
• Disparate sources<br />
• Few standards<br />
• Electronic sources<br />
• Standard platform recipes<br />
• Little in-built context<br />
• >60% of FTE effort<br />
Current<br />
• In-built context<br />
• NO FTE effort<br />
Future<br />
• Few standards<br />
• Significant effort (reactive)<br />
• Agreed Business Standards<br />
• Little effort (proactive)<br />
A Companywide ELN as the Enabler for a Recipe Data Warehouse Pascal Maes 15
Analyze: Data Visualization<br />
A Companywide ELN as the Enabler for a Recipe Data Warehouse Pascal Maes 16
Current State<br />
Homo Sapiens Based Data Integration<br />
Lab Documentation Plant Documentation Business/Quality<br />
ELN, LES, CDS, LIMS, SDMS… MES, Data historian… ERP, QMS…<br />
A Companywide ELN as the Enabler for a Recipe Data Warehouse Pascal Maes 17
End State<br />
Data<br />
Mart<br />
Stability<br />
Data<br />
Mart<br />
Process<br />
Quality<br />
Analysis<br />
Data<br />
Mart<br />
Process<br />
Data<br />
Data<br />
Mart<br />
Analytical<br />
Data<br />
Recipe Based Data Warehouse<br />
Lab Documentation Plant Documentation Business/Quality<br />
ELN, LES, CDS, LIMS, SDMS… MES, Data historian… ERP, QMS…<br />
Data<br />
Mart<br />
Clinical /<br />
Biomarkers<br />
A Companywide ELN as the Enabler for a Recipe Data Warehouse Pascal Maes 18
Building a Knowledge Based Organization<br />
Common Recipe Approach<br />
Ensures that we all “speak<br />
the same language”<br />
promoting consistency<br />
Common Data Warehouse<br />
Enables leveraging of<br />
information across systems to<br />
help drive data driven<br />
decisions<br />
A Companywide ELN as the Enabler for a Recipe Data Warehouse Pascal Maes 19
What is the standard for recipes? S88/S95<br />
ISA | International Society for Automation<br />
• S95 is the international standard for the integration of enterprise<br />
and control systems.<br />
– Standard data models and terminology<br />
• Equipment – Material - Personnel<br />
• S88 is the international standard for defining production processes<br />
– Emphasize good practices for the design and operation of batch<br />
manufacturing plants<br />
– Can be used to improve control of batch manufacturing plants<br />
– Can be applied regardless of the degree of automation<br />
A Companywide ELN as the Enabler for a Recipe Data Warehouse Pascal Maes 20
S95 / S88 Recipe Data Model<br />
Process<br />
(S88)<br />
Personnel<br />
(S95)<br />
Equipment<br />
(S95)<br />
Material<br />
(S95)<br />
A Companywide ELN as the Enabler for a Recipe Data Warehouse Pascal Maes 21
The S88 Process Model<br />
PROCESS PROCESS<br />
STAGE<br />
PREPARE DOUGH<br />
PROCESS<br />
OPERATION<br />
Dispense Solid<br />
Ingredients<br />
PROCESS<br />
ACTION<br />
CAKE PREPARE OVEN Preheat Oven Set<br />
PREPARE PAN Grease & Flour Pan Add<br />
DISPENSE IN PAN<br />
BAKE<br />
CAKE<br />
PLATFORM<br />
Dispense Liquid<br />
Ingredients<br />
Mix dough<br />
Dispense in pan<br />
Bake in oven<br />
Add<br />
Add<br />
Add<br />
Add<br />
Make<br />
Add<br />
Add<br />
Mix<br />
Dispense<br />
Bake<br />
Name Target Material Equipment<br />
temp. 350°F oven<br />
grease<br />
pan<br />
CHOCOLATE<br />
Flour pan<br />
2 cups Flour bowl<br />
CAKE<br />
2 cups Sugar<br />
Baking<br />
PARAMETER<br />
1 teaspoon<br />
bowl<br />
Powder<br />
well in the<br />
spoon<br />
centre<br />
LIST<br />
2 eggs<br />
1 cup milk<br />
Until<br />
smooth<br />
dough<br />
bowl<br />
bowl<br />
bowl<br />
whisk<br />
prepared<br />
pan<br />
40 min oven<br />
A Companywide ELN as the Enabler for a Recipe Data Warehouse Pascal Maes 22
The S88 Process Model<br />
PROCESS PROCESS<br />
STAGE<br />
PREPARE DOUGH<br />
PROCESS<br />
OPERATION<br />
Dispense Solid<br />
Ingredients<br />
PROCESS<br />
ACTION<br />
CAKE PREPARE OVEN Preheat Oven Set<br />
PREPARE PAN Grease & Flour Pan Add<br />
DISPENSE IN PAN<br />
BAKE<br />
CAKE<br />
PLATFORM<br />
Dispense Liquid<br />
Ingredients<br />
Mix dough<br />
Dispense in pan<br />
Bake in oven<br />
Add<br />
Add<br />
Add<br />
Add<br />
Make<br />
Add<br />
Add<br />
Mix<br />
Dispense<br />
Bake<br />
A Companywide ELN as the Enabler for a Recipe Data Warehouse Pascal Maes 23
The S88 Process Model<br />
PROCESS<br />
PROCESS<br />
PROCESS<br />
PROCESS<br />
PROCESS<br />
PROCESS<br />
STAGE<br />
PROCESS<br />
STAGE<br />
PROCESS<br />
STAGE<br />
PROCESS<br />
STAGE<br />
PROCESS<br />
STAGE<br />
PROCESS<br />
OPERATION<br />
PROCESS<br />
OPERATION<br />
PROCESS<br />
OPERATION<br />
PROCESS<br />
OPERATION<br />
PROCESS<br />
OPERATION<br />
PROCESS<br />
ACTION<br />
PROCESS<br />
ACTION<br />
PROCESS<br />
ACTION<br />
PROCESS<br />
ACTION<br />
PROCESS<br />
ACTION<br />
PLATFORM<br />
Product<br />
Recipe<br />
Site<br />
Recipe<br />
Master<br />
Recipe<br />
Control<br />
Recipe<br />
A Companywide ELN as the Enabler for a Recipe Data Warehouse Pascal Maes 24
Recipe<br />
Implemen<br />
tation<br />
(ELN, LES,<br />
MES)<br />
System<br />
Independent<br />
Recipe<br />
Design<br />
Knowledge<br />
Based<br />
Organization<br />
Recipe<br />
Warehouse<br />
Implemen<br />
tation<br />
A Companywide ELN as the Enabler for a Recipe Data Warehouse Pascal Maes 25
Platform for ID, assay & purity<br />
Process Process Stage Process Operation Parameter list<br />
ID, Assay and chromatographic purity Instrumentation HPLC System X<br />
Data Acquisition System X<br />
Autosampler Vials X<br />
Reagents and solution Reagents X<br />
Mobile Phase A, B, C, D X<br />
Dilution Solvent X<br />
Blank Solution X<br />
Reference Solution 1, 2, 3 X<br />
Selectivity Solution X<br />
Sample Solution X<br />
Procedure HPLC Conditions X<br />
Sequence (X)<br />
Rinse Program X<br />
System Suitability X<br />
Chromatographic Characteristics X<br />
Identification test Identification of active (X)<br />
Calculations Resolution -<br />
Recovery of control solutions -<br />
Assay of active -<br />
A Companywide ELN as the Enabler for a Recipe Data Warehouse<br />
Pascal Maes 26<br />
Determination of related compounds -
Process Operation: Prepare Sample Solution<br />
• Example Procedural Description<br />
• Weigh accurately 20 tablets.<br />
• Determine the mean tablet weight (= G in g).<br />
• Grind the tablets in a mortar <strong>with</strong> pestle to a fine powder.<br />
• Weigh accurately an amount of homogenized powder equivalent to 10<br />
tablets (= qs in g) into a 200-mL volumetric flask.<br />
• Add approximately 100 mL dilution solvent by graduated cylinder.<br />
• Shake mechanically for 30 minutes at moderate speed.<br />
• Dilute to volume <strong>with</strong> dilution solvent.<br />
• Shake up manually vigorously.<br />
• Filter the Sample Solution through a chemical resistant 0.45 µm filter.<br />
• Discard the first 3 mL filtrate.<br />
A Companywide ELN as the Enabler for a Recipe Data Warehouse Pascal Maes 27
Process Operation: Prepare Sample Solution<br />
Process<br />
Operation<br />
• Example Process Operation: S88/S95 Description<br />
PA no<br />
Process<br />
Action<br />
Parameter<br />
Name<br />
Parameter<br />
Target<br />
Parameter<br />
Actual<br />
Prepare Sample solution<br />
1Weigh 20 $Weight Tablets 20 20 tablets analytical balance<br />
2Determine mean tablet weight<br />
3Grind all tablets mortar and pestle<br />
5Weigh equivalent of 10 tablets analytical balance<br />
6Transfer into 200 mL volumetric flask<br />
7Add approx. 100 mL graduated cylinder dilution solvent<br />
10Shake mechanically 30 min linear shaker<br />
11Dilute to volume dilution solvent<br />
12Shake vigourously manual<br />
13Equilibrate to RT 2 2 h Closed cabinet<br />
14Shake vigourously manual<br />
15Filter solution CR 0.45µm filter<br />
16Discard into waste 3 mL filtrate<br />
17Fill to appropriate height autosampler vial<br />
Upper Value of<br />
Range (MOR)<br />
Lower Value of<br />
Range (MOR)<br />
Parameter<br />
Units<br />
Equipment<br />
Class<br />
A Companywide ELN as the Enabler for a Recipe Data Warehouse<br />
Equipment<br />
Instance<br />
Material<br />
Name<br />
Pascal Maes 28
Traditional Test Method Creation<br />
Method Development<br />
A set of iterative or designed experiments to determine<br />
product specific set of parameters for each test<br />
Experiment 1<br />
Experiment 2<br />
Burette: 10mL<br />
Experiment n<br />
Amount: 250 mg<br />
Stir time: 2 KFT<br />
Burette: min 10mL<br />
Draft<br />
Amount: 250 mg<br />
Stir Burette: time: 2 min 10mL<br />
Amount: 250 mg<br />
Stir time: 2 min<br />
Test Method<br />
Description<br />
Validation Test 1<br />
PAPER EDMS<br />
Validation Test 2<br />
Validation Test n<br />
Test Method<br />
Description<br />
TRANSFER<br />
Global Execution<br />
Test execution on global scale after extensive<br />
method transfer activities.<br />
Method Validation<br />
“Confirm suitability of analytical procedure for intended use”<br />
The confirmation is usually assessed by performing several experiments<br />
MV Report<br />
A Companywide ELN as the Enabler for a Recipe Data Warehouse Pascal Maes 29
Recipe Based Test Method Creation<br />
Method Development<br />
A set of iterative or designed experiments to determine<br />
product specific set of parameters for each test<br />
Experiment 1<br />
Recipe Aware<br />
Experiment 2<br />
Recipe Aware<br />
Burette: 10mL<br />
Experiment n<br />
Amount: 250 mg<br />
RECIPE<br />
Stir Recipe<br />
Burette: time: 2 min Aware<br />
10mL<br />
PARAMETER<br />
Amount: 250 mg<br />
LIST<br />
Stir Burette: time: 2 min 10mL<br />
Amount: 250 mg<br />
Stir time: 2 min<br />
Validation Test 1<br />
PAPER EDMS<br />
Validation Test 2<br />
Validation Test n<br />
LAB EXECUTION<br />
SYSTEM<br />
Recipe<br />
based<br />
execution<br />
Review by exception<br />
Global Execution<br />
Test execution on global scale after extensive<br />
method transfer activities.<br />
Method Validation<br />
“Confirm suitability of analytical procedure for intended use”<br />
The confirmation is usually assessed by performing several experiments<br />
MV Report<br />
A Companywide ELN as the Enabler for a Recipe Data Warehouse<br />
Pascal Maes 30<br />
Test Method<br />
Description
Recipe<br />
Implemen<br />
tation<br />
(ELN, LES,<br />
MES)<br />
System<br />
Independent<br />
Recipe<br />
Design<br />
Knowledge<br />
Based<br />
Organization<br />
Recipe<br />
Warehouse<br />
Implemen<br />
tation<br />
A Companywide ELN as the Enabler for a Recipe Data Warehouse Pascal Maes 31
Recipe Execution in ELN<br />
A Companywide ELN as the Enabler for a Recipe Data Warehouse Pascal Maes 32
ELN Recipe Implementation<br />
Background<br />
Materials<br />
Equipment<br />
Samples<br />
Process Spreadsheet<br />
Process Table<br />
Process Recipe<br />
A Companywide ELN as the Enabler for a Recipe Data Warehouse Pascal Maes 33
Process Operation: Prepare Sample<br />
Solution<br />
Process<br />
Operation<br />
• Create condensed S88/S95 description<br />
PA no<br />
Process<br />
Action<br />
Prepare Sample solution<br />
Parameter<br />
Name<br />
Parameter<br />
Target<br />
Parameter<br />
Actual<br />
Upper Value of<br />
Range (MOR)<br />
Lower Value of<br />
Range (MOR)<br />
1Weigh 20 $Weight Tablets 20 20 tablets analytical balance<br />
2Determine mean tablet weight<br />
3Grind all tablets mortar and pestle<br />
5Weigh equivalent of 10 tablets analytical balance<br />
Parameter<br />
Units<br />
Equipment<br />
Class<br />
6Transfer into 200 mL volumetric flask<br />
7Add approx. 100 mL graduated cylinder dilution solvent<br />
10Shake mechanically 30 min linear shaker<br />
11Dilute to volume dilution solvent<br />
12Shake vigourously manual<br />
13Equilibrate to RT 2 2 h Closed cabinet<br />
14Shake vigourously manual<br />
Weigh 20 tablets Analytical balance<br />
15Filter solution CR 0.45µm filter<br />
16Discard into waste 3 mL filtrate<br />
17Fill to appropriate height autosampler vial<br />
Equipment<br />
Instance<br />
A Companywide ELN as the Enabler for a Recipe Data Warehouse<br />
Material<br />
Name<br />
Pascal Maes 34
Process Operation: Prepare Sample Solution<br />
A Companywide ELN as the Enabler for a Recipe Data Warehouse<br />
RECIPE<br />
PLATFORM<br />
Technique: {param1}<br />
Burette: {param2}<br />
Amount: {param3}<br />
Amount: {param4}<br />
Stirring time: {param5}<br />
Field Name<br />
RECIPE<br />
PARAMETER<br />
LIST<br />
Array of Field<br />
Values<br />
Pascal Maes 35
Recipe<br />
Implemen<br />
tation<br />
(ELN, LES,<br />
MES)<br />
System<br />
Independent<br />
Recipe<br />
Design<br />
Knowledge<br />
Based<br />
Organization<br />
Recipe<br />
Warehouse<br />
Implemen<br />
tation<br />
A Companywide ELN as the Enabler for a Recipe Data Warehouse Pascal Maes 36
Recipe Based Data Warehouse<br />
Operational<br />
Source Systems<br />
ELN<br />
LES<br />
MES<br />
LIMS<br />
PIMS<br />
ERP<br />
Extract<br />
Extract<br />
Extract<br />
Extract<br />
Extract<br />
Extract<br />
Data<br />
Staging Area<br />
Services:<br />
Clean, combine,<br />
and standardize<br />
Conform<br />
dimensions<br />
NO USER QUERY<br />
SERVICES<br />
Data Store:<br />
Flat files and<br />
relational tables<br />
Processing:<br />
Sorting and<br />
sequential<br />
processing<br />
Load<br />
Load<br />
Data<br />
Presentation<br />
Data Mart #1<br />
DIMENSIONAL<br />
Atomic and<br />
Summary data<br />
Based on a<br />
single<br />
Business process<br />
DW Bus:<br />
Conformed<br />
facts &<br />
dimensions<br />
Data Mart #2 ...<br />
(Similarly designed)<br />
Access<br />
Access<br />
Data<br />
Access Tools<br />
Ad Hoc Query<br />
Tools<br />
Report Writers<br />
Analytic<br />
Applications<br />
Modeling:<br />
Forecasting<br />
Scoring<br />
Data mining<br />
A Companywide ELN as the Enabler for a Recipe Data Warehouse Pascal Maes 37
ELN<br />
Discovery &<br />
Screening<br />
PLATFORM Recipe<br />
CONTROL Recipe<br />
RECIPE DATA WAREHOUSE<br />
Pre-Clinical<br />
BCP DSSc<br />
Parameter list<br />
MES LES<br />
MASTER Recipe<br />
CONTROL Recipe<br />
Batch Records<br />
Lab Record<br />
Filing, Transfer<br />
eCTD<br />
Reporting<br />
Pharmaceutical Development & Manufacturing Sciences (CMC)<br />
Clinical Development Submission<br />
Trending<br />
Troubleshooting<br />
Visualization<br />
Phase<br />
IIIB IV<br />
A Companywide ELN as the Enabler for a Recipe Data Warehouse Pascal Maes 38
RW Project Published<br />
Fermier, Adam; McKenzie, Paul; McWeeney,<br />
Shaun; Murphy, Terry; Schaefer, Gene<br />
Transforming Data into Information:<br />
An Engineering Approach.<br />
Pharmaceutical Manufacturing. 10<br />
(Issue 8), 20-26 (2011).<br />
A Companywide ELN as the Enabler for a Recipe Data Warehouse Pascal Maes 39
Thank You<br />
Pascal Maes, PhD.<br />
Janssen Research & Development<br />
Pharmaceutical Development & Manufacturing Sciences / Strategic Operations
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