integranova – lilly’s experience

03/2011 Joaquín Rincón

Company Confidential Copyright © 2000 Eli Lilly and Company

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Integranova – Lilly’s experience

4th Scientific Advisory Board Joaquín Rincón EO Architecture Manager


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Who is Lilly. Lilly in Spain. Experience with Integranova

Conclusions

Agenda



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A pharmaceutical company of innovation.



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Funded at Indianapolis in 1876. Present in 179 countries. 41.000 employees all over the world. Almost 7.000 are R+D related. Leader of the industry in R+D investment (20% of sales) Clinical trials in more than 30 countries.

Eli Lilly and Company

www.lilly.com



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1.250 employees in Alcobendas, Madrid. (1 of every 5 in R+D). MANUFACTURING CENTER. Investments of 30 mill € over the last three years. Exports to 130 countries. CENTRO DE INVESTIGACIÓN BÁSICA. 100 scientists. CENTRO DE INVESTIGACIÓN CLÍNICA. More than 65 health care professionals. Investments of 60 mill € over the last ten years

www.lilly.es

Lilly in Spain.



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www.lilly.es

Lilly in Spain.



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www.lilly.es

AMERICA

31 AFRICA

24

EUROPE

45 ASIA / Far East

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Australia

2

Lilly in Spain.



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Lilly in Spain: THE VALUE CHAIN

Target

Identification

Trials

development

"leads"

Generation

"leads“

Optimization First

doses in

humans Phase I Phase II

Commercialization

PRODUCT

Candidates

Developmen

t

Hypothesis

Generation

PROGRAM PROJECT

Phase III Registry Launch

Improvement

Clinical Investigation

Regional Data Center

Medical Chemistry

Doctor

Patient



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Eli Lilly and Company: GCDMs

CRF

SVC

CRF

SVC

CRF

SVC

~23-25 DV staff +

TL's, AA's, Clerks ~12

DE staff

Onc CV ID NSD End

~27-30 DV staff +

TL's, AA's, Clerks

Onc CV ID NSD End

~15 DV staff +

TL's, AA's, Clerks

Americas GCDM

Host

US Affiliate

Training Coordinator

OC Mgr. OC Mgr.

10

DE staff

5

DE staff

EU/VAMC GCDM

Host:

Spanish Affiliate

Asia/Pacific GCDM

Host:

Australian Affiliate

GCDM Global Director

Onc CV ID NSD End

Quality Coordinator

OC Mgr.

= currently on board

Total Staff = ~110+

114 trials 32000 patients

2.700.000 data sheets/month



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Integranova Experience



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Once upon a time in 2003…

Mainly by chance we had the opportunity to have a demo of Integranova MES.

We expend quite a lot of time to understand it well.

The results were impressive.



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First Pilot (I)

We decided to make a pilot project.

The project was the creation of the Company’s club web. Mainly the management of a library plus some activities organized by the club.

We defined several conditions for the project:

• Lilly employees will be in charge of the development, but with the help of Integranova consultants.

• Integranova would be the responsible for the project and of the final “product”



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First Pilot (II)

4 Lilly people had a one week training

A Integranova consultant was in Lilly’s offices for two weeks. A programmer was there one week and also made some other

changes from Integranova offices.



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First Pilot - Results

The results were very good:

• We had a prototype in 48 hours

• The application was ready in less than a month

• Perhaps the biggest problem is to get used with the architecture of the generated code

• Good training is also very important

The Proof of Concept can be considered a success



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So …

We decided to continue with the second project

That was a little bit more complex and critical



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2nd Project

The project was a solution to manage the Retention and Stability Samples from the manufacturing site.

It’s a regulated process that is related with the quality of the product so it’s GMP.

GMP stands for Good Manufacturing Practices and is one of the most strict regulations of the world (only comparable with the regulations of nuclear energy or aerospace industry) provided by the FDA (Food and Drug Administration)



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2nd Project - Special Requisites

Electronic Record

This means that any status of all the data of the system can be recreated for any moment in time.

This requirement implies a strong control over any action that can take place in the application



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2nd Project - Results

The project was delivered in just one month time…



19 03/2011 Joaquín Rincón


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Errors found during testing phase

Make a guess:

In all the cases they were errors in the model, due to bad understanding of the requisites



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Trouble Tickets during 18 months

Make a guess:

12 in the first two months and another 8 along 16 months?



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Trouble Tickets during the subsequent 18 months

Make a guess:

The first one after one year. Both times the problem was a configuration parameter of the app. server



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Conclusions – Based on our experience

The productivity of the design/construct/deploy/test phases can be easily multiplied by four (even more for applications that suite well)

The relation 70-30 for support cost vs. the rest of the life cycle is no longer true. The benefits don’t come only from the increased productivity, but from the increased quality and less support.

Integranova support team is very good, both in knowledge and speed.



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Conclusions – Based on our experience

The bigger benefits come after two or three projects.

80 to 90 percent of the manual changes are related with the user interface.

Any needed change, change request for support, for example, is a change in the model and you have 100% security that the generated code is going to work.



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Conclusions

Integranova MES is not valid for all projects, so it´s important to understand

that it is not a “one-size-fits-all” solution for the large variety of development projects.



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Conclusions

My personal opinion is that this kind of tools are going to allow the next step in the evolution of the development.

First, assembler allowed us to avoid Machine Code. Then, third generation languages avoided having to deal with assembler.

Now, with Integranova MES, we can avoid third generation languages and move to models. It seems as the next logical step towards real engineering and leaving behind the “artisan era”.



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Thanks Gracias

Joaquín Rincón Cinca. [email protected]

EO Architecture Manager


integranova – lilly’s experience

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