Integranova – lilly’s experience

Integranova – Lilly’s experience

4th Scientific Advisory Board
Joaquín Rincón
EO Architecture Manager

03/2011 Company Confidential 1
Joaquín Rincón Copyright © 2000 Eli Lilly and Company

Agenda

 Who is Lilly. Lilly in Spain.

 Experience with Integranova

 Conclusions


A pharmaceutical company of
innovation.


Eli Lilly and Company

 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.

www.lilly.com


Lilly in Spain.
 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
www.lilly.es
years


Lilly in Spain.

www.lilly.es


Lilly in Spain.

EUROPE
45 ASIA / Far East
AMERICA 27
31
AFRICA
24

Australia
2

www.lilly.es


Lilly in Spain: THE VALUE CHAIN
Candidates Regional Data Center
Hypothesis
Generation Developmen
t
Target Commercialization
"leads“
Identification
Optimization
First
Trials doses in Launch Doctor
Phase I Phase II Phase III Registry
development humans Patient
Improvement

"leads"
Generation PRODUCT

PROJECT PROGRAM

Medical Chemistry Clinical Investigation


Eli Lilly and Company: GCDMs
GCDM Global Director = currently on board
Training Coordinator

Quality Coordinator

114 trials
OC Mgr. OC Mgr. OC Mgr.

CRF Onc CV
32000 patients
ID NSD End CRF Onc CV ID NSD End CRF Onc CV ID NSD End
SVC

~12
2.700.000 data sheets/month
~23-25 DV staff +
TL's, AA's, Clerks
SVC

10
~27-30 DV staff +
TL's, AA's, Clerks
SVC

5
~15 DV staff +
TL's, AA's, Clerks
DE staff DE staff DE staff

Americas GCDM EU/VAMC GCDM Asia/Pacific GCDM
Host Host: Host:
US Affiliate Spanish Affiliate Australian Affiliate

Total Staff = ~110+

Integranova Experience


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.


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”


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.


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


So …

We decided to continue with
the second project

That was a little bit more
complex and critical


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)


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

2nd Project - Results

The project was delivered in just one
month time…


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


Trouble Tickets during 18 months
Make a guess:

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


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


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.

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.


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.


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”.

Thanks
Gracias

Joaquín Rincón Cinca.
rincon_joaquin@lilly.com

EO Architecture Manager


Integranova – lilly’s experience

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