Transcript No Slide Title

“Industrial Product Development Best Practices for
Vaccines”
Rémi PAULE
Deputy Director, Methods & Indicators,
Global Manufacturing Technology
Sanofi pasteur
Storyboard Presentation – Unique Customization
February 20-21, 2007 / St. Pete’s Beach, FL
Sanofi pasteur
Rémi PAULE
Our mission
• To protect and improve human health worldwide by
providing superior, innovative vaccines for the
prevention and treatment of disease and by playing an
active role in the immunization community to maximize
vaccination.
Unique Customization :
Internal sanofi pasteur requirement :
 To optimize manufacturing technology efficiency and
sanofi pasteur time to market by ensuring a better
control of our Industrial development processes
sanofi pasteur in brief
•
•
•
•
•
•
2005 net sales : € 2,062 millions (26,9% growth rate over 2004)
Staff : more than 8,500* employees
More than a billion doses of vaccines sold to protect more than 500
million people in the world
A wide range of vaccines against 20 diseases
A presence in 150 countries
15% of our sales reinvested in R&D
Improve
reliability of
commitments
on timelines
and quality
Reduce
duration
and costs
of projects
Research & Development
•
Sanofi pasteur is focused on developping new and improved
vaccines for every stage of life. The company’s scientists are
working in several areas:
– New vaccine combinations that will protect against several
diseases simultaneously, thus reducing the number of
injections,
– continuous efforts to improve the effectiveness and tolerability
of existing vaccines.
– Developping new vaccines for infectious diseases for which no
vaccines exist.
– New technologies and routes of administration
Establish
a shared
referential for
all participants
of the
project
Implementation
of a unique set of
industrial project
best practices
Storyboard Presentation – Unique Customization
February 20-21, 2007 / St. Pete’s Beach, FL
Set up a
consistent
approach for
the phasing of
all industrial
projects
Sanofi pasteur
Rémi PAULE
Company
Logo
A global project process based on
• a referential describing project
phases and detailed activities
New product
Development
Stage
Gate
1
New process
Implementation
Investments
Phase 1
Stage
Gate
2
Stage
Gate
3
Phase 2
• a Stage Gate (SG) review
process (at phases ends)
Gate
Gate
Gate
Gate
Gate
1
2
3
4
5
6
NEEDS
DEFINITION
FEASABILITY
DETAILED
DEFINITION
APS
INDUSTRIAL OPERATIONS
site level
Phase 3
Gate
NEEDS
FEASABILITY PRELIMINARY
DEFINITION
STUDY
DEFINITION
SANOFI
PASTEUR
Company level
EXECUTION
APD
EXECUTION
Exit
gate
VALIDATION CLOSURE
VALIDATION
A scaling up
Stage Gate process
MANUFACTURING TECHNOLOGY
depsrtment level
CLOSURE
US site
The SG process is based on :
a review of the detailed action plan (Next Phases)
(a dynamic view showing activity accomplishments) .
Fr site 1
Ca site
Fr site 2
• a review of the status of the set of
deliverables requested at the gate
Livrables
Statut approv
Délivrables et Decisions
al
Commentaires
Décision
GO NO GO
Paramètres critiques figés
Lots à l'échelle pilote (représentative de l'échelle industrielle)
effectués
1 seul lot de 30 L. par concentration (Taille de lot
approuvée AR)
Bornes des paramètres opérationnels fixées
Validation prévue en avril
Rapport d'étude de robustesse à échelle pilote disponible
Pas de produit disponible pour d'autres lots
Choix filtration stérilisante le 22-03-06 (choix 4xC ou
7xC le 28/04/06)
Pas de produit disponible pour d'autres lots (1 lot de
back up)
Procédé figé, prêt pour validation
Protocole d'étude de robustesse à échelle industrielle disponible
Tous les documents de validation des méthodes CQ disponibles
en cours
Méthodes de CQ transférées depuis le CQ Dev au CQ
Pas de nouvelle méthode à transférer pour phase 3
Disponibilité des réactifs de titrage est critique en
attente pour fin mai
Matières premières, réactifs, lots de semences libérés et prêts à être
utilisés pour la phase de validation
Résutats d'études de stabilité sur lots pilotes partiellement
disponibles
Rapports QI, QO et QP (non produits dépendants) approuvés pour
tous les équipements
Disponibilité : 2 mois à +5°, et le 28-04 pour le 3° mois
Plan d'action de validation et VMP disponibles
shipper vessels supplémentaires livrés fin mai, à
qualifier avant le 12 juin
Prot. validation prévus dispo le 9 juin (COPIL 2); Pas
de comparabilité
en cours pour le 13 avril
Techniques et Dossiers de lots disponibles (procédé industriel)
Dispo prévue fin avril
Formation des équipes opérationnelles de production terminée
prévue fin mai
Protocoles de validation du procédé et de comparabilité disponibles
Stage gate 3
à planifier pour disponibilité mi mai
Recettes SAP disponibles
voir slide COPIL spécifique
Evaluation du risque projet mis à jour
Décision de ne pas faire
Plan projet mis à jour
Décision pour lancer la phase de VALIDATION
GO
Commentaires globaux sur la phase, les interfaces, la stratégie :
Storyboard Presentation – Unique Customization
February 20-21, 2007 / St. Pete’s Beach, FL
NO
GO
Date prévisionnelle
pour Gate 6 :
sept-06
Sanofi pasteur
Rémi PAULE
Company
Logo
Team:
Results:
 Sponsor :
René LABATUT (VP Global MTECH)
 Project Leader : Jean Michel VIOLAY / Rémi PAULE
 A common referential to manage our industrial
projects worldwide, and a shared process between
functions involved.
 A process providing a clear and harmonized picture
of our projects. The SG follow up is used as a basis
for our Key Project Milestone indicator .
 A better mid & long term visibility about project
portfolio that improve our prioritization process.
 A dynamic road map used as a basis for cycle time
reduction for projects
(Director / Project leader – Global MTECH)
 Project team :
Peter THOMPSON (MTECH US)
Larry TAN (MTECH Ca)
François LEGUELLEC (MTECH Fr)
+ all directors from functions
involved in projects (R&D,
QUALITY, manufacturing, …)
Lessons Learned:


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

Involvement : This SG process based on a simple and practical « road map » is easily implemented, with good
buy in by the users and the management
Visibility : The delivery of a dynamic view of each project increases reactivity and promotes flexibility and
decision making process regarding the project strategy.
Efficacy - Shared vision across functions : The implementation of this referential & stage gate process
increases commitments and expectations between all the functions involved in the projects
Change management process : Continuous improvement is managed with close relationship with all functions
involved in projects, to promote partnership and buy in of these Best Practices and Stage Gate process
Next steps : To improve the road map with standard schedules in order to manage project cycle time reduction.
Storyboard Presentation – Unique Customization
February 20-21, 2007 / St. Pete’s Beach, FL