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Logistics Ireland 2010
Rx for Global Supply Chain
Paul Condon
Genzyme Ireland Ltd
Presentation Overview
• Genzyme Corporation
• Genzyme in Ireland
• Corporate Operations Strategy
• Waterford Operations Mandate
• Supply Chain Strategy
Our Global Corporation
• >12,000 employees worldwide
• Helping patients in 100 countries
• 17 manufacturing sites
• 20 major marketed products
• 2009 revenue of $4.5 billion
• 85 locations in >40 countries
• Henri Termeer: Chairman, CEO
Our Revenue Growth
$0
$500
$1,000
$1,500
$2,000
$2,500
$3,000
$3,500
$4,000
$4,500
$5,000
'95 '96 '97 '98 '99 '00 '01 '02 '03 '04 '05 '06 '07 '08 '09 '10
$M
(1H)
Our Focus
We develop
breakthrough therapies
to meet unmet medical needs
We are committed to
making a significant improvement
in patients lives
We are patient focused
Our Major Marketed Products and Services
Cerezyme®
Fabrazyme®
Aldurazyme®
Myozyme®
LumizymeTM
Personalized
Genetic Health
Renagel®
Renvela®
Hectorol®
Thyrogen®
Renal and
Endocrinology
Mozobil®
Clolar®
Campath®
Fludara®
Leukine®
Thymoglobulin®
Hematology and
Oncology
Genetics
Diagnostics
Other
Synvisc®
Synvisc-OneTM
Carticel®
MACI®
SepraTM Products
Biosurgery
Personalized Genetic Health
• LSDs (Lysosomal Storage Disorders)– Ultra-rare diseases (<10,000 patients worldwide)
– Progressive, debilitating diseases
– Missing enzyme causes health problems
• LSDs & Genzyme– Produce genetically engineered biologics to replace the
enzyme
– Introduced the first product approved to treat an LSD (1991)
– Marketed Products
• Cerezyme® (imiglucerase for injection) for Type 1 Gaucher disease
• Fabrazyme® (agalsidase beta) for Fabry disease
• Aldurazyme® (laronidase) for MPS-I
• Myozyme® (alglucosidase alfa) for Pompe disease
• LumizymeTM (alglucosidase alfa) for late-onset Pompe disease
Fabrazyme – Fabry disease
Renvela – chronic kidney disease not on dialysis
Mipomersen – hoFH and severe hypercholesterolemia
Prochymal – steroid refractory graft vs. host disease
Alemtuzumab – multiple sclerosis
Ataluren – Cystic Fibrosis
Prochymal – Crohn's disease
Eliglustat tartrate oral therapy – Gaucher disease
TSH – nontoxic multinodular goiter
Clolar – previously untreated adult AML
Thymoglobulin – myelodysplastic syndromes
Acid Sphingomyelinase – Niemann-Pick Type B
GC 1008 – kidney sclerosis
Gene therapy – Parkinson's disease
Mozobil – tumor chemosensitization
0 1 2 3 4 5
Late Stage Product Pipeline
Pre-Clinical Phase 1 Phase 2 Phase 3Post
Marketing
Genzyme – a world leader
• Consistently named a top employer by Science
• Rated among the most generous in-kind givers by
BusinessWeek
• Consistently named to the Dow Jones
Sustainability World Index
• Genzyme Center among the most
environmentally responsible U.S. buildings
• Genzyme was named one of the most ethical
companies by Ethisphere magazine
• Awarded the National Medal of Technology
Genzyme Ireland Operations
Pharmaceutical Investment in Ireland
• Number 1 location in Europe for Life Sciences projects
• 8 of the top 10 Pharma companies in Ireland (13/20)
• €34bn in Pharmaceutical Exports
• 44,000 employed in Life Sciences
• Excellent regulatory record
• 32 FDA approved Pharmaceutical Plants
• €1bn+ Corporate Tax
World’s Leading Companies in Ireland
37 acres on the edge of Waterford city.
Genzyme Waterford - Brief History
• Purchased Luxottica (Rayban) facility on 15 acres in 2001– Additional 16 acres purchased from IDA.
• Phase 1 (2002): Rayban facility converted to OD I tabletting. – Renagel & Renvela (Cholestagel to follow)
• Development Facility (2003)
• Phase 2 (2006): Sterile Fill/Finish added to expanded site.– Thymoglobulin, Myozyme, Cerezyme
• Phase 3 (2008): OD II facility – Renagel & Renvela
• Phase 4 (2008): Fill/Finish expansion project commenced
• €450m capital investment on site to date
Number of People
• December 2002
– 83 Team Members
• December 2003
– 140 Team Members
• December 2004
– 197 Team Members
• December 2005
– 268 Team Members
• December 2006
– 328 Team Members
• December 2007
– 401 Team Members
• December 2008
– 459 Team Members
• December 2009
- 465 Team Members
• Irish Medicines Board – November 2007
– Routine GMP Inspection of OD & FF
• Health Canada – November 2007
– PAI for Fill Finish products
• US Food & Drug Administration, CBER– January 2008
– Thymoglobulin Routine Inspection
• Gulf Central Committee– February 2008
– Fill Finish & Oral Dose Audit
• ANVISA Brazil – April 2008
– Fill Finish & Oral Dose Audit
• Ukraine Dept of Health – June 2008
– Fill Finish & Oral Dose Inspection
• Japan PMDA – Oct 2008
– PAI & Fill Finish Inspection
• FDA – Nov 2008
– Oral Dose Inspection
Genzyme Ireland – Regulatory Inspection History
• Irish Medicines Board – October 2002
– Initial Audit of Tablet Operations
• US Food & Drug Administration, CDER – June 2003
– PAI for Renagel Supply to US
• Gulf Central Committee – September 2003
– Supply of Renagel to GCC Countries
• Irish Medicines Board – September 2004
– IMP Audit (Clinical Supply) – solid and liquid dosage forms
• ANVISA Brazil – October 2004
– Supply Renagel to Brazil
• Irish Medicines Board – June 2005
– Testing & Release of Biological Products/Initial FF audit
• Irish Medicines Board – October 2005
– Routine GMP Inspection of Oral Dose area
• Irish Medicines Board – January 2006
– Approval of Fill Finish Operations
• US Food & Drug Administration, CBER – April 2006
– PAS for Thymoglobulin Supply to US
• US Food & Drug Administration, CBER– January 2008
– Thymoglobulin Routine Inspection
• Gulf Central Committee– February 2008
– Fill Finish & Oral Dose Audit
• ANVISA Brazil – April 2008
– Fill Finish & Oral Dose Audit
• Ukraine Dept of Health – June 2008
– Fill Finish & Oral Dose Inspection
• Japan PMDA – Oct 2008
– Fill Finish Inspection
• US Food & Drug Administration, CDER– Nov 2008
– Oral Dose Routine Inspection
• Iranian MoH– Feb 2009
– Thymoglobulin PAI Inspection
• Mexican MoH– May 2009
– Thymoglobulin PAI Inspection
• ANMAT Argentinian MoH– October 2009
– Fill Finish PAI Inspection
• US Food & Drug Administration, CBER– October 2009
– Myozyme PAI Inspection
• Irish Medicines Board – November 2009
– Routine GMP Inspection of OD & FF
Genzyme Ireland – Regulatory Inspection History (cont)
18
Supply Chain Context
“In today’s business world, efficient supply chain management, that
is aligned with business strategy, is necessary to remain competitive
and profitable.
Competition is no longer company versus company, but supply chain
versus supply chain.”
Prof. Carlos Cordon, IMD, Switzerland
Seeking dynamic alignment means treating your supply chain as a
living being not a mechanical beast.
John Gattorna
Vision: Genzyme Manufacturing & Corporate Operations
• A core strategic asset known for its operational
excellence across a broad range of technology
platforms and an unfailing ability to deliver a
quality product to patients in need.
World Class Manufacturing
Corporate Operations Goals & Priorities for 2010
1.Quality Systems
2.Product Supply
3.Technology Leadership
4.Massachusetts Biologics
5.Behavioral Change
Product Supply
• We recognize the importance of ensuring product availability and supply chain predictability, visibility, and flexibility
• Until our product arrives as scheduled to serve the patient in need, we cannot claim success for any aspect of our operation – Ultimate measure of operational excellence
To achieve the Waterford organisation’s potential by
developing a sustainable, competitive Manufacturing
Environment supplying Genzyme’s growing patient
product needs around the world.
Waterford Site Vision
Key Elements to our Strategic Plan
2008 2012
Patient Supply
Additional
Finishing Platform
Additional Volume and
Products
Key Supply Sites & ~ 25 CMOs
Haverhill
GeelLyon
MA
Supply Chain in Biotech Manufacturing
• Cells are grown in bio-reactors and product is
purified.
• Bulk is filled into vials
• Drug product is packaged to meet country and
language specific requirements
• All this happens in a time and temperature
sensitive manner.
What are our supply chain challenges today?
Manage and introduce new products.
Increase visibility, planning, forecasting &
execution robustness
Manage global complexities
Deliver product safely around the world
Control associated risks
Ensure compliance to regulations and local duties
Deliver cost savings
What are our supply chain challenges today?
• We need to move from a supply centric focus (push
=output and optimisation) to a demand driven network
(pull)
• This involves a change of mindset and a calibration of
what is driving the business.
• Our lean thinking is helping us move in this direction.
• Need space? - empty the warehouse we have, don’t
build another one!
StrategicStrategic
Sourcing
Product
Governance
TacticalProject &
Resource
Planning
Supply
Planning
Production
Planning
Warehouse
Planning
Transport
Planning
Demand
Planning
Service
Planning
Execution PlanningPurchasing/
Receiving
Manuf’ing
Execution
Warehouse
Operations
Transportn.
Execution
Order
Promising
Manag’t
Support &
Reverse
Logistics
Greater Collaborative Processes
Strategic Source Make Strategic Move Sell Strategic
Where are we trying to get to
Global
Distribution
Logistics Ireland 2010
Thank You
Paul Condon
Genzyme Ireland Ltd
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