LSS and Commercialisation in MSDDaniel J. HoeyMerck Sharp & Dohme (Ireland) Ltd.
16th October, 2009
Agenda
• About Merck & Co., Inc.
• Lean Six Sigma and Commercialisation
• Merck Sharp & Dohme in Ireland
• Lean Commercialisation of ISENTRESSTM
Merck & Co., Inc.
• Founded: 1891• Number of employees: ~55,000• Global reach: Does business in 140 countries• 2008 revenue: $23.9 billion
Merck is a global research-driven pharmaceutical company dedicated to putting patients first.
Lean Six Sigma
Align andIntegrate
Achieve “DNA”in the Business
Build Foundation
MaturityLevels
KeyFocus
Key Metrics
ProjectSuccess,
Infrastructure, Capabilities
Early Wins
Training
# BB, GB
Savings/Revenue
Process Metrics
Cycle Time
Industry LeadershipLean Six Sigma
embedded in Key Processes
Sponsorship
Business Benefits
Deploy broadlyacross Merck
Alignment toScorecard
Depth ofpenetration
“Pull”“Push”“The Way We Work”
Owned by the Business
Level 1 Level 2 Level 3
Current Maturity Goal
Commercialisation
Focus on Through Put
Focus on Cost & Reliability
Focus on Speed & Cost
SupplyResearch Commercialisation
PCC I IIA IIB III Launch Long-term Supply
POC
MSD in Ireland
Carlow
Ballydine
Dublin
Ballydine Plant… facts
• Established API manufacturing plant in 1976
• Significantly expanded in 1999 to add Fac03
• Named API Commercialisation site in 2005
• Implemented MPS and Commercialisation organisational changes in December, 2006
• Formulation facility project started in 2007; operational end 2009
• Global API supplier for ~40% of Merck sales (excl. vaccines)
• ~400 Employees
• 25 international customers ~30 shipments/month
Ballydine Plant… mission
PHARMSUPPLY
PHARMPROCESS
DEVELOPMENT
APIPROCESS
DEVELOPMENT
APISUPPLY
PGM ROA ACCESS
MPS-Lean Six Sigma+
Commercialisation
Lean Processes Ready for Supply- Minimal/No Capital for launch- Technical issues resolved- Variability removed- Standardised work developed- Electronic instructions developed- PAT needs determined- Raw materials qualified- In-process tests removed
Ballydine Plant… mission
Lean CommercialisationISENTRESSTM
1. Quality (better)
2. Don’t short the market (more reliable)
3. Rapid Launch and ability to react (faster)
4. Cost to enable developing country access (cheaper)
• First in a new class of treatments for HIV
• Changes paradigm in HIV management
• Impact 40 million people worldwide
ISENTRESSTM reducing cost
Business Need• Reduce Product Cost
• Minimise at-risk Capital
• Enable Access Latin America1.7 million
East Asia750,000
Eastern Europe & Central Asia
1.7 million
Sub-Saharan Africa24.7 million
Caribbean250,000
North America1.4 million
North Africa & Middle East
460,000
Western Europe740,000
South & South-East Asia7.8 million
Oceania81,000
Total number living with HIV - 40 million
Source: WHO, 3 by 5 Progress Report: December 2005Achievements• 18% reduction in API standard cost
• 40% reduction in Cycle Time
• 22% improvement in Capacity
• < $50K Capital for initial campaign
• Transitioning from Internal to External Supply
ISENTRESSTM creating a robust process
Challenges• Supplier/Input:
– Raw material quality
• Process:– Reject rate ~13%
• Output/Customer:– Market threat
Resolution• Stabilize Supplier process
• DMAIC to improve Merck Process
– Identify KPIV’s
– DOE to optimize charge ratio
– Modified the process423-8411-8504-7492-7480-7468-7456-7444-7432-7420-7408-7
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Batch
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_X=0.0363
UCL=0.0629
LCL=0.0097
Use Test PCR
Reg Spec. = 0.30
Process A
I Chart of Imine %
423-8411-8504-7492-7480-7468-7456-7444-7432-7420-7408-7
0.6
0.5
0.4
0.3
0.2
0.1
0.0
-0.1
-0.2
-0.3
Batch
Individual Value
_X=0.0363
UCL=0.0629
LCL=0.0097
Use Test PCR
Reg Spec. = 0.30
Process A
I Chart of Imine %
Cpk0.34 to 5.08
Lean Processes Ready for Supply
Minimal/No Capital for launch
Technical issues resolved
Variability removed
Standardised work developed
Electronic instructions developed
PAT needs determined
Raw materials qualified
In-process tests removed
Summary
• Capability development is a powerful motivator of employees
• Operational Excellence can help expand the mandate for the Irish subsidiary
• Lean Six Sigma is an enabler for process development and new product introduction
• Irish plants can establish a mission that enables them to compete on value, in ways other than low cost.