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LSS and Commercialisation in MSD Daniel J. Hoey Merck Sharp & Dohme (Ireland) Ltd. PowerPoint Presentation
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LSS and Commercialisation in MSD Daniel J. Hoey Merck Sharp & Dohme (Ireland) Ltd. 16 th October, 2009. Agenda. About Merck & Co., Inc. Lean Six Sigma and Commercialisation Merck Sharp & Dohme in Ireland Lean Commercialisation of ISENTRESS TM. Merck & Co., Inc.

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Presentation Transcript
agenda
Agenda
  • About Merck & Co., Inc.
  • Lean Six Sigma and Commercialisation
  • Merck Sharp & Dohme in Ireland
  • Lean Commercialisation of ISENTRESSTM
merck co inc
Merck & Co., Inc.

Merck is a global research-driven pharmaceutical company dedicated to putting patients first.

  • Founded: 1891
  • Number of employees: ~55,000
  • Global reach: Does business in 140 countries
  • 2008 revenue: $23.9 billion
lean six sigma
Lean Six Sigma

Level 1

Level 2

Level 3

Build

Foundation

Align and

Integrate

Achieve “DNA”

in the Business

Maturity

Levels

Business

Benefits

Deploy broadly

across Merck

Alignment to

Scorecard

Depth of

penetration

Project

Success,

Infrastructure,

Capabilities

Key

Focus

Industry Leadership

Lean Six Sigma embedded

in Key Processes

Early Wins

Training

# BB, GB

Savings/Revenue

Process Metrics

Cycle Time

Key Metrics

“The Way We Work”

Owned by the Business

Sponsorship

“Push”

“Pull”

Current Maturity

Goal

commercialisation
Commercialisation

Focus on Through Put

Focus on Speed & Cost

Focus on Cost & Reliability

Research

Commercialisation

Supply

I

IIA

PCC

IIB

Launch

Long-term Supply

III

POC

msd in ireland
MSD in Ireland

Dublin

Carlow

Ballydine

ballydine plant facts
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
Ballydine Plant… mission

PHARM

SUPPLY

API

PROCESS

DEVELOPMENT

PHARM

PROCESS

DEVELOPMENT

API

SUPPLY

ballydine plant mission9
Ballydine Plant… mission

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

PGM ROA ACCESS

lean commercialisation isentress tm
Lean CommercialisationISENTRESSTM
  • Quality (better)
  • Don’t short the market (more reliable)
  • Rapid Launch and ability to react (faster)
  • 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
isentress tm reducing cost
ISENTRESSTMreducing cost

Eastern Europe & Central Asia

1.7 million

Western Europe

740,000

  • Business Need
  • Reduce Product Cost
  • Minimise at-risk Capital
  • Enable Access

East Asia

750,000

North America

1.4 million

North Africa & Middle East

460,000

Caribbean

250,000

South & South-East Asia

7.8 million

Latin America

1.7 million

Sub-Saharan Africa

24.7 million

Oceania

81,000

Total number living

with HIV - 40 million

  • Achievements
  • 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

Source: WHO, 3 by 5 Progress Report: December 2005

isentress tm creating a robust process
ISENTRESSTMcreating a robust process

Cpk

0.34 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

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 process
summary
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.