Documenti di Didattica
Documenti di Professioni
Documenti di Cultura
May 6, 2008
Presented by:
Marc Kikuchi
Agenda
• Marketplace Dynamics
• Possible Approaches
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Agenda
• Marketplace Dynamics
• Possible Approaches
80%
50% 53%
70% 57%
61% 65%
60%
50%
88% 88% 87% 85% 84%
40%
30%
50% 47%
20% 43%
39% 35%
10%
0%
2003 2004 2005 2006 2007 2003 2004 2005 2006 2007
Brands Generics
Source: IMS Health, IMS National Prescription Audit Plus, National Sales Perspectives, Dec 2007
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U.S. Generics Market Opportunity
$70 210
$60 180
$50 150
Units (billions)
$ (billions)
$40 120
$30 $60.8 90
$53.9
$47.8
$20 $42.4 60
$35.8
$31.4
$10 30
$0 0
2006 2007 2008 2009 2010 2011
Source: IMS HEALTH
Top 20 companies in 2007 by numbers of prescriptions dispensed in the US with unbranded generics
Source: IMS Health
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Agenda
• Marketplace Dynamics
• Possible Approaches
• Technological capabilities
– Most companies have evolved from Active Pharmaceutical Ingredient
(API) suppliers to Finished Dosage Form (FDF) manufacturers to
creating their own product line
– Vertical integration from R&D to API and FDF through final packaging
also results in reduced costs
– Contract Research and Manufacturing Services (CRAMS) model
becoming more prevalent in co-development deals
4
Challenges of Global Generics Sourcing
• Do you really know your manufacturer?
• How much product and financial risk is the company willing to take?
Agenda
• Marketplace Dynamics
• Possible Approaches
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Design Phase Framework Overview
1 •Define Project Scope
•Gain executive alignment and sponsorship
Project Initiation •Create governance structure
•Assemble project team
2 •Rules of engagement
•Communications plan
Project plan •Project schedule
•Partner selection criteria and methodology
3 •Cultural education
•Partner meetings and visits
Due Diligence •Industry analysis
•External factor evaluation (regulatory, legal, etc.)
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Cultural Education
• Logistics
– Is a VISA required for this country?
– What are the VISA requirements?
– Medications and vaccinations recommendations
• Behaviors
– How do you greet someone?
– What are common practices?
– What are things to avoid doing?
• Companies
– Are you meeting with the right people?
– How are you getting from place to place?
– Where do you stay?
6
Execution Phase Framework Overview
5 •People, process and technology
•Project schedule with key events and milestones
Plan of attack •Opportunity prioritization
•Short-term transition, mid-term execution and
long-term strategy
7 •Organizational design
•Process creation, implementation and execution
Process •Contract management, audit, etc.
Infrastructure •Alliance management capabilities
•International Law and In-country Legal Issues
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Partner Selection Process – Example
Screening Filters
1
2
3
Company Reputation
Capabilities
5
Product Portfolio
Capacity
Sales
Intl
Due Detailed
Possible Diligence Visits
Partners “Lite”
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Global manufacturers evaluated on four primary criteria
1. Regulatory
– Review quality and manufacturing policies and procedures as well as
corporate regulatory philosophy
– All manufacturers currently approved and recently inspected by FDA
2. Financial
– Review available public and non-public financial data
– All manufacturers are financially stable and well capitalized
3. Ownership
– Evaluate ownership structures
– Meet with original owners or direct family descendants from originators in
senior management roles
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India – Some Facts and Figures continued
• Labor costs
– For qualified labor, rates tend to
be 50% less than US
– For unqualified labor, rates tend
to be 70-80% less than US
• Infrastructure
– Capital investment on facilities is
approximately 80% less than US
– Time to complete is ~4x faster
• Freight
– Freight costs tend to be 3x
higher than US
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Thank you!
Contact information:
Marc Kikuchi
Vice President – Global Generics Supply Chain Management
AmerisourceBergen Drug Corporation
E-mail: mkikuchi@amerisourcebergen.com
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