This document discusses challenges and opportunities for ensuring adequate raw materials supply for pandemic vaccines. It identifies critical raw materials and managing inventory, supply, and communication as key issues. The presentation outlines Merck Millipore's pandemic preparedness plan, which focuses on mapping vaccine manufacturer needs, assessing its own capacity and capabilities, and strengthening internal and external communication to support pandemic response. Close collaboration between vaccine manufacturers and suppliers is emphasized to develop risk assessments, inventory plans, and communication protocols to maximize preparedness.

1. Pandemic Vaccine Supply
Challenges & Opportunities: A Raw Materials Perspective
Priyabrata Pattnaik, Ph.D.
Director – Worldwide Vaccine Initiative
9th – 12th June, 2014
Suntec Singapore Convention & Exhibition Centre
S I N G A P O R E

2. Discussion Outline
Pandemic Preparedness Background1
2
Raw Materials Challenges & Opportunities
Merck Millipore’s Pandemic Preparedness Plan3
4
Summary
2

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Pandemic Preparedness Background

4. Pandemic Influenza – A look back
4
Pandemic Year
& Common Name
Origin Subtype WW Mortality
1918
“Spanish Flu”
Unclear H1N1 20 – 50 Million
1957-1958
“Asian Flu”
Southern China H2N2 (Avian) 1 – 4 Million
1968-1969
“Hong Kong Flu”
Southern China H3N2 (Avian) 1 – 4 Million
2009-2010
“A(H1N1) 2009”
North America H1N1 (Swine) 100,000 – 400,000
Adapted from WHO Report of the Review Committee on the Functioning of the International Health Regulations (2005) in Relation
to Pandemic (H1N1) 2009

5. Global Action Plan on Influenza Vaccines
5
“if a pandemic were to occur, the potential
vaccine supply would fall several billion doses short
of the amount needed…..”
- Geneva, World Health Organization, 2006
Global pandemic influenza action plan to increase vaccine supply
Approaches Identified:
1. Increase Seasonal Vaccine Use
2. Increase Production Capacity
3. Further Research and Development

6. Increasing Production Capacity
6
0
5
10
15
20
25
30
35
0
200
400
600
800
1,000
1,200
1,400
1,600
2005 2006 2007 2008 2009 2010 2011 2012
ManufacturingCapacity
(MillionsofDoses)
Year
Manufacturing Capacity (Millions of Doses)
Countries Manufacturing Influenza Vaccine
CountriesManufacturing
InfluenzaVaccines
~4X
increase in capacity
~2x
# of countries producing influenza
vaccine
Figure derived from Partridge et al, Vaccine 28 (2010), 4709-4712, Partridge et al, Vaccine 31 (2013), 728-731, WHO Global
pandemic influenza action plan, (2006)

7. 7
President’s Council of Advisors on Science and Technology, (2010), Report to the President on Reengineering the Influenza
Vaccine Production Enterprise to Meet the Challenges of Pandemic Influenza.
Varied
Production Platforms
Unique
process requirements
Further Research & Development

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Pandemic Vaccine Raw Materials
Challenges & Opportunities

9. Raw Materials Challenges and Opportunities
9

10. 1 - Defining Critical Raw Materials
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Alignment with suppliers
is essential!
• Does the supplier know
their product is being used
in this process?
• Does the supplier
understand implications of
a pandemic?

11. 1- Defining Critical Raw Materials (Cont.)
CHALLENGES
Lack of visibility
 Supplier may not know:
 what their products are used for
 how much would be needed in case
of a pandemic
 Vaccine manufacturer may not know:
 supplier’s surge capacity limitations
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OPPORTUNITIES
Information sharing
 Suppliers should share:
 capacity limitations
 inventory concerns
 at-risk products
 Vaccine manufacturers should share:
 process-specific Bill of Materials
 timing of orders,
 expectations of delivery times
Develop joint risk-assessments and risk mitigation strategy

12. 2 - Managing Inventory & Supply
12
100 units
60 units
150 units
A
B
C
Seasonal
Production
1,000 units
1,200 units
2,000 units
Pandemic
Production
Need to Bridge the Gap

13. 2 - Managing Inventory & Supply (Cont.)
CHALLENGES
Inventory management
Major financial implications to carrying
inventory for all parties
Storage and distribution may not align
with pandemic scenario needs
Second sourcing
Some raw materials may not have
alternative suppliers
Where alternatives are available,
significant validation work may be
required
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OPPORTUNITIES
Increase control over inventory
management
Identify what each party is willing to
commit
Consider options:
Supplier managed inventory
Vaccine manufacturer managed
inventory
Hybrid model
Increase visibility of forecast to
n-1 and n-2 suppliers
Work with suppliers to develop aligned inventory & supply plans

14. 14
3 - Managing Communication
Image source: headguruteacher.com

15. 3 - Managing Communication (Cont.)
CHALLENGES
Numerous parties involved
Suppliers, governments, vaccine
manufacturers, contract manufacturers,
distribution channels
Communication channels, contact points
can be unclear
Right frequency unknown
Absence of agreed upon plans can result
in too much or too little communication
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OPPORTUNITIES
Dedicated point of contact
Pandemic preparedness & response
contact to handle all communication
between supplier and vaccine
manufacturer
Same person responsible to interface
with government agencies, CMOs,
suppliers, etc.
Predetermined triggers and
communication frequency
e.g. Inter pandemic – quarterly,
alert phase – bi-weekly or weekly,
pandemic phase – daily.
Work with suppliers to develop joint communication plans

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Merck Millipore’s Pandemic Preparedness Plan

17. Merck Millipore’s History of Preparedness
17
Have had in place since 2005 and continuously updating
2005: HHS Pandemic Influenza Plan
2006: Business Continuity Plan (BCP)
2007: Pandemic Preparedness Plan
2009: Updated (H1N1)
Etc…
• Crisis Management & Response
Plans
• WW Pandemic Tracking
• Implementation of in-house
trainings
• Identification of critical assets and
resources
• Travel bans, social distancing, etc

18. Merck Millipore’s Preparedness Update
1. Vaccine Manufacturer Needs Mapping
2. Merck Millipore Capacity & Capabilities
3. Internal & External Communication
18
3 focus areas for the latest update:

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Summary

20. Summary
 Raw materials supply is critical to pandemic preparedness
 Vaccine manufacturers need to work closely with suppliers:
 Develop joint risk assessments and risk mitigation plans
 Develop aligned inventory and supply plans
 Develop joint communication plans
 Merck Millipore’s Pandemic Preparedness Plan
 Focusing on the opportunities above
 Actively engaging our customers & encouraging discussion
 Merck Millipore can help to maximize your preparedness!
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