pandemic vaccine supply - challenges & opportunities: a raw materials perspective
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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
Discussion Outline
Pandemic Preparedness Background 1
2 Raw Materials Challenges & Opportunities
Merck Millipore’s Pandemic Preparedness Plan 3
4 Summary
2
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
Global Action Plan on Influenza Vaccines
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“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
Increasing Production Capacity
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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
Man
ufac
turin
g C
apac
ity
(M
illio
ns o
f Dos
es)
Year
Manufacturing Capacity (Millions of Doses) Countries Manufacturing Influenza Vaccine
Countries M
anufacturing Influenza Vaccines
~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)
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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
Presentation title in footer | 00 Month 0000 8
Pandemic Vaccine Raw Materials Challenges & Opportunities
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?
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
2 - Managing Inventory & Supply
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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
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
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
Merck Millipore’s History of Preparedness
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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
Merck Millipore’s Preparedness Update
1. Vaccine Manufacturer Needs Mapping
2. Merck Millipore Capacity & Capabilities
3. Internal & External Communication
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3 focus areas for the latest update:
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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