Pandemic Vaccine Supply - Challenges & Opportunities: A Raw Materials Perspective

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

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Pandemic Preparedness Background

Pandemic Influenza – A look back

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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


Pandemic Vaccine Raw Materials Challenges & Opportunities

Raw Materials Challenges and Opportunities

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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

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3 - Managing Communication

Image source: headguruteacher.com

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 Pandemic Preparedness Plan

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

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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