Delivering Clinical Investigational Products for Global Trials

Ted Quiroz
Director, Global Clinical Supply Chain
Amgen Inc.
…to serve patients
Enbrel®
(etanercept)
EPOGEN®
(Epoetin alfa)
Aranesp®
(Darbepoetin alfa)
Sensipar®
(cinacalcet HCl)
Vectibix™
(panitumumab)
We aspire to be the best human therapeutics company.
We will live the Amgen values and use science and
innovation to dramatically improve people’s lives.
Our Goals
Deliver the Best Pipeline- Corporate
Build the Best Pipeline- Operations
Supply Every Patient Every Time- Operations
How does a company develop 28
therapies, conduct over 200
clinical trials, serve over 40,000
patients, in 48 countries?
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Phase 1
Phase 2
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Clinical trials entering unfamiliar, recently developing infrastructures
Fierce competition for enrolling new patients globally
Sustaining cold or frozen shipments through multi-connection
international locations
– The movement of biologics differs significantly compared to small molecule
• Ambient products are easier to move- Maintaining temperature is critical
• Less concern about shock and vibe- Proteins are more sensitive
• Stability profile takes longer to establish
Transport validation potentially complex, nontransparent lanes
Safely securing comparator products through international sources
Keen global partner management tactics
• Coordination across opposite time zones
• Awareness of cultural differences
• Infrastructure- Limited presence globally
In our company, Global Clinical Supply Chain Management plays a key
role in coordinating and managing the variables related to Amgen’s
pipeline from concept to delivery
– Gather requirements with R&D- Review demand and set forecasts
– Plan overall study needs- Pre-clinical and Clinical
• Build inventories working with Manufacturing
• Define label and packaging needs
– Work with partners to ensure delivery of product
• Transportation
• Distribution
– Provide ongoing Support- Customer Service
• Systems- IVR set up , testing and issue management
• Reconciliation
• Manage daily activities with depots in LA, Asia, and NA
Clinical Supply Chain Management plays an expanded role
compared to traditional roles from other companies
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With entry into new countries, it is critical to define the supply chain
needs
– To manage multiple countries, multiple products, different country
requirements
Solution: Develop cross Functional Study Teams Aligned through therapeutic
areas and products
– Global Regulatory Affairs provides critical information per country
– Transportation lanes- Qualification process
– Preferred vendors versus in country expertise
– Import/Export needs
• Dedicated experts
• In country experts- consultants and CROs
– Utilize vendors that best meet your need- Expertise still emerging
• Cold Chain Reliability- Fully understand cold chain products
• Demonstrate competency to reduce product risk- Contingency planning
• Execute accurate, detailed contracts with vendors- KPIs
Note: Rapid growth can lead to missing the details
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Competition for new patients globally- Enter new countries quickly and efficiently
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Expanded label content
In-house labeling and packaging operations
Amgen Distribution Centers
Master service agreements
Movement of Refrigerated and Frozen drug product
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Transport validation- Robust testing program
Transport Packaging Configurations- Manufacturing in global locations
Provide packaging materials to support trials- depots or LSPs
Securing Comparators globally
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Source local when possible- Improve distribution lead times and costs
Minimize re-labeling when possible
Ensure blinding strategy can be supported- 2-8 C versus ambient pack outs
Partner relationships
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Infrastructure- Expand presence globally through partners
Time zone differences- Meet partners regularly
Cultural differences- Understand the do’s and don’ts
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Be science-based
Compete intensely and win
Work in teams
Create value for patients,
staff, and stockholders
Trust and respect each other
Ensure quality
Collaborate, communicate,
and be accountable
Be ethical
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1980:
"
1985:
1991:
Amgen founded NEUPOGEN®
NEUPOGEN®
(original name:
(Filgrastim)
launched, named
AMGen)
discovered “Product of the Year”
by Fortune Magazine
1980
1985
1990
1994:
2002:
2005:
Amgen receives
US Department of
Commerce National
Medal of Technology
Neulasta®
(pegfilgrastim)
launched
Kepivance™
(palifermin)
launched
Amgen acquired
Immunex, including
ENBREL
1995
2000
2004
1983:
1989:
2001:
2004:
IPO
(Ticker Symbol: AMGN)
Enbrel® (etanercept)
discovered by Immunex
EPOGEN® (Epoetin alfa)
discovered
EPOGEN® launched,
named “Product of the Year”
by Fortune Magazine
Aranesp®
(darbepoetin alfa)
launched
Sensipar®
(cinacalcet HCl)
launched
Tularik acquisition
completed
(
This presentation contains forward-looking statements that are based on management’s current expectations and beliefs and are subject
to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described. All
statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including
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