The IAM Annual Conference 2017

1. Asset Management Opportunities in the
Biopharmaceutical R&D Sector
Dr Phillip Richardson
2017 Institute of Asset Management Annual Conference 27th June 2017

2. Asset Management Opportunities in Biopharma R&D
Introduction &
Business Context
Asset Management
Opportunities:
• Strategy & Planning
• Decision Making
• Lifecycle Delivery
• Organisation & People
• Risk & Review
• Asset Knowledge
Conclusions3
2
2
1
Contents
Institute of Asset Management Anatomy

3. Asset Management Opportunities in Biopharma R&D
Introduction & Business Context

4. • Over-riding factor in
(Bio)Pharmaceutical research and
development is patent life and the
knock-on impact onto ‘drug pipeline’
• AZ’s ambition is to be World Leading
Pharma Company in specific
targeted disease areas
• Achieved through promoting
achievement of ‘Scientific
Excellence’ as the core Business
strategy
• Attracting and retaining world class
scientists is key to achieving this
ambition…….
• ……but safe, productive, reliable
and resilient assets are an essential
enabler to this ambition
Business Drivers for Asset Management in Pharma R&D
4

5. • Former ‘block-buster’ approach to R&D
being replaced by much more refined
targeting of disease areas
• Collaboration with like-minded research
establishment is now seen as the model
most likely to bring rapid patient benefit
• In 2013 AZ announced the relocation of
its UK R&D Hub to the Cambridge
biomedical campus to benefit increased
collaboration opportunities with nearby
institutes
• Currently building a 70,000m2 R&D
centre with associated Energy and
Server Centre
• Question: How can adopting an adopting
an Asset Management approach secure
productive science from day#1?
AstraZeneca’s New UK R&D Hub, Cambridge UK
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6. Asset Management Opportunities in Biopharma R&D
Strategy & Planning

7. • Link to Productive Science and the New
Cambridge Site Being a Great place to Work
• Recognition that the Pharma Sector is not very
mature in its Asset Management Thinking -
willingness to ‘Steal with Pride’
• Modelled on ISO55000 but take some of the
more practical guidance from PAS55 to form
the Asset Management System – IAM Anatomy
as a framework
• Importance of the need for an agile Asset
Management System that can support ‘Start-
up’ as much as ‘Business as Usual’
• Recognition of the importance that the Asset
Management System fit well within the overall
Cambridge FM Integrated Management
System
Buildings
Supply Chain
Management
Asset
Information
Cambridge FM Integrated Management System
Maintenance
Management
Capital
Projects
Management
Energy &
Utilities
Management
Workplace
& Space
Planning
Scientists &
Equipment
Occupants
Operational
(Soft)
Services
Scientific
Equipment
Maintenance
Site Leaders
Business
&
Customer
Outcomes
Business
Continuity
Management
SHE &
Occ.
Health
Laboratory
Services
Management
Enabling
Services
SHE
Management
Scientific Services
OperationalServices
AssetManagementServices
Direct
Customer
Impact
Services
Asset Management Policy
7 IMED Biotech Unit I Option to include TA or IMED function

8. • Asset Scope: focussed on the New
Cambridge Site but recognises the
importance of exiting from the interim
Cambridge facilities and potential future
assets on CBC
• Service Scope:
– Facilities Maintenance
– Energy & Utilities
– Building monitoring & control
– Investment projects
– Asset information management
• Governance & Sourcing Scope:
– Strategic
– Tactical
– Operational
Asset Management Scope
8 IMED Biotech Unit I Cambridge Site Operations
Asset
Solution + Service
Solution = Customer
Outcomes
Asset Solution Capability
Poor Good Excellent
Poor Poor OK OK
Good OK Good Good
Excellent OK Good Exceptional
Service
Solution
Capability
Aspiration
for NCS

9. Asset Management Opportunities in Biopharma R&D:
Decision Making

10. • Governance Model - Operational
Asset Management provided by
outsourced Partner Organisations –
small AZ team providing governance
• Plan Do Check Act cycle is intended
model for all the Site Operations
services
• Plan – strategic demand identified,
tactical resource provisions made,
inform the right operational service
interventions
• Do – Supplier define and execute
the day-to-day operational service
delivery
• Check – Customer (and Business)
outcomes measured, deviations
identified and joint improvement
measures defined
• Act – Provide Governance:
Direction, Accountability & Control
Asset Management Decision Making – Governance Cycle
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11. • Asset Management Critical Success
Criteria:
– Safe and compliant assets delivered
through well governed operational plans
– Fully supports productive science
through capable and available asset
base
– Enables NCS to be ‘A Great Place to
Work’
– Data driven decision making in which
assets are characterised by current and
accurate asset information
– Effective life cycle investment aligned to
Business Objectives with efficient
operational cost management
– Minimises use of natural resources and
fosters sustainable approaches
– Business risk associated with asset
failures fully understood. Asset
continuity and recovery plans in place
and tested
• Strategic Value measured by
realisation of CSFs versus Total Cost
of Ownership (baselined from current
interim operations)
• What are the ‘right’ customer impact
KPIs to measure realisation of AMS
benefits?
Asset Management Decision Making - Control
11
Strat-
egy
•Business Objectives
•Site Master Plan & Asset
Strategies
Tactical
•Asset Plans
•In-year capital & revenue
budget
Operat-
ional
•Operational activity
•Maintenance, Investment,
E&U, Asset Info
Perform-
ance
CostRisk

12. Asset Management Opportunities:
Lifecycle Delivery

13. • Importance of recognising the need to actively manage Early Life Cycle
• How to ensure ‘Productive Science from Day#1’ with a large and highly complex asset base
– Soft-landings approach through having Partners involved in commissioning to gain understanding
of and confidence in the asset
– Early establishment of a local project organisation – recognise that the needs of science will
change from ‘Day#-1”
– Really good reactive service – recognise the (inevitable?) instabilities in the early-life asset base
– Run against agreed Asset Strategy from day#1
Lifecycle Management – Early Life Management
13 IMED Biotech Unit I Cambridge Site Operations
Asset Related Cash Flow
New Prime Mature AgeingAcquire
Handover

14. • Mixed model maintenance Strategy
– Condition and Performance based
predictive service
– Planned preventative for compliance
driven elements
– Reactive service for customer
requests
– Rapid response for critical
breakdowns including implementing
contingency plans
• Understanding and influencing the
resilience provided through the Capital
Project
• Reliability Centre Maintenance approach
to developing maintenance plans
• Integrated Natural Resources
minimisation not just Energy
Management
Lifecycle Management – Maintenance Delivery
14 IMED Biotech Unit I Cambridge Site Operations

15. Asset Management Opportunities in Biopharma R&D:
Organisation & People

16. • Importance of working
with strategic partners
rather than short-term,
cost based contracts
• Sourcing against strategic
Asset Management
principles rather than
detailed engineering
RFI/RFPs
• Big risk factor will be
recruiting the volume of
capable Asset
Management service
operatives in the
Cambridge area
Organisation & People – Sourcing Strategy
16 IMED Biotech Unit I Cambridge Site Operations

17. • Biopharmaceutical R&D has a
number of relatively unique
compliance areas (home office,
radioactive materials, explosive
atmospheres)
• ….but also is bound by the basic
compliance requirements of all
buildings (e.g. fire safety,
legionella control, pressure
systems, etc.)
• AZ exercises compliance though
appointing competent Partners
who undertake a ‘duty Holdership’
role in these compliance areas…..
• ….but AZ maintains accountability
by appointing Accountable
Engineers to scrutinise, report and
lead CAPA processes
•
Organisation & People – Governance Principles
17 IMED Biotech Unit I Cambridge Site Operations

18. Asset Management Opportunities in Biopharma R&D
Risk & Review

19. Risk & Review: Business Continuity Management
19
Business
Impact
Analysis
Business
Interrupt-ion
Risk Assess-
ment
Asset Risk
Manage-
ment
Manage-
ment of
controls
BCP Incident
Response &
Recovery
Exercise,
Maintain &
Review
• Business Impact Analysis to determine
what’s really important to business
based on tolerability
• Critical activities have high business
impact in short period requiring rapid
recovery
• Business Interruption Risk Assessment
(BIRA): what failures could impact
critical activities, consequence,
likelihood and controls
• Manage asset based failure modes –
Haz-Op, CDM, FMEA, critical spares,
etc.
• Manage defined controls or accept /
transfer/terminate risk.
• Business Continuity Plan, Incident
response and crisis management .
Recovery
• Comms, Practice & Embed

20. • Asset performance, cost and risk aligned
to ‘Kano Model’
– Recognises that much of the
outcome of Asset Management
remains invisible to the Occupants –
particularly in the area of compliance
– However occupants do value asset
management service and asset
capability outcomes that directly
improve their own capability –
capacity, availability and quality
– Real value come out of introducing
novel solutions that contribute to
step-change improvements in
productivity
• Intensification of science is one of the
principles for Cambridge – Highly
dependant on environmental system
Risk & Review: Asset Performance
20 IMED Biotech Unit I Cambridge Site Operations
Asset Under-
Investment
Asset Benefits
Fully Realised
Asset Benefits
Fail to be Realised
“Performance”
(Value-added)
“Basic”
“Excite”
(Innovative)
High Asset
Investment
*Kano, Noriaki;
Nobuhiku Seraku;
Fumio Takahashi;
Shinichi Tsuji (April
1984). Journal of the
Japanese Society for
Quality Control (in
Japanese) 14 (2): 39–
48.

21. Asset Management Opportunities in Biopharma R&D
Asset Information Management

22. • AZ Has a number of Asset
information management systems
that support Asset Management:
– Computerised Maintenance
Management in SAP
– Drawing and Document
management system
– Building Information Models
– Numerous compliance
monitoring systems including
cloud based repositories
• How to realise the benefit of this
information being readily accessible
is a challenge
• Chosen to develop a SharePoint
solution to provide a simple and
intuitive gateway into these system
for Partner organisations
Asset Information: Integrated IT Systems
22 IMED Biotech Unit I Cambridge Site Operations

23. • AZ has been working extensively with
the Designers and Construction
Managers to help develop a BIM solution
that will provide on-going benefit to Site
Operations
• Some of these benefits include:
– Alignment of the asset systems in
the BIM to the asset structure in SAP
to ensure ease of interrogating the
asset record post-handover
– Replace real dated real estate
management tool by BIM to keep up-
to-date record of asset use by
function
– Use of BIM to publish drawings to
future project contractors and receive
these back to maintain good change
control
• Challenges with number of federated
models and diversity of underlying tools
Asset Information: Building Information Modelling
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24. Asset Management Opportunities in Biopharma R&D
Conclusions

25. • Biopharmaceutical R&D has some
unique challenges for Asset
Management - but many that apply
across a number of industries:
– Compliance & legislative drivers
– Cost pressures
– Workforce capability
• Opportunities to ‘steal with pride’
from other industries where speed to
market and early-life capability is
key
• Challenge will be to establish an
agile Asset Management System
that recognises the unique change
management drivers of a very young
asset base.
Conclusions: Asset Management in Biopharmaceutical
R&D Sector
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26. • Many thanks for your
attention.
• Any Questions?
• Please contact
phillip.richardson@astrazeneca.com
With any feedback…..including
your own experiences, good and
bad, with managing young assets!
Opportunities for Asset Management in Biopharmaceutical
R&D Sector
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