The document outlines a Delphi-based expert assessment focusing on future challenges for pharmaceutical supply chains, highlighting critical trends such as new product types, healthcare delivery methods, and emerging market opportunities. The study aims to gather insights from industry experts to develop effective strategies for managing complex supply chain dynamics and regulatory changes. Additionally, it emphasizes the importance of a collaborative approach among stakeholders to enhance performance and adapt to evolving market needs.

1. Focus Group “Future Challenges
for Pharmaceutical Supply Chains”
A Delphi-based Expert Assessment of
Critical Trends and Prospects

2. Executive Summary
Our Approach
Extensive review of future
trends and prospects for
pharmaceutical supply chains
Conduct Delphi Study to reveal
likelihood, impact and
moderators of future trends and
prospects
Establish Focus Group and
research cluster to develop
concepts for robust and efficient
pharmaceutical supply chains
Your Benefit
Benefit from our expertise and
broaden your perspective on
key strategic challenges
Bundled expert knowledge
accomplishes time- and cost
savings and the ability to
prioritize strategic challenges
Knowledge transfer from other
fields, learning effects,
avoidance of pitfalls,
individual solutions
Identify
Assess
Manage

3. Agenda
Delphi Study
Future Trends
Introduction
Focus Group
1
2
3
4
Joint European Pharma Centre5

4. Agenda
Delphi Study
Future Trends
Introduction
Focus Group
1
2
3
4
Joint European Pharma Centre5

5. 1. Introduction
The Managing and Scientific Team
Prof. Dr. Constantin Blome
University of Sussex, UK
Professor of Operations
Management
Prof. Susan Newell
University of Sussex, UK
Professor of Information
Systems
Dr. Des Doran
University of Sussex, UK
Senior Lecturer Operations &
Supply Chain Management
Dr. Thanos Papadopoulos
University of Sussex, UK
Senior Lecturer
Information Systems
Dr. Dimitra Petrakaki
University of Sussex
Senior Lecturer in
Information Systems
Dr. Martin C. Schleper
EBS University, Germany
Lecturer and Project
Manager
Dr. Hannes Hofmann
EBS University, Germany
Prof. Dr. Michael Henke
Technical University Dortmund /
Fraunhofer IML
Professor of Corporate Logistics

6. 1. Introduction
Project Timeline
Focus
Group
! Real time expert
assessment of
future trends
and challenges
for
pharmaceutical
supply chains
! Clustering,
analysing and
synthesizing
results
! Anonymous
feedback to
participants
! Conception and
preparation of
project
! Identify
upcoming trends
and challenges
for
pharmaceutical
supply chains
! Contact and
acquire
participants from
key European
pharmaceutical
companies
! Analyse and
synthesise
results
! Write executive
report and
disseminate
results
! Identify key
research topics
! Meeting of all
participants and
presentation of
results
! Kick off of Focus
Group
Launch
Compile
Report
Delphi
Mar - Apr 2015 May - June 2015 July - Aug 2015 Sept - Oct 2015 Tbd.
Research
Cluster
! Engage in joint
practice-
oriented
research
projects
! Joint
conferences
! Access to and
visibility in key
European
markets

7. Agenda
Delphi Study
Future Trends
Introduction
Focus Group
1
2
3
4
Joint European Pharma Centre5

8. 2. Delphi Study
Introducing the Delphi Technique
! Developed at the RAND Corporation
in the 1950s
! Widely accepted method to achieve
convergence of opinion concerning
real-world knowledge solicited from
experts within certain topic areas
! In contrast to surveys (“what is”), the
Delphi technique addresses future
states ( what could be/should be”)
The Delphi Technique can be used for achieving the following objectives:
1. Determine or develop a range of possible
program alternatives
2. Explore or expose underlying assumptions or
information leading to different judgements
3. Identify information that might lead to a
consensus on the part of the respondent group
4. Correlate informed judgements on a topic
spanning a wide range of disciplines
5. Educate the respondent group as to the
diverse and interrelated aspects of the topic

9. 2. Delphi Study
The Delphi Technique - Characteristics
! Delphi applies multiple iterations of questionnaires to create consensus of
opinion concerning a specific topic among a panel of selected subjects
! Applying multiple iterations, Delphi offers a feedback process allowing
participants to reassess their initial judgements about information given in
previous iterations
! Delphi provides anonymity to participants
! Delphi is suitable to various statistical analysis techniques
These characteristics are designed to offset the shortcomings of conventional
means of pooling opinions obtained from group interactions (i.e., influences
by dominant individuals, noise, and group pressure for conformity).

10. 2. Delphi Study
The Real Time Delphi Process
Phase 1
! Integrate practical and academic
knowledge to create views on the
future of Pharma’s SC
Phase 2
! Invite participants to online
questionnaire
! Real time evaluation of answers
Phase 3
! Participants’ responses are put
into context of whole group
! Reassessment of responses
Identify areas of
agreement and
disagreement
Real time
feedback to
increase level of
consensus

11. 2. Delphi Study
Selecting Participants
Who are we looking for to join the Delphi Study?
1. Top management decision makers who will utilise the outcomes
of the Delphi Study
2. Professional staff members together with their support team
3. Highly trained and competent experts from strategic and
operative supply and operations functions
" Size of final panel should be between 30 to 50 participants

12. Agenda
Delphi Study
Future Trends
Introduction
Focus Group
1
2
3
4
Joint European Pharma Centre5

13. 3. Future Trends
Overview
New product types
Due to the rise of new product types,
pharmaceutical supply chains need to be
orchestrated to tackle associated complexity and
cost pressure.
New modes of healthcare delivery
As healthcare will be increasingly delivered to
patients’ homes, efficient ‘final mile’ distribution
networks have to be designed.
Emphasis on outcomes
As proving cost-effectiveness of medicines will
become imperative, pharmaceutical supply chains
need to deliver novel health management services.
Regulatory/Government
Gradual licensing and incremental launching
require supply chains to be agile and adjustable to
rapidly altering demands.
Importance of emerging markets
The growing importance of emerging markets make
great demands on pharmaceutical supply chains’
governance mechanisms.
Environmental pressures
New and eco-friendly processes will require re-
organisation and substantial investments into
pharmaceutical supply chains.
Greater public scrutiny
Greater public awareness stresses the need for risk
management across the extended supply chain and
greater supply chain transparency.
Big Data
New interface technologies to collect detailed
patient data will enable personalized medicine,
improved forecasting and demand information.
Consolidation and integration
Consolidation among pharmacies, wholesalers and
hospitals demands integration of pharmaceutical,
medical devices and healthcare service supply
chains.
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3
4
5
6
7
8
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14. 3. Future Trends
New Product Types
! Specialist treatments (e.g. biologics, gene and tissue based therapies, human
cell therapies) require innovative production and shipping standards
! Personalised medicine and poly pills have to be finished at pharmacy or ‘point-
of-care’)
! Product life-cycles will get shorter and increased competition reduces periods
of exclusivity
Fixed dose
combinations
Imaging
Tissue engineering
Nano-pills
Therapeutic
monoclonals
Pharmaco-
genomics
Biomarkers
Gene-based
therapies
Nano-carriers
Human cell
therapies
2010 2012 2015 2020
KEY Mainstream technologies already happening Gene/Cell/Tissue technologies Nanotech-related technologies
Source: PwC
Prevalence of new product types will put pharmaceutical supply chains under
pressure for innovation.

15. 3. Future Trends
Regulatory / Government
! In contrast to current binary practice, future launch processes will become
more incremental as new methods for assessing, approving and monitoring
medicines emerge
! ‘Live licensing’ and phased approaches will displace big-bang launches
resulting in a longer interval between initial launch and peak sales, a slower
climbing revenue curve and a more protracted payback period for investments
! Instead of large upfront investments into supply chains designed to cope with
peak volumes, new product launches will require supply chains that can be
rapidly adjusted as licenses alter
Revenue
Time
Peak Sales
80% 40%
In light of gradual licensing and adapted launching processes, pharmaceutical
supply chains will have to reach new levels in agility and responsiveness.

16. 3. Future Trends
Emphasis on Outcomes
! Financially stretched governments and
health insurers increasingly demand
clear evidence on effectiveness of
medicines
! Pharma has to move from manufacturing
and distributing medicine to ensuring that
patients get the most from therapies by
supplementing their products with
supporting services
! Supply needs to tap into diagnostics and
health management services
Future pharmaceutical supply chains not only have to deliver high quality
products but also services to prove their efficacy.

17. 3. Future Trends
New Modes of Healthcare Delivery
! Instead of relying on hospitals and specialists, patients will self-administer
their medicines and take a more active role in managing their own care
management
! Many diseases currently cured in hospitals will be treated at home
! Healthcare delivery will increasingly need to cover a diffuse network of nurses
and community carers
! Final mile distribution networks, use of electronic health records, e-prescribing
and remote monitoring will stimulate demand driven supply chains
www.compuware.com
Trends and Directions in Healthcare Delivery
Illness Wellness
Acute Care Primary Care
Inpatient Outpatient
Individual Health Community Well-Being
Fragmented Care Managed Care
Independent Institutions Integrated Settings
Service Duplication Continuum of Services
Future pharmaceutical supply chains will be characterized by patient-centred
and demand driven structures.

18. 3. Future Trends
Importance of Emerging Markets
! 90% of incremental growth in the global pharmaceutical
market over the next five years is expected to come from
emerging countries
! Manufacturing sources in emerging countries already
account for 15% of the formulated drugs sold in the US
! How to select the right supply partners albeit fragmented
market and unreliable data on supplier reliability?
! How to pick appropriate governance and contract
models?
! How to manage quality, product safety, and delivery risks?
! How to ensure that intellectual property is appropriately protected?
New supply chain governance mechanisms will be required to establish efficient
buyer relationships in emerging markets.

19. 3. Future Trends
Greater Public Scrutiny
! Both, FDA and EMA report a progressing
increase in the number of product quality
problems leading to record recalls
! Other administrations tighten their rules
as well (e.g. Indian government
mandates track-and-trace barcodes on
all export-intended drugs)
Par
In M
proc
Number of quality defects
There has been a progressive increase in the
number of quality defects over the years. Causes
for this increase are multifactorial and the Agency
is studying the root causes in order to draw general
lessons from these incidents which can be used to
further improve the quality of medicines.
Number of quality defects
Quality defects reported
2013 178
2012 148
2011 154
Number of quality defects (2011-2013)
EMA Number of quality defects
Fiscal Years 2011 - 2013
FDA Warning Letters
Fiscal Years 2008 – 2013
445 474
673
1720
4882
6760
0
1000
2000
3000
4000
5000
6000
7000
2008 2009 2010 2011 2012 2013
FDA Warning Letters
Fiscal Years 2008 - 2013
Pharmaceutical supply chains need to
develop robust compliance and risk
management measures.

20. 3. Future Trends
Environmental Pressures
! Population growth will increase pressure
on natural resources (e.g. water shortage)
! International drive to curb CO2 emissions
! Environmental controls are likely to
increase
! Traditional centres of pharmaceutical
manufacturing as well as logistic hubs will
become more vulnerable to extreme
weather events
Environmental pressures will require
substantial investments into
pharmaceutical supply chains (e.g. eco-
friendly production, relocating of plants).

21. 3. Future Trends
Big Data
! Detailed patient data including genetic
information will be available but require
close compliance with legislation
preventing data misuse at the same
time
! Revolution of inventory management
! Shortages and expensive emergency
orders can be prevented
Developing expertise in patient data
mining will increase efficiency and enable
precise demand forecasting

22. 3. Future Trends
Consolidation and Integration
! Consolidation of once fragmented industry segments (Originals, Generics,
OTC, Bio-Pharma)
! Consolidation among buyers (pharmacies, wholesalers, hospitals and
physician practices)
! Restricted health budgets, trend to tender offers and emerging two class
health care further reduces profitability of pharmaceuticals
! Thus, overcoming competition and greater integration of pharmaceutical,
medical devices and healthcare service supply chains becomes crucial to
curb new potentials
Future pharmaceutical supply chains will be characterized by a high degree of
integration.

23. Agenda
Delphi Study
Future Trends
Introduction
Focus Group
1
2
3
4
Joint European Pharma Centre5

24. Time- and cost savings are accomplished applying bundled expert knowledge, transferring innovations from other fields, fast
learning effects, individual corporate solutions, directly implementable operating instructions and avoidance of pitfalls others have
already made or will do
! Collaboration within the Focus Group
! Develop benchmarks to identify individual strengths
! Practice-oriented conceptual advancements
! Develop use cases collaboratively
! Identify corporate weak points
! Discuss and advance solutions in an expert forum
! Develop transferable knowledge and best practices
! Practical input
! Expert assessment of future trends and prospects
! Typical practical problems regarding trends and prospects
! Individually developed solutions
! Scientific input
! Latest academic research insights
! Generic conception and innovative ideas for designing
and organizing supply chains
4. Focus Group
The Focus Group Approach
The focus group serves as practice- and science-driven forum to increase corporate
supply chain competence
Realization at participating companies
LearningProcess
! Identify immediate improvements and operating instructions for supply chains
! Individual discussions and tailored conceptions and measures for supply chains
Efficiently adapt pharmaceutical supply chains to critical trends and prospects

25. 4. Focus Group
The Focus Group Approach cont.
! Advance
supply
chains
! Practical and scientific expertise
! Innovative ideas and concepts
! Prevention of potential pitfalls
! Learning effects
! Individually tailored solutions
! Immediate operating instructions
! Know-how of
participating
firms
! Know-how of
scientific
partners
! Time and cost savings
! Efficient process development
Initiating a mutual learning process of corporate practice and academia
generates several benefits

26. Agenda
Delphi Study
Future Trends
Introduction
Focus Group
1
2
3
4
Joint European Pharma Centre5

27. 5. Joint European Pharma Centre
Excellence in Practice-Oriented Research
Launch Research Cluster: „European Pharma Research Centre“
! Joint research projects with qualified researchers on challenges of highest
practical relevance
! Joint conference visits and representation at highest academic level
! Access to and visibility in key European pharmaceutical markets (Belgium,
Denmark, Germany, Switzerland)
Corporate Experts
NGOs

28. Further Questions?
Contact Information
Dr. Hannes Hofmann
EBS University for Business and Law
Institute for Supply Chain Management-
Procurement and Logistics (ISCM)
+ 49 1638631236
Hannes.Hofmann@gmx.com
Prof. Dr. Constantin Blome
Professor of Operations Management
University of Sussex
School of Business, Management and Economics,
Jubilee Building 302,
Falmer, Brighton, UK,
BN1 9SL
+44 1273 876509
C.Blome@sussex.ac.uk