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see also www.lifesciencesoutlook.com Dutch Life Sciences & Health Outlook 2013 The Life Sciences & Health Outlook is created under the supervision of Prof. dr. Fred van Eenennaam and Ir. Maarten Koomans. It is supported by the International Academic Advisory Council -Academic partners- -Developer- “From Bench to Bed” Monitoring and improving the Dutch life sciences & health cluster -Since 2009- -Partners- -The Fourth Edition-

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Page 1: Dutch Life Sciences Health Outlook 2013 Online

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see also www.lifesciencesoutlook.com

Dutch Life Sciences & Health Outlook 2013

The Life Sciences & Health Outlook is created under the supervision of Prof. dr. Fred van Eenennaam and Ir. Maarten Koomans. It is supported by the International Academic Advisory Council

-Academic partners- -Developer-

“From Bench to Bed”

Monitoring and improving the Dutch

life sciences & health cluster

-Since 2009-

-Partners-

-The Fourth Edition-

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Dear reader and friends,

This year’s “Dutch Life Sciences and Health Outlook 2013: “From Bench to

Bed” is the fourth since the need emerged for a yearly systematic

report on the Dutch Life Sciences and Health Cluster by companies,

research institutes and policy makers. We would like to

acknowledge and thank the valuable contribution of many to the Outlook 2013.

Especially, we would like to thank the firms and institutions in the life

sciences cluster, the national and international policy makers, our international

academic council members and their academic institutions, the members of the

120 universities of Harvard Prof. Porter Microeconomics of Competitiveness

network, the Netherlands Center for Competitiveness, the members of our

network in the world class “sister life sciences and health clusters”, CEBR for all

the generous support and feedback.

We hope that this year as well, you will appreciate all the project management and

data collection efforts done by The Decision Group and the timeconsuming task of

systematic data collection, methodology update and database management.

The main aim of the Dutch Life Sciences and Health Outlook in 2009 was set: “to

show up an objective, systematic, way, with a limited set of meaningful indicators

the economic and social effects and progress of the firms of the Dutch Life

Sciences and Health Cluster, to make and help align firm decisions, cluster and

specific Life Sciences and Health national policies”.

The economic and

social effects and

progress firms of the

Dutch Life Sciences

and Health Cluster

Over the years, the Outlook has evolved. Definitions and procedures were

revisited and updated, scope was broadened, and health is included.

We think you will be impressed with the development and

transformational capability of the Dutch Life Sciences and

Health Cluster. Last years we have received much positive

feedback on the Dutch Life Sciences Health Outlook, with

over 3000 downloads of the report, a circulation of

1000 reports, over 100 questions on the Dutch Life

Sciences and Health Cluster and 16 national and

international presentations.

For those who are new to the Dutch Life Sciences and

Health a short history of the development of the Life

Sciences and Health Outlook may be useful. See box

History on page 4 for a brief overview.

Dutch Life Sciences & Health Outlook 2013

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Firstly, the team paid extra attention to the development of Small and Medium

Sized companies and employment/talent capture. The ability to attract, retain

and develop talent at all levels is a major point of competition between the life

sciences and health clusters, also a major focus of the Regiegroep lsh and its

Human Capital Agenda. Secondly, we are proud to announce that we have

developed a set of indicators to capture the applied research output from a large

part of the Dutch Healthcare System. All involved in the Life Sciences and

Health Outlook, have long expressed the wish to incorporate the interface

between firms and the health system more systematically.

The Samenwerkende Topklinische opleidings

Ziekenhuizen (STZ), some of its key members

and our academic council and network have

developed tested and collected in a pilot the set of

indicators success.

New

The consequences of economic crisis, the transformation of the Dutch Life

Sciences and Health towards a more Small and Medium Sized Company base

and the rising demands and cost pressures on the Dutch Healthcare system are

the drivers behind the main additions to the 2012 Dutch Life Sciences and

Health Outlook.

The selected motto for this year is “From Bench to Bed”. We were

particularly interested in the cluster reaction towards the austerity budgets

across Europe. Pressures on support from government on investing in life

sciences cluster, support programs as well as cost pressures in the health

systems have a transformational effect on life sciences clusters around the

world.

On June 14 we will present the results on the health outlook part. We are

very excited about this major addition and hope that more health

organizations active in applied research will join for the Life Sciences and

Health Outlook 2014.

The main findings are:

1. Small and medium companies are compensating the restructuring

of large companies,

in rate of employment and number of companies.

2. A) The number of products (drugs) at the final phases of clinical

trials has increased,

as well as the total number of products in development, and the

number of medical devices on the market.

B) The revenue of small and medium companies has declined,

the large companies showed growth.

3. The cluster attracts private investments,

public investments are under pressures.

The Dutch Life Sciences and

Health Cluster need a stronger

focus on patient value

Entrepreneurs and industry

must be clearer on what

the benefits of their

treatments, medical devices

and diagnostics are for

patients and society.

Dutch Life Sciences & Health Outlook 2013

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Last but not least, the Dutch Life Sciences & Health Outlook 2013 also contains

information on the three spin-off projects of The Decision Group and one

research initiative at Erasmus University in 2012, which are tools to invest in

a healthy cluster; investing in value for patients and talent.

a) The Harvard Style Business Case written on the successful biotech

company Prosensa and its interplay and development inside and outside

the Dutch Life Sciences Cluster, which can be used for teaching at various

universities and for promotional activities within the Netherlands or abroad

b) A two year study on determining the Value of Diagnostics has been

successfully concluded. The pilot studies have clearly shown ways in which

the adoption rates of good new diagnostics can be improved. This is of key

importance for both the improvement of the Dutch healthcare system and the

success of the companies involved.

c) A major effort has been made over the past 5 years with close cooperation

with Harvard on Patient Relevant medical Outcome Measures. The

outcome measures and the related developed proprietary methodology are the

core of Value Based Healthcare which aims at better healthcare and cost

effectiveness. Amongst Catherina Ziekenhuis Eindhoven, St. Antonius

Ziekenhuis Nieuwegein, Erasmus MC Rotterdam have shared part of their first

results.

The convergence of biotech firms with pharmaceutical and med tech

companies, as well as the increasing technological spill overs between the so

called blue, green, white and red biotech firms were the main points of

attention in 2012. Definitions collection methods and procedures were

revisited and consequently changed, the 2010, 2011 data corrected

accordingly in the 2011 Life Sciences and Health Outlook.

A combination of the latest economic/cluster theory and policies, experience

with and an understanding of the life sciences industry and the healthcare

sectors as well as international business and academic experience had led to

this request. In 2010, the main focus on the Outlook was on (a) the selection

and comparative measuring of the core 6 cluster performance measures, (b)

the selection of the 7 key international “sister clusters” and (c) the

determination of existing and preferred cluster and specific Life Sciences and

Health National Policies.

Prof. Dr Fred van Eenennaam and ir Maarten

Koomans were asked in 2009 whether they were

willing and able to compile a yearly Dutch Life

Sciences and Health Outlook.

History

In 2011 the Outlook team focused on (a) the improved rigor of the

methodology, the data collection and the cross checking of data, (b) whilst

helping set the life sciences and cluster strategic agenda from the firms

perspective in the cluster.

Dutch Life Sciences & Health Outlook 2013

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Industry is seeking ways to substantiate their claims using these new

methodologies and approaches. Our Academic Council and the team

envision this development as essential to increase “valorization” from a

firms/investors perspective for fast adoption. The Value Based Healthcare

Center Europe supports the developments in The Netherlands and Europe.

d) At the Erasmus University a study has been started to investigate

(Greenfield) Foreign Direct Investment attractions to life

sciences and health clusters. To attract “Smart Money”, to develop the

Dutch Life Sciences and Health cluster further in the future has been

identified as an important policy area.

We hope you enjoy reading this year’s Dutch Life Sciences and Health

Outlook. Please provide us with suggestions, feedback and the occasional

encouragement. If you have any questions, please feel free to contact us.

We very much view our work as work in progress in a rapidly transforming life

sciences and health cluster. Therefore, we encourage you to participate in

next year’s outlook and welcome your help in research ideas and making

them happen.

On behalf of the team of The Decision Group; Kim Brüheim and Bodgan Toma,

business analysts.

With warmest regards,

Prof. dr. Fred van Eenennaam

Partner The Decision Group, Institute & Ventures

Ir. Maarten Koomans

Partner The Decision Group, Institute & Ventures

-Academic partners- -Developer- -Partners-

Dutch Life Sciences & Health Outlook 2013

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1. Small and medium companies are

compensating the restructuring of large

companies,

in rate of employment and number of

companies.

2. A) The number of products (drugs) at the

final phases of clinical trials has

increased,

as well as the total number of products in

development, and the number of medical

devices on the market.

B) The revenue of small and medium

companies has declined,

the large companies showed growth.

3. The cluster attracts private investments,

public investments are under pressures.

Dutch Life Sciences & Health Outlook 2013:

-Siz

e-

-Ou

tpu

t-

-In

pu

t-

Conclusions Context Advise

Providing

affordable

care

Health

Wealth

A. Keep, attract and develop

talent

B. Partnerships, co-

operations, and strategic

dialogues become

increasingly more important

C. Clarification on public

investments

(Large) companies are

rebuilding their business

models towards products

that add value to patients,

with a greater reliance on

partnerships.

Summary

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Should you like to make a decision based on:

Performance and

progress

See: 18 - 22

Small & Medium Companies

See : 22, 23, 24, 35, 47, 49

Growth in products

See: 37, 38, 50, 51

Cluster attracts Private

Investments

See: 43, 44, 55 - 57

Health Cluster

See: 29, 30, 31, 68-76

Patient Value

See: 10, 11, 60, 61, 64

Revenue

See:

39, 40, 52

Spin offs

See: 28, 64, 66, 67

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Contents of the Dutch Life Sciences Outlook 2013

Since 2009, a yearly systematic Outlook is presented on the performance and progress of the Dutch life

sciences & health (LSH) cluster.

Key Outcomes Dutch Life Sciences & Health Outlook

Executive summary 17

The Outlook 2013 has been compiled with the utmost care based upon available data in 2012. The authors are well aware of the fact that the data position on the Dutch

LSH cluster needs to be improved by the cluster to allow for adequate monitoring of the effects of proposed strategic policy actions. Readers are advised to contact the

authors of the report to avoid potential misinterpretations of the reported results. The authors welcome suggestions for improvement on the Outlook 2014 (please contact

[email protected]).

1

3

2 Dutch life sciences & health cluster success

Measuring performance and progress 32

Contents

4

Monitoring Cluster Size, Input and Output

Size: Number of companies & Employment 46

Output: Revenue & Number of products 50

Input: Public investments & Private investments 53

5

Strategic assessment of the cluster

Advice and Spin offs 58

Appendices

A. History & development of the Outlook 78

B. Monitoring methodology 90

C. About the involved partners 117

D. Bibliography 121

E. Glossary of terms 126

F. Consulted experts and organizations 132

6

Applied Research

Health Outlook – Health Cluster 2013 68

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Context of the Dutch Life Sciences & Health Outlook 2013

The Dutch cluster stands out by providing affordable care that add value to patients and professionals in

the context of more pronounced government budget reduction.

Health Wealth

Economic, financial and Euro crisis combined with

budget reduction and change of government structure

and policy

Higher life expectancy and increased incidence of

chronic illnesses a.o. lead to increased demand for

health

Image might be subject to copy-right. www.futuretimeline.net, accessed on 31.01.2013

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Affordable care that adds value to patients

(Large) companies are rebuilding their business models towards focused products that add value to

patients, with a greater reliance on partnerships.

1. From being opportunistic—pushing a broad array of

compounds on the premise that every chance is worth

exploring—to being focused on the most promising areas of

science and most attractive target customers.

2. They will transition from fully integrated pharma companies to

greater reliance on partnerships to manage risk and return,

across both product pipelines and functions.

3. They will gradually change their emphasis from science-driven

therapeutics to customer solutions with the drug at the center.

4. They will replace functional organization models with business

units that encourage more integrated decision-making, coupled

with direct accountability for the consequences of those

decisions.

In 2004, Gilbert et al. wrote an article on the need to

rebuild the business model; with four main suggestions

to improve.

Source : http://windhover.com Source : http://sync.nl

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From Bench to Bed

Insurance companies responsible for the “Bed” side partner with industry responsible for the “Bench” side.

Investments in better diagnostics, less invasive treatments and prevention of complications, that improve outcomes against costs. LSP &

Achmea are willing to invest €50 mio and Holland Venture & Menzis have set up an investment fund of €8 mio.

Source : http://www.achmea.nl Source: http//www.hollandventure.com/

Example of innovation that lead to patient value are Rijnstate and Prosensa.

Rijnstate, one of 28 STZ

hospitals in The Netherlands,

developed a practical solution

to the waiting lists for its CT

scan: the “walk-in- CT scan”.

Patients do not need an

appointment and without a

Scan-schedule, patients can be

seen and scanned directly,

often combined with an

outpatient visit.

Source: http://www.rijnstate.nl.

Duchenne Muscular

Dystrophy (DMD ) is a rare

disease and responsible

for respiratory and cardiac

failure. Prosensa develops

with the help of many

partners, a drug that may

improve these patients

outcomes.

Source: Prosensa, press release 08th of Nov 2011

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Definition of the Dutch Life Sciences & Health cluster (1/2)

In 2012 the scope of the Outlook was primary on the “Bench” side.

Agriculture Chemicals and

energy

Food

Technology

Red biotech

Pharma

Medical technology (incl. imaging)

Bio-materials

Nutriceuticals

Agrofood

Horticulture &

propagation

materials

Chemical

Energy

Health

Engineering

Regenerative medicine

Healthcare

Creative

industry

Education

and other

Healthcare delivery

2012

Scope of

the outlook

Applied research

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Definition of the Dutch Life Sciences & Health cluster (2/2)

Monitoring innovation “From Bench to Bed” broadened the scope of the Dutch lsh Outlook 2013 by

capturing partnership between life sciences and healthcare.

Agriculture Chemicals and

energy

Food

Technology

Red biotech

Pharma

Medical technology (incl. imaging)

Bio-materials

Nutriceuticals

Agrofood

Horticulture &

propagation

materials

Chemical

Energy

Health

Engineering

Regenerative medicine

Healthcare

Creative

industry

Education

and other

Healthcare delivery

2012 2013

Scope of

the outlook

Applied research

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Focus of the Dutch Life Sciences & Health Outlook 2013

The performance of the innovative core of the cluster of both the industry and part of the teaching and

specialized care and cure providers is the focus of the Dutch LSH Outlook 2013.

Fundamental Research NGI, Hubrechts Institute

R&D

companies

• Drugs and

Medical Device

companies

• (Pharma, Biotech,

Medical

Engineering)

Specialized Risk Capital

VC Firms, Angel Networks

Specialized

Research service

providers

• Contract

Manufacturing

Organizations,

• Contract Research

Organizations

• Clinical studies

• Synthesis services Specialized Business

Services

Banking, Accounting, Legal

Health Insurance

Laboratory, Clinical Testing

Laboratory Equipment

Analysis Software

Diagnostic Substances

Containers and Packaging

Medical Equipment

Ophthalmic Goods

Educational Institutions Universities

Cluster Organizations

Niaba, Nefarma, Biofarmind, LSH

Chemical products

Bioelectronics,

Bioinformatics

Regulation

CCMO, METCs, FDA, EMA

Translational Research TiPharma, BMM, CTMM

Marketing & Sales

Reimbursement

Healthcare Insurance Companies,

VWS dep of GMT

core value chain1

Manufacturing

Distribution

Specialized

Research

suppliers

Suppliers Value Chain Service Providers

© 2013 The Decision Group

The cluster map shows both the value chain and supporting industries for the Dutch LSH cluster. Within

the cluster, the Outlook 2013 focus is on the innovative core of the value chain, from Bench to Bed

1referred to in topsector plan as innovative core The cluster map is in the process of international recognition

Care and Cure

providers

* Teaching and

Specialized Hospitals

*16 out of 28 STZ hospitals are included

2012

2013

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The Outlook 2013 edition : Health evolvement

The Outlook 2013 edition features new indicators capturing the applied research in Dutch hospitals:

“From Bench to Bed”.

Outlook 2010 edition: Proof of Concept

Provided a proof of concept with academic grounding and involvement of entrepreneurs.

Outlook 2011 edition: Data position Improved the data position with more up to date and primary data.

Outlook 2013 Edition: Health included

Benefits for the readers of the 2013 edition:

Forecasts and trends in the Dutch life sciences

cluster

New indicators on applied research and innovation in

healthcare and cooperation with the innovative industry

Broadened scope “From Bench to Bed”

Analysis & Tools for a healthy cluster

Nyenrode LSH | Biotech Outlook 2010

Monitoring and improving

the red biotech cluster

The Nyenrode LSH | Biotech Outlook is created under supervision of prof. dr Fred van Eenennaam and Ir Maarten Koomans.

Draft – for High Profile Group review only – October 2009

Cover page to be updated

Outlook 2012 edition: Forecast & Survey

Data position over the years enables comparison and trends. A survey was held to check expectations.

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Firm by firm rechecked database

A detailed recheck of the entire updated database was done for the Dutch Life Sciences & Health Outlook

2013. A new and separate database was built to analyze data on applied research within hospitals.

Per company data

1. Education 2. Funda-

mental

Research

3. Transla-

tional

Research

4. R&D 5. Manufac-

turing

6. Specialized

research

supplier

7. Specialized

research

services

8. Marketing &

Sales

9. Distri-

bution

10. Care &

Cure provider

yes

yes yes yes

Data on the

activities in The

Netherlands of

each company

within the value

chain

Data on employment, and

revenue from Chamber of

Commerce and annual

reports

Data on number of products

from Thomson Pharma,

ClinicalTrials.gov, survey and

company websites

Prosensa Therapeutics b.v.

Protein Labelling Innovation

ProteoNic

Proxy Laboratories

PURAC biomaterials

Firm by firm checked database

Additional internal and external validity checks performed:

• Databases

• 25+ sources

• New checks on public investments

• Annual reports checked for revenue

• Recheck KvK (chamber of commerce) update

• Patent database check

• Hospital data from over 10

sources within individual

hospitals

Database Healthcare

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Key outcomes Dutch Life Sciences & Health Outlook 2013

Executive Summary

© IRRI Images

1

U2OS cells by Leonie Kollenstart, Bsc. – Student Biomedical Sciences

(green=actin, blue=nucleus)

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Copyright © 2009-2013 The Decision Group.The Dutch Life Sciences & Health Outlook 2013 appeared in February 2013.

Contact The Decision Group: +31(0)346-574942, [email protected], www.thedecisiongroup.nl

1. Small and medium companies are compensating the restructuring of large

companies,

in rate of employment and number of companies.

2. A) The number of products (drugs) at the final phases of clinical trials has

increased,

as well as the total number of products in development, and the number of medical

devices on the market.

B) The revenue of small and medium companies has declined,

the large companies showed growth.

3. The cluster attracts private investments,

public investments are under pressures.

Key conclusions Dutch Life Sciences & Health Outlook 2013:

-Siz

e-

-Ou

tpu

t-

-In

pu

t-

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The performance of the Dutch life sciences cluster (2010-2011)

The Dutch life sciences cluster displays growth in number of companies and products, at the same

revenue level, with raised private investments and with beginning decreasing public investments.

Summary of cluster performance (2010-2011)

SIZE

Number of companies: 343 (+4.3%)

Employment: 22.732 jobs (-6.7%)

OUTPUT

Revenue: 17.8 b€ (+0.6%)

Number of products: 122 (+10%)

INPUT

Public investments: 291 m€ (-2%)

Private investments raised:1887 m€ (+574%)

Note: 2011 data is the most recent available at the moment of publication for all indicators

Monitoring methodology

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Dutch Life Science Performance in the international context

Above average performance for private investments raised is displayed by the Dutch LSH cluster when

compared to international key clusters. Boston area scores highest on 3 out of 6 performance indicators.

2011

The Dutch LSH cluster1 compared to international key

life sciences & health clusters scores:

Above average for private investment (1887 m€ ) due to

the acquisition of Crucell for 1687 m*€

Below average ( the average amount of public

investments in key cluster for 2011 was 304 m € ) on

public investments raised (291 m€ in 2011) due to

decreasing investments in PPPs.

1 A more detailed account of this data is given in Chapter 3.

Performance 2011

* The average exchange rate $/ € of 2011 was used as published

by the Dutch Central Bank.

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Dutch Life Science Progress in the international context

Above average progress in the number of products, private investments and slightly above average in

number of companies.

2010-2011

The progress of the Dutch lsh cluster compared to

international key life sciences & health clusters

scores:

Above average on:

• Private investments (574% increase from

297m€ in 2009 to 1887m€ in 2010)*1.

• Number of products (10% increase from 111

in 2010 to 122 in 2011).

• Small and Medium companies have grown in

employment by 5%

Below average for 3 out of 6 performance indicators.

• Public investments decreased from 297 m€ in

2010 to 291 m€ in 2011, mainly due to a

decrease in matching investments in PPPs by

knowledge institutes2 .

• Employment has decreased from 24.385 to

22.732 mainly due to restructuring of large

companies.

• Revenue has grown although below average

(from 17.7 to 17.8 b€).

Progress

1 A more detailed account of this data is given in Chapter 2 and 3. 2 For Private investments raised and number of products the scale is adjusted to make a practical comparison possible

2010 - 2011

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Dutch Life Science cluster performance compared with the Dutch economy

In 2010-2011 the LSH employment growth rate declined by 6.7% compared to a slight increase by 0.5% in the

Netherlands. The LSH company growth (4%) outperforms the Dutch economy (2%), both have a decreasing

trend.

Source: Employment growth the Netherlands: CBS statline 2012 and The Decision

Group database

Source: Company growth in the Netherlands CBS statline 2012 and The Decision

Group database

In 2010-2011 the average growth rate of employment of the

LSH cluster decreased by 6.7%, while the employment of the

LSH cluster by companies < 500 employees has grown by 5%.

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Dutch Life Science cluster - forecast on cluster size

Based on preliminary data* on 2012, a steady growth of employment with less than 500 employees is

forecasted towards 8800 employees. The growth in number of companies is expected to continue to 350.

* See appendix B on calculation page 101

2012 estimate

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Location of new started companies based on postal - codes Newly started companies location ( < 25 km )

Location Abbott and MSD ( 1381 CP and 5342 CC)

Newly started companies location ( 26 < km < 219)

Restructuring opens new doors for the Dutch lsh cluster

Newly started companies are founded next to the production facilities of large companies that are

restructuring their activity in the Netherlands.

35 % of the new companies are located at

less than 25 km from Abbott and MSD

Source: FD, 28-12-2010

Source: FD, 23-6-2011

2.6 km

6 km

10.2 km

2.6 km

22.5 km

19.5 km

114 km

172 km

107 km

110 km

103 km

70 km

65.7 km

109 km

55.4 km

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Output – Number of drugs & Revenue

The number of drugs in development has risen by 19.6% from 56 to 67 products. The revenue of medium

sized companies shows a decline from 1.4 to 0.8.

- Source: The Decision Group database -

93

104 111

122

67 56

- Source: The Decision Group database -

18.7 18.2

17.8 17.7

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Input - Private investments

Cluster attracts private investments. Almost 90% of the private investment raised are due to the acquisition

of all shares of Crucell by J&J. Venture capitalist investments increased by 11% compared to 2010.

Sources: Press releases individual companies, NVP report 2012

167

622

280

1887

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Invest in a healthy cluster

The Dutch LSH cluster expects to cope with the restructuring of large companies. For a healthy cluster

investments in talents and partnerships, co-operations and strategic dialogues are desirable.

Business knowledge Cluster building

Public investment Investment climate

Partnerships, co-operations,

and strategic dialogues

between life science and health

strengthen the cluster.

Clarification on Public

Investments and alignment

and coordination of policy.

Policies with a focus on

patient value, at the level of

interactions between life

sciences and health: From

Bench to Bed.

Attract and hold life sciences &

health talents on various

levels, from PhD positions to

analysts and technicians.

Keep track of the developments

on healthcare abroad with new

concepts as Value Based

Health Care and Value of

Diagnostics.

Encourage the healthy private

investment climate via tax

regulations and other policies.

Show the success of the cluster to

the rest of the world by monitoring

performance.

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Spin off projects of the outlook for a healthy cluster

Patients and companies can make use of 3 spin off projects, to assess and increase the focus on patient

value and cost efficiency improvement.

The Harvard style case written on the successful biotech

company Prosensa and its interplay and development inside

and outside the Dutch Life Sciences Cluster, which can be

used for teaching at various universities and for promotional

activities within the Netherlands or abroad

* For details see page 61, 63, 64

A two year study on determining the Value of Diagnostics

has been successfully concluded. The pilot studies have

clearly shown ways in which the adoption rates of good new

diagnostics can be improved. This is of key importance for

both the improvement of the Dutch healthcare system and

the success of the companies involved.

A major effort has been made over the past 5 years with close cooperation with

Harvard on Patient Relevant medical Outcome Measures. The outcome

measures and the related developed proprietary methodology are the core of

Value Based Health Care which aims at better healthcare and cost

effectiveness. Amongst Catherina Ziekenhuis Eindhoven, St. Antonius

Ziekenhuis Nieuwegein, Erasmus MC Rotterdam, have shared part of their first

results. Industry is seeking ways to substantiate their claims using these new

methodologies and approaches. Our Academic Council and the team envision

this development as essential to increase “valorization” from a firms/investors

perspective or fast adoption “From Bench to Bed” from a

health/medical/patient/health economics view.

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Robert E. Burke – Professor at the George Washington University

Fred van Eeneennaam – Professor of Strategy and Dynamics of Strategy

Leonard H. Friedman – Professor at George Washington University

Christian H.M. Ketels – Principal Associate Harvard Business School

Göran Lindqvist - Principal Associate at the CSC Stockholm School of Economics

Victoire de Margerie – Professor at Grenoble School of Management

Health Outlook 2013

The focus on Patient value is supported by a monitor on the applied research. 16 hospitals which are doing

applied research provided data. The definition of health indicators was supported by an international

academic council.

Overview of the participating hospitals

which provided data on applied research.

146 Dutch Hospitals include 8 University Medical

Centers and 28 STZ hospitals engaged in research

Members of the international academic advisory council:

Total 146

General hospitals 84

of which

SAZ 40

OvA 16

STZ 28

University Medical Centers 8

Specialized hospitals 32

of which

Audiology Canters 5

Dialysis Centers 3

Epilepsy Centers 2

Cancer Centers 10

Radiotherapy centers 6

Asthmatics Centers 3

General 3

Rehabilitation institutions 22

1. St. Antonius Ziekenhuis Nieuwegein

2. Atrium Medisch Centrum

3. Catharina Ziekenhuis Eindhoven

4. HagaZiekenhuis

5. Jeroen Bosch Ziekenhuis

6. Maasstad Ziekenhuis

7. Meander Medisch Centrum

8. Medisch Centrum Alkmaar

9. Medisch Centrum Haaglanden

10. Medisch Centrum Leeuwarden

11. Onze Lieve Vrouwe Gasthuis

12. Reinier de Graaf Gasthuis

13. Rijnstate

14. Sint Lucas Andreas Ziekenhuis

15. Spaarne Ziekenhuis

16. St. Elisabeth Ziekenhuis Tilburg

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Sneak preview of the performance of the Dutch health cluster

Measured in publications citied, STZ has a significant contribution to applied research output with 2075

publications citied in 2010 and scores 1.3 on impact compared to the worldwide average of 1.0.

Since 2007 the number of publications citied has grown steadily.

1473 1527

1806

2075

All but one of the STZ members (blue bars) rank above the

international citation score average. A STZ publication scored 1.3**

on average (30% above international average) on this citation index

Source: STZ and The Decision Group database

Source: STZ & NFU (red bars are Academic Medical Centers)

** Self citations are not included; citations taken from web of science

– Sneak preview of research performance in Dutch healthcare –

All indicators are presented in spring 2013

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Learn, Share and Inspire

The Life Science and Health Outlook aims for further improving. Learn from it, share it, get inspired and

join the Health Outlook 2013 and LSH Outlook 2014.

June, 14th 2013 February 2014

*

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Dutch life sciences & health cluster success 2

Measuring performance and progress

C. Elegans – Celdivision by J. Van Der Berg, Bsc. – Student Biomedical Sciencs

(red=membrane, green=histones)

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Performance indicator #1: Number of companies

The total number of companies increased by 4.3% from 329 (2010 ) to 343 (2011). The number of companies

with 1 to 5 employees have steadily contributed to the growth of the Dutch LSH cluster by 6.2%.

- Source: The Decision Group database -

298 314

329 343

See for a detailed definition and overview Appendix B on Monitoring methodology.

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Performance indicator #1: Number of companies

The Dutch cluster shows above average growth of 4.3% in number of companies, when compared to key

international clusters which have grown jointly by 3.2% between 2010 and 2011.

Note: The UK cluster is defined as the East and Southeast of England, including London area; Check the radar diagram on p.20 on compared progress.

- Source: The Decision Group database, avaiable cluster reports and direct contact with cluster organizations -

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Performance indicator #2: Employment

From 2010 until 2011 employment decreased by 6.7% mainly due to the restructuring of large companies. 36%

of the labor force is employed by companies with 51-500 employees whereas in 2010 the share was 21.5%.

- Source: The Decision Group database -

24095 24255 24385 22732

See for a detailed definition and overview Appendix B on Monitoring methodology.

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Performance indicator #2: Employment

All key clusters show a small growth in employment. The Dutch cluster shows a decrease in employment

after the restructuring. U.K. cluster is the leading employer, here the labor force has grown by 7%.

- Sources: The Decision Group database, available cluster reports and direct contact with cluster organizations -

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Performance indicator #3: Number of products

The number of drugs in development has risen by 19.6% from 56 to 67 products. The number of medical

devices remains at the same level when compared to 2010.

- Source: The Decision Group database -

1Medical devices include devices & diagnostics that alter or measure body’s functions. See for a detailed definition and overview Appendix B on Monitoring methodology.

93 104

111

122

67 56

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Performance indicator #3: Number of products

The Netherlands displays, across the years, an average growth rate of 9.7% in the total number of

products, which situates it above the 6% average growth rate displayed by the international key clusters.

- Sources: The Decision Group database, available cluster reports and direct contact with cluster organizations -

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Performance indicator #4: Revenue

Medium companies reported a decrease of 57% in revenue from 1.4 to 0.8 in 2011. The revenue reported by

large companies has increased by 3% compared to 2010, causing a total revenue that slightly increases.

- Source: The Decision Group database -

18.7 18.2 17.8 17.7

*

* The fluctuation in total revenue is due to dwindling revenue reported by companies with up to 250 employees.

See for a detailed definition and overview Appendix B on Monitoring methodology.

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Performance indicator #4: Revenue

The Dutch cluster keeps its 4th position for the second year in row. Compared to last year the overall

revenue of LSH clusters has risen by 6.7%.

- Sources: The Decision Group database, available cluster reports and direct contact with cluster organizations -

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Performance indicator #5: Public investments

The level of total public investments decreased by 2.1 %: public investments in PPPs decreased by 2.6% from

150 m€ in 2010 to 146 m€ in 2011 while the level of matching investments and subsidies stayed constant*.

*Note: Investments counted are those that have been granted. In the calculation of the performance indicator, funding is equally distributed over the years for which it is intended to be used,

even though the budget spending per year can differ.

248 248

297 291

- Sources: NGI, The Decision Group analysis

See for a detailed definition and overview Appendix B on Monitoring methodology.

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Performance indicator #5: Public investments

The public investments in the Dutch LSH cluster are 2nd highest with 291m€ in 2011 compared to the key

clusters in absolute terms.

1373

817

991

1158

- Sources: The Decision Group database, available cluster reports and direct contact with cluster organizations -

Note: Investments counted are those that have been granted. In the calculation of the performance indicator, funding is equally distributed over the years for which it is intended to be used, even

though the budget spending per year can differ.

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Performance indicator #6: Private investments raised

Private investments maintain their volatility. 90% of the private investment are due to the acquisition of all

shares of Crucell by J&J. Venture capitalist investments increased by 11% in 2011 from 145 to 161 m€.

Sources: Press releases individual companies, NVP report 2012

167

622

280

1887

See for a detailed definition and overview Appendix B on Monitoring methodology.

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1 The international data include the major PIPE deals, IPOs and FOPOs from a range of sources. See also Appendix B monitoring methodology for a more detailed description of the main

contributions to the performance indicators used in this Outlook.

Performance indicator #6: Private investments raised

Considering the absolute value of private investment raised, the Dutch LSH cluster takes the 3rd position

with 1887 m€ when compared to the key clusters.

- Sources: The Decision Group database, available cluster reports, financial reports & website and direct contact with cluster organizations -

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Monitoring Cluster Size, Input and Output

Key performance indicators:

• Size : Number of companies & Employment

• Input: Public investments & Private investments

• Output: Revenue & Number of products

3

Zebra fish larvae 24hr - by Anneloes Dummer, Bsc. – Student Biomedical Sciencs

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Performance indicator #1: Number of companies (1/2) Life Science

Companies with up to 5 employees will grow in 2012 by 5%. These companies represent 57% of the total

number of companies in the Dutch Life Science cluster in 2012.

- Source: The Decision Group database; 2012 data has reference date October 2012 -

57%

9% 12%

8%

14%

See for a detailed definition and overview Appendix B on Monitoring methodology.

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Performance indicator #1: Number of companies (2/2) Life Science

Since 2005 the Dutch LSH cluster displays continuous growth to 361 companies. The base is given by the

increase in number of companies with 1 to 5 employees, which have grown at an average rate of 4.8%.

- Source: The Decision Group database; 2012 data has reference date October 2012 -

228

249

276

298 314

329

361 344

Forecast Factual data

See for a detailed definition and overview Appendix B on Monitoring methodology.

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Performance indicator #2: Employment Life Science

The share of employment with top 10 companies has decreased from 80 % (19567 employees) in 2010 to

73 % (16648 employees) in 2011.

- Source: The Decision Group database -

Company Location /Division Employment 2009 ( in NL ) Employment 2010 ( in NL ) Employment 2011 ( in NL ) Type

1 MSD 8675 8563 5500

R&D, manufacturing, marketing &

sels

2 Philips Philips Healtcare 3353 3353 3192

R&D, manufacturing, marketing &

sels

3 Johnson & Johnson 1329 1585 1370

R&D, manufacturing, marketing &

sels

J&J/ Crucell 495 751 541

Janssen Biologics 834 834 829

4 Medtronic 1084 1084 835

R&D, manufacturing, marketing &

sels

5 Abbott 958 986 2057

R&D, manufacturing, marketing &

sels

6 TEVA Pharmachemie 643 643 560

R&D, manufacturing, marketing &

sels

7 Astellas Pharma 575 575 571

R&D, manufacturing, marketing &

sels

8 DSM DSM Biologics 403 403 403

R&D, manufacturing, marketing &

sels

9 Novartis 400 436 436

R&D, manufacturing, marketing &

sels

10 PURAC Biomaterials 354 354 354

R&D, manufacturing, marketing &

sels

Company Location /Division Employment 2009 (in NL) Employment 2010 (in NL) Employment 2011 (in NL) Type

1 MSD 8675 8563 5500 R&D, manufacturing, marketing & sales

2 Philips Philips Healtcare 3353 3353 3192 R&D, manufacturing, marketing & sales

3 Johnson &

Johnson 1329 1585 1370 R&D, manufacturing, marketing & sales

J&J/ Crucell 495 751 541

Janssen Biologics 834 834 829

4 Medtronic 1084 1084 835 R&D, manufacturing, marketing & sales

5 Abbott 958 986 2057 R&D, manufacturing, marketing & sales

6 TEVA

Pharmachemie 643 643 560 R&D, manufacturing, marketing & sales

7 Astellas

Pharma 575 575 571 R&D, manufacturing, marketing & sales

8 DSM DSM Biologics 403 403 403 R&D, manufacturing, marketing & sales

9 Novartis 400 436 436 R&D, manufacturing, marketing & sales

10 PURAC

Biomaterials 354 354 354 R&D, manufacturing, marketing & sales

See for a detailed definition and overview Appendix B on Monitoring methodology.

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Performance indicator #2: Impact of restructuring

Less employment with large companies is compensated by the growth rate of employment with companies

with less than 500 employees by 9% in 2012; a positive reaction to restructuring of large companies.

- Source: The Decision Group database -

Forecast Factual data

9%

5%

See for a detailed definition and overview Appendix B on Monitoring methodology.

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Performance indicator #3: Number of products (1/2)

The top 25 companies with the most products in development are responsible for 70% of all products that

are currently being developed in the Dutch LSH cluster (84 out of 122)1.

1 The main sources for the number of drugs that companies have in development are the Thomson Pharma database, Medtrack, website searches, and Biotech Gate.

2 The main source for the number of medical devices that companies have in development is website searches for the individual companies. Philips is not included in this list as no reliable estimate

can be made based on available data on products in development and no open source is available on the number of products in development.

3 Medical Medical devices include devices & diagnostics that alter or measure bodily functions. See for a detailed overview Appendix B on Monitoring methodology.

- Source: The Decision Group database -

Company Drugs¹ Phase 1 Drugs Phase 2 Drugs Phase 3 Medical Devices in Development ²,³

Abbott B.V. 5 2

Akkolens international 2

AM-Pharma 2

Blue Medical Devices 10

Cavadis B.V. Utrecht 2

Crucell 2 3

Elana b.v. 2

Emultech bv 2

Enceladus Pharmaceuticals B.V. 1 1

Expand Biotechnology BV 2

Galapagos 1 1

Genmab B.V. 1 1

IS diagnostics 4 5 1

Kiadis Pharma 2

Medisse BV 5

Medspray 3

Merck BV 1 1

Mucosis 1 1

Mymetics BV 1 2

OctoPlus N.V. 1 2

Pantarhei Bioscience 2 2 1

PPD 2

Prescient Medical Europe 2

Prosensa Therapeutics b.v. 1 1

Skyline Diagnostics 3

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Performance indicator #3: Number of products (2/2)

In 2011 the Dutch total number of products increased by 10%, from 542 to 595.

- Source: The Decision Group database -

595

542

473

422

93 104 111 122

See for a detailed definition and overview Appendix B on Monitoring methodology.

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Performance indicator #4: Revenue impact of restructuring

The Revenue increased slightly (by 0.1 billion €) in 2011. Restructuring of large companies is expected to

lead to a decrease in revenue by 1.0 b€ in 2012.

- Source: The Decision Group database – forecast based on actual numbers of dismissals in 2012 -

1Assuming that all other factors remain unchanged (ceteris paribus)

1.0b€

Forecast Factual data

See for a detailed definition and overview Appendix B on Monitoring methodology.

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Performance indicator #5: Public investments (1/2)

Overall by 2015, the level of public investments is expected to shrink by 20%. The level of subsidies will

remain constant.

Source: NGI, Life Sciences & Health, news reports, program websites, government innovation budget 2012

Forecast Factual data

*

* Public investments for 2016 are hard to predict, however we know it will be significantly less due to the currently effect of the new funding policy which is hard to predict too.

Note: Investments counted are those that have been granted. In the calculation of the performance indicator, funding is equally distributed over the years for which it is intended to be used, even

though the budget spending per year can differ.

See for a detailed definition and overview Appendix B on Monitoring methodology.

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Note: Investments counted are those that have been granted. In the calculation of the performance indicator, funding is equally distributed over the years for which it is intended to be used, even

though the budget spending per year can differ. The dashed blocks show the impact of the closing of the top institutes, assuming that all other investments remain at the level of 2012.

Performance indicator #5: Public investments (2/2)

With actual policies, by 2015, matching investments in PPPs by knowledge institutes are expected to be

insignificant while the matching investments by private partners are likely to stay at the level of 2010/2011

Source: NGI, Life Sciences & Health, news reports, program websites, government innovation budget 2012

Forecast Factual data

*Public investments for 2016 are hard to predict, however we know it will be significantly less due to the currently effect of the new funding policy which is hard to predict too.

*

See for a detailed definition and overview Appendix B on Monitoring methodology

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Data for 2012 on Venture capital is not yet available. Depicted in the graph is 2012 prediction based on available data on August 2012. See details on calculation in appendix B page 113.

Performance indicator #6: Private investments raised (1/3)

Although private investments keep their volatile character, the Dutch lsh cluster proves to be healthy;

since 2009 to 2012 venture capital investments have increased at an average growth rate of 11%.

Source: press releases of individual companies

Forecast Factual data

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1 The potential value of deals for the Dutch lsh cluster is calculated based on employment of the company in the Dutch cluster and therefore varies from the total value of the strategic alliances.

Performance indicator #6: Private investments raised (2/3)

After 2009 the total value of strategic alliances signed continued to decrease. In 2012 the Dutch lsh

cluster managed to sign startegic alliances with potential of 48 m€ *.

*Source: press releases individual companies, moment of measurement August 2012

Forecast Factual data

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Performance indicator #6: Private investments raised (3/3)

In 2012 private investments have increased mainly due to IPOs and milestone payments. Across the

years, in average, 63% of the private investments is raised through venture capital investments.

Source: press releases of individual companies

395

167

321

260

215

304

Forecast Factual data

Data for 2012 on venture capital is not yet available. Depicted in the graph for 2012 is a prediction. See appendix B on calculation page 113

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Strategic assessment of the cluster

Advice and Spin offs

© Knitty Mary

4

© Hyperoxidation and oligomerization of PrxII (green) halts cell cycle progression when H2O2 levels are high. (JCB 175(5) TOC1)

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Invest in a healthy cluster

The Dutch LSH cluster expects to cope with the restructuring of large companies. For a healthy cluster

investments in talents and partnerships, co-operations and strategic dialogues are desirable.

Business knowledge Cluster building

Public investment Investment climate

Partnerships, co-operations,

and strategic dialogues

between life science and health

strengthen the cluster.

Clarification on Public

Investments and alignment

and coordination of policy.

Policies with a focus on

patient value, at the level of

interactions between life

sciences and health: From

Bench to Bed.

Attract and hold life sciences &

health talents on various

levels, from PhD positions to

analysts and technicians.

Keep track of the developments

on healthcare abroad with new

concepts as Value Based

Health Care and Value of

Diagnostics.

Encourage the healthy private

investment climate via tax

regulations and other policies.

Show the success of the cluster to

the rest of the world by monitoring

performance.

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Cluster building - Crossover between Life Sciences and Health

The increase need for a focus on patient value and cost reductions determines the life sciences, industry

and healthcare to cooperate and start strategic dialogues on all markets.

Strategic Dialogues on the delivery, insurance, purchasing and product market

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Cluster building – Focus on Patient Value

Define areas and medical conditions where in the care delivery value chain, can patient value be

increased. A shift from me-too products, towards focused products that add value to patients

Examples - Focus areas

Rare diseases

Personalized

Medicine

(Neuro)Degenerative

diseases

Care Delivery Value Chain

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Investment climate – Monitoring Performance

The Dutch LSH cluster outperforms the international clusters in progress amongst other things in the

number of products. Showing the success to the world might attract new investors.

Monitoring Performance

Life Sciences Health

N.E.A. invests for the first time in a Dutch Biotech Company.

Source: www.prosensa.nl

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Investment climate – Encourage private investments

Current tax rules and policies may hold back private investment. Stimulating policies and tax regulations

will strengthen the Dutch LSH cluster.

Report by PWC on the investment climate

Source: pwc.nl

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Public Investment – Start with Patient Value

In the current LSH landscape, the discussion is mainly focused on cost reductions. Our aim is to turn the

discussion and start with Patient Value and Health Outcomes.

It is our aim, as Value Based Health Care – Center Europe,

to share key practices, our experiences and developed

methodology on Value Based Health Care to put Patient

Value at the core. www.vbhc.nl

Create patient centered relations with your customers or how

to generate growth with pricing pressures. The key to an

affordable healthcare includes a strong and responsible role of

the life sciences industry.

Spin off project of the Outlook

Source: www.vbhc.nl Source: Porter, M.E. (2010) What is value in healthcare? The New England

Journal of Medicine, 363;26

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Public Investment – Clarification on Public Investments

In addition, alignment, coordination and clarification should be created and continued to guarantee

stability and progress of the cluster.

Source: Topsector Life Sciences & Health – Dutch LSH Conference, Leiden, December 11, 2012 - www.topsectoren.nl

Regiegroep Life Science & Health

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Business Knowledge – Talent

A shortage of technical personnel may also have an impact on the LSH cluster. Attracting and keeping

talent is essential for a successful cluster; o.a. the Regiegroep LSH is active to stimulate talent.

“Next to a good investment climate, attracting AND keeping talent is essential for a successful cluster” - Göran Lindqvist

Principal Associate at the Center for Strategy and Competitiveness (CSC) at the Stockholm School of Economics and Cluster Observatory project manager

Spin off project of the Outlook

Source: www.topsectoren.nl

Source: NRC Dagblad, November 7, 2012

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Business Knowledge – Developments (abroad)

Next to talent, business knowledge will be strengthened by keeping track of national and international

developments including emerging clusters.

Spin off project of the Outlook

Did you know that in The Netherlands:

• Diagnostics influences as much as 60-70% of healthcare decision

making ?

• Expenditure on diagnostics is even less than 6% of the total health

expenditure?

Today, too often diagnostics is regarded as a non value adding healthcare

activity or as black box. Policymakers and managers tend to see treatment

and diagnostics as one, however there is a huge difference. Treatment

cures people. Diagnostics improves clinical decision making, which has an

impact on treatments. This fundamental shift in thinking causes an

increasing number of organizations to struggle with the central question;

how to assess the value of diagnostics.

The Decision Group performed a study on diagnostics; and developed a

framework to asses the value. www.thedecisiongroup.nl

Source: www.thedecisiongroup.nl Source: www.vhbc.nl

Source: hcmatters.com

Source: C&EN – Chemical & Engineering News

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Applied Research

Health Outlook – Health Cluster 2013

© Michael Tam

5

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Health Outlook 2013

The strategic dialogues focus on patient value and are supported by a monitor on the applied research;

the Health Outlook.

The objective of the Outlook is to annually measure

1. Valorization by hospitals

2. Cooperation of hospitals with the innovative

industry in the Dutch Life Sciences & Health

cluster.

The result is to

1. Contribute to further support, connect, and improve

the innovative Life Sciences & Health cluster (by

enriching the existing Life Sciences Outlook with

information on applied research )

2. Create a valuable tool as basis for healthcare policy

decisions (for individual hospitals and at national

level.)

Health Outlook: monitoring From Bench To Bed

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Total 146

General hospitals 84

of which

SAZ 40

OvA 16

STZ 28

University Medical Centers 8

Specialized hospitals 32

of which

Audiology Canters 5

Dialysis Centers 3

Epilepsy Centers 2

Cancer Centers 10

Radiotherapy centers 6

Asthmatics Centers 3

General 3

Rehabilitation institutions 22

Health Landscape 2013

The Dutch Healthcare system consists of 146 Dutch Hospitals; including 8 University Medical Centers and

28 STZ hospitals engaged in applied research.

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Activities of STZ hospitals

STZ hospitals distinguish themselves on 3 pillars: top-clinical and top-referential patient care, education,

and applied research and innovation.

Sources: 1) STZ, Toelatings- en hervisitatiecriteria (July 2011), 2) STZ, 15 jaar STZ: Wat STZ-ziekenhuizen verbindt, 3) STZ, expertisecentra in beeld (2011), STZ, STZ opnieuw in beeld

(2010), 4) internal communication 5) STAKEHOLDER OPINIONS ON THE POSITION OF THE NETHERLANDS IN CONDUCTING CLINICAL DRUG TRIALS (2011)

Patient care

122+ expertise centers

(providing tertiary care with

>30% referrals from outside

the catchment area)

27% of topclinical care,

compared to 64% by the

academic hospitals

42% of all Dutch hospital care

(A+B segment)

870.000 hospital admissions

per year

General

28 hospitals with approx. 90.000 employees (approx. 4500 staff, 2000 residents, and 60 professors)

Education

50% of medical-specialist

education (26% academic

hospitals)

36% of all AIOS (51%

academic hospitals)

198 nurses being trained (311

academic hospitals, 2009)

Research

Focus on applied research and innovation

METCs, biobanks and participation in Parelsnoer

Excellent networks for gynaecology, cardiology, diabetes and

hypertension

Plan for improvement of research infrastructure

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Value adding activities for the innovative industry by STZ hospitals

The STZ hospitals perform many education and research activities across the value chain with value for

the innovative industry.

Education

• Business

courses

• Biology

• Chemistry

Fundamental

research

• Stem cell

research

• Development

al biology

Translational

research

• Target Finding,

Validation, and

Animal Models

• Lead selection and in

silico Modeling

• Predictive Drug

Disposition and

Toxicology

• Biomarkers and

Biosensoring

• Drug Formulation,

Delivery, and

Targeting

• Pharmaceutical

Production

Technologies

R&D & Manufacturing

Discovery, research,

product & process

development of :

• Antibodies

• Anti-infectives

• Biosimilars

• Cell therapy

Self-initiated

heatlhcare research:

R&D based on physican

expertience and practical

healthcare improvement

Marketing

& sales

• Marketing

activities

• Commerci

alization

• Pricing,

reimburse

ment

Distribution

& storage

• Logistics

Care & Cure

providers

• Therapy

• Diagnosis

Specialized research suppliers • Supplying biochips

• Supplying bioelectronics

• Supplying bioinformatics

Specialized research services • Contract manufacturing

• Contract research

• Drug delivery

- Illustrative purpose - © 2011 The Decision Group

Executing clinical phase II-

IV studies

Adoption of new

products and

treatments

Activities in the value chain of the Dutch Life Sciences & Health cluster

phase III phase IV

Activities of STZ hospitals

phase II

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Focus of the Health Outlook

The focus of the health outlook includes all activities at the end of the value chain, which improve the

result of cooperation with the innovative industry.

© 2011 The Decision Group

1. Executing clinical phase II-IV studies

2. Self-initiated healthcare research

3. Adoption of new products and treatments

Activities of (STZ) hospitals that provide highest value for the

innovative industry:

Focus of the Health part of the Outlook

Example of the adoption of new products and

treatments by an STZ hospital

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Performance indicators

Performance indicators monitor the success of a cluster or set of organizations. Typically, performance indicators cannot be influenced directly by policy.

Steering indicators

Steering indicators can be influenced directly by policy makers. Typically, steering indicators are selected

that have high impact on the success of a cluster or set of organizations.

Monitoring & Measuring

As with the Life Sciences Outlook, the Health outlook is based on indicators: a) Performance indicators

and b) Steering indicators.

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Measuring contribution of Dutch healthcare

The contribution of healthcare to applied research in the Dutch LSH cluster is measured in 8 key

performance and 7 key steering indicators covering both industry sponsored and self-initiated research.

Performance Indicators

INPUT

Industry investments

Hospital R&D investments

SIZE

Size of clinical trials (number of patients in trial)

Inflow of patients from outside catchment area

OUTPUT

Lead time of clinical trials

Number of publications

Number of products

Number of new protocols and treatments

Number of best practices shared among hospitals

Costs of research projects

Level of expertise

Staff responsiveness

Participation of staff in the development, undertaking and

use of research

Presence of research support offices and transfer facilities

in each hospital

Cooperation relationships of hospital research

Key Steering Indicators

* Adoption rate of new products is a new indicator expected to be added in the 2014 version

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Sneak Preview - KPI 7 Output: Number of Publications

Measured in publications citied, STZ has a significant contribution to applied research output with 2075

publications citied in 2010 and scores 1.3 on impact compared to the worldwide average of 1.0.

Since 2007 the number of publications citied has grown steadily.

1473 1527

2075

All but one of the STZ members (blue bars) rank above the

international citation score average. A STZ publication scored 1.3**

on average (30% above international average) on this citation index

Source: STZ and The Decision Group database

Source: STZ & NFU (red bars are Academic Medical Centers)

** Self citations are not included; citations taken from web of science

– Sneak preview of research performance in Dutch healthcare –

All indicators are presented in spring 2013

1806

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Appendices

© Ty Night

7

A. History, development and structure of the Dutch Life Sciences Outlook 78

B. Monitoring methodology 90

C. About the involved partners 117

D. Bibliography 121

E. Glossary of terms 126

F. Consulted experts and organizations 132

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Appendix A – History, development and structure of the Dutch Life Sciences & Health Outlook

Using the entrepreneurs’ perspective

© Branco Social Media

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Focus of the Dutch Life Sciences & Health Outlook 2013

Building on the Dutch Life Sciences Outlook 2010, 2011 & 2012, this edition focuses on forecast and

trends and “From Bench to Bed”.

© 2013 The Decision Group

- For ongoing analysis on the cluster progress, check the website of The Decision Group (www.thedecisiongroup.nl) or contact the researchers -

Nyenrode LSH | Biotech Outlook 2010

Monitoring and improving

the red biotech cluster

The Nyenrode LSH | Biotech Outlook is created under supervision of prof. dr Fred van Eenennaam and Ir Maarten Koomans.

Draft – for High Profile Group review only – October 2009

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Partners to create the Dutch Life Sciences and Health Outlook 2013

The Life Sciences & Health innovation program and The Decision Group proudly present the fourth

edition of the yearly Outlook on the Dutch LSH cluster.

The Outlook is commissioned by the ‘STZ-

ziekenhuizen’.

STZ stands for the Dutch association of Top

Clinical Hospitals. STZ members can be seen

as high care hospital providers and top

referral centers. In the same time STZ plays

an important role in applied medical research

having the aim to provide effective and

efficient care with focus on patient value.

Contacts:

Maarten Rook

Norbert Groenewegen

[email protected]

www.stz-ziekenhuizen.nl

The Outlook is created in cooperation with the Grenoble School of Management, School of

Public Health, part of The George Washington

University, Stockholm School of Economics

The Outlook is created in cooperation with

consulting firm The Decision Group.

The Decision Group helps clients take better

strategic decisions, using methods such as

strategic dialogue and strategic alignment. The

creation of the Outlook is supervised by Prof. dr.

Fred van Eenennaam, and ir. Maarten Koomans

managing partners of The Decision Group.

Contacts:

Prof. dr. Fred van Eenennaam

Ir. Maarten Koomans,

Kim Bruheim, MSc.

Bogdan Toma, BA, BSc

+31(0)346-574942

[email protected]

www.thedecisiongroup.nl

Contact:

Prof. dr Fred van Eenennaam

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International Academic Advisory Council

The International Academic Advisory Council1 has been set up, with the members providing advice on the

development of the Outlook, cluster policies and methodology development.

Göran Lindqvist

Principal Associate at the Center for Strategy and

Competitiveness (CSC) at the Stockholm School of

Economics and Cluster Observatory project

manager. His research focuses on agglomerations,

clusters, cluster initiatives, and cluster policy.

Robert E. Burke

Professor at the George Washington University

Professor Burke is a medical sociologist and a

nationally known expert in long-term care, with

extensive experience in developing, evaluating and

implementing health care policy and managing

multidisciplinary professional staff.

Leonard H. Friedman

Professor at the George Washington University

Dr. Leonard Friedman is an expert on the

mechanisms of organizational change and strategic

decision-making in health service organizations.

Victoire de Margerie

Professor at Grenoble School of Management

Dr. de Margerie is specialized in strategy, technology

management and corporate governance and holds

various management and executive positions in

Germany, France and the USA in multinational

industrial groups. She holds numerous positions in

boards of listed companies.

Christian H.M. Ketels

Principal Associate Harvard Business School

Dr. Christian Ketels is a member of the Harvard

Business School faculty at Professor Michael E.

Porter’s Institute for Strategy and Competitiveness

and Director of The Competitiveness Institute (TCI), a

global network of professionals interested in

competitiveness and cluster development.

1The council meets twice a year with Prof. dr. Fred van Eenennaam as chair and Kim Bruheim, MSc. as secretary of the council.

Fred van Eenennaam

Professor of Strategy and Dynamics of Strategy

Professor Fred van Eenennaam is an expert on

corporate governance & strategy. He is also well

known for his expertise in the life sciences and

healthcare industry.

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Methodology development (1/3)

The first Outlook was developed in 2009 to provide a proof of concept with academic grounding and

involvement of entrepreneurs.

*The High Profile Group (HPG) is made up of highly regarded professionals that are noted for their achievements in business, science and politics. The HPG was formed to advise on

future organization and direction of the Dutch Life Sciences & Health Initiative and gives recommendations regarding the opportunities, hurdles and future of the sector.

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Methodology development (2/3)

The Life Sciences Outlook continuously develops with regard to the academic grounding, the

involvement of entrepreneurs and the methodology.

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Methodology development (3/3)

The Life Sciences Outlook 2012 edition had more focus on forecasting and methodology was reconfirmed

internationally and by various academic insights.

* On August 29, 7 affiliates of the Microeconomics of Competitiveness (MoC) network of Prof. Michael Porter of Harvard Business School, took the

initiative to found a European Chapter of the network

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Cluster timeline

The Life Sciences Outlook 2013 edition includes Health. The methodology for Health indicators was

approved by the International Academic Advisory Council and STZ.

Health considered to be

included

Development of health

indicators

Commitment

TDG to continue monitoring

the LS&H

Validate methodology

International Academic

Advisory Council

Validate methodology

Pilot health indicators

launched

Partnership

TDG and STZ

collaborate

Monitoring

Top-sector and LS&H

monitor

Agenda

Top-sector present

agenda

Support withdrawn

LS&H quit

New support

NIABA takes over part of

LS&H

Academic gounding

Involvement

entrepreneurs

2012 2013 Set up dialog Set up agenda Data collection Draft report 2012

JAN –MAR 2012 MAR –JUNE 2012 JUNE –SEPT 2012 OCT –DEC 2012

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What is the structure of the Dutch Life Sciences Outlook?

Monitoring of the cluster success and key business impact areas is used to improve the cluster compared

to international key LSH clusters.

Dutch LSH cluster;

Key recommendations

Improving the Dutch LSH cluster compared to

selected international key LSH clusters .

Improving

Dutch LSH cluster;

Cluster success

Measuring performance and progress

Dutch LSH cluster;

Key business impact areas

Strategic assessment of progress

Monitoring

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Why is a successful cluster of importance?

The focus of the Outlook is on the perspective of entrepreneurs. Entrepreneurs are more successful when

they operate in an internationally successful trading cluster with a strong local dynamic.

Prof. Fred van Eenennaam and Prof. Michael Porter jointly work

on the application and development of cluster theory.

Prof. Dr. Fred van

Eenennaam, founder and

chairman of The Netherlands

Center for Competitiveness,

has been put in the limelight by

Prof. Dr. Michael Porter. He is

now included in the Harvard

Business School,

Microeconomics of

Competitiveness Affiliate Hall of

Fame.

The Diamond Model by Prof. Michael Porter can be used to

assess the competitiveness of clusters.

Prof. M. Porter and prof. F. van Eenennaam at

the opening of the Nyenrode Life Sciences &

Healthcare Institute (May 13, 2009).

Prof. F. van Eenennaam is co-

chairman of the global impact

council of the Microeconomics

of Competitiveness initiative

under the leadership of Prof.

Porter’s Institute of Strategy

and Microeconomics of

Competitiveness of Harvard

Business School, to which 80

universities and business

schools from around the world

are affiliated.

- For ongoing analysis on the cluster progress, check the website of The Decision Group (www.thedecisiongroup.nl) or contact the researchers -

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Further development of monitoring methodology

The focus of this year has been on “From Bench to Bed”, monitoring and improving the Dutch life

sciences & health cluster.

2) DEFINITIONS

Definitions of the key performance

indicators

3) MEASURING

Data collection for the key

performance indicators

MONITORING METHODOLOGY

1) CHOICES

Choice of the key performance

indicators

Actions/adjustments:

The KPIs were validated by

results of the European

Commission project: EU

Biocluster Project "Regional

Biotechnology"

The KPIs are used as starting

points for a European Cluster

assessment project

Connection is made with cluster

observatory

Actions/adjustments:

Wider cluster definition to take

the context of the cluster more

into account

Adjusted & validated definitions

(e.g. addressed issue of related

industries)

Focus in monitoring on core

value chain of the cluster to

capture the core of the cluster

Actions/adjustments:

Development of firm by firm

checked database (1000+

companies checked)

Use of all available Chamber of

Commerce data on employees,

companies and revenue (5000+

records checked)

Review of all press releases of

publicly known strategic alliances

of Dutch companies

Cross checks of data with 100+

data sources

Used data from 10 individual

international cluster organizations

© 2013 The Decision Group

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International connect

Cooperation is started within an international network of life sciences clusters to create an internationally

validated methodology for cluster monitoring.

participating clusters in CEBR SIG session on cluster assessment (December 15th, 2011, Brussels)

International network of involved life sciences

& health clusters

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Appendix B – Monitoring methodology

© IITA Image Libary

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Background on Monitoring methodology

The Monitoring methodology of the Life Sciences Outlook consists of: 1) choices, 2) definitions, and 3)

measurement of the key performance indicators.

2) DEFINITIONS

Definitions of the key performance

indicators

3) MEASURING

Data collection for the key

performance indicators

The key performance indicators are selected

to best reflect the success of the Dutch LSH

cluster:

Cluster Size

1. Number of companies

2. Employment

Cluster Output

3. Number of products

4. Revenue

Cluster Input

5. Public investments

6. Private investments raised

The data collection methodology is set

up to provide accurate measurements:

MONITORING METHODOLOGY

1) CHOICES

Choice of the key performance

indicators

The key performance indicators are

defined to best reflect the success of

the Dutch LSH cluster:

© 2013 The Decision Group

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What are the choices of the key performance indicators?

The overall Dutch LSH cluster success is measured using three value drivers and six key performance

indicators.

Cluster input

5. Public investments (€)

6. Private investments raised (€)

Cluster size

1. Number of companies (#)

2. Employment (employees)

Cluster output

3. Number of products (#, drugs, devices, technologies)

4. Revenue (€)

DEFINITIONS MEASURING CHOICES

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How are the key performance indicators selected? (1/2)

Choices are based on desk research, literature studies and an extensive strategic dialogue with

entrepeneurs and academic partners.

Hypotheses Framing Business

impact areas

Feb-Mar ‘09 Apr-May ‘09 May 13 ‘09

Sep-Oct ‘08

Research &

analysis

Set DIRECTION Create FOCUS

De

sig

n a

pp

roac

h Gather sector

opinions and

validation

Interviews round 2

Seminar

Interviews round 1

phase 1 phase 2 phase 3

Research &

analysis

Present Business impact areas:

Life Sciences Healthcare Event 2009

Opening Nyenrode Life Sciences &

Health Care Institute

Research &

analysis Validation and

fine tuning

Fix FRAMEWORK

phase 4

Validate RESULTS

Validate in field

Analysis and

draft

Jun-Aug ‘09

DEFINITIONS MEASURING CHOICES

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How are the key performance indicators selected? (2/2)

Choices are validated in 2010 by various academic contacts, business experts and other researchers.

Presentation to high

profile group

Sep-Oct ‘09 Nov 4 ‘09 Jun-Sep ‘10

Academic REFLECTION

Final check

in field

phase 5 phase 6 phase 7

Finalize

Outlook 2010

Set Academic COUNCIL

phase 8

Validate METHODOLOGY

Reflection with

Academic partners

Validation of KPIs

with academic

council Validate

methodology

Nov 29 ‘10

CEBR Meeting

Cambridge

KPIs and KSIs Health Outlook were

developed , introduced and approved

by the members of the academic

council and STZ members.

phase 9

Jan ‘11

Validate

data

DEFINITIONS MEASURING CHOICES

April ‘13

KPIs and KSIs

Health

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What were design considerations?

The main goal of the design was to find a set of indicators that would help to improve the cluster success.

• The focus of the Dutch Life Sciences and Health Outlook is on economic and social success of the Dutch LSH cluster, as scientific success is the focus of others like the Dutch Royal Academy of Sciences (KNAW). The Academic council has been discussing to add a measure on patents.

• The combined set of performance indicators gives insight in the success of the entrepreneurs in the Dutch LSH cluster.

Focus

• To ensure that the performance indicators is practical for policy makers, a small controllable set of performance indicators is selected that can be influenced and steered upon.

Use

• The scope of the Dutch Life Sciences Outlook is the Dutch LSH cluster. Scope

• High social interests in new healthcare products (performance indicator “Number of products”).

• Taking into account the stage of development of the Dutch LSH cluster (performance indicators “Number of companies” and “Employment”)

• Relatively high dependence on private and public investments in biotech, due to the large and high risks involved in their R&D (performance indicators “Public investments” and “Private investments raised”).

Tuning to Dutch LSH

• The approach has been validated in the field by 40+ expert interviews, seminar with 300 participants, academic reflection and tested with finished report 2010. Validation

• The performance indicators monitor success. This way the performance indicators directly match the experience of entrepreneurs. There is a clear distinction compared to other cluster monitors like the 12 pillars of competitiveness used in the Global Competitiveness Index of the World Economic Forum. There, competitiveness involves the factors that enable a nation or cluster to be successful. (“We define competitiveness as the set of institutions, policies, and factors that determine the level of productivity of a country”, The Global Competitiveness Report 2008-2009, World Economic Forum).

Aim

All choices made to select the performance indicators are based on the added value for entrepreneurs.

DEFINITIONS MEASURING CHOICES

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What was the starting point for selecting the six key performance indicators?

The six key performance indicators were selected from in total over 50 different indicators, resulting from

international best practices and academic literature.

Six performance indicators

Cluster Size

1. Number of companies

2. Employment

Cluster Output

3. Number of products

4. Revenue

Cluster Input

5. Public investments

6. Private investments raised

DEFINITIONS MEASURING CHOICES

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Definitions - scope

The Dutch LSH cluster contains all companies that 1) perform R&D on products or 2) manufacture

products that alter or measure bodily functions (human or animal) aimed at improving health effects,

including supporting and related industries, with direct focus on these companies.

1Based on the cluster theory M. Porter – Harvard Business School.

Green

biotechnology /

food

Dutch LSH cluster

Medical Technology

White (industrial)

biotechnology

Medical

Engineering

Nutriceuticals

Red

Biotechnology

Engineering

The Life Sciences Outlook monitors the Dutch LSH cluster, which includes red biotech,

medical technology and the pharmaceutical industry, and overlaps several other clusters1.

© 2013 The Decision Group

Scope of the

Dutch Life

Sciences

Outlook 2011,

2012 and 2013

Biomaterials

DEFINITIONS MEASURING CHOICES

Pharmaceutical Industry

Applied research

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Definitions - focus (1/2)

The Dutch Life Sciences Outlook focuses on the value chain of the Dutch LSH cluster.

Suppliers (e.g. lab equipment, power

supply, water supply)

Service Providers

(e.g. legal, consultants, bank)

Value Chain (companies or organization

with activities that directly

contribute to the development

of products aimed at

improving health effects)

DEFINITIONS MEASURING CHOICES

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Focus of the Dutch Life Sciences & Health Outlook 2013

The Dutch Life Sciences and Health Outlook focuses on the core value chain.

Fundamental Research NGI, Hubrechts Institute

R&D

companies

• Drugs and

Medical Device

companies

• (Pharma, Biotech,

Medical

Engineering)

Specialized Risk Capital

VC Firms, Angel Networks

Specialized

Research service

providers

• Contract

Manufacturing

Organizations,

• Contract Research

Organizations

• Clinical studies

• Synthesis services Specialized Business

Services

Banking, Accounting, Legal

Health Insurance

Laboratory, Clinical Testing

Laboratory Equipment

Analysis Software

Diagnostic Substances

Containers and Packaging

Medical Equipment

Ophthalmic Goods

Educational Institutions Universities

Cluster Organizations

Niaba, Nefarma, Biofarmind, LSH

Chemical products

Bioelectronics,

Bioinformatics

Regulation

CCMO, METCs, FDA, EMA

Translational Research TiPharma, BMM, CTMM

Marketing & Sales

Reimbursement

Healthcare Insurance Companies,

VWS dep of GMT

core value chain1

Manufacturing

Distribution

Specialized

Research

suppliers

Suppliers Value Chain

Service Providers

© 2013 The Decision Group

1referred to in topsector plan as innovative core The cluster map is in the process of international recognition

Care and Cure

providers

* Teaching and

Specialized Hospitals

*16 out of 28 STZ hospitals are included

2012

2013

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Definitions - value chain

The value chain consists of the main activities that enable the development, production and use of new

drugs and medical technologies.

Education

• Business

courses

• Biology

• Chemistry

Fundamental

research

• Stem cell

research

• Development-

al biology

Translational

research

• Target Finding,

Validation, and

Animal Models

• Lead selection and in

silico Modeling

• Predictive Drug

Disposition and

Toxicology

• Biomarkers and

Biosensoring

• Drug Formulation,

Delivery, and

Targeting

• Pharmaceutical

Production

Technologies

R&D &

Manufacturing

Discovery, research,

product & process

development of :

• Antibodies

• Anti-infectives

• Biosimilars

• Cell therapy

• Drug delivery

• Gene therapy

• Generics

• Nucleaic acid drugs

Marketing &

sales

• Marketing

activities

• Commercializa-

tion

• Pricing,

reimbursement

Distribution

& storage

• Logistics

Care & Cure

providers

• Therapy

• Diagnosis

Specialized research suppliers • Supplying biochips

• Supplying bioelectronics

• Supplying bioinformatics

Specialized research services • Contract manufacturing

• Contract research

• Drug delivery

- Illustrative purpose - © 2013 The Decision Group

DEFINITIONS MEASURING CHOICES

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Performance indicator 1: Number of companies (1/3)

Performance indicator 1 is defined as companies in the core value chain of the Dutch LSH cluster that 1)

perform R&D or 2) manufacturing ...

Companies in the core value chain of the

Dutch lsh cluster

that

Definition

The Dutch LSH cluster contains all companies that perform

R&D of products or manufacture products that alter or measure

bodily functions (human or animal) aimed at improving health

effects, including supporting and related industries, with direct

focus on these companies.

• Veterinary companies are included in this definition.

• Companies that develop medical devices based on engineering

are included.

• Blue and green biotechnology companies are not included.

• Nutriceutical companies that are on the intercept between the

green and red biotechnology are not included.

Rationale

The Dutch LSH cluster is defined according to the cluster theory

of Prof. Michael Porter.

DEFINITIONS MEASURING CHOICES

perform R&D or manufacturing

Definition

R&D: “Creative work undertaken on a systematic basis

in order to increase the stock of knowledge, including

knowledge of man, culture and society, and the use of

this stock of knowledge to devise new applications”

(OECD)

Manufacturing “is defined as the physical or chemical

transformation of materials of components into new

products, whether the work is performed by power-

driven machines or by hand, whether it is done in a

factory or in the worker's home, and whether the

products are sold at wholesale or retail. Included are

assembly of component parts of manufactured

products and recycling of waste materials.” (UN)1

Rationale

Companies that perform R&D and manufacturing are

part of the core value chain of the Dutch LSH cluster,

which focuses on being a breeding ground for high-

tech innovation.

1 International Standard Industrial Classification of All Economic Activities, Revision 3, United Nations, 1990, Series M, No. 4, Rev. 3.

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Performance indicator 1: Number of companies (2/3)

or 3) offer specialized research services or 4) are specialized research supplier ...

or

specialized research supplier

Rationale

Definition

Specialized Research Suppliers

are companies whose core business is to supply

products specifically to the R&D companies in the

core value chain.

The relation between companies that are specialized

research suppliers and the R&D companies is very

strong. The companies contribute to the total revenue

of the cluster and are often high- tech companies

themselves.

DEFINITIONS MEASURING CHOICES

offer specialized research

services

Rationale

Definition

Specialized Research Service Providers

are companies whose core business is to deliver

services specifically aimed at the research

activities performed by the R&D companies in the

core value chain. Examples are product

development services, analytical services,

screening, contract manufacturing and contract

R&D to the lsh industry, as well as the

development of platform technologies.

The relation between companies that are specialized

research suppliers and the R&D companies is very

strong. Companies that provide Specialized Research

Services give an essential contribution to the success of

the cluster and are often high-tech innovative companies.

or are

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Performance indicator 1: Number of companies (3/3)

…that are dedicated or diversified private companies within the Netherlands.

dedicated or diversified private companies

within

Rationale

Definition

Rationale

Definition

Rationale

Definition

The Netherlands

Two types of companies are

distinguished:

1. Dedicated companies that only

perform activities in LSH

2. Diversified companies that

perform activies outside of LSH

Both type of companies are included.

• When a company has several

offices in The Netherlands, this is

counted as 1 company in the

number of companies.

• Companies that are taken over by

another firm are no longer

counted as a separate company.

Companies that perform core value

chain activities in the Netherlands.

In practice, a company is included if it

has a department in the Netherlands

in which these activities take place.

Life Sciences Outlook includes:

1. An R&D office in the Netherlands

of a non-Dutch multinational.

2. Trust offices of multinationals that

only function as an administrative

office are not included.

Diversified companies are included,

because they contribute to the LSH

cluster. Their revenue, employment, and

number of products is only counted for

the fraction of their activities in LSH.

The performance indicator counts

independent legal entitities. The

number of offices provides no

additional insight in the success of the

cluster.

Foreign companies with offices in the

Netherlands provide an important

contribution to the cluster, unless they

are trust offices.

DEFINITIONS MEASURING CHOICES

A legal entity, registered in the

Dutch Chamber of Commerce.

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Performance indicator 1: Number of companies

The number of companies in the Dutch LSH cluster in 2011 is based on The Decision Group database

2013.

No assumptions were made for performance

indicator 1.

Methodology

Sources

1 The Decision Group database 2013

2 Contact NGI, TTOs, science parks

3 Chamber of Commerce data available on August 2012

Number of companies in

the Core Value Chain

NL 2010

3431

Main assumptions and consistency checks

Number of

manufacturing

companies

74

1

2

3

Number of

specialized research

service providers

153

1

2

3

Number of R&D

companies

227

1

2

3

Number of

specialized research

suppliers

95

1

2

3

+

1The different types of companies do not add up to 329 as several companies are counted in more than one category.

DEFINITIONS MEASURING CHOICES

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including

Rationale

Definition

Rationale

Definition

Performance indicator 2: Employment

Performance indicator 2 is defined as the employment of all companies in the cluster including all offices

in the Netherlands, for the part of their activities in Dutch LSH cluster.

Employment of all

companies in the cluster

all offices in The

Netherlands

The employment of all companies

included in the Number of

companies (key perf. indicator 1) is

taken into account.

activities in Life Sciences

& Health

Rationale

Definition

Only the employment related to

activities in life sciences & health gives

an indication of the success of the

Dutch lsh cluster.

The employment is only included for

activities in life sciences & health.

The employment for activities that

are not in life sciences & health are

not included. For example: for

Philips, only the employment of

Philips Healthcare is included.

The employment of all offices

located in the Netherlands is

included, independent of the

activities of the offices.

Personnel in the marketing and

sales department of a

pharmaceutical company is not

included, as the Outlook focuses on

activities that directly contribute to

the development of products aimed

at improving health effects.

for the part of their

DEFINITIONS MEASURING CHOICES

Company provides an important

contribution to the LSH cluster (e.g.

it creates a pool of experienced

management that can work in

LSH).

The combined group of employees of

the companies in the core value chain of

the cluster is an essential asset of the

cluster which enables startup of new

companies and growth of the cluster.

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Performance indicator 2: Employment

Employment of the Dutch LSH cluster in 2011 is based on data from the Chamber of Commerce.

• Companies for which no employment

data is available in the Chamber of

Commerce are assumed to have one

employee.

Methodology

1 2 Chamber of Commerce data available on August 2012

Sources

Per company check of annual reports and websites (for the top 10)

+

19.6 All employment data is in thousands

of employees for 2011.

51+ employees

2.6

6-50 employees

0.5

1-5 employees 1

Employment

NL 2011

22.7

1The values can appear erroneous due to rounding.

Main assumptions and consistency checks

a

a

1

2

1

DEFINITIONS MEASURING CHOICES

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Performance indicator 3: Number of products (1/2)

Number of products, performance indicator 3, is defined as the: number of drugs and medical devices...

Products developed by R&D companies in the Dutch lsh cluster can be divided in 2 categories:

1. Drugs: a drug, broadly speaking, is any substance that, when absorbed into the body of a living organism, alters normal bodily

functions (WHO).

2. Medical devices: “Medical device” means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or

calibrator, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination,

for human beings for one or more of the specific purposes of (WHO): • diagnosis, prevention, monitoring, treatment or alleviation of disease

• diagnosis, monitoring, treatment, alleviation of or compensation for an injury

• investigation, replacement, modification, or support of the anatomy or of a

physiological process

• supporting or sustaining life

3. Technology platorm: technology that enables the creation

of products that directly support product development.

Drugs and medical devices are end products that are directly for or used by patients, whereas technology platforms are business to

business products with indirect impact on the well-being of patients.

The number of drugs and medical devices...

in the

Rationale

Definition

Proxy

The focus of the Life Sciences Outlook is on monitoring drugs and medical devices and not on technology platforms.

• control of conception

• disinfection of medical devices

• providing information for medical purposes by means of in vitro examination of

specimens derived from the human body and which does not achieve its primary

intended action in or on the human body by pharmacological, immunological or

metabolic means, but which may be assisted in its function by such means.

DEFINITIONS MEASURING CHOICES

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Performance indicator 3: Number of products (2/2)

...in development within the Netherlands.

The following phases of drug development exist:

1. Pre-clinical phase

2. Phase I

3. Phase II

4. Phase III

5. On market

Medical devices are counted as individual devices if they provide a

different added value aimed at improved health effects (e.g., devices

that are distinguished by different software versions without added

health effects are not counted as separate devices).

The Life Sciences Outlook focuses on products for

which research and development activities take

place within The Netherlands. In practice this

means that a company must have at least one

R&D division within the Netherlands.

The products of multinationals with an office in the

Netherlands that do not perform R&D in the

Netherlands are not included.

in development the Netherlands

within

On-market products are not included, as the added value of

R&D on market products is relatively low

To obtain good insight in the productivity of the

Dutch LSH cluster, only products that are

researched and developed in the Netherlands are

included.

Rationale

Definition

Rationale

Definition

Proxy

The focus of the Life Sciences Outlook is on drugs in phase I-III and

medical devices in development. The product phases are defined in line

with the definition of the FDA/EMA.

DEFINITIONS MEASURING CHOICES

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Performance indicator 3: Number of products

The number of products for Dutch lsh companies are calculated on the level of the individual companies

in the core value chain.

• It is assumed that the Thomson Pharma database is complete regarding the number of drugs in development phase I,II,III.

Companies that are not listed in this database are assumed not to have drugs in phase I,II,III.

• It is assumed that medical device companies provide a complete overview of the products they have in development on their websites.

Medical devices in

development

55

Number of

products NL 20111

1

Sources

2

Thomson Pharma, Individual company websites, The Decision Group database, Medtrack

Individual company websites, The Decision Group database

2

+

Methodology

122

1The values can appear erroneous due to rounding.

Main assumptions and internal and external validity checks

b c

DEFINITIONS MEASURING CHOICES

Drugs in

development

phase I,II,III

67

1

b

c

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Performance indicator 4: Revenue

Performance indicator 4 is defined as: The revenue of all companies in the core value chain of the LSH

cluster coming from activities in life sciences & health that are taxed in the Netherlands.

The revenue of all companies in the

core value chain of the lsh cluster

taxed in the

Netherlands

activities in life

sciences & health

coming

from

that

are

Rationale

Definition

Rationale

Definition

Rationale

Definition

Revenue is the total amount of money received by a

company registered in the Netherlands for goods sold or

services provided during a certain time period. It also

includes all net sales, exchange of assets; interest and

any other increase in owner's equity and is calculated

before any expenses are subtracted (based on

Investorword 2010).

Main sources of revenue are product sales, license

deals and government grants.

The revenue of all R&D companies included in

the Number of companies (perf. indicator #3)

is taken into account.

Only the revenue of companies

that pay taxes in the

Netherlands contributes to the

Dutch economy.

Only the revenue of activities

in or related to life sciences &

health give an indication of the

success of the Dutch lsh

cluster.

Revenue is only included from

activites in life sciences &

health. The revenue from

activities that are not in life

sciences & health are not

included. For example: for

Philips, only the revenue of

Philips Healthcare is included.

Corporate tax refers to a

direct tax levied on the profits

made by companies or

associations and often

includes capital gains of a

company. Earnings are

generally considered gross

revenue minus expenses.

DEFINITIONS MEASURING CHOICES

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Performance indicator 4: Revenue

Revenue data is based on Chamber of Commerce data per individual company and cross checked with

annual reports for large companies.

• For the calculation of company revenue it is

assumed that medium-sized companies have on

average a revenue between 8.8 and 35m€ and

small companies have on average a revenue

between 0 and 8.8m€, according to categories

used by the Dutch Chamber of Commerce.

Methodology

1 Chamber of Commerce data available on August 2012, per company

Sources

2 Company annual reports

0.5

Revenue

NL 20111

17.7

Total revenue

Main assumptions and consistency checks

d

1The values can appear erroneous due to rounding.

Small (0-50 empl)

Medium (51-250

empl)

Large (> 250 empl) 1

+

f(x) = (35-8.8)*(x – 50 / (250-50))

g(x) = 8.8 * (x/50)

+

Total revenue 1

g(x)

+

Employment

1

Total revenue 1

f(x)

+

Employment

1

2

16.5

0.8

d

d

DEFINITIONS MEASURING CHOICES

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Mergers and Acquisitions

Overview of public and private investments raised for companies in the core value chain of the Dutch LSH cluster

Adapted from: MaRS BioEntrepreneurship Lecture Series Strategic Financing in Biotechnology, Roman Masley, SHI Capital

Stage

Am

ou

nt

(€)

Angel

Investors

IPO

(In

itia

l P

ublic

Off

erin

g )

PIPE (Private Investments

in Public Equity)

Strategic Alliances • Option structures

• Co-development and production

Tax credits

• In/out-licensing

• Milestone payments

• WBSO • Innovation box

Public

Investments

Private Investments (private equity)

Private Investments (public equity)

FO

PO

(F

ollo

w-o

n P

ublic

Off

erin

g)

Private Investments

(private and public equity)

© 2011 The Decision Group

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Performance indicator 5: Public investments

Public investments, performance indicator #5, is defined as public investments in translational research

and in companies in the core value chain of the Dutch LSH cluster.

Public investments are investments made

by the government using any available

financial instrument, such as funding,

grants, subsidies, and fiscal incentives1.

The core value chain is defined as

companies that perform R&D,

manufacturing,specialized research

service providers, and specialized

research suppliers

Rationale

Definition

Rationale

companies in the core value

chain of the lsh cluster Public investments

Public investments provide a direct

measure of the dedication of a

government to a specific sector.

Public investments in companies in the

core value chain have direct impact on

the economic performance of the Dutch

LSH cluster.

Translational research involves

moving knowledge and discovery

gained from the basic sciences to its

application in clinical and community

settings.

Indirect investments in education are

not included.

Rationale

Definition

translational research

PPPs are considered closely linked

with teh activities of companies in the

core value chain.

in and in

Proxy

The focus of the Life Sciences

Outlook is on public investments in

PPPs.

Definition

DEFINITIONS MEASURING CHOICES

The Life Sciences Outlook includes all

public investments dedicated to the lsh

cluster. For general investments a

materiality2 cut-off is used of 1%: only

general investments above this cut-off are

included in performance indicator #5.

Proxy

1Investments counted are those that have been granted. In the calculation of the performance indicator, funding is equally distributed over the years for which it is

intended to be used, even though the budget spending per year can differ.

2Based on the 1989 definition International Accounting Standard Committee (IASC).

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Performance indicator 5: Public investments

Public investments in the Dutch LSH cluster in 2009, 2010 and 2011 were included at the individual

program and subsidy level and checked with the individual institutions.

Public investments

NL 20101

Subsidies

1 AgentschapNL, NGI, LSH

Methodology

Sources

No assumptions were made to calculate

the public investments.

2 Individual websites of subsidies and programs

+

All monetary amounts are in m€ for 2011.

1

Public investments

in PPPs

146

78

291

1The values can appear erroneous due to rounding.

Main assumptions and consistency checks

Matching investments

in PPPs by

knowledge institutes

67

1

1

2

2

2

DEFINITIONS MEASURING CHOICES

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Performance indicator 6: Private investments raised DEFINITIONS MEASURING CHOICES

Private investments raised is defined as the private investments raised (M€) by companies in the core

value chain of the Dutch LSH cluster.

Definition

Private investments raised is the commitment of private money or capital to

the purchase of financial instruments or other assets so as to gain profitable

returns in the form of interest, income (dividend), or appreciation of the value

of the instrument1.

Private investments raised by the companies in the Dutch lsh cluster include:

Business Angel investments, Venture Capital investments, Venture debt and

Royalties, Initial Product Offerings (IPOs), Private Investment in Public Equity

(PIPEs), Follow-on Public Offerings (FOPOs), and Strategic Alliances.

Proxy

The Life Sciences Outlook uses all private investment raised mentioned

above except business angels investments and strategic alliances that are

not publically known.

Private investments raised

Rationale

Business angels investments and strategic alliances that are not publically

known are assumed to be relatively small compared to the total private

investments in the cluster and it proves very difficult to find reliable data.

Definition

The core value chain is defined as companies

that perform R&D, Manufacturing,Specialized

Research Service Providers, and Specialized

Research Suppliers

Proxy

The Life Sciences Outlook calculates an

investment in a company as an investment in the

cluster if the headquarters is in the cluster. For

companies with their headquarters outside the

cluster, the investment is calculated based on

the % of employees working in the Dutch cluster.

companies in the core value

chain of the LS&H cluster

Rationale

Private investments in companies in the core

value chain have the most direct impact on the

economic performance of the Dutch lsh cluster.

Companies with headquarters and activities in the

cluster will allocate a significant part of the

investment in the cluster

by

1Adapted from Sullivan, Arthur; Steven M. Sheffrin (2003). Economics: Principles in action. Upper Saddle River, New Jersey 07458: Pearson Prentice Hall. pp. 271. ISBN 0-

13-063085-3.

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Performance indicator 6: Private investments raised

Private investments raised are based on an extensive scan of press releases of companies in the cluster

and data from the Dutch Private Equity & Venture Capital Association (NVP).

Methodology

Sources

• Strategic alliances include milestone payments that are publicly available. Assumption is that most large milestone

payments are made public.

• Private Investment in Public Equity (PIPEs) or Follow-on Public Offerings (FOPOs) are adressed by a company in

their press releases.

+

All monetary amounts are in m€

for 2011

Total private investments

NL 20111

Venture capital

Initial Public

Offerings (IPOs),

1

1

Strategic alliances

milestone payments

161

1902

0

43

2

1The values can appear erroneous due to rounding.

Main assumptions and consistency checks

x

y

x

DEFINITIONS MEASURING CHOICES

Follow-on Public

Offerings (FOPOs)

2

11

Press releases search on internet

Press releases search on website of all listed core value

chain companies in the cluster

y

Private Investment in

Public Equity (PIPEs)

1687

y

2

1

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Appendix C – About the involved partners

© Blue Ridge Kitties

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The Life Sciences & Health - Focusing on patient value

The main objective of STZ is to capitalize on knowledge by stimulating the applied research with focus

on patient value.

The Outlook is commissioned by the ‘Life

Sciences & Health’ innovation program.

Contact: Willem de Laat, MD, PhD

Annemiek Verkamman

+31(0)71-3322033

[email protected]

www.lifescienceshealth.com

Driven by the cluster and empowered by

the Ministry of Economic Affairs, the LSH

program has the objective to improve the

life sciences innovation and investment

climate in the Netherlands. The Outlook

is part of the four-year work plan.

The Outlook is commissioned by the ‘STZ-

ziekenhuizen’.

Contacts:

Maarten Rook

Norbert Groenewegen

[email protected]

www.stz-ziekenhuizen.nl

STZ stands for the Dutch association of Top

Clinical Hospitals. STZ members can be seen

as high care hospital providers and top

referral centers. In the same time STZ plays

an important role in applied medical research

having the aim to provide effective and

efficient care with focus on patient value.

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Value Based Healthcare Center Europe

Value Based Healthcare Center works closely with Prof M. Porter from Harvard Business School on the

concepts of value-based healthcare with the goal of making better decision for patient value.

The Outlook is supported by Value Based Health

Care Center Europe

Contacts:

ir. Maarten Koomans

+31(0)346-574942

www.vbhc.nl

It the vision, and the aim of Value Based Health

Care – Center Europe, to share key practices,

our experiences and knowledge on Value

Based Health Care to put Patient Value at the

core.

Value Based Health Care Center Europe

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About The Decision Group

The Decision Group is a niche strategy consulting firm founded in 1996 and with an industry focus on the

healthcare & life sciences industry.

The Outlook is created in cooperation with

consulting firm The Decision Group.

Contacts:

Prof. dr. Fred van Eenennaam,

Ir. Maarten Koomans

Kim Bruheim, MSc.

Bogdan Toma,BA, BSc.

+31(0)346-574942

[email protected]

www.thedecisiongroup.nl

The Decision Group helps clients take better

strategic decisions, using methods such as

strategic dialogue and strategic alignment. The

creation of the Outlook is supervised by prof.

dr. Fred van Eenennaam & ir Maarten

Koomans, managing partner of The Decision

Group.

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Appendix D - Bibliography

© Blue Ridge Kitties

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Bibliography (1/4)

1. Abbott (2012) Annual Report 2011, Illinois, USA

2. AgentschapNL (2012) Innovatiekrediet: Jaarverslag 2011, Den Haag, NL

3. AkzoNobel (2012) Annual report 2011: Tomorrow’s Answers Today:, Amsterdam, NL

4. AMT (2012) Annual Report 2011, Amsterdam, NL

5. Astellas (2012) Annual Report 2011, Tokyo, JA

6. Battelle BIO (2010) State Bioscience Initiatives 2010, USA

7. Battelle BIO (2011) The U.S. Biopharmaceuticals Sector: Economic Contribution to the Nation, USA

8. Battelle BIO (2012) Battelle/Bio state Bioscience Industry Development 2012, USA

9. Biocom (2012) 2012 Southern California Economic Impact Report, San Diego, USA

10. C&EM –Chemical and Engeneering News (2011) Big Pharma Talks Emerging Markets Strategy, January 14th, 2011

11. California Healthcare Institute (2010) California Biomedical Industry 2010 Report, La Jolla, CA, USA

12. California Healthcare Institute (2011) 2011 California Biomedical Industry Highlights, La Jolla, CA, USA

13. California Healthcare Institute (2011) 2011 California Medical Technology Industry, La Jolla, CA, USA

14. California Healthcare Institute (2011) California Biomedical Industry 2011 Report, La Jolla, CA, USA

15. California Healthcare Institute (2011) California Biomedical Industry2011 Executive Summary, La Jolla, CA, USA

16. Carlyle & Conan (2012) Life Sciences Trends 2012, Morrisville, USA

17. CCMO (2012) Jaarverslag 2011, Den Haag, NL

18. CLUSNET Final Report by Goran Lindqvist & Orjan Solvell (2011). Organising Clusters for Innovation: Lessons from city regions in Europe

19. Cluster Biotechnology Bavaria (2011) Life Sciences in Greater Munich Biotech Region: Playing in top position in Europe’s Biotech

Champions League, Martinsried, DE

20. Cluster Biotchnology Bavaria (2012) Bavarian Biotech Report 2011, Martinsried, Germany

21. Commission for Technology and Innovation (2012) Annual Report: Innovation Promotion Agency CTI 2011, Bern, CH

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Bibliography (2/4)

22. Ernest & Young (2011) Medical technology report 2011

23. Ernest & Young (2012) Beyond borders Global biotechnology report 2012

24. Ernest & Young (2012) Global Life Science report 2012: Progressions. The third place: health care everywhere

25. Federal Department of Economic Affairs, Commission for Technology and Innovation CTI, Innovation Promotion Agency (2012) Activity

Report 2011, Switzerland

26. Galapagos (2012) Rebound; Annual Financial Report 2011, Mechelen, BE Genmab (2012) Turning Science into Medicine: Annual Report

2011, Copenhagen, DK

27. Germany Trade & Invest (2011) The Medical Biotechnology Industry in Germany – Issue 2011/2012, Berlin, DE

28. HBM Partners (2012) HBM Pharma/Biotech M&A Report, Zug, CH

29. HM Government (2012) Strength and opportunity 2011. The landscape of medical technology, medical biotechnology, industrial

biotechnology and pharmaceutical sector in the U.K., Dec 2011, U.K.

30. Info m4 Programme (2011) Personalized Medicine and Targeted Therapies – A New Dimension in Drug Development , Germany

31. Johnson & Johnson (2012) Annual Report 2011, New Brunswick, N.J., USA

32. Kamer van Koophandel Brabant (2012) Innovatiepoort Healthsector – versie III, Eindhoven, NL

33. Massachusetts Biotechnology Council (2011) Biotechnology Industry Snapshot 2011, MA, USA

34. Massachusetts Biotechnology Council (2011) Biotechnology Employment & Investment Update 2009, MA, USA

35. Medical Cluster (2012) Swiss medical Cluster Annual Report 2011, Switzerland

36. Medicon Valley (2012) Medicon Valley Report 2011

37. Medtronic (2011) The face of innovation: Annual report 2011, Minneapolis, MN, USA

38. Medtronic (2012) Transforming for growth: Annual report 2012, Minneapolis, MN, USA

39. Merck (2012) Form 10-K 2011 Merck & Co., Inc., Whitehouse Station, N.J., USA

40. Munich Biotech Cluster (2012) Biotechnology in Munich, Martinsried, Germany

41. Munich Biotech Cluster (2012) m4 Personalized Medicine in Munich, Munich, Germany

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Bibliography (3/4)

42. Nederlandshe Bank , Wisselkoersen 2011, www.dnb.nl accessed on 27.07.2012

43. Netherlands Genomics Initiative (2012) Jaarverslag 2011, Den Haag, NL

44. Novartis (2012) Annual Report 2011, Basel, CH

45. OctoPlus (2012) Annual Report 2011, Leiden, NL

46. NRC Dagblad, November 7th, 2012

47. Pfizer (2012) 2011 Financial Report, New York, N.J., USA

48. Pharming (2012) Annual Report 2011, Leiden, NL

49. Philips (2012) Annual Report 2011, Amsterdam, NL

50. Porter, M.E. (2010) What is value in healthcare? The New England Journal of Medicine, 363;26

51. Price Waterhouse Coopers (2011) California Biomedical Industry 2011 report

52. Price Waterhouse Coopers , California Health Institute (2009) California Biomedical Industry 2009 Report

53. Price Waterhouse Coopers , California Health Institute (2010) California Biomedical Industry 2010 Report

54. Price Waterhouse Coopers, California Health Institute (2012) California Biomedical Industry 2012 Report

55. Price Waterhouse Coopers, Terug naar de eenvoud, ruimte voor ondernemerschap, September 26th, 2012

56. Royal DSM NV (2012) Integrated Annual Report 2011, Heerlen, NL

57. SGS (2012) 2011 Annual Report, Geneva, CH

58. SwedenBio (2012) Sweden – the Country of Life Science 2011

59. SwedenBio (2012) The Swedish Drug Development Pipeline 2011

60. Swiss Biotech(2012) Swiss Biotech Report 2012

61. Teva (2012) Form 20-F 2011 Teva Pharmaceutical Industries Limited, Petach Tikva, ISR

62. World Bank, GDP and Population Statistics, www.worldbank.org, accessed on 03.09.2012

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Bibliography (4/4)

63. www.cbs.nl, CBS Statline, accessed on August 2012

64. www.prosensa.nl, accessed on January 2013

65. www.stz.nl, accessed on January 2013

66. www.vbhc.nl, accessed on January 2013

67. www.topsectoren.nl, accessed on January 2013

See the respective Outlooks for the references of the Biotech Outlook 2010 and the Life Sciences Outlook 2011&2012

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Appendix E – Glossary of terms

© Blue Ridge Kitties

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Glossary of terms (1/3)

Biotechnology :

The OECD has developed both a single definition of biotechnology and a list-based definition of different types of biotechnology (see box

below). The single definition defines biotechnology as “the application of science and technology to living organisms, as well as parts,

products and models thereof, to alter living or nonliving materials for the production of knowledge, goods and services.”

Biotechnology (list-based definition):

• OECD list-based definition of biotechnology techniques.

• DNA/RNA: Genomics, pharmacogenomics, gene probes, genetic engineering, DNA/RNA.

• Sequencing/ synthesis/ amplification, gene expression profiling, and use of antisense technology.

• Proteins and other molecules: Sequencing/ synthesis/ engineering of proteins and peptides (including

large molecule hormones); improved delivery methods for large molecule drugs; proteomics, protein.

• Isolation and purification, signaling, identification of cell receptors.

• Cell and tissue culture and engineering: Cell/tissue culture, tissue engineering (including tissue

scaffolds and biomedical engineering), cellular fusion, vaccine/immune stimulants, embryo manipulation.

• Process biotechnology techniques: Fermentation using bioreactors, bioprocessing, bioleaching,

biopulping, biobleaching, biodesulphurisation, bioremediation, biofiltration and phytoremediation.

• Gene and RNA vectors: Gene therapy, viral vectors.

• Bioinformatics: Construction of databases on genomes, protein sequences; modelling complex biological

processes, including systems biology.

• Nanobiotechnology: Applies the tools and processes of nano/microfabrication to build devices for studying

biosystems and applications in drug delivery, diagnostics etc.

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Glossary of terms (2/3)

Life Sciences companies:

“Those companies that apply the possibilities of organisms, cell cultures, parts of cells or parts of organisms, in an innovative way

for the purpose of industrial production. They may also supply related services and hardware and software.” (source: Action Plan

Life Sciences, Ministry of Economic Affairs).

“Existing technological fields, including biotechnology, pharmacology, biology, chemistry, physics and informatics, are integrated

into this definition” (source: Action Plan Life Sciences, Ministry of Economic Affairs).

Dedicated biotech companies:

Those companies that have their core activities in biotech. This can be R&D, services, manufacturing/producing,

supplying/distributing.

Red Biotech:

Biotechnology with applications in health care.

White Biotech:

Biotechnology with industrial applications.

Green Biotech:

Biotechnology with applications in food or agriculture.

Medical technology companies:

Medical technology companies are involved in research, development, production and marketing of systems and devices for

medical applications in humans and animals. (source: Biotech Gate). See also page 95.

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Glossary of terms (3/3)

Pre-clinical: Refers to the testing of experimental drugs in the test tube or in animals - the testing that occurs before trials in humans may be

carried out. (http://clinicaltrials.gov, January 2011)

Phase I: Initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with

increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients.

(http://clinicaltrials.gov, January 2011)

Phase II: Controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients

with the disease or condition under study and to determine the common short-term side effects and risks. (http://clinicaltrials.gov,

January 2011)

Phase III: Expanded controlled and uncontrolled trials after preliminary evidence suggesting effectiveness of the drug has been obtained,

and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug and provide adequate

basis for physician labeling. (http://clinicaltrials.gov, January 2011)

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Financial terms (1/2)

IPO:

“Initial public offering: the first sale to the public of shares in a company, leading to a stock market listing (flotation).” (Financial Times

Lexicon)

In/out licensing:

“Receiving/granting permission from/to another company or institution to use a brand name, patent, or other proprietary right, in exchange for

a fee or royalty.” (Galapagos, Annual Report 2009)

Venture Capital:

“Private equity or institutional funding for start-up companies considered to have strong growth prospects. There can be several phases of

investment (see seed money), through to the stage when the company is able to go public. Venture capital firms may also provide

management assistance and other services.

This is equity or quasi equity funding provided by professional investors to young, high growth oriented companies, typically to finance their

early market development and growth. As well as funding, investors usually provide value-added services. Funding is often provided in

stages, providing sufficient cash to reach the next milestone.” (Financial Times Lexicon)

Note that this can refer to both non-listed and listed companies.

Private equity:

“Injection of funds by specialised investors into private companies with the aim of achieving high rates of return.

This is equity or quasi equity funding provided by professional investors to mature private companies with the aim of gaining a financial

return through interests, dividends and capital gain at exit.” (Financial Times Lexicon)

Milestone payment:

Payment related to a major achievement in a project or program; In the context of biotech companies, this can be a milestone in the drug

development process, but also the first commercial sale, which requires approvement and reimbursement by payers.

Example:

GSK and Prosensa started an “exclusive worldwide collaboration for the development and commercialisation of RNA based therapeutics for Duchenne Muscular Dystrophy (DMD).” “The financial

terms include a GBP £16 million (USD $25 million) upfront payment. Furthermore, Prosensa is eligible to receive up to GBP £412 million (USD $655 million) in milestone payments if all four

compounds are successfully developed and is also entitled to double-digit royalties on product sales (Oct 2009, www.gsk.com).

Prosensa “received a £7.5m milestone payment from GlaxoSmithKline (GSK) as a result of achieving a data milestone in its Phase IIa open label extension trial of GSK2402968 (PRO051), being

developed to treat Duchenne Muscular Dystrophy (DMD) under its agreement with GSK. The milestone payment was based upon achievement of a successful safety review, with no serious safety

signals observed.” (Oct 2010, www.prosensa.eu)

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Financial terms (2/2)

Alliance

“An agreement between two or more organizations to work together. If two or more organizations are in alliance with each other, they work

together.” (Financial Times Lexicon)

Angel investor

“A wealthy individual who invests in a start-up company with his or her own money. Also known as business angel, the individual provides

equity or quasi equity funding to growth oriented private companies with the aim of achieving a financial return through capital gain at

exit. As well as money, they also provide value-added services.” (Financial Times Lexicon)

Buyout

Buyout refers to a situation where the existing owners of a firm are "bought out" by another group, usually management and/or workers of

that firm. A buyout may be for the whole firm or a division or plant as the case applies. (OECD, Glossary of Statistical Terms)

Management buyout

Management Buy-out or MBO is the term used for the funds provided to enable operating management to acquire a product line or business,

which may be at any stage of development, from either a public or private company.

Leveraged buyout

Leveraged buyout is defined as the purchase of a company or a controlling interest of a corporation's shares or product line or some

business. A leveraged buyout is accomplished with borrowed money or by issuing more stock.

Debt financing

“Debt financing means when a firm raises money for working capital or capital expenditures by selling bonds, bills, or notes to individual

and/or institutional investors. In return for lending the money, the individuals or institutions become creditors and receive a promise to repay

principal and interest on the debt.” (FundingPost.com, Venture Capital Glossary)

PIPE

“PIPE or Private Investment in Public Equity is a term used when a private investment or mutual fund buys common stock for a company at a

discount to the current market value per share.” (FundingPost.com, Venture Capital Glossary)

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Appendix F – Consulted experts and organizations

© Malevda

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Consulted experts (1/6)

The help and insights of many cluster experts were essential in realizing the Dutch Life Sciences Outlook

2013.

1Participants in the Cluster Assessment meeting organized by the Council of European BioRegions (CEBR) on November 29, 2010 2Dedicated interviews on the creation of the Life Sciences Outlook 2011 3Consulted for data on the performance and progress of the Dutch and key international clusters. 4Participants in the workgroups dedicated to the recommendations formulated in the Outlook 2010.

First name Last name Position Company / Institute Country

Maria Aguirre1 Director BioBasque Agency (SPRI) Spain (Basque Region)

Nic Alexakis3 CEO Swiss Biotech Association Switzerland

Bas Allart3 - Universiteit Utrecht The Netherlands

Nerea Alonso1 General scientific contact, local responsible Biocat Spain (Catalonia)

Pytrik Altena3 Advisor Innovation, Intelligence and Coordination Agentschap NL The Netherlands

Frank Baaijens4 Scientific Director BMM The Netherlands

Soroya Beacher4 Chair OSCAR The Netherlands

Michel Bergh2 Director TTO Erasmus MC The Netherlands

Peter Bertens4 Senior Policy Advisor Nefarma The Netherlands

Peter Biedermann3 Cluster Manager Swiss Medical Cluster Switzerland

Chantal Blok3 Business Development Manager A-skin The Netherlands

Graeme Boyle1 Director Nexxus Scotland

Mariana Brandão1 Director Finance and Human Resources Biocant Portugal (Portugese

science park)

Bjorgunn Bretti3 - Universiteit Utrecht The Netherlands

Jasper Buijs3 Business Development Manager BioMedbooster The Netherlands

Nettie Buitelaar3,4 Managing Director Leiden Bio Science Park The Netherlands

Juan Carmona-Schneider1 Senior Consultant ZENIT GmbH Germany (Ruhr Area)

Hans Clevers4 Director Hubrecht Institute The Netherlands

Fabrizio Conicella1 General Manager bioPMed cluster Italy (Milan)

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Consulted experts (2/6)

First name Last name Position Company / Institute Country

Daan Crommelin4 Scientific Director TI Pharma The Netherlands

Vibeke Dalhoff3 Business Development Manager, Life Sciences Copenhagen Capacity Denmark

Jaap de Boer4 Medical Director Genzyme Nederland The Netherlands

Lou de Leij4 Dean of Research UMCG The Netherlands

Sandra de Wild4 Senior (Policy) Advisor Life Sciences & Health Agentschap NL The Netherlands

Christine d'Oliveira4 - Agentschap NL The Netherlands

Horst Domdey1,3 Managing Director BioM Munich Germany

André Domin1 Director Technologiepark Heidelberg

GmbH Germany

Richard Douglas2 Senior Vice President Genzyme United States

Pauline Evers4 Beleidsmedewerker Medicijnen NFK The Netherlands

Wendy Ewart3 - Medical Research Council United Kingdom

Sanna Fennet3 Management Assistant LURIS, Leiden University The Netherlands

Carola Goossens3 Medewerker Business Development TTO Erasmus MC The Netherlands

Niels Van Gorp Consultant (former) The Decision Group The Netherlands

Timo Gubbens3 Business Development Manager

Life Sciences Center

Amsterdam - TTO Academic

Medical Center Amsterdam

The Netherlands

Nick Guldemond4 Program Director Health TU Delft The Netherlands

Heidi Hamers4 Managing Director CTMM The Netherlands

Jeanine Hendriks4 Co-founder & Head Product Development CellCo Tec The Netherlands

Joris Heus3 PhD TTO AMC The Netherlands

Lia Hoenjet3 - BiomedBooster The Netherlands

Hans Hopmans4 Senior Manager Procurement & Innovation Achmea The Netherlands

Ester Hulleman3 Office Manager TTO VU & Vumc The Netherlands

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Consulted experts (3/6)

First name Last name Position Company / Institute Country

Hugo Hurts2 Director Pharmaceutical Affairs and Medical

Technology

Ministry of Health, Welfare and

Sports (VWS) The Netherlands

Stefan Jacobs3 - Innovation Lab TU/e The Netherlands

Stig Joergensen3 - Medicon Valley Alliance Denmark/Sweden

Georg Kaab3 - BioM Munich Germany

Richard Kemper3 Advisor IPC Agentschap NL The Netherlands

Marcel Kenter4 Executive Director CCMO The Netherlands

Hermine Klein1,3 Marketing Manager Leiden Bio Science Park The Netherlands

Wim-Jan Koot3 Team Leader Business Development Valorisatie UMC St Radboud The Netherlands

Saskia Koster-Klarenbeek3 Sales Kamer van Koophandel The Netherlands

Richard Kouri3 Executive Director BioSciences Management NC State University United States

Ada Kruisbeek4 Director TTO VU&VUMC The Netherlands

Rene Kuijten2 Partner Life Sciences Partners The Netherlands

Rene Kuijten4 Partner Life Sciences Partners The Netherlands

Folkert Kuipers4 Dean UMCG The Netherlands

Guus Kullberg4 Director New Business Agis The Netherlands

Colja Laane4 Director Netherlands Genomics Initiative The Netherlands

Gea Lamberts3 Office Manager St. Business Generator

Groningen The Netherlands

Jennifer Landress3 Senior VP & COO Biocom (San Diego) United States

Peter Leeflang2,4 Head of the department innovation and availability

of medical products

Ministry of Health, Welfare and

Sports (VWS) The Netherlands

Dink Legemate4 Scientific Director Parelsnoer Initiatief The Netherlands

Peter Luijten4 Chief Scientific Officer CTMM The Netherlands

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Consulted experts (4/6)

First name Last name Position Company / Institute Country

Laure MacDonald3 Head of Licensing LURIS, Leiden University The Netherlands

Sandra Michielsen1 - Amsterdam Innovation Motor The Netherlands

Semme Molenaar3 - SBGG The Netherlands

Erica Monfardini1 Pharmaceutical Industry Expert PriceWaterhouseCoopers Luxembourg

Daniel Mulder3 Advisor PR

Nederlandse Vereniging van

Participatiemaatschappijen

(NVP)

The Netherlands

Gerhard Mulder3 Innovatieadviseur Syntens The Netherlands

Leon Mur4 Project Manager Bio Science Leiden Bio Science Park The Netherlands

Imran Nasrullah3 - MassBio US (Massachusetts,

Boston)

Lita Nelsen2 Director Technology Licensing Office -

MIT United States

Vinit Nijhawan2

Lecturer and Executive-in-Residence of Institute

for Technology Entrepreneurship and

Commercialization (ITEC)

Boston University United States

Jaap Oostra3 CTO Applikon Biotechnology The Netherlands

Riikka Paasikivi1 Program Director Culminatum Innovation Oy Ltd

Helsinki Finland

Marja Peperkamp3 Advisor IPC Agentschap NL The Netherlands

Frank Pieper4 Life Sciences Consultant BioTxs The Netherlands

Ivo Piest4 Director Corporate Finance Kempen & Co The Netherlands

Marnix Pool3 Director Kennis Conversie Fonds RUG Houdstermaatschappij BV The Netherlands

Anne Portwich3,4 Investment Manager Life Sciences Partners The Netherlands

Sergiy Protsiv3 Doctoral student Stockholm School of Economics Sweden

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Consulted experts (5/6)

First name Last name Position Company / Institute Country

Kees Recourt4 Owner Recourt LS The Netherlands

Tonnie Rijkers3,4 Manager Genomics Centres Netherlands Genomics Institute The Netherlands

Hans Schikan4 CEO Prosensa BV The Netherlands

Oscar Schoots3 Director Universiteit Utrecht Holding BV The Netherlands

Berverley Sherbon3 - Medical Research Council United Kingdom

Liesbeth Siderius4 Chair Stichting Shwachman

Syndroom Support Holland The Netherlands

Peter Sijmons4 Director LabScores The Netherlands

Claire Skentelbery1 Director of Operations, Europe Unlimited &

Network Manager

Council of European

BioRegions Belgium

Bob Smailes4 Director Leiden University Research &

Innovation Services The Netherlands

Teresa Soop1 Analysis and Development Director Stockholm Science City Sweden

Emiel Staring4 Managing Director Biomedical Materials program BMM The Netherlands

Rein Strijker4 Chief Commercial Officer Pharming Group NV The Netherlands

Gerrit Tent4 CEO Biogen The Netherlands

Alie Tigchelhoff3,4 Managing Director Utrecht Science Park The Netherlands

Kenneth Tindall3 - North Carolina Biotech US (RTP Area)

Harrold van Barlingen4 Managing Director Thuja Capital The Netherlands

Clemens van Blitterswijk4 Professor Tissue Regeneration Universiteit Twente The Netherlands

Ruud van de Bilt3 HeadTransfer & Liaison Groep TTO UMCG The Netherlands

Michiel van den Berg3 Analist WBSO Agentschap NL The Netherlands

Peter van den Berg3,4 Advisor Innovation Intelligence Agentschap NL The Netherlands

Louise van den Bos4 - UMC St Radboud The Netherlands

Taco van der Feltz4 Executive Search Consultant Russel Reynolds The Netherlands

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Consulted experts (6/6)

First name Last name Position Company / Institute Country

Sander van Deventer4 Board Member Amsterdam Molecular

Therapeutics The Netherlands

Peter van Hoorn4 Professor Science Business & Innovation VU Faculty of Exact Sciences

(FEW) The Netherlands

Fenrir van Koert3 Technopartner AgentschapNL The Netherlands

Paula van Rossum3 Project Manager Life Sciences Utrecht Science Park The Netherlands

Suzanne Verboon3 Manager Innovatie Samenwerking in het MKB AgentschapNL The Netherlands

Henk Vietor3 CEO Skyline Diagnostics The Netherlands

Ian Viney3 Head of Evaluation Medical Research Council United Kingdom

Ingrid Vodegel3 COO Aeon Astron Europe The Netherlands

Armand Voorschuur4 Senior beleidsadviseur farmaceutische zaken Nefarma The Netherlands

Jelle Wiarda1 - Healthy Ageing Network The Netherlands

Jan Wisse4 Director Niaba The Netherlands

Bart Wuurman4 CEO AM-Pharma BV The Netherlands

Bernhard Zechendorf1 Project Manager European Commission Belgium