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Dutch Life Sciences & Health Outlook 2013

-Since 2009-The Fourth Edition-

From Bench to Bed Monitoring and improving the Dutch life sciences & health cluster

-Developer-

-Academic partners-

-Partners-

1 see also www.lifesciencesoutlook.com 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

Dutch Life Sciences & Health Outlook 2013


Dear reader and friends,
This years Dutch Life Sciences and Health Outlook 2013: From Bench to Bed is the fourth since the need emerged for 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.

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 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,

Over the years, the

Outlook has evolved. Definitions and procedures were

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

The social

economic effects

and and

For those who are new to the Dutch Life Sciences and

with

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.

over 3000 downloads of the report, a circulation of 1000 reports, over 100 questions on the Dutch Life
Sciences and Health Cluster and

progress firms of the Dutch Life Sciences

16 national and

and Health Cluster

international presentations.

2 see also www.lifesciencesoutlook.com

Dutch Life Sciences & Health Outlook 2013

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. 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 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. Entrepreneurs and industry must be clearer on what

the benefits of their


treatments, medical devices and diagnostics are for

The Dutch Life Sciences and Health Cluster need a stronger focus on patient value

patients and society.


The 1.

main findings are:


Small and medium companies are compensating the restructuring of large companies, in rate of employment and number of companies.

The

Samenwerkende

Topklinische

opleidings

New
On Health Outlook 2014.

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. 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.

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 3.

The cluster attracts private investments, public investments are under pressures.
3 see also www.lifesciencesoutlook.com

Dutch Life Sciences & Health Outlook 2013

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

History

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.

Harvard Style Business Case written on the successful biotech Prosensa and its interplay and development inside and outside

A combination of the latest economic/cluster theory and policies, experience with and an understanding of the life sciences industry and the healthcare

company

the Dutch Life Sciences Cluster, which can be used for teaching at various universities and for promotional activities within the Netherlands or abroad

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. 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. The convergence of biotech firms with pharmaceutical and med tech companies, as well as the increasing technological spill overs between the so

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.

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.

4 see also www.lifesciencesoutlook.com

Dutch Life Sciences & Health Outlook 2013

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.

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 years outlook and welcome your help in research ideas and making
them happen.

d)

At the Erasmus University a study has been started to investigate

On behalf of the team of The Decision Group; Kim Brheim and Bodgan Toma, business analysts.

(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.

With warmest regards,

Prof. dr. Fred van Eenennaam Partner The Decision Group, Institute & Ventures

We hope you enjoy

reading this years Dutch Life Sciences and Health


Ir. Maarten Koomans Partner The Decision Group, Institute & Ventures

Outlook. Please provide us with suggestions, feedback and the occasional encouragement. If you have any questions, please feel free to contact us.

-Developer-

-Academic partners-

-Partners-

5 see also www.lifesciencesoutlook.com

Summary

Dutch Life Sciences & Health Outlook 2013:

Context Providing affordable care Health

Conclusions

Advise

-Size-

1.

Small and medium companies are compensating the restructuring of large companies, in rate of employment and number of companies.

A. Keep, attract and develop talent

2.

Wealth

-Input-

(Large) companies are rebuilding their business models towards products that add value to patients, with a greater reliance on partnerships.

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.

-Output-

B. Partnerships, cooperations, and strategic dialogues become increasingly more important

C. Clarification on public investments 3. The cluster attracts private investments, public investments are under pressures.

6 see also www.lifesciencesoutlook.com

Should you like to make a decision based on:

Small & Medium Companies Patient Value

Health Cluster

See: 10, 11, 60, 61, 64

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

Performance and

Cluster attracts Private Investments


See: 43, 44, 55 - 57

Revenue
See: 29, 30, 31, 68-76

progress

Growth in products

Spin offs

See: 18 - 22

See: 37, 38, 50, 51

See: 39, 40, 52

See: 28, 64, 66, 67

7 see also www.lifesciencesoutlook.com

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. Contents

1 2

Key Outcomes Dutch Life Sciences & Health Outlook Executive summary 17 Dutch life sciences & health cluster success Measuring performance and progress Monitoring Cluster Size, Input and Output Size: Number of companies & Employment Output: Revenue & Number of products Input: Public investments & Private investments Strategic assessment of the cluster Advice and Spin offs

32

46 50 53

Appendices A. History & development of the Outlook B. Monitoring methodology C. About the involved partners D. Bibliography E. Glossary of terms F. Consulted experts and organizations

78 90 117 121 126 132

4 5

58

Applied Research Health Outlook Health Cluster 2013

68

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 info@thedecisiongroup.nl).
8 see also www.lifesciencesoutlook.com

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
Higher life expectancy and increased incidence of chronic illnesses a.o. lead to increased demand for health

Wealth
Economic, financial and Euro crisis combined with budget reduction and change of government structure and policy

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

9 see also www.lifesciencesoutlook.com

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.
In 2004, Gilbert et al. wrote an article on the need to rebuild the business model; with four main suggestions to improve.
1. From being opportunisticpushing a broad array of

compounds on the premise that every chance is worth exploringto 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.

Source : http://windhover.com

Source : http://sync.nl

10 see also www.lifesciencesoutlook.com

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. Source: Prosensa, press release 08th of Nov 2011

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.

11 see also www.lifesciencesoutlook.com

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


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

Healthcare delivery

Healthcare

Applied research

Scope of the outlook

Education and other

Food

2012 Regenerative Health medicine Nutriceuticals BioEngineering materials Red biotech Medical technology (incl. imaging)

Agrofood

Pharma

Technology
Chemical Horticulture & propagation materials

Creative industry

Energy

Agriculture

Chemicals and energy


12 see also www.lifesciencesoutlook.com

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.
Healthcare delivery

Healthcare

Applied research

Scope of the outlook

Education and other

Food

2012 2013 Regenerative Health medicine Nutriceuticals BioEngineering materials Red biotech Medical technology (incl. imaging)

Agrofood

Pharma

Technology
Chemical Horticulture & propagation materials

Creative industry

Energy

Agriculture

Chemicals and energy


13 see also www.lifesciencesoutlook.com

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.
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

Suppliers
Bioelectronics, Bioinformatics

Value Chain
Care and Cure providers * Teaching and Specialized Hospitals

Service Providers
Cluster Organizations Niaba, Nefarma, Biofarmind, LSH

Distribution Marketing & Sales Regulation CCMO, METCs, FDA, EMA

Analysis Software Manufacturing Medical Equipment


Specialized Research service providers Contract Manufacturing Organizations, Contract Research Organizations Clinical studies Synthesis services

Laboratory Equipment

Ophthalmic Goods

R&D companies Drugs and Medical Device companies (Pharma, Biotech, Medical Engineering)

core value chain1 Reimbursement Healthcare Insurance Companies, VWS dep of GMT
Specialized Business Services Banking, Accounting, Legal

Diagnostic Substances

Specialized Research suppliers

Translational Research

Containers and Packaging

TiPharma, BMM, CTMM

Specialized Risk Capital VC Firms, Angel Networks 2013 Health Insurance Laboratory, Clinical Testing
2013 The Decision Group

Fundamental Research
NGI, Hubrechts Institute

2012

Chemical products
1referred

Educational Institutions
Universities
The cluster map is in the process of international recognition

to in topsector plan as innovative core

*16 out of 28 STZ hospitals are included


14 see also www.lifesciencesoutlook.com

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 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
Monitoring and improving

Cover page to be updated

Nyenrode LSH | Biotech Outlook 2010

the red biotech cluster

Draft for High Profile Group review only October 2009

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

Outlook 2012 edition: Forecast & Survey


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

Outlook 2011 edition: Data position


Improved the data position with more up to date and primary data.

Outlook 2010 edition: Proof of Concept


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

15 see also www.lifesciencesoutlook.com

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.
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 Per company data
Prosensa Therapeutics b.v. Protein Labelling Innovation ProteoNic Proxy Laboratories PURAC biomaterials

Firm by firm checked database

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

Database Healthcare
Data on the activities in The Netherlands of each company within the value chain

1. Education 2. Fundamental Research

3. Translational Research

4. R&D 5. Manufac- 6. Specialized turing research supplier yes yes yes

7. Specialized research services

8. Marketing & 9. DistriSales bution

10. Care & Cure provider

yes

16 see also www.lifesciencesoutlook.com

1 Key outcomes Dutch Life Sciences & Health Outlook 2013


Executive Summary

U2OS cells by Leonie Kollenstart, Bsc. Student Biomedical Sciences (green=actin, blue=nucleus)
IRRI Images

17 see also www.lifesciencesoutlook.com

Key conclusions Dutch Life Sciences & Health Outlook 2013:

1. Small and medium companies are compensating the restructuring of large companies, in rate of employment and number of companies.

-Size-Input-Output-

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.

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, info@thedecisiongroup.nl, www.thedecisiongroup.nl

18 see also www.lifesciencesoutlook.com

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. Monitoring methodology 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 19 see also www.lifesciencesoutlook.com

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.

Performance
2011

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.

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

* The average exchange rate $/ of 2011 was used as published by the Dutch Central Bank. 20 see also www.lifesciencesoutlook.com

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.

Progress
20102010-2011 - 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).

1 2

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

21 see also www.lifesciencesoutlook.com

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.
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%.

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

22 see also www.lifesciencesoutlook.com

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.

2012 estimate

* See appendix B on calculation page 101 23 see also www.lifesciencesoutlook.com

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

114 km

65.7 km 2.6 km 70 km 22.5 km 10.2 km 103 km 19.5 km 6 km 55.4 km 2.6 km 110 km

Source: FD, 28-12-2010

109 km 107 km 172 km

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) Source: FD, 23-6-2011

24 see also www.lifesciencesoutlook.com

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.

18.2

18.7

17.7

17.8

122 104 93

111

56

67

- Source: The Decision Group database -

- Source: The Decision Group database -

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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.

1887

622 280

167

Sources: Press releases individual companies, NVP report 2012

26 see also www.lifesciencesoutlook.com

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
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.

Cluster building
Partnerships, co-operations, and strategic dialogues between life science and health strengthen the cluster.

Public investment
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.

Investment climate
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.

27 see also www.lifesciencesoutlook.com

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.

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. 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

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.

* For details see page 61, 63, 64 28 see also www.lifesciencesoutlook.com

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.
1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. St. Antonius Ziekenhuis Nieuwegein Atrium Medisch Centrum Catharina Ziekenhuis Eindhoven HagaZiekenhuis Jeroen Bosch Ziekenhuis Maasstad Ziekenhuis Meander Medisch Centrum Medisch Centrum Alkmaar Medisch Centrum Haaglanden Medisch Centrum Leeuwarden Onze Lieve Vrouwe Gasthuis Reinier de Graaf Gasthuis Rijnstate Sint Lucas Andreas Ziekenhuis Spaarne Ziekenhuis St. Elisabeth Ziekenhuis Tilburg

146 Dutch Hospitals include 8 University Medical Centers and 28 STZ hospitals engaged in research

Total General hospitals of which SAZ OvA STZ University Medical Centers Specialized hospitals of which Audiology Canters Dialysis Centers Epilepsy Centers Cancer Centers Radiotherapy centers Asthmatics Centers General Rehabilitation institutions 40 16 28

146 84

8 32 5 3 2 10 6 3 3 22

Members of the international academic advisory council:


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 Gran Lindqvist - Principal Associate at the CSC Stockholm School of Economics Victoire de Margerie Professor at Grenoble School of Management 29 see also www.lifesciencesoutlook.com

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.
Sneak preview of research performance in Dutch healthcare All indicators are presented in spring 2013

Since 2007 the number of publications citied has grown steadily.

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

2075

1806
1473 1527

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 30 see also www.lifesciencesoutlook.com

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

31 see also www.lifesciencesoutlook.com

2 Dutch life sciences & health cluster success


Measuring performance and progress

C. Elegans Celdivision by J. Van Der Berg, Bsc. Student Biomedical Sciencs (red=membrane, green=histones)

32 see also www.lifesciencesoutlook.com

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%.

329 298

343

314

- Source: The Decision Group database -

See for a detailed definition and overview Appendix B on Monitoring methodology. 33 see also www.lifesciencesoutlook.com

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.

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

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. 34 see also www.lifesciencesoutlook.com

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%.

24095

24255

24385
22732

- Source: The Decision Group database -

See for a detailed definition and overview Appendix B on Monitoring methodology. 35 see also www.lifesciencesoutlook.com

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 -

36 see also www.lifesciencesoutlook.com

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.

122
104 93 111

56

67

- Source: The Decision Group database -

1Medical

devices include devices & diagnostics that alter or measure bodys functions. See for a detailed definition and overview Appendix B on Monitoring methodology. 37 see also www.lifesciencesoutlook.com

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 -

38 see also www.lifesciencesoutlook.com

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.

18.2

18.7

17.7

17.8

- Source: The Decision Group database -

* 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. 39 see also www.lifesciencesoutlook.com

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 -

40 see also www.lifesciencesoutlook.com

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*.

297 248 248

291

- Sources: NGI, The Decision Group analysis *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. 41 see also www.lifesciencesoutlook.com

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 1158 991 817

- 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.

42 see also www.lifesciencesoutlook.com

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.

1887

622 280

167

Sources: Press releases individual companies, NVP report 2012

See for a detailed definition and overview Appendix B on Monitoring methodology. 43 see also www.lifesciencesoutlook.com

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 -

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. 44 see also www.lifesciencesoutlook.com

3 Monitoring Cluster Size, Input and Output


Key performance indicators: Size : Number of companies & Employment Input: Public investments & Private investments Output: Revenue & Number of products

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

45 see also www.lifesciencesoutlook.com

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.

57%

12% 9% 8%

14%

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

See for a detailed definition and overview Appendix B on Monitoring methodology. 46 see also www.lifesciencesoutlook.com

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%.

329

344

361

298
276 249 228

314

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

Forecast

See for a detailed definition and overview Appendix B on Monitoring methodology. 47 see also www.lifesciencesoutlook.com

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.

Company
1 MSD
1 MSD

Location /Division Employment 2009 (in NL)


Company

Employment 2010 (in NL)

Employment 2011 (in NL)

Type
R&D, manufacturing, marketing & sels R&D, manufacturing, marketing & sels

Location /Division Employment 2009 ( in NL ) Employment 2010 ( in NL ) Employment 2011 ( in NL ) Type 8675 8563 5500 R&D, manufacturing, marketing & sales
8675 8563 5500

2 Philips 3 Johnson & Johnson


2 Philips

Philips Healtcare
Philips Healtcare

3353
3353

3353
3353

3192
3192

R&D, manufacturing, marketing & sales R&D, manufacturing, marketing & sales
1370

1329
1329

1585
1585

1370 541
751 834 1084 986 643

3 Johnson & Johnson

R&D, manufacturing, marketing & sels

J&J/ Crucell Janssen Biologics 4 Medtronic 5 Abbott


4 Medtronic J&J/ Crucell Janssen Biologics

495 834 1084 958 643 575


575 495 834 1084 958 643

751 834 1084 986 643 575


575

829 835 2057 560 571

541 829 835 2057 560 571

R&D, manufacturing, marketing & sales R&D, manufacturing, marketing & sales R&D, manufacturing, marketing & sales
R&D, manufacturing, marketing & sels R&D, manufacturing, marketing & sels R&D, manufacturing, marketing & sels

6 TEVA 5 Abbott Pharmachemie


6 7 AstellasTEVA Pharmachemie Pharma 7 Astellas Pharma

R&D, manufacturing, marketing & sales


R&D, manufacturing, marketing & sels

8 DSM 9 Novartis
8 DSM 9 Novartis

DSM Biologics
DSM Biologics

403 400
403 400

403 436
403 436

403 436
403 436

R&D, manufacturing, marketing & sales R&D, manufacturing, marketing & sales
R&D, manufacturing, marketing & sels

R&D, manufacturing, marketing & sels

10 PURAC Biomaterials

354
354

354
354

354
354

R&D, manufacturing, marketing & sales R&D, manufacturing, marketing &


sels

10 PURAC Biomaterials

- Source: The Decision Group database -

See for a detailed definition and overview Appendix B on Monitoring methodology. 48 see also www.lifesciencesoutlook.com

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.

9%

5%

Factual data - Source: The Decision Group database See for a detailed definition and overview Appendix B on Monitoring methodology.

Forecast

49 see also www.lifesciencesoutlook.com

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.
Company
Abbott B.V. Akkolens international AM-Pharma Blue Medical Devices Cavadis B.V. Utrecht Crucell 2 3 2 10 2

Drugs Phase 1 Drugs

Phase 2 Drugs
5

Phase 3
2

Medical Devices in Development ,


2

Elana b.v.
Emultech bv Enceladus Pharmaceuticals B.V. Expand Biotechnology BV Galapagos Genmab B.V. IS diagnostics 4 1 1 1 5 1 1 1 1

2
2 2

Kiadis Pharma
Medisse BV Medspray Merck BV Mucosis Mymetics BV OctoPlus N.V. 1 1 1

2
5 3 1 1 2 2 1

Pantarhei Bioscience
PPD Prescient Medical Europe Prosensa Therapeutics b.v. Skyline Diagnostics

1
2 2

1 3

- Source: The Decision Group database 1


2

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

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.
Medical devices include devices & diagnostics that alter or measure bodily functions. See for a detailed overview Appendix B on Monitoring methodology. 50 see also www.lifesciencesoutlook.com

3 Medical

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


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

595 542 473 422

93

104

111

122

- Source: The Decision Group database -

See for a detailed definition and overview Appendix B on Monitoring methodology. 51 see also www.lifesciencesoutlook.com

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.

1.0b

Factual data - Source: The Decision Group database forecast based on actual numbers of dismissals in 2012 1Assuming

Forecast

that all other factors remain unchanged (ceteris paribus ) See for a detailed definition and overview Appendix B on Monitoring methodology. 52 see also www.lifesciencesoutlook.com

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.

Factual data

Forecast

Source: NGI, Life Sciences & Health, news reports, program websites, government innovation budget 2012 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. * 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. 53 see also www.lifesciencesoutlook.com

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

Factual data

Forecast

Source: NGI, Life Sciences & Health, news reports, program websites, government innovation budget 2012 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. *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 54 see also www.lifesciencesoutlook.com

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%.

Factual data Source: press releases of individual companies

Forecast

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. 55 see also www.lifesciencesoutlook.com

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 *.

Factual data

Forecast

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

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. 56 see also www.lifesciencesoutlook.com

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.

395 321 260 215 167

304

Factual data

Forecast

Source: press releases of individual companies

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 57 see also www.lifesciencesoutlook.com

Strategic assessment of the cluster


Advice and Spin offs

58 see also www.lifesciencesoutlook.com Knitty Mary Hyperoxidation and oligomerization of PrxII (green) halts cell cycle progression when H2O2 levels are high. (JCB 175(5) TOC1)

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
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.

Cluster building
Partnerships, co-operations, and strategic dialogues between life science and health strengthen the cluster.

Public investment
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.

Investment climate
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.

59 see also www.lifesciencesoutlook.com

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

60 see also www.lifesciencesoutlook.com

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
Care Delivery Value Chain Examples - Focus areas

Rare diseases

Personalized Medicine

(Neuro)Degenerative diseases
61 see also www.lifesciencesoutlook.com

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 62 see also www.lifesciencesoutlook.com

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

63 see also www.lifesciencesoutlook.com

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.

Spin off project of the Outlook

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.

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

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

Source: www.vbhc.nl

64 see also www.lifesciencesoutlook.com

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.
Regiegroep Life Science & Health

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

65 see also www.lifesciencesoutlook.com

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 - Gran 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

66 see also www.lifesciencesoutlook.com

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
Source: C&EN Chemical & Engineering News

Source: hcmatters.com

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.vhbc.nl

Source: www.thedecisiongroup.nl 67 see also www.lifesciencesoutlook.com

5 Applied Research
Health Outlook Health Cluster 2013

68 see also www.lifesciencesoutlook.com Michael Tam

Health Outlook 2013


The strategic dialogues focus on patient value and are supported by a monitor on the applied research; the Health Outlook. Health Outlook: monitoring From Bench To Bed

The objective of the Outlook is to annually measure 1. 2. Valorization by hospitals 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.)

69 see also www.lifesciencesoutlook.com

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.

Total General hospitals of which SAZ OvA STZ University Medical Centers Specialized hospitals of which Audiology Canters Dialysis Centers Epilepsy Centers Cancer Centers Radiotherapy centers Asthmatics Centers General Rehabilitation institutions 40 16 28

146 84

8 32 5 3 2 10 6 3 3 22

70 see also www.lifesciencesoutlook.com

Activities of STZ hospitals


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

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

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

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

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) 71 see also www.lifesciencesoutlook.com

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

Specialized research suppliers


Supplying biochips Supplying bioelectronics Supplying bioinformatics

Activities of STZ hospitals

Specialized research services


Contract manufacturing Contract research Drug delivery

phase II

phase III

phase IV

Executing clinical phase IIIV studies

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

Marketing & sales


Marketing activities Commerci alization Pricing, reimburse ment

Distribution & storage


Logistics

Care & Cure providers


Therapy Diagnosis

Self-initiated heatlhcare research:


R&D based on physican expertience and practical healthcare improvement

Adoption of new products and treatments

2011 The Decision Group

- Illustrative purpose 72 see also www.lifesciencesoutlook.com

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.
Activities of (STZ) hospitals that provide highest value for the innovative industry:
1. Executing clinical phase II-IV studies
2. Self-initiated healthcare research 3. Adoption of new products and treatments

Example of the adoption of new products and treatments by an STZ hospital

Focus of the Health part of the Outlook

2011 The Decision Group

73 see also www.lifesciencesoutlook.com

Monitoring & Measuring


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

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.

74 see also www.lifesciencesoutlook.com

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

Key Steering Indicators


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

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

* Adoption rate of new products is a new indicator expected to be added in the 2014 version
75 see also www.lifesciencesoutlook.com

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.
Sneak preview of research performance in Dutch healthcare All indicators are presented in spring 2013

Since 2007 the number of publications citied has grown steadily.

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

2075 1806 1473 1527

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 76 see also www.lifesciencesoutlook.com

7 Appendices
A. History, development and structure of the Dutch Life Sciences Outlook B. Monitoring methodology C. About the involved partners D. Bibliography E. Glossary of terms F. Consulted experts and organizations 78 90 117 121 126 132

77 see also www.lifesciencesoutlook.com

Ty Night

Appendix A History, development and structure of the Dutch Life Sciences & Health Outlook
Using the entrepreneurs perspective

78 see also www.lifesciencesoutlook.com

Branco Social Media

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.

Nyenrode LSH | Biotech Outlook 2010


Monitoring and improving

the red biotech cluster

Draft for High Profile Group review only October 2009

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

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 79 see also www.lifesciencesoutlook.com

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 STZziekenhuizen. 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 info@stz-ziekenhuizen.nl 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.

Contact: Prof. dr Fred van Eenennaam

Contacts: Prof. dr. Fred van Eenennaam Ir. Maarten Koomans, Kim Bruheim, MSc. Bogdan Toma, BA, BSc +31(0)346-574942 info@thedecisiongroup.nl www.thedecisiongroup.nl

80 see also www.lifesciencesoutlook.com

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.
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. Porters Institute for Strategy and Competitiveness and Director of The Competitiveness Institute (TCI), a global network of professionals interested in competitiveness and cluster development. 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.

Gran 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.

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.

1The

council meets twice a year with Prof. dr. Fred van Eenennaam as chair and Kim Bruheim, MSc. as secretary of the council.
81 see also www.lifesciencesoutlook.com

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. 82 see also www.lifesciencesoutlook.com

Methodology development (2/3)


The Life Sciences Outlook continuously develops with regard to the academic grounding, the involvement of entrepreneurs and the methodology.

83 see also www.lifesciencesoutlook.com

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 84 see also www.lifesciencesoutlook.com

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.

Academic gounding
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

2012

JAN MAR 2012

MAR JUNE 2012

JUNE SEPT 2012

OCT DEC 2012

2013

Set up dialog

Set up agenda

Data collection

Draft report 2012

Involvement entrepreneurs 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

85 see also www.lifesciencesoutlook.com

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.

Monitoring
Dutch LSH cluster; Cluster success Measuring performance and progress Dutch LSH cluster; Key business impact areas Strategic assessment of progress

Improving
Dutch LSH cluster; Key recommendations Improving the Dutch LSH cluster compared to selected international key LSH clusters .

86 see also www.lifesciencesoutlook.com

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.
The Diamond Model by Prof. Michael Porter can be used to assess the competitiveness of clusters. 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. Prof. F. van Eenennaam is cochairman of the global impact council of the Microeconomics of Competitiveness initiative under the leadership of Prof. Porters Institute of Strategy and Microeconomics of Competitiveness of Harvard Business School, to which 80 universities and business schools from around the world are affiliated.

Prof. M. Porter and prof. F. van Eenennaam at the opening of the Nyenrode Life Sciences & Healthcare Institute (May 13, 2009).

- For ongoing analysis on the cluster progress, check the website of The Decision Group (www.thedecisiongroup.nl) or contact the researchers 87 see also www.lifesciencesoutlook.com

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.
MONITORING METHODOLOGY
2013 The Decision Group

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

2) DEFINITIONS Definitions of the key performance indicators


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

3) MEASURING Data collection for the key performance indicators


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

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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.

International network of involved life sciences & health clusters

participating clusters in CEBR SIG session on cluster assessment (December 15th, 2011, Brussels)
89 see also www.lifesciencesoutlook.com

Appendix B Monitoring methodology

90 IITA Image Libary see also www.lifesciencesoutlook.com

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.
MONITORING METHODOLOGY
2013 The Decision Group

1) CHOICES Choice of 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

2) DEFINITIONS Definitions of the key performance indicators


The key performance indicators are defined to best reflect the success of the Dutch LSH cluster:

3) MEASURING Data collection for the key performance indicators


The data collection methodology is set up to provide accurate measurements:

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What are the choices of the key performance indicators?

CHOICES

DEFINITIONS

MEASURING

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

Cluster size 1. Number of companies (#) 2. Employment (employees)

Cluster output 3. Number of products (#, drugs, devices, technologies) 4. Revenue ()

Cluster input 5. Public investments () 6. Private investments raised ()

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

CHOICES

DEFINITIONS

MEASURING

Choices are based on desk research, literature studies and an extensive strategic dialogue with entrepeneurs and academic partners.
Set DIRECTION Create FOCUS Interviews round 1
Research & analysis Gather sector opinions and validation

Fix FRAMEWORK

Validate RESULTS

Interviews round 2
Research & analysis Validation and fine tuning Research & analysis

Seminar

Validate in field
Analysis and draft

Design approach

Present Business impact areas: Life Sciences Healthcare Event 2009 Opening Nyenrode Life Sciences & Health Care Institute

Hypotheses Sep-Oct 08 Feb-Mar 09

Framing Apr-May 09

Business impact areas May 13 09 Jun-Aug 09

phase 1

phase 2

phase 3

phase 4

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

CHOICES

DEFINITIONS

MEASURING

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

Academic REFLECTION

Set Academic COUNCIL

Validate METHODOLOGY
KPIs and KSIs Health Outlook were developed , introduced and approved by the members of the academic council and STZ members.

Final check in field

Reflection with Academic partners

Finalize Outlook 2010

Validation of KPIs with academic Validate council methodology Validate data

KPIs and KSIs Health

Presentation to high profile group Sep-Oct 09 Nov 4 09 Jun-Sep 10

CEBR Meeting Cambridge Nov 29 10 Jan 11 April 13

phase 5

phase 6

phase 7

phase 8

phase 9

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What were design considerations?

CHOICES

DEFINITIONS

MEASURING

The main goal of the design was to find a set of indicators that would help to improve the cluster success.
All choices made to select the performance indicators are based on the added value for entrepreneurs.

Scope

The scope of the Dutch Life Sciences Outlook is the Dutch LSH cluster.
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). 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. 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. 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). The approach has been validated in the field by 40+ expert interviews, seminar with 300 participants, academic reflection and tested with finished report 2010.
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Aim

Focus

Use

Tuning to Dutch LSH

Validation

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

CHOICES

DEFINITIONS

MEASURING

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

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Definitions - scope

CHOICES

DEFINITIONS

MEASURING

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.
The Life Sciences Outlook monitors the Dutch LSH cluster, which includes red biotech, medical technology and the pharmaceutical industry, and overlaps several other clusters1.

Dutch LSH cluster


Nutriceuticals Engineering Applied research Medical Technology

Scope of the Dutch Life Sciences Outlook 2011, 2012 and 2013

Red Biotechnology
Pharmaceutical Industry

Medical Engineering Biomaterials

Green biotechnology / food

White (industrial) biotechnology


2013 The Decision Group

1Based

on the cluster theory M. Porter Harvard Business School. 97 see also www.lifesciencesoutlook.com

Definitions - focus (1/2)

CHOICES

DEFINITIONS

MEASURING

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

Value Chain
Suppliers
(e.g. lab equipment, power supply, water supply) (companies or organization with activities that directly contribute to the development of products aimed at improving health effects)

Service Providers (e.g. legal, consultants, bank)

98 see also www.lifesciencesoutlook.com

Focus of the Dutch Life Sciences & Health Outlook 2013


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

Suppliers
Bioelectronics, Bioinformatics

Value Chain
Care and Cure providers * Teaching and Specialized Hospitals

Service Providers
Cluster Organizations Niaba, Nefarma, Biofarmind, LSH

Distribution Marketing & Sales Regulation CCMO, METCs, FDA, EMA

Analysis Software Manufacturing Medical Equipment


Specialized Research service providers Contract Manufacturing Organizations, Contract Research Organizations Clinical studies Synthesis services

Laboratory Equipment

Ophthalmic Goods

R&D companies Drugs and Medical Device companies (Pharma, Biotech, Medical Engineering)

core value chain1 Reimbursement Healthcare Insurance Companies, VWS dep of GMT
Specialized Business Services Banking, Accounting, Legal

Diagnostic Substances

Specialized Research suppliers

Translational Research

Containers and Packaging

TiPharma, BMM, CTMM

Specialized Risk Capital VC Firms, Angel Networks

2013
Health Insurance Laboratory, Clinical Testing
2013 The Decision Group

Fundamental Research
NGI, Hubrechts Institute

2012

Chemical products
1referred

Educational Institutions
Universities
The cluster map is in the process of international recognition

to in topsector plan as innovative core

*16 out of 28 STZ hospitals are included


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Definitions - value chain

CHOICES

DEFINITIONS

MEASURING

The value chain consists of the main activities that enable the development, production and use of new drugs and medical technologies.
Specialized research suppliers
Supplying biochips Supplying bioelectronics Supplying bioinformatics

Specialized research services


Contract manufacturing Contract research Drug delivery

Education
Business courses Biology Chemistry

Fundamental research
Stem cell research Developmental 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 Commercialization Pricing, reimbursement

Distribution & storage


Logistics

Care & Cure providers


Therapy Diagnosis

2013 The Decision Group

- Illustrative purpose 100 see also www.lifesciencesoutlook.com

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

CHOICES

DEFINITIONS

MEASURING

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 ...
that

Companies in the core value chain of the Dutch lsh cluster


Definition

perform R&D or manufacturing


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.

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 powerdriven 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 hightech innovation.

Rationale The Dutch LSH cluster is defined according to the cluster theory of Prof. Michael Porter.

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)

CHOICES

DEFINITIONS

MEASURING

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


or or are

offer specialized research services


Definition

specialized research supplier


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.

Specialized Research Suppliers are companies whose core business is to supply products specifically to the R&D companies in the core value chain.

Rationale

Rationale

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.

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.

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

CHOICES

DEFINITIONS

MEASURING

that are dedicated or diversified private companies within the Netherlands.


within

dedicated or diversified

private companies

The Netherlands
Definition

Definition

Definition

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.

A legal entity, registered in the Dutch Chamber of Commerce. 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.

Rationale

Rationale

Rationale

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.

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Performance indicator 1: Number of companies

CHOICES

DEFINITIONS

MEASURING

The number of companies in the Dutch LSH cluster in 2011 is based on The Decision Group database 2013.
Main assumptions and consistency checks No assumptions were made for performance indicator 1.

Methodology

Number of manufacturing companies 74

1 2 3

Number of 1 specialized research 2 service providers 3 153

Number of companies in the Core Value Chain NL 2010 3431

+
Number of R&D companies 227 1 2 3 Number of 1 specialized research 2 suppliers 3 95

1The

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

Sources 1 2 3

The Decision Group database 2013 Contact NGI, TTOs, science parks Chamber of Commerce data available on August 2012

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Performance indicator 2: Employment

CHOICES

DEFINITIONS

MEASURING

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.
including
for the part of their

Employment of all companies in the cluster


Definition

all offices in The Netherlands


Definition

activities in Life Sciences & Health


Definition

The employment of all companies included in the Number of companies (key perf. indicator 1) is taken into account.

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.

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.

Rationale

Rationale

Rationale

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.

Company provides an important contribution to the LSH cluster (e.g. it creates a pool of experienced management that can work in LSH).

Only the employment related to activities in life sciences & health gives an indication of the success of the Dutch lsh cluster.

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Performance indicator 2: Employment

CHOICES

DEFINITIONS

MEASURING

Employment of the Dutch LSH cluster in 2011 is based on data from the Chamber of Commerce.
Main assumptions and consistency checks
a Companies for which no employment data is available in the Chamber of Commerce are assumed to have one employee.

Methodology

1 51+ employees 2

All employment data is in thousands of employees for 2011.


Employment NL 2011 22.7

19.6
1 6-50 employees

+
2.6 1

1-5 employees
a

0.5
1The

values can appear erroneous due to rounding.

Sources 1
Chamber of Commerce data available on August 2012

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

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

CHOICES

DEFINITIONS

MEASURING

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

The number of drugs and medical devices...


Definition

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

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.

3. Technology platorm: technology that enables the creation of products that directly support product development.
Proxy

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

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.

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


...in development within the Netherlands.
within

CHOICES

DEFINITIONS

MEASURING

in development
Definition

the Netherlands
Definition

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).
Proxy

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.

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.
Rationale Rationale

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.

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Performance indicator 3: Number of products

CHOICES

DEFINITIONS

MEASURING

The number of products for Dutch lsh companies are calculated on the level of the individual companies in the core value chain.
Main assumptions and internal and external validity checks
b

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.

Methodology Drugs in development phase I,II,III 67 1

Number of products NL 20111 122

Medical devices in development


c

55

1The

values can appear erroneous due to rounding.

Sources 1 2

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

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Performance indicator 4: Revenue

CHOICES

DEFINITIONS

MEASURING

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.
coming from that are

The revenue of all companies in the core value chain of the lsh cluster
Definition

activities in life sciences & health


Definition

taxed in the Netherlands


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.

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.

Rationale

Rationale

Rationale

The revenue of all R&D companies included in the Number of companies (perf. indicator #3) is taken into account.

Only the revenue of activities in or related to life sciences & health give an indication of the success of the Dutch lsh cluster.

Only the revenue of companies that pay taxes in the Netherlands contributes to the Dutch economy.

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Performance indicator 4: Revenue

CHOICES

DEFINITIONS

MEASURING

Revenue data is based on Chamber of Commerce data per individual company and cross checked with annual reports for large companies.
Main assumptions and consistency checks
d 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

Large (> 250 empl)

Total revenue

1 2

16.5
Revenue NL 20111 17.7

Medium (51-250 empl) 0.8

Total revenue
d

+
1

f(x)
Small (0-50 empl)

Employment 1

Total revenue 0.5 f(x) = (35-8.8)*(x 50 / (250-50))


d

+
1

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


1The

g(x)

Employment

values can appear erroneous due to rounding.


Chamber of Commerce data available on August 2012, per company Company annual reports

Sources 1 2

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

Mergers and Acquisitions Strategic Alliances Amount ()


Option structures Co-development and production In/out-licensing Milestone payments

Private Investments
(private equity)

Private Investments
(private and public equity)

IPO (Initial Public Offering )

Private Investments
(public equity)
(Follow-on Public Offering)

Public Investments

Angel Investors

(Private Investments in Public Equity)

Tax credits

WBSO

Innovation box

FOPO

PIPE

Stage
Adapted from: MaRS BioEntrepreneurship Lecture Series Strategic Financing in Biotechnology, Roman Masley, SHI Capital 2011 The Decision Group 112 see also www.lifesciencesoutlook.com

Performance indicator 5: Public investments

CHOICES

DEFINITIONS

MEASURING

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.
in and in

Public investments

translational research

companies in the core value chain of the lsh cluster


Definition

Definition

Definition

Public investments are investments made by the government using any available financial instrument, such as funding, grants, subsidies, and fiscal incentives1.
Proxy

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.
Rationale

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.
Proxy

The core value chain is defined as companies that perform R&D, manufacturing,specialized research service providers, and specialized research suppliers

The focus of the Life Sciences Outlook is on public investments in PPPs.


Rationale Rationale

Public investments provide a direct measure of the dedication of a government to a specific sector.
1Investments

PPPs are considered closely linked with teh activities of companies in the core value chain.

Public investments in companies in the core value chain have direct impact on the economic performance of the Dutch LSH cluster.

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. on the 1989 definition International Accounting Standard Committee (IASC).
113 see also www.lifesciencesoutlook.com

2Based

Performance indicator 5: Public investments

CHOICES

DEFINITIONS

MEASURING

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.
Main assumptions and consistency checks No assumptions were made to calculate the public investments.

Methodology

All monetary amounts are in m for 2011.

1 Matching investments in PPPs by 2 knowledge institutes 67 Public investments in PPPs 1 2

Public investments NL 20101 291

146 1 Subsidies 2 78

1The

values can appear erroneous due to rounding.


AgentschapNL, NGI, LSH Individual websites of subsidies and programs

Sources 1 2

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Performance indicator 6: Private investments raised

CHOICES

DEFINITIONS

MEASURING

Private investments raised is defined as the private investments raised (M) by companies in the core value chain of the Dutch LSH cluster.
by

Private investments raised


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. 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.

companies in the core value chain of the LS&H cluster


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.

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

1Adapted

from Sullivan, Arthur; Steven M. Sheffrin (2003). Economics: Principles in action. Upper Saddle River, New Jersey 07458: Pearson Prentice Hall. pp. 271. ISBN 013-063085-3.
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Performance indicator 6: Private investments raised

CHOICES

DEFINITIONS

MEASURING

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).
Main assumptions and consistency checks
x 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 y their press releases.

Methodology

Venture capital 161 Initial Public Offerings (IPOs), 0 Follow-on Public Offerings (FOPOs) 11 1

All monetary amounts are in m for 2011

Total private investments NL 20111 1902

Strategic alliances milestone payments


x

43

Private Investment in 2 Public Equity (PIPEs) 1687

1The

values can appear erroneous due to rounding.

Sources Press releases search on internet 1 2


Press releases search on website of all listed core value chain companies in the cluster

116 see also www.lifesciencesoutlook.com

Appendix C About the involved partners

117 Blue Ridge Kitties see also www.lifesciencesoutlook.com

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 by the Life The Outlook is commissioned STZziekenhuizen. & Health innovation program. Sciences

Driven by the cluster and empowered by the Ministry of Dutch association of Top STZ stands for theEconomic Affairs, the LSH Clinical Hospitals.the objective to improve the program has STZ members can be seen as life scienceshospital providers and top high care innovation and investment referral centers. In the same time STZ plays climate in the Netherlands. The Outlook an is part of the four-year work plan. important role in applied medical research having the aim to provide effective and efficient care with focus on patient value. Contact: Willem de Laat, MD, PhD Annemiek Verkamman Contacts: +31(0)71-3322033 Maarten Rook
Norbert Groenewegen

info@stz-ziekenhuizen.nl www.stz-ziekenhuizen.nl

info@lifescienceshealth.com www.lifescienceshealth.com

118 see also www.lifesciencesoutlook.com

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 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


Contacts: ir. Maarten Koomans +31(0)346-574942 www.vbhc.nl

119 see also www.lifesciencesoutlook.com

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. 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. Contacts: Prof. dr. Fred van Eenennaam, Ir. Maarten Koomans Kim Bruheim, MSc. Bogdan Toma,BA, BSc. +31(0)346-574942 info@thedecisiongroup.nl www.thedecisiongroup.nl

120 see also www.lifesciencesoutlook.com

Appendix D - Bibliography

121 Blue Ridge Kitties see also www.lifesciencesoutlook.com

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: Tomorrows 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 Europes 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

122 see also www.lifesciencesoutlook.com

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
123 see also www.lifesciencesoutlook.com

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

124 see also www.lifesciencesoutlook.com

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 125 see also www.lifesciencesoutlook.com

Appendix E Glossary of terms

126 Blue Ridge Kitties see also www.lifesciencesoutlook.com

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) 130 see also www.lifesciencesoutlook.com

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)

131 see also www.lifesciencesoutlook.com

Appendix F Consulted experts and organizations

132 Malevda see also www.lifesciencesoutlook.com

Consulted experts (1/6)


The help and insights of many cluster experts were essential in realizing the Dutch Life Sciences Outlook 2013.
First name Maria Nic Bas Nerea Last name Aguirre1 Alexakis3 Allart3 Alonso1 Position Director CEO General scientific contact, local responsible Company / Institute BioBasque Agency (SPRI) Swiss Biotech Association Universiteit Utrecht Biocat Country Spain (Basque Region) Switzerland The Netherlands Spain (Catalonia)

Pytrik
Frank Soroya Michel Peter Peter Chantal Graeme Mariana Bjorgunn Jasper Nettie Juan Hans Fabrizio
1Participants 2Dedicated

Altena3
Baaijens4 Beacher4 Bergh2 Bertens4 Biedermann3 Blok3 Boyle1 Brando1 Bretti3 Buijs3 Buitelaar3,4 Carmona-Schneider1 Clevers4 Conicella1

Advisor Innovation, Intelligence and Coordination


Scientific Director Chair Director Senior Policy Advisor Cluster Manager Business Development Manager Director Director Finance and Human Resources Business Development Manager Managing Director Senior Consultant Director General Manager

Agentschap NL
BMM OSCAR TTO Erasmus MC Nefarma Swiss Medical Cluster A-skin Nexxus Biocant Universiteit Utrecht BioMedbooster Leiden Bio Science Park ZENIT GmbH Hubrecht Institute bioPMed cluster

The Netherlands
The Netherlands The Netherlands The Netherlands The Netherlands Switzerland The Netherlands Scotland Portugal (Portugese science park) The Netherlands The Netherlands The Netherlands Germany (Ruhr Area) The Netherlands Italy (Milan)

in the Cluster Assessment meeting organized by the Council of European BioRegions (CEBR) on November 29, 2010 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. 133 see also www.lifesciencesoutlook.com

Consulted experts (2/6)

First name Last name Daan Crommelin4 Vibeke Dalhoff3 Jaap de Boer4 Lou de Leij4 Sandra de Wild4 Christine d'Oliveira4 Horst Domdey1,3 Andr Richard Pauline Wendy Sanna Carola Niels Timo Domin1 Douglas2 Evers4 Ewart3 Fennet3 Goossens3 Van Gorp Gubbens3

Position Scientific Director Business Development Manager, Life Sciences Medical Director Dean of Research Senior (Policy) Advisor Life Sciences & Health Managing Director Director Senior Vice President Beleidsmedewerker Medicijnen Management Assistant Medewerker Business Development Consultant (former) Business Development Manager

Company / Institute TI Pharma Copenhagen Capacity Genzyme Nederland UMCG Agentschap NL Agentschap NL BioM Munich Technologiepark Heidelberg GmbH Genzyme NFK Medical Research Council LURIS, Leiden University TTO Erasmus MC The Decision Group Life Sciences Center Amsterdam - TTO Academic Medical Center Amsterdam TU Delft CTMM CellCo Tec TTO AMC BiomedBooster Achmea TTO VU & Vumc

Country The Netherlands Denmark The Netherlands The Netherlands The Netherlands The Netherlands Germany Germany United States The Netherlands United Kingdom The Netherlands The Netherlands The Netherlands The Netherlands

Nick Heidi Jeanine Joris Lia Hans Ester

Guldemond4 Hamers4 Hendriks4 Heus3 Hoenjet3 Hopmans4 Hulleman3

Program Director Health Managing Director Co-founder & Head Product Development PhD Senior Manager Procurement & Innovation Office Manager

The Netherlands The Netherlands The Netherlands The Netherlands The Netherlands The Netherlands The Netherlands

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Consulted experts (3/6)

First name Last name Hugo Stefan Stig Georg Richard Marcel Hermine Wim-Jan Saskia Richard Ada Rene Rene Folkert Guus Colja Gea Jennifer Peter

Position Director Pharmaceutical Affairs and Medical Hurts2 Technology 3 Jacobs 3 Joergensen 3 Kaab 3 Kemper Advisor IPC 4 Kenter Executive Director 1,3 Klein Marketing Manager 3 Koot Team Leader Business Development 3 Sales Koster-Klarenbeek Kouri3 Executive Director BioSciences Management 4 Kruisbeek Director 2 Kuijten Partner 4 Kuijten Partner 4 Kuipers Dean 4 Kullberg Director New Business 4 Laane Director Lamberts3 Landress3 Leeflang2,4

Dink Peter

Legemate4 Luijten4

Company / Institute Ministry of Health, Welfare and Sports (VWS) Innovation Lab TU/e Medicon Valley Alliance BioM Munich Agentschap NL CCMO Leiden Bio Science Park Valorisatie UMC St Radboud Kamer van Koophandel NC State University TTO VU&VUMC Life Sciences Partners Life Sciences Partners UMCG Agis Netherlands Genomics Initiative St. Business Generator Office Manager Groningen Senior VP & COO Biocom (San Diego) Head of the department innovation and availability Ministry of Health, Welfare and of medical products Sports (VWS) Scientific Director Parelsnoer Initiatief Chief Scientific Officer CTMM

Country The Netherlands The Netherlands Denmark/Sweden Germany The Netherlands The Netherlands The Netherlands The Netherlands The Netherlands United States The Netherlands The Netherlands The Netherlands The Netherlands The Netherlands The Netherlands The Netherlands United States The Netherlands

The Netherlands The Netherlands

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Consulted experts (4/6)

First name Last name Laure MacDonald3 Sandra Michielsen1 Semme Molenaar3 Erica Monfardini1 Daniel Gerhard Leon Imran Lita Mulder3 Mulder3 Mur4 Nasrullah3 Nelsen2

Position Head of Licensing Pharmaceutical Industry Expert Advisor PR Innovatieadviseur Project Manager Bio Science Director Lecturer and Executive-in-Residence of Institute for Technology Entrepreneurship and Commercialization (ITEC) CTO Program Director Advisor IPC Life Sciences Consultant Director Corporate Finance Director Kennis Conversie Fonds Investment Manager Doctoral student

Company / Institute LURIS, Leiden University Amsterdam Innovation Motor SBGG PriceWaterhouseCoopers Nederlandse Vereniging van Participatiemaatschappijen (NVP) Syntens Leiden Bio Science Park MassBio Technology Licensing Office MIT

Country The Netherlands The Netherlands The Netherlands Luxembourg The Netherlands The Netherlands The Netherlands US (Massachusetts, Boston) United States

Vinit
Jaap Riikka Marja Frank Ivo Marnix Anne Sergiy

Nijhawan2
Oostra3 Paasikivi1 Peperkamp3 Pieper4 Piest4 Pool3 Portwich3,4 Protsiv3

Boston University
Applikon Biotechnology Culminatum Innovation Oy Ltd Helsinki Agentschap NL BioTxs Kempen & Co RUG Houdstermaatschappij BV Life Sciences Partners Stockholm School of Economics

United States
The Netherlands Finland The Netherlands The Netherlands The Netherlands The Netherlands The Netherlands Sweden

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Consulted experts (5/6)

First name Last name Kees Recourt4 Tonnie Rijkers3,4 Hans Schikan4 Oscar Schoots3 Berverley Sherbon3 Liesbeth Peter Claire Bob Teresa Emiel Rein Gerrit Alie Kenneth Harrold Clemens Ruud Michiel Peter Louise Taco Siderius4 Sijmons4 Skentelbery1 Smailes4 Soop1 Staring4 Strijker4 Tent4 Tigchelhoff3,4 Tindall3 van Barlingen4 van Blitterswijk4 van de Bilt3 van den Berg3 van den Berg3,4 van den Bos4 van der Feltz4

Position Owner Manager Genomics Centres CEO Director -

Company / Institute Recourt LS Netherlands Genomics Institute Prosensa BV Universiteit Utrecht Holding BV Medical Research Council Stichting Shwachman Chair Syndroom Support Holland Director LabScores Director of Operations, Europe Unlimited & Council of European Network Manager BioRegions Leiden University Research & Director Innovation Services Analysis and Development Director Stockholm Science City Managing Director Biomedical Materials program BMM Chief Commercial Officer Pharming Group NV CEO Biogen Managing Director Utrecht Science Park North Carolina Biotech Managing Director Thuja Capital Professor Tissue Regeneration Universiteit Twente HeadTransfer & Liaison Groep TTO UMCG Analist WBSO Agentschap NL Advisor Innovation Intelligence Agentschap NL UMC St Radboud Executive Search Consultant Russel Reynolds

Country The Netherlands The Netherlands The Netherlands The Netherlands United Kingdom The Netherlands The Netherlands Belgium The Netherlands Sweden The Netherlands The Netherlands The Netherlands The Netherlands US (RTP Area) The Netherlands The Netherlands The Netherlands The Netherlands The Netherlands The Netherlands The Netherlands

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Consulted experts (6/6)

First name Last name Sander Peter Fenrir Paula Suzanne Henk Ian Ingrid Armand Jelle Jan Bart Bernhard van Deventer4 van Hoorn4 van Koert3 van Rossum3 Verboon3 Vietor3 Viney3 Vodegel3 Voorschuur4 Wiarda1 Wisse4 Wuurman4 Zechendorf1

Position Board Member Professor Science Business & Innovation Technopartner Project Manager Life Sciences Manager Innovatie Samenwerking in het MKB CEO Head of Evaluation COO Senior beleidsadviseur farmaceutische zaken Director CEO Project Manager

Company / Institute Amsterdam Molecular Therapeutics VU Faculty of Exact Sciences (FEW) AgentschapNL Utrecht Science Park AgentschapNL Skyline Diagnostics Medical Research Council Aeon Astron Europe Nefarma Healthy Ageing Network Niaba AM-Pharma BV European Commission

Country The Netherlands The Netherlands The Netherlands The Netherlands The Netherlands The Netherlands United Kingdom The Netherlands The Netherlands The Netherlands The Netherlands The Netherlands Belgium

138 see also www.lifesciencesoutlook.com

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