Biotechnology in Poland The industry view

Biotechnology in Poland The industry view 3

I am delighted to present the results of this report, the first Deloitte survey of the biotechnology industry in Poland. Biotechnology is expected to be one of the key technologies of the 21st century, capable of transforming industries as diverse as healthcare, agriculture, food, consumer and industrial products to name just a few. It is essential for the transformation of the Polish economy into an innovative, knowledge based economy that a robust and healthy biotechnology industrial base exists and prospers.

This survey seeks to measure the state of play and take the pulse of the emerging biotechnology industry in Poland. In preparing this survey, we have been admirably supported by our partners NCBR and LSBC, and our thanks and appreciation goes to them as well as to all the companies which took part.

Interpretation of the results of any survey can always be biased by the observer’s viewpoint, but with that caveat in mind, I see several key messages that emerge from the survey which should be considered by both industry players and policymakers.

The overall picture of the Polish biotech market is broadly positive although a few areas require further attention.

• Polish biotech companies are currently working mainly at the research/ prototype stage emphasising that this is still a very immature industry needing nurturing.

• More than half of our respondents see the conditions to conduct biotechnology operations in Poland as moderate to very good with potential to improve in the coming year.

• The key constraint is access to funding due to the existence of an equity funding gap, as well as the complexity of accessing public/ EU funding. Clearly, getting from the research/ prototype stage to a commercialised product will require significant additional funding and currently that funding path is not clear. We recommend that policymakers should estimate the future capital needs of biotech companies. Based on this, an assessment of potential funding shortfalls at each stage of development should be made in order to develop a strategy to provide and encourage public and private funding into the sector at each stage of development.

• In terms of commercialisation of core technology, over three quarters of our entrepreneurs are planning to either sell the company/ technology or sign a licensing agreement with a large company. However, a significant portion plan to develop and launch their products themselves. The route to regulatory approval of biotechnology products, as well as commercialisation (including entrepreneurs reaping the financial benefits of their technology), is fraught with hurdles. Companies will need to be realistic about what are their core skills and what they can realistically achieve in-house.

We hope that the survey and its results inspire debate and, more importantly action, to create, promote and support this nascent industry. We encourage companies and institutions involved in industry to take part in future editions as well as providing feedback on the issues and questions that the survey should address.

Oliver MurphyPartnerDeloitte Advisory Sp. z o. o. Life Science and Healthcare Leader

Introduction and executive summary

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Another viewpoint on the survey results

LSBC has worked with small and large life science companies in Poland, sources of capital, government agencies and universities. It has reviewed literally hundreds of projects.

The survey executed by our partner Deloitte with the help of NCBR, presents a realistic picture of the situation in Poland. From our hands on position, we see great potential. It is clear that the government and its agencies, such as NCBR, are making great and hugely positive strides forward in the creation of an environment which nurtures innovation and generates value.

The survey picks up, but does not fully highlight, the critical lack of commercial experience and management within Poland – which LSBC sees on a day-to-day level. Put simply, first time entrepreneurs and executives “don’t know what they don’t know”. For the sector to be successful, there has to be an understanding and emphasis on the need to work to international standards. It is critical that entrepreneurs realise that success in life science is difficult to manifest at a national level with its exceptionally high development costs; particularly in pharmaceuticals, devices and diagnostics. Strategy and R&D has to be tailored to international standards if the sector is going, in due course, to impact positively on Polish GDP.

There is no shortage of good ideas and bright educated people. In fact the amount of talent is extraordinary. This talent will form the foundation for Poland’s future innovative economy. However, the fledgling Polish Life Science Innovative economy cannot afford to re-invent the wheel, at the same time Western management, working with Polish entrepreneurs, must also adapt to Polish business culture. Ultimately the innovative economy has to use the substantial funding it receives from the EU to create a sustainable innovation ecosystem. This money will run out, and business must be prepared for that. Great emphasis must be placed on using EU funding as the foundation of a sustainable life science ecosystem though high quality public-private collaboration to select projects, create investment funds, manage R&D and intellectual property and nurture the next generation of innovators, entrepreneurs and managers

This is a good moment to participate in Poland’s development – even for those who are not that brave.

Dr. Roland KozlowskiPresident and OwnerLife Science Biznes Consulting (LSBC) Sp. Z o.o


In terms of Innovation

The Biotechnology Industry in Poland Report, co-authored by Deloitte, NCBR and LSBC, evaluates the fast-growing biotechnological market in Poland. The sector deserves special attention because it is a focus point for large businesses and biotechnology is a key National Smart Specialisation area for “innovation policy”.

One of the main findings of the report is a positive (moderate, good or very good) view of three-quarters of the respondents on the conditions for conducting business in the biotechnology field in Poland. Furthermore, companies generally do not express any negative views on the regulations imposed by the legal framework with almost one in three predicting an improvement in this respect in the coming year.

Access to funds for new projects remains the main challenge for biotechnological companies in Poland. Over half of the respondents name the lack of access to capital as the main threat to their continuation as a going concern. The majority also indicate access to commercial capital or subsidies as “too complicated”.

Furthermore, over three-quarters of the respondents name the availability of qualified personnel as ‘difficult’ or ‘poor’.

The aforementioned challenges faced by companies in the Polish biotech sector can make it difficult for them to compete with Western industry leaders who have both the financial and human capital necessary to operate effectively.

Consequently, in order to mitigate the operational risk in the biotech sector, Polish companies should turn to the Open Innovation model. The model enables them to take advantage of the potential advantages offered by their environment as a result of cooperation with entities within and outside the industry. The model helps them develop new technologies and business models more effectively and, at the same time, addresses the setbacks faced by the Polish biotech market through cutting operating costs and providing access to external talent.

The Open Innovation model is based on the assumption whereby an organisation is not able to employ the best experts in a given area, therefore it should work closely with others around it to make the most of the human capital, know-how and to develop new technologies.

Open Innovation allows organisations to open new revenue channels, optimise their resources, reduce the risk posed by innovative activities and increase growth potential.

The effectiveness of the model has been proven by the Deloitte report “Executing an Open Innovation Model” which looks into the effects of the open approach on the biopharmaceutical market. The report shows that companies using the open model are three times more likely to put a new pharmaceutical on the market than ones operating in accordance with the traditional closed model.

Enterprises using the Open Innovation model should put special emphasis on effective protection of their intellectual property. If the IP management strategy is aligned properly, big players as well as biotechnological start-ups can use available instruments such as patent rights, licences, and confidentiality clauses to develop their ideas without the fear of any dishonesty from the environment they operate in.

It is worth mentioning that according to the report, three-quarters of firms in Poland rate the system of protection of intellectual property positively (as moderately effective or effective).

In view of the above, one can be optimistic about the declarations made by over two-thirds of the respondents to our survey of the Polish market who claim that they will cooperate with external partners, use external intellectual property or make their IP environment available to others. More action in this area could accelerate the pace of growth on the Polish biotech market.

Magdalena Burnat-MikoszPartnerInnovation Consulting and R&D, Grants and Incentives Advisory Leader


Stay the same

Improve

61,9%

38,1%

Moderate Weak Good Very good

42,9% 28,6% 23,8% 4,8%

I consider current business conditions for operating biotechnology companies in Poland to be:

I expect that within the next 12 months the overall conditions in the biotechnology sector in Poland will:

28,6% of the respondents consider current business conditions for the performance of biotechnology companies in Poland to be good or very good.

38,1% of the respondents expect an improvement in the overall conditions in the biotechnology market in Poland within the next 12 months. Notably, not a single respondent expect the conditions to deteriorate.

Survey results

8

Friendly

4,8%

Complicated

23,8%

Moderate

71,4%

33,3%

23,8%

14,3%

14,6%

9,5%

4,8%

Access to public/ EU funding

Access to capital

Tax regulations

Legal framework

Availability of qualified employees

Other

At present, the most significant market risks for my company stem from:

I consider the current legal framework for biotechnology companies in Poland to be:

According to 57,1% of respondents, access to capital (in general and in terms of the EU/public funding) is the most significant reason for the market risks their companies face.

14,6% of the respondents judge that the most significant market risks result from the legal framework both in general and in terms of taxation.

According to 71,4% of the respondents, the current legal framework for biotechnology companies in Poland is moderately friendly.


The results of the survey conducted by Deloitte show that the provisions of law in their current shape by no means pose the key obstacle to the development of biotechnology firms in Poland. A vast majority of respondents (76,2%) consider the current law as “friendly” or “moderately friendly” which is a good result considering that the entrepreneurs’ overall attitude towards the provisions of law is rather cold.

In fact, the provisions concerning the protection of inventions or intellectual property in the broad sense deserve a positive view because, on average, the level of protection in this respect in Poland is not much different from the rest of Europe. Unfortunately, one cannot take an equally positive view on the laws ruling the relations between the public and private sector that businesses in such heavily regulated sectors as biochemistry have to face on a daily basis. It is worth pointing out that often it is not the wording of the laws which is the main problem, but their practical application, the lack of clear guidance they offer to entrepreneurs, or their formalistic interpretation of the provisions. In this respect, there is a big gap to cover between Poland and countries considered as leaders of biotechnological innovation where the public sector provides biotechnological start-ups with strong support and makes their life easier.

It should be emphasised, however, that the importance of cooperation between the public and private sectors for innovation, including biotechnological innovations, has been increasingly appreciated in Poland, recently, with new regulations on the commercialisation of R&D results of higher education institutions being an example of this trend.

Bartosz Michalski, Managing Associate, Deloitte Legal

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Complicated

66,7%

Moderate

33,3%

Complicated Moderate Friendly

42,9% 52,3% 4,8%

Efficient Moderate Inefficient

28,6% 47,6% 23,8%

Stay the same

61,9%Improve

28,6%Deteriorate

9,5%

I expect that, within the next 12 months, the legal framework will:

I think that the Polish system of intellectual property protection is:

The majority of respondents do not expect any significant changes in the legal framework within the next 12 months. An improvement in the legal framework is expected by 28,6% of the respondents.

According to 47,6% of the respondents, the Polish system of intellectual property protection is moderate.


Complicated

66,7%

Moderate

33,3%

Complicated Moderate Friendly

42,9% 52,3% 4,8%

Stay the same

61,9%Improve

28,6%Deteriorate

9,5%

I think that the present tax framework for biotechnology companies is:

In my opinion, the current access to funding for biotechnology companies is:

According to 52,3% of the respondents the current tax framework for biotechnology companies is moderate.

According to 66,7% of the respondents, the current level of the access to funding for biotechnology companies is complicated.

Based on the analysis of the survey results, the tax framework is not perceived as friendly towards the biotechnology companies. In fact, it is considered as more complicated than the general legal framework of the industry. This is probably due to the complexity of the tax provisions, frequent changes in the regulations, discrepancies in tax authorities’ interpretations and diversity in judicial decisions. Consequently, one in seven respondents (14%) named tax regulations as the source of the most significant market risks.

It should be highlighted that Companies within the very capital-sensitive biotechnology industry treat difficulties in getting access to funding as a major obstacle to running their businesses. The issue could be addressed by providing appropriate support through various tax incentives. Unfortunately, the current shape of the tax framework facilitating the undertakings in biotechnology may seem insufficient. One may hope that this issue would be noticed and addressed by the legislator.

Cezary Kosiński, Senior Consultant, Tax Advisory

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Research

10,5%Prototype

21%Concept checking

47,4%

Market entry

15,8%

CE mark/ clinical tests

5,3%

Other4,8%

Foreign PE/VC funds

9,5%

IPO on the WSE or

NewConnect

23,8%

Polish PE/VC funds

61,9%

Moderate Complicated Easy

47,6% 28,6% 23,8%

At present, the access to properly qualified employees can be assessed as:

I expect that the equity financing will be provided by:

The access to properly qualified employees in Poland is assessed as moderate by 47,6% of the respondents.

The respondents’ expectations regarding the provision of equity financing are focused on Polish and foreign PE/VC funds, which were mentioned in 71,4% of the answers. IPO on the WSE or NewConnect was indicated by 23,8% of the respondents surveyed.


Research

10,5%Prototype

21%Concept checking

47,4%

Market entry

15,8%

CE mark/ clinical tests

5,3%

Research Preclinical trials

II phase of clinical tests

III phase of clinical

test/approval

68,4%

21%5,3% 5,3%

Other4,8%

Foreign PE/VC funds

9,5%

IPO on the WSE or

NewConnect

23,8%

Polish PE/VC funds

61,9%

Moderate Complicated Easy

47,6% 28,6% 23,8%

What is the stage of development of your Company’s core technology (pharmaceutical research companies):

What is the stage of development of your Company’s core technology/main activity:

In the case of 68,4% of respondents, the core technology for work on medicines is in the research phase. For only 5,3% of surveyed companies this technology is either in more mature Phase II or III of clinical trials.

In 47,4% of the companies surveyed, the core technology relating to the activity other than work on new medicines reached the level of concept checking.

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Be a pioneer study

5,3%Support innovation

21%

Be groundbreaking

31,6%Substantially support innovation

42,1%

Incentives do not affect the level of our R&D budget

5,3%

Both R&D subsidies and tax incentives have an equal impact on our R&D budget

15,8%

Puresystem of subsidies for R&D activity

21% Mixed system (subsidies + tax incentives)

57,9%

Moderate Difficult Easy

40,0%

55,0%

5,0%

Sale of the technology/

product

33,3%

License agreement wih

a large company

38,1%

Sale of the company

4,8%

Internal development and

launch

23,8%

What is – in your opinion – the most realistic way for the commercialisation of the core technology developed by your Company:

I assess the current access to public/ EU funding (incl. funds on R&D) in terms of biotechnology activities as:

According to 38,1% of the respondents, the most realistic way for the commercialisation of the core technology developed by their companies is a licence agreement with a large company.

Sale of the technology/product was chosen in 33,3% of the answers.

Internal development and launch, the most complex and expensive route, was chosen by 23,8% of respondents.

According to 40% of the respondents, the current access to public/EU funding in terms of biotechnology activities is moderate.


Be a pioneer study

5,3%Support innovation

21%

Be groundbreaking

31,6%Substantially support innovation

42,1%

Incentives do not affect the level of our R&D budget

5,3%

Both R&D subsidies and tax incentives have an equal impact on our R&D budget

15,8%

Puresystem of subsidies for R&D activity

21% Mixed system (subsidies + tax incentives)

57,9%

What type of incentives would have the greatest impact on the growth of the R&D budget in your Company:

I expect that the majority of results of my Company’s work will:

According to the majority of respondents, a mixed system consisting of R&D subsidies and tax incentives would have the greatest impact on the growth of the R&D budget in their companies.

According to 63,1% of the respondents surveyed, the results of their works will support innovation in general or in a substantial way.

31,6% of the respondents expect that the results of their works will be ground-breaking.

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No

52,6%Yes

47,4%

No

15,8%Yes

84,2%

I cooperate on R&D projects with unrelated entities

I do not use the Open innovation model

I utilise know-how licenses, patents etc. owned by large companies

I grant access to know-how licences, patents etc. to other companies operating in my sector

52,6%

36,8%5,3% 5,3%

Unacceptable level of risk

5,3%Lack of appropriate human capital

5,3%

Inappropriate cooperation with third parties

15,8%

Lack of know-how

5,3%

Lack of appropriate R&D infrastructure

15,8%Lack of appropriate financial assets

52,5%

The main barrier for conducting R&D activity is:

Regarding the Open innovation concept, the following statement is true:

According to over the half of the respondents surveyed, lack of appropriate financial assets is the main barrier for conducting R&D activity.

The lack of appropriate R&D infrastructure and inappropriate cooperation with third parties were both mentioned by 15,8% of the respondents.

The lack of know-how, lack of appropriate human capital and unacceptable levels of risk were the least chosen barriers.

Over the half of the respondents cooperate on R&D projects with unrelated parties within the concept of Open Innovation.

In 5,3% of the companies surveyed know-how, licences and patents owned by large companies are utilised or access to know-how, licences, patents etc. is granted to other companies operating in the sector.


No

52,6%Yes

47,4%

No

15,8%Yes

84,2%

I cooperate on R&D projects with unrelated entities

I do not use the Open innovation model

I utilise know-how licenses, patents etc. owned by large companies

I grant access to know-how licences, patents etc. to other companies operating in my sector

52,6%

36,8%5,3% 5,3%

Do you think that your Company employs appropriate managers to ensure commercial success?

Do you think that employment of experienced managers will be crucial to ensure the success of your Company?

The vast majority of the respondents surveyed believe that their companies employ appropriate managers to ensure commercial success.

47,4% of the respondents believe that employment of experienced managers will be crucial to ensure the success of their companies.

18

more than 100

23,3%

31-100

26,3%0-30

47,4%

Highly positive

5,3%

Beneficial

63,2%

Negative

31,5%

How do you perceive your cooperation with academic institutions?

How many people are employed in your company?

According to the majority of the respondents, their cooperation with academic institutions is beneficial.

47,4% of the respondents represent companies employing up to 30 people.


more than 100

23,3%

31-100

26,3%0-30

47,4%

Highly positive

5,3%

Beneficial

63,2%

Negative

31,5%

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Mining of Existing Data(literature, databases, data epositories, medical records, etc.)

Experiment Design

Data Collection

Data Analysis & Modeling

In Silico Validation

Results Interpretation

WET-LAB Validation

WET-LAB Experiment

Experimental steps in a professional labBioinformatics-related steps assisted by Deloitte

From profiling a disease, to designing a new medicine, or identifying new areas of use for an established product and enabling patient follow up to ensure people get the right medication, data analysis is key. Today’s Precision Medicine is about understanding patients at risk and stopping disease progression early by employing individual therapeutic strategies. Companies and health systems around the world have been collecting data for years but have they been getting the most out of it?

Deloitte Systems Biology has the power to unleash value by converting massive amounts of data into enhan- ced clinical value. That means improved diagnostics, increased performance and efficiency for the pharmaceutical and health technology company, more informed doctor decision making and better treatment for the patient via innovative therapeutic targeting systems.

A new era of biotechnology innovation is upon us: The development of powerful experimental techniques, such as Next Generation Sequencing (NGS), has made it possible to collect molecular data in unprecedented volume and detail. Complex genome experiments enable deciphering the genetic and epigenetic code of every cell, measuring the transcription level of each gene and understanding their role in disease processes.

To retain competitive edge, pharmaceutical companies must be able to access, transform and parse data from multiple sources and in multiple formats: epidemiology databases,

disease prevalence, text files, scientific experiments, clinical development programs, prescription usage data, clinical audit and social media postings.

Healthcare Professionals need easy, consistent access to all of this data to treat patients efficiently and prevent the progression of serious conditions.

Massive amounts of data generated through clinical experiments bring enormous possibilities but pose considerable computational challenges. The size of such datasets is often expressed in gigabytes and the number of parameters which are investigated at the same time is calculated in thousands and sometimes even in millions. Addressing such challenges requires advanced bioinformatics tools and methods as well as relevant experience.

Deloitte Systems Biology provides you with a team of data scientists who can get the most out of your data.

Deloitte Systems Biology has been created to provide advanced professional analytical services to facilitate the whole research process: from research to patient.

At every stage of the study, from hypothesis construction and experimental design to the interpretation of the results, we offer assistance in the development of analytical methods to ensure that the findings are meaningful, reliable and powerful.

Deloitte Systems Biology Turning Big Data into Big Value


Why Deloitte?

Deloitte Systems Biology combines the established expertise of Deloitte Big Data Analytics with excellence in Bio science.

Our scientific experts have the ability to unlock value in disease diagnostics and treatment via a pragmatic and creative approach to biostatistics. The power of data lies in its in depth analysis.

We bring a unique combination of professional, top quality experience in advisory services, analytical skills and excellent computational resources, together with expertise in Systems Biology methodology, delivered by experts with an international academic track record.

Our data scientists offer you comprehensive customised analytical solutions to get the best value out of research projects, clinical development programs and therapeutic applications.

Who can benefit?

Pharmaceutical companies and health systems need to spend less time preparing data sets for analysis and more time discovering insights that they can turn into business and clinical value.

Our bioinformatics experts can assist you in analysing large-scale experimental data generated through powerful state of-the-art experimental techniques, such as DNA sequencing, RNA sequencing, ChIP-seq and many more.

Our team not only offers competitively superior bioinformatics expertise but creatively identifies a route to clinical excellence and patient management through targeted disease profiling:

• Unleashing the power of high-throughput experiments which can bring valuable insight into the drug investi- gative process. Such analysis greatly facilitates the drug discovery process by helping to prioritise drug targets.

• Genome/exome sequencing data analysis and interpretation, leading to the design of personalised therapeutic approaches.

• Advanced statistical analysis and predictive modeling to help describe and understand the biological parameters which lead to more informed translational research and predictive outcome modeling.

• Integration of multisource types of biological and biomedical data which leverage existing knowledge to identify new treatment opportunities, supporting the process of drug repositioning and researching competitive health technologies for strategic advantage.

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How can we help?

Statistical analysis and modeling

• Advanced statistical analysis conducted on various types of biological data.

• Development of machine learning-based models to describe biological parameters.

• In addition to a broad spectrum of state-of-the-art algorithms, such as linear and logistic regression, support vector machines, neural networks, decision trees and random forests, we use Rough Sets, a knowledge discovery method which produces rule-based models easily interpretable by humans.

• Development of computational tools to conduct customised data analysis.

• Extraction of data from existing data repositories and knowledge databases using innovative data mining techniques.

Interpretation of experimental data

• DNA-seq with SNP calling – Whole genome, whole exome or target DNA sequencing with identification of polymorphisms and point mutations. Such analysis can be applied in population genetic studies to characterise genetic structures in association with studies to predict the impact of the SNP on a certain trait; identifying the genetic background of a disease in the clinical setting and in candidate gene studies to investigate the influence of the mutation on transcription regulation.

• ChIP-seq – Combination of chromatin immunoprecipi- tation and NGS used to determine transcription factor binding sites or the presence of histone modifications.

• DNase I-seq – DNase I hypersensitive sites sequencing usually employed along with motif analysis or ChIP-seq to investigate protein-DNA interactions and transcriptional regulatory networks.

• RNA-seq – Transcriptome sequencing to quantify the expression level of genes or splicing variants.

• Microarrays – Biochip-based technique for measuring transcript levels as a cheaper and widely used alternative to RNA-seq.

• RNAi screening – Large-scale experimental approach which employs RNA interference to investigate the cellular regulatory networks.

• Genome-wide association studies (GWAS) and quantitative trait mapping (QTL) – Analysis of the association between polymorphisms and a certain trait in a given population.

• Other types of biological and biomedical data.


Our experts

Marcin Kruczyk, [email protected]

Marcin Kruczyk has over five years of experience in the field of data analysis and data science. His areas of specialisation are machine learning, statistical analysis and data mining. Marcin holds a PhD degree in Bioinformatics. During his doctoral studies at Uppsala University he developed novel machine learning techniques and methods for solving statistical challenges. Among others, he invented and developed Random Reducts – a powerful method based on Rough Sets Theory dedicated to solve feature selection problems in large datasets. During his scientific career, Marcin analysed various types of datasets including population, genetics and epigenetics. He integrated datasets obtained from various technologies such as Next Generation Sequencing, microarrays, qPCR and others. As a PhD student, Marcin improved his competencies participating in various classes and courses including the prestigious Statistical Analysis of Genomic Data Course at Cold Spring Harbor Laboratory, New York, USA. Before his PhD studies, Marcin graduated from Warsaw University of Technology with a Master’s degree in Electronics and Information Technology with a specialisation in Electronics and Computer Engineering.During an internship with WB Electronics, he designed and developed cutting edge hardware solutions for mili- tary purposes. These experiences let him have not only a scientific but also a technological view on projects.

Weronika Sikora-Wohlfeld, [email protected]

Weronika Sikora-Wohlfeld has over six years of experience in the statistical analysis of biological data. Throughout her academic education and scientific career, Weronika has gained international and interdisciplinary experience both in the life science and IT fields. Starting from an experimental discipline (M.Sc. degree in Biotechnology at the Jagiellonian University in Kraków), her interests evolved into statistical and computational disciplines including Computational Biology (PhD degree at the Technical University Dresden) and Systems Medicine (postdoctoral appointment at Stanford University). Weronika’s expertise covers the development and application of statistical and computational tools to analyse and integrate large-scale biological data, the functional investigation of genomic screens and the interpretation of the whole genome sequence data. Weronika has conducted numerous research projects carried out with co-workers and external collaborators, including industry partners. During her postdoctoral appointment at Stanford University, she was working with Intel Big Data Solutions/Data Center Group on the development and implementation of computational tools based on ‘Big Data’ technologies to aid analysing biomedical data.

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Contacts

Oliver MurphyPartner, Financial Advisory Life Science & Healthcare Leader in PolandPhone: +48 (22) 511 06 98E-mail: [email protected]

Oliver is a graduate of the University of Manchester in Economics and Government, and a member of the ICAEW. Oliver is the former Treasurer of the British Polish Chamber of Commerce and a Supervisory Board member of Youth Business Poland, an organisation which provides support and mentoring to young entrepreneurs in Poland. Oliver has a wide range of corporate finance, due diligence and restructuring and integration experience within both the UK and Poland and leads the life science and healthcare practice of Deloitte in Poland. Oliver has led fundraising for innovative life sciences companies in the UK and has worked on many transactions in the Polish life sciences and healthcare sector.

Maciej DaleckiAssistant Director, Financial AdvisoryLife Science & HealthcarePhone: +48 (22) 511 03 37E-mail: [email protected]

Piotr ŚwiętochowskiDirector, AuditLife Science & HealthcarePhone: +48 (22) 511 05 45E-mail: [email protected]

We want to hear your feedback!

Please share with us your thoughts on the report at [email protected]

Cezary KosińskiSenior Consultant, TaxLife Science & HealthcarePhone: +48 (22) 5110390E-mail: [email protected]

Bartosz MichalskiManaging Associate, Deloitte LegalLife Science & HealthcarePhone: +48 (22) 5110654 E-mail: [email protected]

Magdalena Burnat-MikoszPartner w Dziale Konsultingu DeloitteLider Innovation Consulting oraz R&D and Government IncentivesPhone: +48 (22) 511 00 65E-mail: [email protected]

Magdalena is a profesional with over 17 years of experience in R&D process management and innovation strategy. She is a specialist in the management of competitiveness promoting public aid programs for en-terprises (EU funds). She supports corporate cost optimisation programs regarding R&D projects through the use of tax incentives and grants (including EU funds). She is actively involved in the development of innovation-supporting policy in Poland. She is a participant in debates regarding the modification of tax in-centive systems supporting R&D activity. She’s an editor and co-author of nine reports and books, among others, devoted to the support of R&D activities and other incentives. She has also presented analyst opinions regarding R&D activities on TV and in the press.


Contacts

Dr. Roland KozlowskiPresident and OwnerLife Science Biznes Consulting (LSBC) Sp. Z o.o

Roland Kozlowski received a first class honours degree from the University of Bath and a PhD from the University of Cambridge. He is a bio-entrepreneur who has worked in the industry for over two decades. Roland has held a number of operational roles including Chief Executive Officer of Lectus Therapeutics and Sense Proteomic Limited, two venture backed companies which he founded, built, and sold. During his career, Roland has gained considerable transactional experience ranging from company sale, purchase, financing and in and out-licensing. In the past, Roland ran Research Groups at the University of Oxford and the University of Bristol where, subsequently, he was a Visiting Industrial Professor. He has published and patented in the life science field. Roland has served on, or advised, the boards of a number of European companies. He also served on the board of the Bio-Industry Association in the UK. Since 2011, he has been president and owner of Life Science Biznes Consulting (LSBC) a company which specialises in commercialising technology from emerging economies, in particular Poland, and building business partnerships between Poland and Western Europe. He advises a number of government agencies in Poland on life science investment and commercialisation strategy and is a co-founder and Venture Partner in Life Science Innovations, a specialist VC fund based in Poland. He also sits on the investment committee of Alderley Park Ventures, a UK life science VC fund.

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This publication was prepared in partnership with National Centre for Research and Development (NCBiR) and Life Science Business Consulting (LSBC) collaborating

together within BRIdge Mentor programme.

About the surveyThis publication is based upon answers received from Polish biotech professionals. The survey was conducted between August and October 2015, over 86 biotech (and biotech industry related) companies were invited to take part in the survey.

Media Partner:

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Executing an open innovation model: Cooperation is key to competition for biopharmaceutical companies

Executive summary

Many biopharmaceutical (biopharma) companies are facing a challenging research and development (R&D) environment and increased competitive pressures. Their heavy reliance on a closed, traditional model of product development might stifle true innovation and may cause biopharma companies to lag behind their more creative peers. Companies in other industries have turned to open innovation (OI) – along a spectrum of openness that ranges from closed/traditional to open/emerging – as one way to successfully overcome many R&D and marketplace challenges by sourcing innovative ideas, knowledge, and new skills/technologies from outside their organization.

Deloitte’s analysis of the current state of OI in biopharma reveals a higher success rate for OI pursuits than for closed-model product development. However, companies have sourced around 80 percent of their R&D pipeline via the more closed end of the OI spectrum. Adoption at the most open end is still infrequent and slow, mainly due to concerns about

intellectual property (IP) rights, adopting new OI-based R&D models, and cultural and management style issues. Nonetheless, for biopharma companies, OI seems to be the way forward, as it appears to be a more cost- and time-effective way to bring drugs to market. In fact, several key trends will likely continue to drive the adoption of OI, especially at the most open end of the spectrum.

Biopharma companies looking to initiate or expand an OI effort should consider evaluating its maturity against this paper’s openness spectrum framework and taking steps towards aligning the OI operating model with the effort’s specific goals and desired outcomes.

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