Needs of Global Start-up companies (Deliverable 2) GlobalStart wp1 Studies Deliverable 2 Needs of Global Start-up Companies Table of contents p
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- Pre-venture Foundation –focus academic clients May 1998 – end 2001
- Technology platform Product Market
- 1 (c) The internationalisation process Know-how / technology
- 2. The university – support for Globalstart companies
- 3. The regional infrastructure – support for Globalstart companies
- 1(a) Profile and background
- Pre-venture Foundation Feb 2002 Current activities
- 1 (c) The internationalisation process Know-how / people
- ANNEX reMYND Technology / products Alzheimer’s disease
- 1 (a) Profile and background
- Pre-venture - foundation 2000 – end 2002 Change focus Mid 2002 – April 2004
- 1 (c) The internationalisation process Know-how / technology
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1 (a) Profile and background Metis Instruments & Equipment is a technology leader in industrial and scientific magnetics, providing a complete range of solutions for the manufacturing industry: magnetizing equipment, diagnostics & quality control systems and co-engineering & consultancy services. In addition to its industrial activities, Metis provides research equipment for pulsed field experiments. At present, Metis is actively involved in most of the major European initiatives in the area of research in high magnetic fields. Using his expertise in advanced research magnet technology, Metis creates new opportunities for the development of lighter, more powerful and less energy-consuming electromagnetic devices. Metis was founded in 1998 by Dr. Luc Van Bockstal and Dr. Alain De Keyser. Both founders were active in the Pulse Field Group (PFG) of the Physics Department at the KULeuven, where they obtained their PhD in 1989 and 1998 respectively. In this department of physics, a new type of electromagnetic device was developed with higher performance (stronger magnetic fields), lower energy consumption and less expensive than the existing ones. Similar instruments were used by other research groups as well. Those research groups were trying to develop their own instrument, not aware of the existing technology at the PFG department. This has set the basis for the original business idea: providing other research groups with electromagnetic instruments based on the superior technology developed at PFG. The business idea was further elaborated in a business plan with the help of Leuven Research & Development (LRD). It was decided to focus first on the development of electromagnetic devices for other research groups as this was a known market and technology application. In addition, the spin-off company should start as quickly as possible to target the industry with industrial applications. 1 (b) Major milestones
1 (c) The internationalisation process Know-how / technology The technology used by Metis is clearly outperforming the technology offered by its (international) competitors. The magnetising equipment of Metis delivers a higher performance at a lower cost. Since 1999-2000, Metis has acquired a leading position in the research-oriented market for strong magnetic field systems. The company is involved in all major European initiatives in this area and participates in a number of national and transnational research projects in order to push the limits of the currently available magnetic field range beyond 80 Tesla. It strives to maintain this position in the future. Networking Metis is involved in major European initiatives in the area of research in high magnetic fields. Via the attendance at international conferences, a network of partners involved in the same research field has been built up. The 5th Framework Program of the EC has created a network of universities - Nijmegen (NL), Toulouse (F), Oxford (UK), Berlijn (D), Amsterdam (NL) and KULeuven. Metis can use the laboratory infrastructure of these universities against a fixed fee. Market The first customers of Metis consisted of research departments of universities. For the founders of Metis, this was a well known market. However, the target of Metis was to change focus to industrial customers. Identification of potential clients appears to be difficult, due to the variety of sectors that use magnetised materials. Moreover the time lag between the first contacts with the customer and the actual order is usually very long, up till more than one year. Most customers were found via internet searches but also via fairs and trade shows. In a later stage, Export Vlaanderen and GOM (Gewestelijke OntwikkelingsMaatschappij) were contacted to find customers outside Belgium The market for magnetizing equipment is mostly nationally defined with one market leader (market share > 60%) and 3 to 5 smaller competitors. Therefore, a good knowledge of the national market is required in order to access the customers. Currently, Metis has 3 major customers in Belgium. Other European clients are mostly situated in Germany, and, to a lesser extent, in France. The north of Italy seems to be an important market, but access to this market remains impossible due to language difficulties and market monopolisation by a large Italian player. Other EU-regions are less important as markets for magnetising instrument. Metis’ strategy is to focus for the next 2 years on the key-accounts in Europe. Then, it plans to target customers outside Europe. Recent reallocation of production facilities that uses magnetising equipment to Eastern Europe and Asia, recent automation of factories in low cost countries such as India and Mexico, creates huge opportunities for Metis. However, these promising markets are more difficult to penetrate because of logistic and aftersales problems. In addition, a good knowledge of the national market is often required to access the local customers. To address these issues, Metis intends to enter these markets via existing dealer networks. The company wants avoid fierce price competition by focussing on the high-end markets. The competitors of Metis are mostly small family-owned enterprises, merely active in their (national) home market and not very innovative. Metis’ main competitor is located in Germany. Large international companies are not targeting the niche market Metis is operating in. By the end of the nineties, many new firms entered the market. These firms were mostly founded by ex-employees of existing firms, who brought along the network of customers. Some of these companies managed to become very successful in a very short notice, mainly because of a good balanced dealer network. However, their technology is clearly inferior to the technology used by Metis. Due to the very fierce price competition in the sector, Metis expects that many competitors will disappear in the next five years. 2. The university – support for Globalstart companies The foundation of the Gemma Frisius Fund (the capital fund associated with the KULeuven) and the publication of some articles about university spin-offs in the university newspaper (Campuskrant), have encouraged the founders to start their own company. Leuven Research & Development (LRD) guided the founders in setting up the business plan and defining the short and long run focus of the company. 3. The regional infrastructure – support for Globalstart companies None of the founders had any management experience before the start-up, since they had been working as researchers in the university labs. Within their prior working environment, they also didn’t have any contacts with firms or other non-academic partners. Therefore, the assistance received from the Board of Directors in terms of management advice was very useful. Board meetings were held very frequently, and the directors were also very cooperative to provide assistance in addition to the board meetings. As the members of the BoD changed frequently, a large and useful network of people with business experience and different specialisations was established (venture capitalists, universities, industry, LRD) Metis is an associate member of Leuven Inc. The lectures and conferences organised by Leuven Inc. are very useful for starting entrepreneurs. However, the network of Leuven Inc. does not bring them into contact with new potential customers. Most customers were found via internet searches but also via fairs and trade shows. Export Vlaanderen is currently helping Metis to find new clients outside Europe. Also the GOM was contacted for this purpose. Promising markets like Asia and Latin America, are more difficult to penetrate because of logistic and after-sales problems In addition, a good knowledge of the national market is often required to access the local customers. To address these issues, Metis intends to enter these markets via existing dealer networks. reMYND
1(a) Profile and background reMYND offers a cost-effective service for in vivo testing of potential Alzheimer’s disease (AD) drugs in transgenic mice and in humanized yeast-based systems. Furthermore, reMYND is involved in the development of high-throughput screening systems for testing compounds active against neurodegeneration and runs a screening program to identify novel Alzheimer’s disease drug targets and compounds using a patent-protected approach. ReMYND was founded in February 2002 by Dr. Stefaan Wera, Prof. Dr. Fred Van Leuven and Prof. Dr. Joris Winderickx as a spin-off of two research labs of the KULeuven. Prof. Dr. Fred Van Leuven is affiliated to the faculty of medicine of the KULeuven and heads the Lab for Experimental Genetics and Transgenese (LEGT). He is an internationally renowned expert on the field. The Experimental Genetics Group (EGG), which is part of above lab, has been involved in the research on transgenic mouse models for the last 10 to 15 years. Prof. Dr. Joris Winderickx, affiliated to the faculty of sciences of the KULeuven, dept. of biology, is a senior researcher at the Functional Biology Lab (headed by Prof. Dr. A. Van Laere). This lab performs research on yeast models used to identify AD drug compounds. Dr. Stefaan Wera obtained a PhD in biology. As such, he acquired some valuable experience with research and research management. Since many years, the research group of Prof. Dr. Van Leuven performed contract research with biomedical and pharmaceutical companies. These contract research activities included compounds testing on transgenic mouse models6. During the last years, industry demand for compound testing in mouse models increased, leading to the decision of Prof. Dr. Van Leuven to spin out these activities. In October 2001, Stefaan Wera was transferred to the labs of Prof. Dr. Van Leuven in order to acquire know-how on these mouse models. During this period the first business plan was drafted, first contacts were made with potential clients and financing of the spin-off project was found. At the moment of foundation, the IP rights on the yeast models and the commercial rights on the mouse models7 were transferred to reMYND. The spin-off company also obtained the right of 1st refusal on the new mouse models developed at the laboratories of Prof. Dr.Van Leuven. Both professors invested financially in the spin-off but did not step in the spin-off as they preferred to remain active in the academic environment. Dr. Stefaan Wera was put in charge of the general management of the spin-off, supported by the 2 professors via their advisory role as members of the Board of Directors. Especially professor Van Leuven is very actively involved in the spin-off by giving academic advice and through his contacts with potential clients. The business plan comprises a three-legged structure. Fee-for-service activities consisting of AD drug testing on mouse models will generate cash. This money will be used for the further development of yeast models. The long term goal of the company is the development of own AD drug compounds. As reMYND had some fee-for-service contracts with customers from the start-up, the company was able to generate income from the start. In the original business plan, focus was on AD. The mouse models of reMYND can be used for AD-purposes only. It will probably take 5 to 15 years before adequate drugs against AD will be developed and during this period of time, mouse models for AD will remain necessary. Once efficient drugs against AD will be on the market, the models will become less valuable. reMYND obtained IWT funding to develop a tau mouse model for AD and other diseases (referred to as ‘tau-opathies’). The company plans to adjust the mice to new diseases, broaden their scala of models and keep them up to date. For this purpose they engaged in an exclusive licensing agreement with another KULeuven lab. Also the yeast model developed by reMYND can be extended to test other diseases than AD. A patent application has been filed for PD. Mouse models and yeast models are different but complementary techniques. Yeast models can be seen as biological models for screening. It allows for the identification of compounds with therapeutic potential out of very large numbers of compounds (‘chemical libraries’). From about 50.000 compounds, an estimate of 100 will be validated further on cell line models, which will deliver up to 10 molecules to be tested on mice. It would be unethical and too expensive to test a large number of compounds directly onto mice. The risk of the project consists of the fact that it is very difficult to predict the market and determine which mouse models will be requested by customers in the future. Moreover, cash available to invest in research is scarce. In 2004, reMYND received the ‘Flanders most innovative start-up’ - award of the Flemish government. 1 (b) Major milestones
1 (c) The internationalisation process Know-how / people Prof. Dr. Van Leuven is an internationally renowned expert on the field. Before reMYND’s incorporation, his laboratory wasconducting many contract research activities with biomedical and pharmaceutical multinationals. reMYND is active in a very knowledge intensive and quickly evolving sector, which necessitate a constant review of all relevant literature. Current know-how is concentrated within a limited number of the staff and not easily transferable to other non-PhD employees. This constitutes a potential risk for the operations and the future development of the company. reMYND can not afford to engage more PhD staff to spread the knowledge over more persons due to financial restrictions. The company can also not afford to reward the current staff with the same high salaries as large pharmaceutical companies do (estimated to be 20% higher). Instead reMYND can offer its staff a congenial and flexible working environment.
Dr. Wera estimates the number of companies active in the research field of AD at 150. Only three of them (in Europe and the USA) offer fee-for-service testing in mouse models. Each of these 3 firms has developed specific mouse models. Depending on the compounds to test, some of these mouse models may be more appropriate than others. To evolve from the research stage to the clinical stage in the drug development industry, the proof of principle needs to be acquired via mouse models. This gives reMYND a kind of monopoly position: for many biomedical and pharmaceutical companies, reMYND is the only alternative for mouse models as the in-house development of these mouse models is very capital and time intensive. Some large pharmaceutical companies, for ex. Johnson & Johnson and Novartis, own similar mouse models, but most companies rely on the services offered by one of the three specialised fee-for-service companies or on academic collaborations. The clients of reMYND are mostly European firms but there are also 4 American companies. Several customers have been acquired via contacts of Prof. Dr. Van Leuven. Asian companies are not easy to reach. Up until now, reMYND has not incurred many problems related to its immediate presence in the global market. Since every client has its own set of requirements for the fee-for-service research, differences in national regulations have almost no effect on reMYND’s activities. Networking The international network of Prof. Dr. Van Leuven has proved to be very useful for attracting customers. 2. The university – support for Globalstart companies LRD was already familiar with the concept of mouse models before the foundation of reMYND because the lab of Prof. Dr. Van Leuven was involved in contract research for many years. LRD gave reMYND very useful support with respect to legal matters (contracts and, to a lesser extent, IP) and general management. Especially in the beginning a lot of support was required. At the start-up, reMYND encountered some difficulties in finding appropriate infrastructure to house their activities. The KULeuven could not offer them lab space that meets the requirements of a starting biomedical company. reMYND is currently housed on a abandoned hospital campus but a new, more appropriate housing facility will be required within the next months/years. 3. The regional infrastructure – support for Globalstart companies After one year, LRD wants its spin-offs to become independent and gradually decreases its support to the spin-off companies. For this reason, reMYND currently outsources all IP related juridical issues to a patent office. Leuven inc offers useful advice and exchanges of best practices between starting entrepreneurs. However, it is limited to the bigger Leuven area, which makes it less interesting for support for global activities. At the moment, many problems such as price setting, accounting procedures, HR issues, etc. remain. ReMYND cannot afford to hire people with experience in these fields. Moreover, due to the particularity of these problems, it is very difficult to find outside support. As an example, Acerta, a firm specialised in HR management, also fails to offer specialised, tailor-made services to young research-intensive companies. ANNEX reMYND Technology / products Alzheimer’s disease Alzheimer’s disease (AD) is characterized by a progressive loss of memory and neuronal functions eventually leading to dementia and death. Apart from causing a major human tragedy this disease poses a tremendous economical challenge. In the United States the number of AD patients is estimated to 4 million. As population ages , AD will become even more important since more than 50% of people older than 85 develop AD compared to 10% of people older than 65. Sporadic forms of AD are caused by mutations in the genes encoding amyloid precursor protein (APP), or presenilin 1 or 2. Aging is the major risk factor for the late onset forms of AD, but increased incidence occurs among carriers of the ApoE4 allele. Whereas TAU phosphorylation and aggregation into tangles contributes to the development of AD, TAU mutations are known to cause Frontotemporal dementia and parkinsonism linked to chromosome 17 (FTDP-17). Current drug development requires extensive characterization of many compounds and their detailed preclinical analysis. Transgenic mouse models of Alzheimer’s disease have proven valuable tools in the search for drugs and treatments (e.g. vaccines) that can slow down development of AD or eventually cure this disorder. reMYND offers, in a fee-for-service business model, in vivo drug testing in a wide variety of transgenic mouse models, created by the laboratory of Prof. Van Leuven.. Although the 'perfect' animal model does not exist, different models express different phenotypic characteristics of AD, and an approach combining the different models available seems the most rewarding. reMYND engineered baker’s yeast (Saccharomyces cerevisiae) strains encode human Tau (patent pending). On in-house defined media and genetic backgrounds (‘reMYND strain’) Tau function is correlated with yeast growth. Hence compounds that allow growth of the reMYND strain have the potential to restore Tau function. This test is currently used in compound and target screens Parkinson’s disease Parkinson’s disease (PD), the second most common neurodegenerative disorder, is a late-onset progressive motor disease. It is marked by selective degeneration of dopaminergic neurons in the substantia nigra and the formation of fibrillar a-synuclein cytoplasmic inclusions, known as Lewy bodies (LBs), which contain a-synuclein and ubiquitin. Considerable progress has been made in understanding the molecular basis of the disease by the identification of mutations in 2 genes, i.e. a-synuclein and parkin, causing familial PD. RNA-TEC
1 (a) Profile and background RNA-TEC is a spin-off from the KULeuven servicing the biotech and pharmaceutical industry with modified and unmodified RNA oligos, synthesized on an intermediate scale and to be used for target validation, diagnostics and drug development. RNA-TEC was founded in 2000 by Prof. Herdewijn and Dr. Brian Sproat. Both founders are experts in their fields of science: Prof. Dr. Piet Herdewijn, is an internationally renowned scientist with more than 20 years of expertise in nucleoside and nucleotide chemistry. His expertise is more in the field of chemistry than RNA. Dr. Brian Sproat has more than 25 years of expertise in the field of nucleotide and oligonucleotide analogues. He is inventor/co-inventor of several patents in the field oligonucleotides. Major shareholder of RNA-TEC was the Gemma Frisius funds, but also the Rega Institute and both founders, Prof. Herdewijn and Dr. Sproat. The Rega Institute is an interfacultary biomedical research institute of the K.U.Leuven, known internationally for its developments in medical research. Before the start-up of RNA-TEC, the market size for isotopically labelled nucleotides was not accurate and exaggerated. Not sufficient business research at the start-up of the company resulted in a wrong assessment of the market. In the second half of 2002, a reorientation of the market was decided upon, initiated by LRD and Johan De Schepper, portfolio manager at LRD. Johan De Schepper was appointed as CEO of the company and he was given the responsibility of general management and marketing. Johan De Schepper has more than 15 years of experience in an international environment. The technology actually used by RNA-TEC for synthesising and purifying oligos is the TBDMS technology. This technology is regarded as one of the leading and robust ways for the manufacturing of RNA and siRNA based oligonucleotides. The protocol has been improved by Dr.Sprout, allowing for large scale production of oligos. RNA-TEC makes the difference by supplying high quality and high purity oligos. Mastering the complexity in a streamlined synthesis protocol allows RNA-TEC to provide very complex oligos and polymers. RNA oligonucleotides have gained high importance in the therapeutic area over the last years. Promising applications for therapeutic oligonucleotides are in the field of stimulating the immune system to treat and prevent cancer, allergies, respiratory diseases, viral infections, etc. A large number of oligonucleotides are currently in different clinical phases. Small interfering RNA (siRNA), a newer technology, can be used to selectively switch off gene function, although delivery (the process of reaching and entering the targeted cells and tissues) is still a major issue for this class. SiRNA is assumed to be the major driver for the market over the next few years. In April 2004 RNA-TEC signed an agreement with Lonza, a Swiss based contract manufacturer of active pharmaceutical ingredients. RNA-TEC and Lonza will provide the market with high quality RNA-oligonucleotides ranging from intermediate scale, manufactured by RNA-TEC, up to industrial quantities, manufactured by Lonza, using the TBDMS technology from RNA-TEC. This cooperation will allow customers to take their projects from the preclinical stage right to the commercial production. According to Johan De Schepper the key to success is enabling the community of researcher to use high purity oligonucleotides in combination with new and effective delivery mechanisms. 1 (b) Major milestones
1 (c) The internationalisation process Know-how / technology Both founders of RNA-TEC, Prof. Piet Herdewijn and Dr. Brian Sproat, are renowned scientists with each more than 20 years of experience in the fields of nucleoside, nucleotide and oligonucleotide industry. Dr. Brian Sproat is inventor/co-inventor of several patents in the field oligonucleotides. He is an authority in the field and his knowledge is very important for the company. One of the shareholders of the company is the Rega Institute. This interfacultary biomedical research institute of the K.U.Leuven, known internationally for its developments in medical research, has given RNA-TEC access to its state-of-the-art technology developed within the institute. Proprietary knowledge enabled the development of a streamlined and acknowledged TBDMS technology for RNA synthesis. The TBDMS technology with streamlined high yield protocols is regarded as one of the leading ways for the manufacturing of RNA and siRNA based oligonucleotides. This method of synthesising and purifying oligos is particularly suited to intermediate and large-scale production. For small-scale oligo production other technologies developed by small scale competitors are better. The expertise acquired guarantees state-of-the-art and streamlined RNA synthesis process, capable of dealing with the highest complexity in a cost effective format. Networking Rega Institute is one of the networking partners since the start of RNA-TEC. This institute has worldwide cooperation with industrial companies. Today, there is not much collaboration anymore between RNA-TEC and the Rega Institute. Also both founders brought in their networks, at the start of RNA-TEC. In April 2004, RNA-TEC and Lonza signed a collaboration agreement regarding TBDMS based Oligonucleotides. Lonza is one of the leading contract manufacturers of active pharmaceutical ingredients. Both companies will combine their efforts to provide the RNA market with state-of-the-art RNA synthesis expertise. RNA-TEC will produce the RNA and siRNA-based oligonucleotides on an intermediate scale, whereas Lonza will manufacture them on an industrial large scale under cGMP (current Good Manufacturing Practice) in its premises. The close and global co-marketing collaboration in which RNA-TEC and Lonza are engaged, are based upon complementing expertise and strengths. Providing a common platform, based on acknowledged synthesis technology, will scale-up their capability and proven operational excellence. Simultaneously, both companies are also investigating other areas where synergies will prove to be instrumental. Market The market for isotopically labelled nucleotides was originally targeted by the business plan, is very low < 1,5 mio USD. In contrast, the market for RNA and siRNA-based oligonucleotides is substantial ras far as small scale is concerned bu on intermediate scale the market is still in the early stage as pharma companies are upscaling their findings. The markt today is not yet so competitive. RNA-TEC’s competitors are mostly situated in the US: some 15 companies in the US, only 6 in Europe. Moreover, in the intermediate-scale production category in which RNA-TEC is operating, there are only a few players. The small-scale sector is dominated by the two top-ranked companies Qiagen and Dharmacon as well as Degussa subsidiary Proligo and Ambion. The customers of RNA-TEC consist of university research labs, large research institutes and big multinationals operating in the biotech and pharmaceutical industry. Most of RNA-TEC’s customers are located in Europe and US. However, nowadays there are also some Asian customers. 2. The university – support for Globalstart companies LRD was contacted by Prof. Dr. Piet Herdewijn, to develop his business idea. LRD also supported the company to reorientate to another market and provided the start-up company with a new CEO, experienced with international business. TiGenix
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