Pharma - Tekes

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Pharma. Tekes programme 2008–2011. Finnish pharmaceutical expertise is, in many areas, world-class. What makes Finland special is the extraordinarily ...
special is the extraordinarily fruitful cooperation between companies and public research organisations in life sciences. The Tekes Pharma programme aims to even further improve the efficiency of development processes, risk management and overall business opportunities within the Finnish pharmaceutical industry. Finland is an ideal development and production base for new innovative drug formulations and a forerunner in networked innovation activity and novel business models within the pharmaceutical industry. Concentrating in developing medication for children and the elderly will bring along new business opportunities especially for small and medium-sized subcontractors and service providers. Long-term investments in research and development have made Finland one of the most research-intensive countries in the world. The Finnish commitment to R&D has created an excellent research and innovation environment.

Tekes, the Finnish Funding Agency for Technology and Innovation

L AYO UT: A H OY | C O V E R P H OTO: G O R I L L A | P R I NT: E R W E K O | D E C E M B E R 200 8

Finnish pharmaceutical expertise is, in many areas, world-class. What makes Finland

Tekes is the main public funding organisation for research and development (R&D) in Finland. Tekes funds industrial projects as well as projects in research organisations, and especially promotes innovative, risk-intensive projects. Tekes offers partners from abroad a gateway to the key technology players in Finland.

Tekes programmes – part of the innovation chain Tekes programmes are an essential part of the Finnish innovation system. These programmes have proved to be an effective form of cooperation and networking for companies, universities and research institutes for developing innovative products, processes and services. Tekes programmes boost development in specific sectors of technology or industry, and the results of the research work are passed on to business systematically. The programmes also serve as excellent frameworks for international R&D cooperation.

www.tekes.fi/pharma Pharma Programme Manager, Pauli Saarenketo, Tekes Tel. +358 10 60 22538 | [email protected] Pharma Programme Coordinator, Johanna Reiman, Biocelex Ltd Tel. +358 50 5774803 | [email protected]

Building competitive edge

Pharma Tekes programme 2008–2011

Solutions in synthesis technologies Leading Finnish experts in synthesis technologies and pharmaceutical companies seek to solve the challenges encountered during drug discovery and development in an extensive research project coordinated by the University of Jyväskylä. Headed by Professor Petri Pihko, a consortium of four academic groups and five Finnish companies aims to accelerate the pharmaceutical development process by solving the problems faced by the pharmaceutical industry in synthesis technology. The participating companies – Orion

Pharma, KemFine, Hormos Medical, Fermion, PCAS Finland and Pharmatory – include manufacturers of generic and proprietary pharmaceuticals as well as manufacturers of pharmaceutical chemicals. The participating groups from the University of Jyväskylä, Tampere University of Technology, Åbo Akademi University and Helsinki University of Technology, on the other hand, are specialists in the catalytic development of new synthesis methodologies in their own respective areas of expertise.

Time is money "The requirements on the safety and purity of pharmaceutical products have increased steadily, in conjunction with the increasing complexity of active pharmaceutical ingredients (API). As a result, the synthesis and manufacture of APIs has become more challenging. Preclinical research alone requires several kilogrammes of the APIs instead of grammes, and the increased complexity of the APIs is making the pharmaceutical development process all the more expensive and time consuming" explains Professor Pihko on the background to the project. "Time is a critical factor in the pharmaceutical industry: delays of a few weeks in the synthesis phase can rapidly accumulate during the pharmaceutical development process, and consequently

lead to losing the race for the market, costing millions of euros. Even minor steps in speeding up the synthesis of active pharmaceutical ingredients are important," he adds.

Tools to fit the need Due to its holistic approach, the research project headed by Pihko is internationally unique. The project aims to produce reliable tools that will be suitable for the needs of initial research phases, preclinical and clinical production as well as industrial production, without the need to change the technology or synthesis routes in different phases of the process. One of the project’s strengths is the fact that established international pharmaceutical companies as well as more specialised companies operating in different fields of the pharmaceutical production phase are engaged in close collaboration. "This kind of collaborative model will almost certainly give rise to lasting collaborative structures and generate new, more specific research projects between public research institutions and the private sector. In this project, the private companies define the research objectives of the collaboration, while the solutions are produced in the academic research teams. It is exceptional to combine extensive industrial insight with academic research so early in the research process."

Pharma fast facts

Lipidomics, a tool for cardiovascular research cooperation between pharmaceuticals, diagnostics and clinical drug research.

The Tekes Pharma programme is a complete package of funding and expert services for R&D and innovation for the pharmaceutical industry, pharmaceutical service companies and research organisations. Pharma runs from 2008 to 2011 with a budget of 58 million euros. Approximately half of the budget is covered by Tekes and half by participating companies.

Eligibility for Tekes funding Tekes financing can be awarded to companies, universities and research institutes registered in Finland. Foreign-owned companies with R&D activities in Finland are eligible for funding.

Aims Pharma aims to develop new processes and methods that improve the efficiency of the pharmaceutical industry. The programme promotes networked business models within the industry and especially cross-industry

Frequency of calls Companies can apply for funding for their R&D projects any time during the course of the programme. For research organisations there are thematic calls for applications approximately once a year.

International cooperation International cooperation in Pharma-funded R&D projects is strongly encouraged and will significantly improve the likelihood of a positive funding decision. Especially small and medium-sized Finnish pharmaceutical companies are encouraged to participate in international R&D cooperation and doing business internationally. Pharma programme actively builds cooperation in China and supports research activities with its Canadian partners. The programme is involved in and promotes the Finnish participation in the European Union’s research programmes.

Pharma focus areas The Tekes Pharma programme funds R&D and innovation projects that fall into the categories of the programme’s focus areas. The focus areas are selected based on the strengths of the Finnish pharmaceutical industry. The programme will in its own part broaden the pools of expertise within the focus areas. Predictive models and methods accelerating and supporting the drug development process • Patient samples and registry data to support research

• Identifying and exploiting biomarkers • Understanding pathogenetic mechanisms as well as pharmacokinetics and mechanisms of action Chemical production technology and innovative medical formulations • Solutions for synthesis and development of cost effective synthetic pathways • New production technologies for promising drug candidates and generic medicines • Innovative drug formulations for children, the elderly and for veterinary use

The development of a national operational model for clinical drug research • Reformation and harmonisation of clinical processes and operations in the public sector, drug and service companies Networked business models • Developing business skills • Productisation of innovations and access of new products to the market

Cardiovascular diseases are the leading cause of disability and death in the world and their prevalence continues to increase worldwide. Zora Biosciences Oy, which is based in Finland, specialises in lipidomics – the study of lipid biochemistry – and develops diagnostic biomarkers for cardiovascular diseases and identifies target molecules for new cardiovascular drugs. Zora’s business model is based on high-quality analyses in lipidomics. The company’s research laboratory specialises in complex mass spectrometry methods and technologies. Zora offers cutting edge services in analysing biological samples to global pharmaceutical companies and academic research organisations. In addition, Zora develops its own prognostic and diagnostic biomarkers and tries to identify new target molecules for the treatment of cardiovascular diseases. International pharmaceutical companies turn to Zora for collaboration in discovery, research and development projects involving lipid mediators. “Our research services are highly specialised and always tailored to the partner’s needs. Our portfolio of lipidomic methods is the only one of its kind in the world: none of our competitors can offer the pharmaceutical industry as extensive, detailed and high-quality data on lipids in a high throughput fashion,”

says Reini Hurme, Chief Executive Officer of Zora.

Promoting personalised medicine “The greatest future promise in our business lies in our own product development – in developing diagnostic biomarkers and finding novel drug targets. New biomarkers will drive personalised medicine initiatives, making sure that the right patient gets the right drug at the right time.” One of Zora Biosciences' significant strengths is its extensive analytics expertise in non-clinical and clinical studies. Work in translational medicine is one of the shared objectives of the pharmaceutical industry in Finland and internationally. The objective is to make more efficient use of pre-clinical data and to translate it into clinical trials, and vice versa. The lipid expertise offered by Zora Biosciences may provide new tools and approaches to translational research in cardiovascular diseases, for instance. “We believe that lipids, due to their evolutionary conservation among species, will be very helpful in translational medicine.”

Networking adds value Zora Biosciences is involved in international research cooperation in areas where joining forces offers clear benefits. The company participates in several EU research projects, gaining access to valuable intangible assets, international visibility and networking opportunities. “Collaboration in international research has expanded our global network and strengthened our scientific knowhow, in addition to offering opportunities to commercialise various research findings,” says Hurme.