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Anna Minidis
Senior Projektledare
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New medicines need capital - and the right development partner
Drug development is at the heart of society. But developing a commercial product is a long, expensive and complex process – and smaller companies can easily get stuck along the way.
"With a long-term development partner, you are more likely to secure everything from funding to expertise and equipment," says Anna Minidis, who works with life sciences at RISE.
In the pharmaceutical sector, it takes an average of 12 years to develop a commercial product. For completely new areas of medicine, it can take even longer, up to 30 years. Only one in 5,000 new substances is eventually approved for sale by regulatory authorities such as the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA) in the EU.
So you need persistence, capital and knowledge if you want your innovation to succeed.
Opportunities for public funding
As a result, there are large amounts of funding available, both nationally in Sweden through Vinnova and through various EU funding instruments, which can often cover up to half of the development costs.
Leif Lyckebäck, Business Developer at RISE, has in his role at RISE helped hundreds of innovation-driven small businesses in different industries to find funding for their development and scale-up work. He believes that there is a lot of public funding available for innovation among small and medium-sized enterprises. But you have to navigate the wide range of grants and subsidies, understand the eligibility criteria and what activities you can apply for.
"There is a lot of public support available for innovative SMEs to promote public health. However, you need to understand at what stage of development you should apply. In addition to funding specifically targeted at drug development and life sciences, there is also a lot of funding to stimulate development based on really deep research and in specifically identified 'impact areas', which can sometimes be relevant to drug development companies. Examples include advanced digitalisation, sustainable manufacturing or civil and military innovation. There is simply a lot of funding to apply for, but at the same time it is difficult for an individual innovator who is not an expert to navigate when, for example, they need to find project funding for their next stage of development."
External innovation support a key factor
Anna Minidis believes that a key factor for success as a small company, compared to large companies, is finding external innovation support.
"Companies are often started by researchers, for example a group of doctors with specific expertise in their field. To go from idea to finished drug and market a product, they need to attract and assemble a team with the expertise needed for efficient, high-quality development along the entire value chain. For example, medical, pharmacological, chemical, formulation, process development, scale-up, analytical, toxicological, quality and regulatory expertise."
Companies can access lab equipment, method development and prototyping, obtain quality data and compile quality documentation.
The development partner accompanies the company all the way
Acting as a link between the research and industrial phases, RISE often acts as a full development partner for smaller companies throughout the entire development journey. It helps the innovator to find the right funding, expertise and guidance at all key stages of development. It also ensures technical expertise and the ability to take the project from the research environment to applied development and scale-up, with the aim of developing industrially and regulatory sustainable methods.
"Companies can gain access to laboratory equipment, method development and prototyping, quality data and quality documentation. We can also play an advisory role and help innovators with a plan and see what development steps the drug needs, adapted to the stage of development it is at," says Anna Minidis.
Just as important as access to funding is ensuring that you own the rights to your innovation. This is critical to the success of a small business.
"RISE has a patent department that can help develop a strategy for securing the intellectual property rights associated with development work. In addition, RISE has a number of other services designed to support innovative small and medium-sized enterprises in various industries – for example, technology readiness assessment, life cycle analysis and various types of certification," says Leif Lyckebäck.
RISE finds funding and acts as a development partner throughout the development journey
RISE helps small and medium sized companies find funding and provides unique capacity in the form of expertise, laboratories and test and demonstration environments. In this way, companies can reduce their time to market and lower their risk. Ultimately, the aim is to create competitive companies for an international market.
Over the past few years, RISE has met with more than 250 small companies as part of the programme. This has generated more than SEK 250 million in funding for about 80 of the companies, and led to more than 100 major expert initiatives and projects in a test and demonstration environment.
