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."

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.

The production, distribution and use of medical devices and medicines have a large climate and environmental footprint. The life science industry needs to do something about it.

“The keys to a green transition lie in many areas: from switching to green carbon sources and reducing material flows, to preventing toxic substances from reaching the ecosystem and making transport more efficient,” says Christina Jönsson, Vice president Marketing, division Materials and production at RISE.

As the life science industry is multifaceted, it is difficult to account for the industry's total climate impact. However, calculations show that the healthcare sector is estimated to account for 4-5 per cent of global carbon dioxide emissions. The majority, 70 per cent, comes from the supply chain, and mainly from transport. And the sector faces particular challenges. The industry is highly regulated, making circular change more difficult to implement than in many other industries.

“Just think of all the disposable items used in healthcare. They have to be of high quality, sterile and non-recyclable due to the risk of infection,” says Björn Gregertsen, Vice President, Life Science, Chemical Processes and Pharmaceutical Development at RISE.

Essential to reduce carbon footprint

Packaging that is in direct contact with medicines and sensitive medical devices - such as sampling devices - is also exempt from the EU's Packaging and Packaging Waste Regulation (PPWR) requirements on recyclability and recycled content until 1 January 2035.

"However, the EU is working intensively on sustainability issues and several other bodies regulating the life sciences industry are also reviewing their regulations. The industry itself is also driving the transition," says Christina Jönsson.

She believes that one way forward is to work much more with differentiation and gives an example:

”The tubes in IVs or catheters that go into the body should probably not be made from recycled products or be recycled. But the disposable plastic gloves that staff use might be.”

Many factors to consider for a sustainable transition

Finding the balance between stable production, economic viability and proven benefits for biodiversity and climate is a challenge.

“Us researchers can help improve understanding of what can change and contribute with relevant assessment methods and tools. This will ensure that efforts are targeted where they are needed and most effective," says Björn Gregertsen.

Reducing the carbon footprint in the pharmaceutical industry necessitates addressing various issues across the entire value chain. 

“By embracing green chemistry principles, companies can minimize harmful emissions and waste,” says Björn Gregertsen. “Additionally, adopting energy-efficient production methods and reducing reliance on fossil fuels for transportation can significantly lower overall carbon emissions. Also, addressing areas like pharmaceutical packaging will make a difference. These combined efforts pave the way for a more sustainable future in the pharmaceutical sector.”

RISE's experts can support companies that want to reduce their impact on people, the environment and the climate through this type of 'green innovation'.

“We're offering advice and circular business models in areas such as material conversion, green chemistry, pharmaceutical development and product life cycle analysis," says Björn Gregertsen.

Sustainable life sciences are the future

It can be wise to get on board with the transition right from the start. Although many of today's regulations have had exemptions for the life sciences industry and healthcare, this is likely to change.

“The issue is on the table but nothing has been decided yet on where, how and when it will be more clearly set out in legislation. But the fact that the discussion is now taking place is a signal for companies to be aware of. The life science companies that work with ecological sustainability in harmony with patient safety will gain market advantages,” says Christina Jönsson. 

Antibiotic resistance is rising to dangerously high levels in all parts of the world. New resistance mechanisms are emerging and spreading globally, threatening our ability to treat common infectious diseases. A growing list of infections – such as pneumonia, tuberculosis, blood poisoning, gonorrhea, and foodborne diseases – are becoming harder, and sometimes impossible, to treat as antibiotics become less effective.

The EBL-1003 substance could, in the future, potentially be used to treat critically ill patients in hospital settings. EBL-1003 is a crystalline free base of an aminoglycoside designed to treat Gram-negative bacterial infections. EBL-1003 for infusion has demonstrated potent broad-spectrum activity and rapid bactericidal killing of Acinetobacter baumannii and other Gram-negative bacteria, including organisms identified by the World Health Organization (WHO) and the Centers for Disease Control and Prevention as urgent and serious threats to human health.

"EBL-1003 has the potential to replace aminoglycosides currently used in the clinic, but whose utility is seriously threatened by rising antibiotic resistance", says Sven Hobbie, CEO at Juvabis. "We were able to make significant progress in the development of a new treatment thanks to our collaboration with RISE".

Test are showing positive results

The molecule that the injectable substance is based on is already in use in veterinary treatment, primarily outside of Europe and the United States. During phase 1, Juvabis collaborated with RISE to further develop the drug, which was subsequently tested on healthy volunteers with positive results.

"During this initial phase, we bought the original substance from the manufacturer and analyzed and refined it in our laboratory in Södertälje", says Bo Lassen, RISE's project manager who is also in charge of the formulation aspect of the project. "We've designed analytical methods and formulations, improved the solid state of the molecule to make it more stable for storage, and evaluated its toxicity and tolerability among other things".

EBL-1003 underwent phase 1 clinical trials as part of the European Gram-Negative Anti-Bacterial Engine (ENABLE), a project sponsored by the Innovative Medicines Initiative that completed in 2021, with another clinical trial sponsored by the National Institutes of Health currently in preparation.

More thorough research is now being conducted to advance the substance's development into a treatment that can be used in healthcare. Even though ENABLE ceased last year, Juvabis’s partnership with RISE continues, and a new funding application has been submitted to also develop the compound for inhalation.