”I have learnt to think in commercial and practical terms.”
– I don’t have any specific role models, there are so many innovative and knowledgeable researchers all over the world. I’m inspired by people daring to take the chance and invest in their ideas. So says Ulrika Norin, one of the young researchers who has received support from KI Innovations during the development of her business idea.
Ulrika Norin is part of the Medical Inflammation Research team at Karolinska Institutet and is primarily working with animal models for autoimmune diseases like rheumatoid arthritis.
– By breeding resistant and susceptible rat- and mouse lines we have identified several naturally occurring variants, polymorphisms, in genes that regulate the development of autoimmunity says Ulrika.
Her project has identified a gene that has never before been described in the context of autoimmunity. The gene was identified by a natural mutation that knocks out the gene expression in rats. The corresponding protein primarily regulates the activation of T cells in the immune system. Without this protein, neither mice or rats develop autoimmune diseases like arthritis. These finding forms open up new opportunities for the development of novel treatments for these types of diseases.
– The lack of protein implied protection thus we are now exploring the possibility to block the function of the protein with inhibitors that potentially could be used for treatment of people suffering from autoimmune diseases, explains Ulrika.
Ulrika has recently defended her PhD thesis after five years of research within the group of professor Rikard Holmdahl. To her, the collaboration with Rikard has meant a lot. He is a well merited researcher who, in addition, has experience from starting companies. He is a good speaking partner, providing advice on what to think about and which roads can be travelled.
Thanks to her collaboration with KI Innovations, Ulrika now sees good possibilities to pursue her project from a commercial point of view.
– I contacted KI Innovations at an early stage in order to get advice. In collaboration with KI Innovations I have assessed whether the function of the gene had already been described and if there were any obvious hurdles for pursuing the project in a commercial direction.
Ulrika also emphasizes that KI Innovations has been of large help in the process of identifying new collaborators and getting the key agreements in place. Collaboration discussions are currently ongoing with pharma and biotech companies that have shown enormous interest in developing new treatments within Ulrika’s research area.
– With the help of KI Innovations I have been trained to think in commercial and practical terms and I have been given the opportunity to expose my project to the pharma industry, concludes Ulrika.
”KI Innovations helped us navigate”
According to Lars Hammarström and Patrik Ernfors: “Getting in touch with KI Innovations when we faced commercialization was a critical success factor. Transforming an academic discovery into a market-ready product is a colossal challenge. And you really need someone to tell you what must be done – and the order in which it should be done.”
Hammarström and fellow researcher Ernfors developed a potential drug candidate for a new brain tumor treatment. They built Glionova Therapeutics, a biotechnology company that evolved from successful Karolinska Institutet research and KI Innovations business expertise and support.
“Early on, we had no thoughts about commercial drug development,” says Hammarström. “That’s the alluring part of free research – you never know where it will lead. Then we came to a point at which it was impossible to ignore our findings, and we realized that we must ensure that our discovery benefits patients.
Hammarström had pharmaceutical industry experience and knew about drug development –including patent issues:
“It’s complicated. A strong patent application demands extremely labor- and resource-intensive documentation – and that’s just the tip of the iceberg. Researchers need support throughout this journey.”
Hammarström most appreciated KI Innovations support with structuring research results in a way that can attract potential financiers. Its network of available qualified experts really impressed him.
“It’s very valuable to get help translating academic discoveries into clinically relevant business strategies, and to analyze market potential. In concrete terms, it’s about what the money can be used for and how fast various stages must be reached. You can have millions in basic research grants, but it’s not money that may be used for patenting,” says Hammarström.
Now Glionova Therapeutics is completely on its own and will soon apply to Sweden’s Medical Products Agency (Läkemedelsverket) for a first clinical trial of the GLN-1001 agent. In animal models, the small molecule demonstrated a promising effect on glioblastoma survival – the most common and aggressive brain tumor. The molecule targets identified tumor cells weaknesses, and the method is an example of a completely new principle for cancer treatment.
”Good ideas aren’t enough”
“Just having a good idea isn’t enough by a long shot; many criteria must be met if we are to succeed,” says Pedro Réu, a doctoral student in cell and molecular biology (at Karolinska Institutet), whose innovation will help solve life’s puzzle in the laboratory.
All who work with cell cultures know that they require orderliness; their daily care alone is very time consuming.
“Cell cultures are somewhat like toddlers. But instead of changing diapers, you replace petri dishes,” says Réu. “And unlike diaper waste, you cannot, for example, dispose of agents or contaminants. Processing takes time. Valuable time that could be used for considerably more productive activities.”
Of course an industrial robot could be programmed to replace petri dishes a few times a week, but this solution would be too expensive and space consuming. And that’s where Réu and his innovation enter the picture: he constructed fully automatic equipment that can manage cell cultures in a way that saves time and reduces waste volumes – at a fraction of the cost for a robot.
“And it’s not any bigger than my palms,” says Réu.
To not jeopardize the patent that he applied for, he didn’t talk too much about this innovation – especially about how it managed potentially hazardous waste.
“There’s a lot to consider when trying to commercialize your idea. For example, you must be careful about the amount of information that you disclose during the journey.”
Of course it’s tempting for academic researchers to share their findings by publishing articles in scientific journals. But publication can often mean that patent opportunities will disappear.
“I approached KI Innovations two years ago. Since then, the staff helped me with everything: verification funding from Vinnova, patent protection, legal advice, prototype development, market analysis, and contacts with potential investors.”
He emphasizes that the road to commercialization is anything but straightforward, and consequently, it would be wise to get help with issues that are unfamiliar.
“You must be realistic and realize that a good idea is certainly a prerequisite for success, but it’s not the end-all. Most start-ups don’t survive – most likely because they underestimated the importance of commissioning help from experts who know all about shortcuts and pitfalls.
I have constant contacts with the coaches; at the same time, I need access to the collective expertise within KI Innovations staff – plus its consultant networks. Had it just been me and my idea, I don’t think I’d have come even halfway.”
”Near miss for key patent”
“We were just about to publish our findings when it dawned on me: this might have implications for patients. I called KI Innovations immediately. That was in June 2014; after just three months, we had provisional patent protection in place.”
Now, Sandra Ceccatelli and her collaborator Stefan Spulber are about to commercialize the fruits of lengthy laboratory labor, namely, a product that (i) enables depression-risk assessment and (ii) provides key information regarding appropriate treatment.
Sandra Ceccatelli is a neurotoxicology professor and head of the Neuroscience department at Karolinska Institutet. The research group she leads identifies connections between injuries that occur in utero and emergence of irreversible changes and behavioral disorders later in life. The article that she was close to submitting for publication in 2014 is about just that. In animal models, researchers could see that exposure to high glucocorticoids levels might be linked to impaired neurogenesis in the hippocampus and depression-like behavior later in life. Ceccatelli and her team observed that distinct manifestations preceded the onset of depression and that with relatively simple means, the manifestations could be assessed.
If all goes as planned, such a test will indicate (i) risk of developing depression and (ii) whether or not selective serotonin reuptake inhibitors (SSRIs) can help certain patients when they are first diagnosed with major depressive disorder. So test results might be potentially valuable for future depression care.
Ceccatelli said that she had help with several key business development phases and patent application phases, and the latter were quite efficient.
“The support and contact network that I can access via KI Innovations are extremely valuable. I may be a senior researcher, but when it comes to entrepreneurship and commercialization, I’m grateful that there are experts I can turn to.”
Ceccatelli wants to dispel a myth that still exists within academia.
“There’s a preconceived notion that scientists, who want to continue into an innovation process, might jeopardize their academic careers. There’s no support for such assumptions. On the contrary, I think it’s very important that researchers learn to identify what can be developed so that patients will benefit.”
In her case, perhaps her academic career might have taken a back seat to the extent that her scientific article publication was a tad delayed due to focus on commercialization. But when the patent application was submitted, she got back on track and during autumn 2015 – a year after she pulled the emergency brake – the article was published in Translational Psychiatry.
“Instead, business development enriched our research, and we are now focusing on two parallel tracks.”