As previously announced on December 13, Diamyd Medical had held a positive in-person meeting with the FDA. Following the meeting, Diamyd Medical has now received the final minutes. The FDA provided affirmative feedback on several pivotal aspects of Diamyd Medical’s development program, including:

Accelerated Approval Pathway: Confirmation that the ongoing DIAGNODE-3 Phase 3 trial aligns with requirements for an Accelerated Approval, leveraging interim efficacy data based on stimulated C-peptide as the primary endpoint from approximately 170 evaluable participants who will complete their 15-month assessments by early 2026.

Safety Dataset and Confirmatory Evidence: Concurrence on the suitability of both the safety dataset and the confirmatory evidence for a potential accelerated approval. The safety dataset includes data from DIAGNODE-3 at filing, along with data from other intralymphatic trials with Diamyd and the three placebo-controlled trials evaluating subcutaneous injections of Diamyd^® from the original meta-analysis published by Hannelius et al. in Diabetologia (2020). Furthermore, concurrence on that DIAGNODE-3 serves as the pivotal trial to demonstrate substantial evidence of effectiveness, supported by DIAGNODE-2 and the aforementioned placebo-controlled trials as confirmatory evidence.

Co-Primary Endpoints: Agreement on simultaneous evaluation of stimulated C-peptide levels and HbA1c as co-primary endpoints at the 24-month final analysis.

Statistical Analysis Plan: Acceptance of the testing strategy for endpoint evaluation, ensuring robust data integrity for both accelerated and full approvals.

The FDA emphasized that the analysis presented in the Trial Outcome Markers Initiative (TOMI) meta-analysis, published by Taylor et al. in Lancet (2023), provides critical insights into the association between C-peptide preservation and clinical outcomes in type 1 diabetes. The FDA agreed that the justification for the required level of C-peptide preservation to support an accelerated approval, including its relationship to a clinically meaningful reduction in HbA1c, could be further discussed at a pre-BLA meeting and included in the Biologics License Application (BLA).

Additionally, the FDA reaffirmed the Orphan Drug Designation for Diamyd for treating a subset of Type 1 Diabetes patients with residual beta cell function. This designation highlights the therapy’s potential to address significant unmet needs in this well-defined patient population.

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The JCA process will begin in January 2025 with new active substances to treat cancer and advanced therapy medicinal products (ATMPs)[2].

During the Brain and Breakfast panel discussion in Finland, panelists discussed the JCA’s implications for biopharmaceutical companies of all sizes in the country, as well as the perspective of the pharmaceuticals pricing board or health technology assessment (HTA) organization, HILA.

As with previous panel discussions in the Nordics, the discussion was lively and productive, with widespread commitment to collaboration and open, transparent dialogue. Panelists included a representative from a large pharmaceutical company, someone from a smaller biopharmaceutical company and a representative from HILA. Both companies involved in the discussion have products that will be subject to the JCA process implemented in January 2025. The session was moderated by Herbert Altmann, PhD, VP, Market Access & Healthcare Consulting Europe, at PharmaLex.

Preparing for the PICO

One area of particular concern for Finland-based affiliates is how to accurately predict the PICO scoping process and align with the requirements. As the panelists pointed out, with a diverse treatment environment across the EU, one key challenge will be how to coordinate the PICO process. This is made more challenging by the fact that each member state has only two weeks to respond to the scoping survey[3].

Companies will need to be proactive with gathering insights from national experts, including oncologists and patient organizations, one of the panelists said. Another panelist echoed these concerns, adding that a complication for companies is whether they can be sure they have the right information. “A scoping mechanism for Finland is needed, and companies can help HILA with this,” the panelist noted.

Working at a local level

During the discussion, panelists shared how they are preparing for the JCA and the role Finnish affiliates will play in creating the JCA documentation.

The panelist from the larger pharmaceutical company noted that they are preparing and are collaborating with the global, Europe-based headquarters. The JCA will be handled centrally with some local input.

The challenge for smaller companies is that preparation for the JCA is an additional requirement, but there aren’t necessarily more resources to support these activities. Therefore, smaller companies may have a higher risk of not being prepared in time to fulfill the new EU HTAR requirements. With this in mind, having greater collaboration across different Nordic countries would help to reduce the burden, especially for small and mid-size companies, while ensuring the Nordic region is well represented in the process.

For its part, the HILA representative noted that the agency is well prepared but is awaiting the final legislation as well as additional resources to support the JCA processes – a feedback process that is very similar to other HTA bodies across Europe.

One issue that was raised is how to ensure Finland remains competitive within the EU. In our experience, the Nordic countries have generally been regarded as first or at least second-tier countries in an EU launch sequence. A concern raised is that any delay in the national assessment phase could affect the position in a product launch phase, and therefore impact when patients in Finland get access to treatments.

Herbert noted during the discussion that Finland, and the Nordics in general, have key selling points that could be highlighted to keep the region front and center. These include unique opportunities to make use of real-world data and biobanks for real-world evidence purposes, such as through Finland’s Fingenious Service[4]. This includes the flexibility in methodological approaches and the leverage of digital innovation in future methods.

PICO scoping

Companies pointed out that after the JCA report is published it should be clear who will assess the product in national level. At the moment, there are different processes if there is a company-initiated application or if the authority decides to start an evaluation. Companies asked for clarification on this.

Companies are eager to see more alignment to address this diverse environment with the PICO scoping and national assessment phase, though questions still remain as to how this will be handled in future. HILA has said that the authorities will work out the PICO scoping, noting that there is a national working group investigating how to harmonize the evaluation processes and adding that it hopes there will only be one responsible authority in future, which would simplify coordination and generate clarity for pharmaceutical and biotech manufacturers.

A productive discussion

While questions and concerns about the JCA process and what it will mean for companies and affiliates in Finland remain, there were many positive takeaways from the panel discussion. It is clear that companies and the authorities are committed to collaborating in order to address concerns about the JCA in general, and the PICO scoping process in particular, to achieve the best outcome for patients in Finland.

This patient-centric approach will support the European Commission’s objective to bring innovative medicines to patients more rapidly while reducing bureaucracy and optimizing the quality of HTA assessments across Europe.

The post Key takeaways from the EU HTA panel discussion in Finland appeared first on NLS.

We are very likely only at the beginning of a scientific era that will yield a range of new protein-based technologies and strategies that almost certainly will make a major difference to how we target and treat diseases in the future.

This year’s Nobel Prize in Chemistry went to David Baker, University of Washington, Seattle, WA, USA; Howard Hughes Medical Institute, USA, and Demis Hassabis and John Jumper, Google’s DeepMind. The Nobel Prize was awarded for their groundbreaking work on computational protein design and protein structure prediction. This includes the innovative development of numerous algorithms, tools and techniques that have been combined with AI to revolutionize how proteins can be predicted and built to mediate distinct biological functions. This enormous scientific effort has resulted in software tools, such as RoseTTAfold and Alphafold, that have been made available to the entire research community to speed up further development and biological research. Such computational tools are now being used to study all classes of proteins, ranging from small peptides to large and complex proteins, such as enzymes and antibodies. Importantly, they are also used to construct new versions of the proteins with tailored binding and transport properties, and also to design functional proteins that nature has never seen before. As such, we are very likely only at the beginning of a scientific era that will yield a range of new protein-based technologies and strategies that almost certainly will make a major difference to how we target and treat diseases in the future.

Related article

The Nobel Prize in Chemistry: The amazing structures of proteins

The Royal Swedish Academy of Sciences has decided to award the Nobel Prize in Chemistry 2024 to David Baker “for computational protein design” and Demis Hassabis and John M. Jumper “for protein structure prediction”.

However, to be able to have such an impact, these technological and computational advancements and designed proteins must be put into practical use. It is therefore inspiring to see how the Institute for Protein Design, led by the Nobel laureate David Baker, is actively training and empowering its students and researchers to turn their scientific discoveries into commercial assets, and fostering a culture for spin-out company creation.

Earlier this year, co-director Prof Johanna Olweus received a large Cancer Grand Challenges grant funded by Cancer Research UK and NIH together with the global team “MATCHMAKERS”, which also includes Nobel Laureate David Baker.

In Norway, we have several research groups working on protein engineering, both as soluble molecules and in a cellular context. For instance, at the Centre of Excellence, Precision Immunotherapy Alliance (PRIMA), funded by the Research Council of Norway, where seven PIs have joined forces to develop new precision immunotherapy strategies, there is extensive use of computational tools to gain new knowledge that can guide development. Earlier this year, co-director Prof Johanna Olweus received a large Cancer Grand Challenges grant funded by Cancer Research UK and NIH together with the global team “MATCHMAKERS”, which also includes Nobel Laureate David Baker. Another PI of PRIMA, Jan Terje Andersen, is working with one of the spin-out companies for the Baker lab. Recently, PRIMA also recruited two associated group leaders, Professor Geir Kjetil Sandve and Associate Professor Victor Greiff, both of whom have a key focus on developing machine learning approaches, software platforms, and computational and experimental tools.

The combination of the strengths of different tools allows us to tailor-design protein structures for a multitude of purposes in medicine. However, proteins also have a vast area of application outside of drug design and personalized health. Within the broader area of life science, including utilization of bioresources, a deeper understanding of proteins is expected to pave the way for new insights that will ensure optimal properties and new solutions for food and feed. This year’s winners stated that they will be almost as excited as they are this year, once the Nobel Prize goes to someone using the powers of the computational tools they have developed, to create new groundbreaking discoveries.

Who knows what the future of life science inventions will bring us? Our prediction is that you wouldn’t be completely wrong if you guess that part of the solution may be protein, protein, protein. 

The post Protein, protein, protein! appeared first on NLS.

BÜCHI Labortechnik AG with headquarters in Flawil, Switzerland, is a leading provider of laboratory technology solutions for R&D, quality control and production worldwide. Established in 1939, BUCHI serves diverse industries such as pharmaceuticals, chemicals, food & beverage, feed, environmental analysis and academia. BÜCHI Labortechnik GmbH is a fully owned subsidiary of BÜCHI Labortechnik AG.

On behalf of BÜCHI Labortechnik GmbH, Best Talent is now seeking a Senior Account Manager to drive business development in Denmark and Southern Sweden. You can read more about the company at www.buchi.com

The Team

You will join a team responsible for the Nordics and Benelux, supported by both application specialists, service technicians, and marketing professionals across Europe. BÜCHI also offers an application laboratory in Germany, helping clients innovate and develop solutions within their field.

Senior Account Manager Denmark
Are you authentic, self-assured, and passionate about selling products you believe in?

• Further expand the market share in Denmark and Southern Sweden
• Manage clients within Pharma, Biotech, Food and Academia sectors
• Operate independently within a European team while working remote

The Challenge

As Senior Account Manager, you will be accountable for sales revenue and focused on continuous growth through existing and new customers. You represent market leading solutions for laboratory evaporation as well as the complete portfolio of BUCHI. Whether the client operates in R&D or Quality Control, the solutions that BUCHI offer are tailor-made to cover a wide range of distinct needs and achieve highest convenience.

You will be responsible for the development and delivery of a territory business plan for the growth of the BUCHI business in line with company targets and goals. You manage existing business and customers as well as actively seeking out new market potential. You take an active part in the BUCHI team meetings and support the business as required.

Solutions are found and developed together with your clients and in close cooperation with your team colleagues in the sales group covering the Nordics and Benelux supported by application specialists, service technicians, marketing etc. This role demands entrepreneurial initiative and a sales-oriented mindset to independently create and drive your projects.

Responsibilities include a substantial budget, existing sales efforts and future portfolio for BUCHI. Success requires thriving in an independent role while working collaboratively within the team.

They offer a unique work environment characterized by influence, collaboration, and problem-solving. The selected candidate can expect a competitive salary package and will report to the Regional Sales Manager, Benelux & Nordics.

Your Talent

Key words for your personality are self-driven, adaptable to remote work, and highly self-motivating.

You are also positive and proactive, seizing opportunities to develop business. You are commercially driven with a proven track record of winning business. You are enthusiastic about engaging with clients and helping them achieve their goals.

You successfully graduated in a natural scientific field of studies, or you have a natural scientific or laboratory apprenticeship.

Your skills include sales with strong motivation for the sales performance and demonstration. You provide significant bottom-line sales results, and you succeed with professional account management. You may already have a network of potential accounts and relevant contacts in the Pharma, Biotech, Food and Academia field.

You possess a winning personality, and you enjoy acting as a role model. You have insight knowledge of both the public and the private life science segment. You understand the culture and the mechanisms in the business, which is vital for the decision-making processes in the market.

You are flexible and enjoy being in an at times hectic environment, often with diversity and many activities. You have great skills being a strategic negotiator with primary attention to pricing and customer counseling. Proficiency in Danish and English.

The post Senior Account Manager appeared first on NLS.

Christian Grøndahl, co-founder & CEO, SNIPR Biome

Christian Grøndahl, co-founder and CEO, SNIPR Biome

How can your company’s solution help tackle AMR?  

“SNIPR Biome is developing SNIPR001, which is a CRISPR-medicine targeting MDR E. coli. SNIPR001 is developed both as an oral prophylactic treatment to reducing the risk of Blood Stream Infections for Cancer patients undergoing Hematopoietic stem cell transplantations.”

What obstacles are you facing that prevent your solution to gain a greater impact? 

“The biggest obstacle is the perceived broken marked for new antibiotics. SNIPR0001 is however targeting a niche segment in the cancer market – around 10,000 patients annually and is more of a rare disease / orphan drug type of medicine.”

We believe it is only a matter of time before such drugs will be in very high demand.

You are one of the many entrepreneurs committing your time and energy to break through with your products, can you share your WHY? 

“The CRISPR technology and the experimental CRISPR medicines which can be developed from this technology hold the promise to bring real impactful benefits to patients and society. Our strategy and passion is to discover and develop future CRISPR medicines to tackle AMR and threat life-threatening infections which are very safe, well tolerated, affordable to produce, and which are very effective in precision target the pathogen causing the disease without disturbing the physiological diversity of the microbiome. We believe it is only a matter of time before such drugs will be in very high demand.”

Jens Hansson, Acting CFO & BD, Chairman of the Board, Colzyx 

Jens Hansson, Acting CFO and BD, Chairman of the Board, Colzyx, Photo: Eskil Söderlind

How could your company help tackle AMR? 

“Colzyx has established a patented technology around collagen VI and from that developed a wound dressing, Woundcom, for rapid wound healing of hard-to-heal wounds (a.k.a. chronic wounds). These types of wounds, e.g. venous leg ulcers and diabetic foot ulcers, are almost always colonized by bacteria and are typically treated with therapies using long courses of antibiotics. Unfortunately, the antibiotics treatment is poorly effective, leading to healing-times of months and years most often. With the number of chronic wound patients measured in tens of millions globally, this of course poses a major risk of causing AMR to occur.”

With the number of chronic wound patients measured in tens of millions globally, this of course poses a major risk of causing AMR to occur.

“Experiments in vivo (porcine) using our product Woundcom confirms that the combination of collagen I and VI accelerates the wound healing of infected wounds dramatically (up to 4 times faster) without the use of antibiotics. Further, in vitro assays on Colzyx’s technology have showed strong antimicrobial effect on all bacterial strains it has been exposed to, also on multi-resistant ones. The wound dressing is formulated using only elements of collagen I and collagen VI, i.e. naturally occurring substances in the human body that have evolved in e.g. mammals over millions of years. The risk of developing antimicrobial resistance towards our technology is therefore low.”

What obstacles are you facing that prevent your solution to gain a greater impact? 

“Colzyx has just launched its wound dressing for rapid wound healing into the veterinarian wound care market for companion animals in the USA and to be followed by the EU. The feedback from the vet clinics have been overwhelmingly positive – both regarding the clinical effect and the way our wound dressing lessens the need for antibiotics, which is a major issue with veterinarians globally. We will now build up a sales and marketing organization to expand our traction in the animal care market and gain greater impact on the AMR scene.”

We are currently in the process of securing additional funding to facilitate the submission of an application to the FDA as a first step towards market access.

“However, to get market access to human care markets we need to get Woundcom FDA-cleared and CE-marked. We are currently in the process of securing additional funding to facilitate the submission of an application to the FDA as a first step towards market access. We will also be needing commercial partners to bring the wound dressings to the patients.”

You are one of the many entrepreneurs committing your time and energy to break through with your products, can you share your WHY? 

“The early results of Colzyx’s collagen VI based technology hold the promise to bring real impactful benefits to patients through improved quality of life and to society through lowered treatment costs. Our everyday passion is to make sure that Colzyx’s products finally reaches its patients to realize that impact – to humans and animals alike.”

Svante Almqvist, Founder & CEO, Phase2Phase Biopharma

Svante Almqvist, Founder and CEO, Phase2Phase Biopharma, Photo: Martin Botvidsson

What are your thoughts on AMR Awareness Week?

“On a personal level, I recognize the emerging challenges associated with AMR. With my family largely dedicated to medicine, I often hear about its impact both in Sweden and globally.”

“In developed countries, over-prescription especially of broad-spectrum antibiotics often aims to maximize treatment, while in developing regions, frequent prescriptions stem from the higher prevalence of severe infections. This makes me realize that AMR knows no borders. Therefore, I believe WHO’s endorsement of a global action plan is key in raising awareness and addressing this issue.”

What challenges do you see within the development of new antibiotics?

“From a CMC- and regulatory standpoint, I do see several challenges stand out. Navigating classifications – whether a product is a medical device under 510(k) or a pharmaceutical – can significantly affect cost and timelines.”

“Developing new antibiotics involves addressing several critical factors, including spectrum of activity (what pathogens does it target?), mechanism of action (how does it kill or inhibit the pathogens?), resistance risks (likelihood of resistance emerging?), and safety and efficacy (ensuring the drug is both safe and effective through rigorous testing).”

“We all know that this is a long and winding road. Fortunately, there are global collaborations like CARB-X and SPIR that provide non-dilutive funding to AMR-related projects, helping to offset some of these challenges.”

How do you view investing in AMR-focused companies versus other indications like oncology, neuro degenerative or orphan indications?

“As an angel investor, Phase2Phase is indication-agnostic. However, investing in companies addressing AMR is a unique opportunity to tackle a global health crisis with strong return potential, particularly as regulatory frameworks and incentives are being put in place to encourage innovation in this space. While oncology, neurodegenerative, and orphan diseases remain critical, AMR’s projected impact – up to 10 million deaths annually by 2050 – underscores its urgency.”

While oncology, neurodegenerative, and orphan diseases remain critical, AMR’s projected impact – up to 10 million deaths annually by 2050 – underscores its urgency.

“We look for high-potential companies with strong science and innovative approaches. We have either invested in or engaged in detailed discussions with several companies in this field, reflecting our strong interest. Examples include Lipum, targeting chronic inflammation via BSSL, with potential ties to AMR (invested), Omnio, developing protein therapies for infection-related inflammation (invested), QureTech Bio, advancing antibiotic alternatives designed to bypass resistance mechanisms, representing a paradigm shift in how we approach bacterial infections (discussing), and Colzyx, developing wound-healing solutions that address infections, a critical aspect of AMR management in chronic wounds (discussing). These companies align well with our vision of supporting high-impact innovations that address clear clinical and market needs.”

The post #WAAW: 3 x Mini-Interviews appeared first on NLS.

This alliance was initiated by Pfizer, Novo Nordisk and Pharma Denmark, and is now gathering a mix of actors. But all over the Nordics, the innovative power is gearing up to put new products, therapies and preventive measures on the market that all help tackle AMR from various angles. Who are the people behind these innovations and why are they committed to work ungodly hours to fight what has been referred to as a ‘silent pandemic’? In a series of mini-interviews, Helena Strigård highlights different Nordic companies sharing what part of the solution they bring to the table and how their impact can be leveraged globally. Today it is Swedish Colzyx’s turn.

Jens Hansson, Acting CFO and BD, Chairman of the Board, Colzyx, how could your company help tackle AMR?  

Colzyx has established a patented technology around collagen VI and from that developed a wound dressing, Woundcom, for rapid wound healing of hard-to-heal wounds (a.k.a. chronic wounds). These types of wounds, e.g. venous leg ulcers and diabetic foot ulcers, are almost always colonized by bacteria and are typically treated with therapies using long courses of antibiotics. Unfortunately, the antibiotics treatment is poorly effective, leading to healing-times of months and years most often. With the number of chronic wound patients measured in tens of millions globally, this of course poses a major risk of causing AMR to occur.

Experiments in vivo (porcine) using our product Woundcom confirms that the combination of collagen I and VI accelerates the wound healing of infected wounds dramatically (up to 4 times faster) without the use of antibiotics. Further, in vitro assays on Colzyx’s technology have showed strong antimicrobial effect on all bacterial strains it has been exposed to, also on multi-resistant ones. The wound dressing is formulated using only elements of collagen I and collagen VI, i.e. naturally occurring substances in the human body that have evolved in e.g. mammals over millions of years. The risk of developing antimicrobial resistance towards our technology is therefore low.

What obstacles are you facing that prevent your solution to gain a greater impact? 

Colzyx has just launched its wound dressing for rapid wound healing into the veterinarian wound care market for companion animals in the USA and to be followed by the EU. The feedback from the vet clinics have been overwhelmingly positive – both regarding the clinical effect and the way our wound dressing lessens the need for antibiotics, which is a major issue with veterinarians globally. We will now build up a sales and marketing organization to expand our traction in the animal care market and gain greater impact on the AMR scene.

However, to get market access to human care markets we need to get Woundcom FDA-cleared and CE-marked. We are currently in the process of securing additional funding to facilitate the submission of an application to the FDA as a first step towards market access. We will also be needing commercial partners to bring the wound dressings to the patients.

You are one of the many entrepreneurs committing your time and energy to break through with your products, can you share your WHY? 

The early results of Colzyx’s collagen VI based technology hold the promise to bring real impactful benefits to patients through improved quality of life and to society through lowered treatment costs. Our everyday passion is to make sure that Colzyx’s products finally reaches its patients to realize that impact – to humans and animals alike.

The post #WAAW: Mini-interview Colzyx appeared first on NLS.

“Y Science is the official side event of Slush [an annual Helsinki startup event that brings together European startups, world-class investors, and tech journalists]  focused on life science innovation. The event gathers about 1,500 attendees, bringing together the curious scientific community and the business world, and showcases the value of science-based innovation to inspire concrete actions and contributions to society. Y Science is organized by the University of Helsinki in collaboration with Helsinki Innovation Services, Orion Corporation, and Aalto University.” 

What will you showcase and offer attendees at the Y Science 2024 event?

“The event will host several talks, three pitching competitions, and a research2business runway, showcasing innovation projects in the fields of health and pharma, food systems, and sustainable materials. Throughout the event, our attendees will also have a chance to connect with researchers, entrepreneurs, investors, corporates, students, and other life science innovation stakeholders in our dedicated networking area. The event is also free of charge and doesn’t require a Slush ticket.”

When it comes to commercializing life science research in Helsinki, what would you say are the biggest challenges right now?

“Like other Nordic ecosystems, Helsinki has access to only limited local VC [venture capital] funding, despite the excellent research and innovations coming from the academic institutions located in the capital regions. Another limitation is that since Finland is a small country, the primary market for health and pharma innovations is often outside the country, frequently in the US or beyond Europe. This creates challenges in building a strong network of partners, key opinion leaders, and future clients, who are typically located thousands of kilometers away. So it’s essential to establish long distance collaborations and navigate different regulatory environments. In connection to this, only a couple of pharma companies (i.e. Bayer and Orion Corporation) have a strong research-and-development presence in Finland, which means that most public-private collaborations are also established with foreign partners.”

What are the biggest advantages of being a Helsinki-based life science researcher aiming to commercialize their findings?

“According to the EU regional innovation scoreboard, Helsinki is part of the second-best research and innovation ecosystem, indicating a strong innovation mindset and a talent-rich community. The capital region also combines strong academic organizations, a leading university hospital, and a lively startup community. Moreover, the Helsinki ecosystem, albeit small, is well connected both internally and with external partners, making it easy to access. Our strong collaborative culture supports public-private partnerships. We also have several key areas of excellence, including AI, digital health, cancer, and neuroscience, as well as an impressive collection of medical data (e.g. projects like FinnGen). Lastly, innovation support is available through international programs such as SPARK Finland, combined with modern testing facilities offered through Health Proof Helsinki.”

How can SPARK Finland help a life science innovator to start and grow a company?

“SPARK Finland is a two-year development program designed to advance healthtech and life science innovations from academic research towards commercialization by helping create fundable, value-creating solutions. It provides mentoring, education, and resources to students, researchers, and clinicians to enhance their market understanding, which is fundamental for success. Participants receive active mentoring from industry experts and attend key industry events abroad, where they showcase their ideas, test their hypotheses, and receive valuable feedback. During its initial years, SPARK Finland has helped create over 30 startups, and there are currently around 40 active projects in the program.”

The post Y Science: Showcasing the value of science-based innovation appeared first on NLS.

Related article

BIO-Europe 2024: Spotlight on Stockholm

The capital of Sweden possesses not only world-renowned academic research and high profile life science companies, it is also home to many of the country’s most important national life science efforts and leading centers.

BIO-Europe has come to town

Also on stage at the opening session was Claire Macht, Portfolio Director of EBD Group Europe. She gave the audience a summary of the event’s long history and progress. And indeed, just as the life science industry has, the event has also had an accelerated development. From around 95 visitors in 1995, to 5,500 this year!

This becomes very obvious when you enter the exhibition hall at Stockholmsmässan in Älvsjö just outside Stockholm city: Circus BIO-Europe has definitely come to town. More than 30,000 one-to-one meetings was scheduled stated the organizers, and the atmosphere was vibrant and buzzing with life science energy.

In between company presentations and interesting sessions, you could walk (a lot!) around the different exhibitors, sit down for a while at a break and breath-session, throw some balls in a basket, or just enjoy a coffee together with a potential collaborator.

Interview: Scantox

The CRO Scantox, headquartered in Ejby, Denmark, has around 450 employees and offices in Denmark, Sweden, Austria and the UK. Olivia Merinder, Business Development Director, is part of Scantox Sweden. We asked Olivia about her company and about her impressions of BIO-Europe.

What are Scantox’s current business priorities?

“We’re currently building up our client base. Scantox has expanded a lot since 2020, since then we’ve grown from 50 people with a focus on regulatory toxicology in Denmark, and now we’re roughly 450 people. We have acquired six sites around Europe in order to expand our portfolio, to not only provide services like regulatory toxicology but also genetic toxicology, discovery services, bioanalysis and CDMO services.

“We’re here at BIO-Europe to find new clients and to show our expanded portfolio to our existing and new clients, and to show how we can help them with their drug development.”

What’s the market sentiment among your clients?

“Right now, everybody is looking for money. Everybody is very interested in going further in their projects but their main priority right now is finding investors. At least on the Scandinavian market there is a slight lack of funding and I don’t know if that’s because there’s less money or if there’s more competition. Business is a bit slower than it was last year.” 

We do attend other toxicology conferences, but going to BIO-Europe and focus on meeting small and medium sized enterprises helps us build our client base.

How important is BIO-Europe to you?

“BIO-Europe is very important for our business development and showing what we can do in addition to our toxicology services. Even though the name Scantox sounds like it’s just toxicology, we do a lot more than that. We do attend other toxicology conferences, but going to BIO-Europe and focus on meeting small and medium sized enterprises helps us build our client base. And also helps us find new clients that are in a phase where they need our help. We’re also looking at what drug development companies are doing and what the market is heading towards, and trying – from our companies perspective – to develop our business in that direction.” 

What are your impressions from BIO-Europe?

“I’m having a good time. I’ve met a lot of people I’ve already know, and there are a lot of Swedish people here, and I’ve had a lot of very good meetings. I’ve had plenty of partnering meeting and all of them have been very good and very helpful.” 

Lesson learned from a serial entrepreneur

The Bio-Europe 2024 program took the visitors on a journey of the past 30 years of partnerships, deals and innovation and envisioned the next 30 years to come. The first session was followed by an interview on stage with our Swedish life science serial entrepreneur, Mathias Uhlén, professor at KTH and KI, founder of the Human Protein Atlas (highlighted in our latest issue), and involved in 30 (!) startups.

He provided for example statistics of significant value created in Swedish life sciences since 2010: Total value created has been USD 70 billion – 84% coming from the Stockholm-Uppsala region.

Uhlén also shared his experience from founding life science companies. Lessons learned included “there is no magical formula” (each journey is unique), “no venture funding without a clear milestone-driven plan”, “aim to be number one in a niche” (avoid being second best), and “it is important to be strategic AND opportunistic”.

On the agenda: Sustainability

After the interview with Mathias Uhlén, there was a session highlighting the importance of sustainability in the pharma industry. Panelists were Magnus Björsne, CEO, AstraZeneca BioVentureHub, Malin Parkler, CEO, Pfizer Sweden, and Lauri Lehtovuori, CEO, Combient Foundry. The three of them discussed what is being done within the pharma industry to become more energy efficient and climate smart, for example by reducing their carbon footprint.

Take home-messages were that the industry cannot only improve themselves (all of us, the entire society, must), the industry could take more responsibility when collaborating with external partners, for example logistics partners, to not only buy but collaborate and do this work together, and last but not least, innovate and together with green tech/tech companies come up with better solutions for the entire pharma supply chain.

Interview: Faron Pharmaceuticals

Faron Pharmaceuticals is a clinical-stage biopharmaceutical company based in Finland and the United States, with a focus on developing bexmarilimab, a first-in-class, humanized antibody that binds the Clever-1 target on myeloid cells and macrophages. The company has 27 employees. Faron was a part of the Finnish pavilion at BIO-Europe 2024, organized by Business Finland, and we asked Yrjö Wichmann, Chief Financial Officer at Faron Pharmaceuticals, about his impressions of the event.

Why are you attending BIO-Europe?

“We are here with a dual task, one is business development because we’re at a stage where we’re considering licensing our drug to big pharma, so that’s the main focus. But we’re also here to meet investors. This is a better conference for business development than for investments though, there aren’t many investors present – especially for us as we’re a listed company. We’re a bit too mature for venture capital investors.” 

Is it important for you/your company to attend BIO-Europe?

“Yes and it’s good that we have several people from the company here, because we have a lot of meetings that are conflicting. Faron has been attending BIO-Europe for a number of years.” 

Have you observed any current Nordic life science trends?

“There is an increased interest into the Nordic market as such, from outside the Nordics. There is also great science in all of the Nordic countries. However, we’re at different stages, in Finland we don’t have an industry in the same manner as in Sweden and Denmark, but it’s growing and we’re seeing a lot of interesting companies coming out of Finland. So, the whole market in the Nordics is quite interesting from an investor perspective. The problem in Europe is that we still live in silos, so we have a French silo, an Italian silo, a Benelux silo, a UK silo, we have a Nordic silo, and these don’t interact with each other. In the US it’s better because it’s one big market. It’s more easy to find investors and projects on a larger market, rather than in these smaller national silos.”

We’re a part of the life science ecosystem in Finland and it is important that it grows and that it is visible, so it is definitely important to be here.

You’re part of the Finnish pavilion, does that help in making international connections?

“It’s good to have a base/a booth where you can agree to meet people. At the same time, the meeting arrangement feature in the conference app is very effective so you don’t necessarily need a booth either. It’s good to be a part of this. We’re a part of the life science ecosystem in Finland and it is important that it grows and that it is visible, so it’s definitely important.” 

What are your impressions from the conference?

“Relatively good. A tighter programme would have been better, but that’s also my fault, we’re too small as a company to attract a lot of meeting invites. We also didn’t approve all of the meeting requests we got, because there’s a huge amount of service providers and we’re not currently in the process of hiring service providers. These conferences tend to become more and more service provider heavy, which is a natural development but not the best for us.”

Women in Life Sciences

During lunchtime, there was a very interesting discussion at the exhibition hall stage on the topic raising the ceiling for women. Christina Lloyd, Chairwomen, VILDA Sverige, Chelsea Ranger, founder and chair, WiLD Norway, Lene Gerlach, founder and chair, WiLD Denmark, and Markus Dietrich, Senior Investment Associate, Hadean Ventures, discussed how more women can be both attracted to and included in leadership roles, and also how they felt about having mandates.

Related article

Momentum Building for Women in Life Science Across the Nordics

With the formation of WiLD Norway, Norway becomes the third of the five Nordic countries to launch an organization dedicated to empowering women in life science. Following the footsteps of Women in Life Science Denmark (WILD) and VILDA in Sweden, something big is brewing across the region, drawing global attention from the life science industry. But why here, and why now? To find out, Nordic Life Science Magazine headed to Oslo to speak with the team behind WiLD Norway.

Money, money, money

Another interesting, and well-attended, session focused on the very hot topic of financing. Lars Gredsted, Lundbeckfonden, Laura Lane, Lilly Ventures, Karl Naegler, Sofinnova Partners, Mårten Steen, HealthCap and Nick Williams, Medicxi, discussed challenges, opportunities and differences between the US and Europe.

They summarized the session by sharing a piece of advice to companies looking to find an investor. In short, take home messages were embrace the feedback you are receiving and make changes accordingly and network-network-network – do not be afraid to ask for advice, and perhaps you will find your next business parter or investor at BIO-Europe next.

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How to pitch to life science VCs

Nordic life science companies are generally of good quality, but can often be better at pitching compared to US-based companies and entrepreneurs. Effective pitching is a skill, and is centered on good storytelling to get an investor’s full attention and buy-in. Since I work for the life science VC, HealthCap, I thought I would share […]

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“It looks to me like this year has not been as successful as earlier years,” he says. “In general there is a lack of early-phase venture capital, which leads to the formation of fewer start-ups than we’d like to see.” 

In general there is a lack of early-phase venture capital, which leads to the formation of fewer start-ups than we’d like to see.

Early-phase funding and seed rounds generally tend to be too small, and the funding sector is not well developed enough, neither in Finland nor in Europe, according to Piispanen. On the bright side though, crowd-funding has been a positive addition to venture capital in Finland, and new angel investors are starting to emerge. 

“I am always complaining about the funding but luckily the situation in Finland is starting to improve,” Piispanen says, and continues: “The Finnish government has decided to establish a national drug discovery center, called Finnish Drug Discovery Center (FDDC) to function as a venture-capital actor and help bring innovations further towards company formation.”

It’s been a bit chaotic, but things are starting to look up now.

On the other side of the Baltic Sea, in Sweden, Business Region Göteborg’s life science investment advisor, Iris Öhrn, muses over recent challenges for Swedish companies.  

“The financial situation in Sweden has been tough, since there are so many listed companies here. When the financial markets started to turn, a lot of the investors pulled out their money as stock markets went down, which put many companies in a precarious situation,” she says. “It’s been a bit chaotic, but things are starting to look up now.”

Nordic Life Science asked Tero Piispanen and Iris Öhrn to share their top advice and things to avoid, for companies trying to attract investment and secure their path to market. 

1. Tailor your investment strategy and your pitch

“It’s crucial to create an investment strategy that’s tailored to the type of investor you’re trying to attract. Big pharma companies, angel investors, and venture capitalists all have their own priorities, and you need to address them accordingly,” says Öhrn.

When it’s time to pitch to an investor, you have to adjust the pitch to the person you’re talking to.

“When it’s time to pitch to an investor, you have to adjust the pitch to the person you’re talking to. Take the time to find out what position they have in the company and identify what it is they want to achieve. For instance, depending on whether they are the gatekeeper, the evaluator or the decision maker you will need to raise different aspects of your business,” she adds. “Companies need to get a better understanding of investors as a stakeholder group. If you don’t manage to do that, you won’t nail the pitch with a compelling reason for them to invest in your company or innovation.”

2. Ask investors for advice, not just money

“Normally, venture capitalists want to be helpful. You can absolutely go to them for advice – don’t just meet them to be seen and make connections, but actually ask for their advice. This is a great way to go out and try to meet with potential investors and future clients,” advises Piispanen.

Normally, venture capitalists want to be helpful. You can absolutely go to them for advice – don’t just meet them to be seen and make connections, but actually ask for their advice.

“I’ve met investors who tell me that they meet many companies asking for funding, and sometimes the answer is no, but the companies don’t take the opportunity to ask  the investors they interact with any questions. The companies can ask for advice or for feedback on their pitch. They only ask for funding, but not for help, which is a lost opportunity as the investors are best-placed to know what a successful pitch looks like,” says Öhrn.

3. Focus on commercial potential and competition

“There is not enough focus on how they intend to be commercially successful. But the investors want to make money, so you need to be able to tell them how you’re going to position yourself on the market,” says Öhrn. “You have to start your market analysis early in the process of company creation. It’s not just a matter of counting how many patients your product can help, but about what the market looks like, how many other products already meet this patient group’s needs, what type of products are out there, and what’s trending.

You have to start your market analysis early in the process of company creation.

“Another thing to be aware of are other emerging products. The life science industry moves fast, so it’s crucial to keep an eye on what the competitors are doing. Sometimes, another company is developing a product that addresses the same needs as you, and if they reach the market first you may find that the market is saturated already by the time your product is ready,” adds Öhrn.

4. Start marketing and networking early

“I’ve noticed that many early-phase companies don’t start their marketing early enough. They don’t realize that they have to start raising awareness early on, and so they don’t start going to partnering events at the beginning of their company’s journey. But dealmaking isn’t done over a couple of months, these processes take a long time. Young companies should get out there and participate in pitch competitions and find other ways to engage with investors and potential clients,” says Piispanen. 

When the time comes to put money on the table, many investors opt to go by connections.

“You have to meet and get to know the investors. Go to events and networking mingles and conferences. Don’t just do it when you need to raise capital, do it to build long-term relationships. When the time comes to put money on the table, many investors opt to go by connections – it’s a matter of who you know and trust. So go out and meet people whenever you can!” emphasizes Öhrn.

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“The laureates’ work has already been of the greatest benefit. In physics we use artificial neural networks in a vast range of areas, such as developing new materials with specific properties,” states Ellen Moons, Chair of the Nobel Committee for Physics at the time of the announcement.

Protein structure prediction

Today’s artificial neural networks are often enormous and constructed from many layers. These are called deep neural networks and the way they are trained is called deep learning. Many researchers are now developing machine learning’s areas of application. Which will be the most viable remains to be seen, while there is also wide-ranging discussion on the ethical issues that surround the development and use of this technology, writes the Royal Swedish Academy of Sciences.

In recent years, this technology has also begun to be used when calculating and predicting the properties of molecules and materials – such as calculating protein molecules’ structure, which determines their function.

Applications include reducing noise in measurements of the gravitational waves from colliding black holes, or the search for exoplanets. In recent years, this technology has also begun to be used when calculating and predicting the properties of molecules and materials – such as calculating protein molecules’ structure, which determines their function, or working out which new versions of a material may have the best properties for use in more efficient solar cells.

The two Laureates

John Hopfield invented a network that uses a method for saving and recreating patterns. We can imagine the nodes as pixels. The Hopfield network utilises physics that describes a material’s characteristics due to its atomic spin – a property that makes each atom a tiny magnet. The network as a whole is described in a manner equivalent to the energy in the spin system found in physics, and is trained by finding values for the connections between the nodes so that the saved images have low energy. When the Hopfield network is fed a distorted or incomplete image, it methodically works through the nodes and updates their values so the network’s energy falls. The network thus works stepwise to find the saved image that is most like the imperfect one it was fed with.

Geoffrey Hinton used the Hopfield network as the foundation for a new network that uses a different method: the Boltzmann machine. This can learn to recognise characteristic elements in a given type of data. Hinton used tools from statistical physics, the science of systems built from many similar components. The machine is trained by feeding it examples that are very likely to arise when the machine is run. The Boltzmann machine can be used to classify images or create new examples of the type of pattern on which it was trained. Hinton has built upon this work, helping initiate the current explosive development of machine learning.

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