Invest Archives - Basel Area Business & Innovation About Basel Area Business & Innovation Tue, 21 Jan 2025 16:08:03 +0000 en-US hourly 1 https://wordpress.org/?v=6.7.1 https://baselarea.swiss//wp-content/uploads/2019/10/cropped-basel-area-favicon-01-32x32.png Invest Archives - Basel Area Business & Innovation 32 32 The Basel Area life sciences ecosystem: opportunities and strengths in a global landscape https://baselarea.swiss/blog-post/the-basel-area-life-sciences-ecosystem-opportunities-and-strengths-in-a-global-landscape/ Tue, 21 Jan 2025 13:36:55 +0000 https://baselarea.swiss/?post_type=blog_post&p=157033 The post The Basel Area life sciences ecosystem: opportunities and strengths in a global landscape appeared first on Basel Area Business & Innovation.

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The Basel Area life sciences ecosystem: opportunities and strengths in a global landscape

The Basel Area continues to solidify its reputation as a leading global hub for life sciences innovation.   

A newly released report developed by EY-Parthenon provides an in-depth look at the region’s unique strengths as a highly favorable environment for innovation, as well as identifying gaps and future improvement strategies for the region.  

This data-driven study validates the Basel Area’s remarkable efficiency and productivity relative to its size, excelling in stakeholder density, infrastructure and strategic investment. It also demonstrates that the region excels in clinical trial activity and per capita output in patents and pipeline assets. 

In addition, the region boasts the largest life sciences talent pool in Europe, with more than 33,000 professionals contributing across the entire ecosystem. This concentration of expertise enables companies to scale rapidly and efficiently. From R&D to commercialization, the region’s unparalleled density, quality and diversity of talent make it a standout destination on the continent. 

Basel Area Life Sciences Ecosystem study

by EY-Parthenon

Why ecosystems matter in life sciences

Deciding where to locate a new commercial or R&D hub is a pivotal decision for life sciences companies. The success of such endeavors often hinges on the quality of the ecosystem in which they are embedded.  A flourishing life sciences ecosystem fosters collaboration, accelerates innovation, and provides the resources that companies need to thrive.

Ecosystem Elements - Source: EY-Parthenon analysis

The study from EY-Parthenon highlights the Basel Area as an innovative ecosystem capable of competing globally with renowned hubs like Boston and London. The report identifies the core strengths and weaknesses of the three ecosystems, drawing on quantitative data and qualitative insights from interviews with key stakeholders.

There are more than 700 biopharmaceutical companies in the region, from small companies to giants like Novartis and Roche. It’s an important center if you want to include Europe in your vision of a global company.

John V. OylerCo-founder, CEO and Chairman, BeiGene

4 key strengths revealed by the study:

#1 – High density and diversity of stakeholders

The Basel Area excels with a concentrated presence of life sciences companies, including major players like Roche, Novartis, and Syngenta, alongside startups, research institutes and investors. This ecosystem fosters collaboration among its players, resulting in exceptional research output, a high density of clinical trials, and numerous partnerships. This all reflects the region’s strong commitment to knowledge exchange and innovation.

 

#2 – Unmatched biopharma focus

The Basel Area is a renowned global biopharma hotspot, with a high density of biopharma companies, a significant share of employment in biopharma, and over 98% of the deals being made and funding being attracted concentrated in this sector. This specialization is supported by tailored investments, robust research and supporting infrastructure that attracts top talent, investors and industry leaders, solidifying the region’s position as a leading hub for drug discovery and commercialization.

 

#3 – Strategic investments and funding

The Basel Area ecosystem benefits from substantial venture capital and late-stage funding, with funding levels per round comparable to those seen in Boston and London, making the ecosystem a highly attractive location for companies expanding to Europe. The study highlights the benefits of investment diversification into other life science sectors – such as digital health and medtech – to enhance resilience, encourage cross-sector innovation, and attract a broader range of stakeholders. 

Moreover, the study calls for an increase in early-stage funding through grants, seed capital and early-series venture capital initiatives, in terms of both volume and value, to remain competitive with global hubs such as Boston and London and foster a more dynamic and inclusive ecosystem that drives sustained innovation and growth.

 

#4 – Advanced infrastructure and laboratory space

Offering laboratory space comparable to Boston on a per capita basis, the Basel Area provides a robust environment for scaling and innovation. Science and technology parks – such as the Switzerland Innovation Park Basel Area foster collaboration among stakeholders, ensuring operational efficiency and connectivity within a highly equipped ecosystem. 

The entire culture is undergoing a shift here towards Entrepreneurship, and the Basel Area is right now the hub for that entire convergence: cultural, scientific and beyond.

Greg VerdineCo-founder and CEO, LifeMine

The ecosystem study from EY-Parthenon confirms the Basel Area as a unique and innovative life science hub boosted by a unique combination of infrastructure, international talent, and proximity to European markets.  

For comparison, Boston in the United States is renowned for its academic institutions and venture capital funding, while London offers access to financial services. The Basel Area distinguishes itself with its unparalleled density of life sciences companies and unmatched R&D capabilities. Its strong biopharma focus, economic productivity and collaborative culture drive innovation despite its smaller size compared to Boston and London. By leveraging its strengths, the Basel Area will further enhance its global competitiveness and solidify its position alongside leading life sciences hubs. 

Get the ecosystem study

by EY-Parthenon
Valentina Francia

Contact us

Valentina Francia

Manager Ecosystems

The Basel Area offers an incredible ecosystem for life sciences companies. It combines top-tier talent, cutting-edge infrastructure, and easy access to European markets.
Our team is here to guide you every step of the way. Reach out to me directly for personalized support.
Email Valentina

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Building the future of healthtech, digital health and techbio in the Basel Area https://baselarea.swiss/blog-post/building-the-future-of-healthtech-digital-health-and-techbio-in-the-basel-area/ Fri, 18 Oct 2024 06:40:52 +0000 https://baselarea.swiss/?post_type=blog_post&p=156512 Meet our Chief Representative USA: with over 30 years in the biotech industry, Kirsten Detrick brings invaluable expertise for companies eyeing European expansion.

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| Interview

Building the future of healthtech, digital health and techbio in the Basel Area

18.10.2024

Meet Shwen, our new US representative with a 20-year career in pharma and an impressive track record in leading teams and driving innovation in the digital health space. He will be attending key events throughout the US and is available elsewhere for anyone who would like to learn more about why the why Switzerland — and the Basel Area in particular — is the go-to place for startups that are thinking about expanding into Europe.

Shwen, you have an impressive resume in digital health and corporate innovation. What is it about these areas that you love? 

Before I started my pharma career, I trained as a neuroscientist so perhaps that’s why I’ve always loved solving problems, testing hypotheses and exploring novel solutions. Even as a child, I was always curious about the crossover of science, medicine and emerging technologies — ever since I got my first Apple II computer in the late 80s and taught myself how to program in BASIC. 

Fast-forward through my 20-year pharma career and I found myself spending most of it leading digital strategy and innovation across different functions like commercial, communications, clinical and enterprise-wide.

 

Can you talk a bit about your work in supporting healthtech startups? 

In most of my biopharma roles, I first worked with internal teams to understand and define the business challenge; then I tried to figure out how to strategically solve them through novel technologies, partnerships, etc. This is why I ended up working with startups, tech companies and the broader digital ecosystem. 

Even though I have worked with startups for most of my career, my focus in the last five years at big pharma companies was to lead enterprise-wise innovation (i.e. across R&D, Clinical, Commercial, Manufacturing, etc.). Hence, I was responsible for sourcing and evaluating novel startups, establishing partnerships with the external digital ecosystem and helping to ensure the success of those partnerships. 

Over the last two or more years, as an independent consultant, I have also taken on more responsibilities as an investor, advisor and mentor to startups globally, including my role as an Mentor-Advisor to PharmStars — a pharma-focused digital health accelerator — and as an Executive-in-Residence at Springboard Enterprises, a nonprofit organization that helps women-led startup leaders grow by providing access to resources, investors and advisors.

 

You are the founder of GenAI4Pharma. Can you give us an overview of what this is and what it aims to achieve?

#GenAI4Pharma is a series of global events that showcase the application of generative AI and LLM-based technologies for the biopharma industry, across the lifecycle, including R&D, Clinical, Commercial and Medical. 

Each event typically starts with several keynotes delivered by experienced leaders in the field, followed by a series of pitches from startups that are developing GenAI-based solutions for the biopharma industry. 

To date, we have run four events in Boston, Basel, London and NYC, and our audience tends to be a mix of biopharma executives, investors, startups, tech companies and consultants/service providers.

We have featured well-respected pioneers in the field, like Alex Zhavoronkov, CEO of Insilico Medicine, Mike Nally, CEO at Generate Biomedicines or Jared Saul, CMO at AWS, and showcased over 20 startups who pitched their pharma-focused GenAI solutions.

 

What attracted you to becoming a representative of Business Location Switzerland and the Basel Area?

I was familiar with the DayOne accelerator through my work with startups and was a member of the selection committee as well as a startup mentor in 2023. I spoke at the recent Boom Summit in 2024, so when I was offered the role with Basel Area, I was excited at the opportunity to help spread the word about the region to my network and beyond. 

 

Your home patch the Boston area in the US is a world-class hub for life science. How do you think the Basel Area compares as a place to set up a startup in healthtech?

I was so impressed that the two regions are so similar! I visited Basel several times during my two-year tenure at Novartis and it reminded me a lot of the Boston ecosystem, with its pharma presence, great schools and vibrant startup community. In fact, I only recently found out that the Canton of Basel-Stadt and the state of Massachusetts have been sister-states since 2002. In addition, the Basel Area has a great talent pool, low tax rates, etc. 

Obviously, what the Basel Area brings to the table that Boston can’t is easy access to continental Europe. It’s multilingual culture — with many people speaking German, French and English — helps make interactions and deal-making with people and organizations across Europe super easy.

 

Who should reach out to you in your new role and how will you be able to help them?

Leaders of established healthtech, digital health and techbio startups who are thinking about expanding to the European market should get in touch with me. I would also love to hear from VCs, as well as anyone managing an incubator or accelerator, who has portfolio companies that might fall into this category. 

I can explain why Switzerland is a great location in which to expand either R&D or commercialization activities (or both!) and discuss the various ways that Basel Area Business & Innovation can help to support that expansion. One of the major ways being the premier DayOne accelerator, our launchpad for healthtech ventures at the interface with pharma and medtech. 

For leaders of pharma or biotech companies looking to settle in Switzerland, I encourage them to reach out to my counterpart Kirsten Detrick, who is specialized in this area.

Follow Shwen on LinkedIn or contact him via email. 

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Roche investing an additional 1.2 billion Swiss francs in Basel https://baselarea.swiss/blog-post/roche-investing-an-additional-1-2-billion-swiss-francs-in-basel/ Fri, 17 Nov 2023 13:52:06 +0000 https://baselarea.swiss/?post_type=blog_post&p=152536 Roche will be putting an additional 1.2 billion Swiss francs towards the renovation of its site in Basel. This investment will be used to finance another research and development building and the modernization of molecule production, in addition to a building for the Institute of Human Biology.

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| News

Roche investing an additional 1.2 billion Swiss francs in Basel

17.11.2023

Roche will be putting an additional 1.2 billion Swiss francs towards the renovation of its site in Basel. This investment will be used to finance another research and development building and the modernization of molecule production, in addition to a building for the Institute of Human Biology.

Significant investments are being made in the northern part of the site (image: Roche)

Roche announced its plans for the further modernization of the infrastructure at its Basel site. To this end, the pharmaceutical firm will be investing 1.2 billion Swiss francs to upgrade the northern part of the site. Since 2014, the company has already invested a sum of 3 billion Swiss francs in its Basel location.

The investment of 1.2 billion Swiss francs will be used to build another 72-meter-high, 13-story research and development building, among other things. The aim here is to provide attractive laboratory workstations for up to 450 researchers. Moreover, a new production building is to be built for the synthetic and chemical production of medicines. The existing building will also be refurbished and expanded, while the plans additionally include a new building for the Institute of Human Biology with space for up to 250 researchers. For this, an existing building will be converted and fully remodeled.

Big plans also for the southern part

“The new buildings will expand the infrastructure for future innovations along the entire pharmaceutical value chain, from research to production”, comments Jürg Erismann, Head of the Basel site, in the press release. He adds: “This is another clear commitment to the Basel research and production site and to Switzerland”. It is expected that the construction work on the research building and other building renovations will be completed by 2030.

As Roche explains in a video covering its site development plans in Basel, wide, generously proportioned green spaces will be created in the southern part of the area. To this end, the research and office buildings will be removed. According to a press release, the cantonal government of the canton of Basel-Stadt also approved a corresponding development plan on November 17. These plans also include a central building for visitors and employees in the park and a possible third high-rise building depending on Roche’s needs in the future.

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Nouscom secures 67.5 million euros in financing https://baselarea.swiss/blog-post/nouscom-secures-67-5-million-euros-in-financing/ Tue, 14 Nov 2023 13:40:37 +0000 https://baselarea.swiss/?post_type=blog_post&p=152473 Biotech company Nouscom has raised 67.5 million euros in a series C financing round. The Basel-based firm intends to use the funds to advance the clinical development of its portfolio of neoantigen cancer vaccines, including the evaluation of the ongoing randomized Phase 2 trial.

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| News

Nouscom secures 67.5 million euros in financing

14.11.2023

Biotech company Nouscom has raised 67.5 million euros in a series C financing round. The Basel-based firm intends to use the funds to advance the clinical development of its portfolio of neoantigen cancer vaccines, including the evaluation of the ongoing randomized Phase 2 trial.

Nouscom, a Basel-based clinical-stage immuno-oncology company, has raised 67.5 million euros in a Series C financing round. The round was led by Andera PartnersBpifrance (through its InnoBio 2 fund) and M Ventures. Other new and existing investors also participated. As part of this financing, representatives of Andera Partners, Bpifrance and M Ventures were appointed to Nouscom’s Board of Directors, according to a statement.

The Basel-based biotech company is developing standardized and personalized cancer vaccines based on viral vectors targeting neoantigens. According to the statement, the fresh capital will be used to advance Nouscom’s clinical pipeline to the most important clinical endpoints. These include a Phase 2 trial for the treatment of colorectal cancer, an ongoing Phase 1b trial for cancer prophylaxis in Lynch Syndrome carriers, and the completion of a Phase 1b trial for personalized cancer immunotherapy in various indications.

Promising development

If positive, the Phase 2 data for the NOUS-209 vaccine, which simultaneously targets 209 neoantigens, “have the potential to position Nouscom’s neoantigen-based cancer vaccines amongst the most thrilling developments in the field,” commented Nouscom CEO Dr. Marina Udier in the statement. Dr. Sofia Ioannidou, Partner at Andera Partners, believes that the “robustness of the clinical results generated so far positions Nouscom as one of the leading biotech companies in the neoantigen cancer vaccine space”.

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How open innovation in healthtech hubs is fueling the rise of digital healthcare https://baselarea.swiss/blog-post/pr-innovation-in-healthtech-rise-of-digital-healthcare/ Tue, 14 Nov 2023 11:00:12 +0000 https://baselarea.swiss/?post_type=blog_post&p=152431 How the ever-increasing uptake of digital solutions is enhancing patient engagement, increasing access to care and lowering the cost of drug development.

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| News

How open innovation in healthtech hubs is fueling the rise of digital healthcare

14.11.2023

The average return on investment within pharmaceutical research and development is at an all-time low, and it is frequently observed that billions of euros are poured into the development of drugs that ultimately do not make it to the market. How the ever-increasing uptake of digital solutions is enhancing patient engagement, increasing access to care and lowering the cost of drug development.

Novartis Campus Basel

Fortunately, digital healthcare technologies may hold the key to increasing pipeline efficiencies, and a new breed of startups looks set to revolutionise the sector, provided they can attract the attention of suitable investors. Healthtech hubs – such as the Novartis Campus in Basel, Switzerland – offer these fledgling companies an environment alongside pharmaceutical giants and other innovative corporations, providing a new collaborative culture to drive drug development deep into the 21st century.

The pharmaceutical industry is behind some of the greatest discoveries in the history of humanity, with distinguished medical minds and novel therapies prolonging lifespans and improving well-being. Vaccines have eradicated diseases and helped to fight global pandemics, while ‘miracle drugs’ such as penicillin and insulin have changed the face of clinical practice, saving millions of lives. However, even with the seemingly endless introduction of new medicines to the clinician’s armamentarium, certain disease areas still lack efficacious therapies, leaving unmet needs and opportunities for companies willing to adapt to enhance drug discovery.

Reinventing the pharmaceutical industry

Digital tools emerging from the booming healthtech sector are responding to the demands of the industry, helping it to evolve so that life-saving therapies can continue to solve the world’s health problems. The ever-increasing uptake of digital solutions is already enhancing patient engagement, increasing access to care, and lowering the cost of drug development.

The latter is especially pertinent for large corporations with multiple therapies in the pipeline, as improving process efficiencies could translate to huge savings. This is evident with the emergence of decentralised and hybrid clinical trials – enabled, in part, by digital tools such as wearable devices with remote monitoring – which offer patients far greater levels of comfort and convenience, while lowering overall costs by improving retention rates, reducing operational overheads and accelerating time to market.

With change comes opportunity

The inevitable shift to a more digitalised industry provides ample opportunities for healthtech startups to grow. Many of these companies have potentially game-changing technologies, but often struggle to find the means to get their ideas to fruition. Conversely, the pharmaceutical giants have ample resources and access to worldwide markets, representing the perfect vehicle for startups to scale, expand globally and get their solutions in front of patients.

The challenge, then, is to bridge the interface between two polar-opposite cultures – startup versus corporate – to enable them to establish successful and symbiotic partnerships.  Healthtech startups are often founded by a mingling of brilliant minds – including scientists, software engineers and health informaticians – but they can lack experience in developing clear, long-term business models, especially when collaborating with big pharma and the exponential scaling that follows.

What they do enjoy and rely on for survival is speed as, with limited resources, they need to move fast. This is in stark contrast to the conservative, risk-averse nature of the pharmaceutical industry, which needs to move slowly, because of the enormous cost of drug development and the ramifications of getting it wrong.

Healthtech hubs – a scientific melting pot

Traditionally, the contrast between these business models could have stopped innovation in its stride. However, modern-day approaches to drug development recognise it as a strength, resulting in the establishment of thriving ecosystems replete with companies of all shapes and sizes.

For example, the Novartis Campus in Basel, Switzerland opened its doors to the outside world in 2021. As a result, the Switzerland Innovation Park Basel Area was established on site, offering a place for startups, growing companies and partners in the life sciences to work in close proximity to one of the largest pharmaceutical companies in the world. In fact, many of the spaces are publicly accessible, breaking the shackles of the traditionally private pharma ethos. This provides a unique environment designed to catalyse scientific progress by encouraging collaboration between great minds from all aspects of drug discovery, from microbiologists and chemists to healthtech developers and data scientists.

Matthias Leuenberger, Country President for Novartis in Switzerland, weighed in on the subject, saying: “The Novartis Campus in Basel is a space for dialogue, collaboration and scientific innovation, characterised by its dynamic and lively working environment and its unique atmosphere encompassing parks, restaurants, cafes, event spaces and sports facilities.

“Every architectural and artistic detail has been carefully selected to better foster inspiration and cooperation, providing the ideal environment where researchers, entrepreneurs and other experts in the healthcare industry can meet to work on new ideas and develop partnerships.

“We open our doors to companies and institutions of different sizes to inspire and bring the best minds in the industry together in Basel, which has established itself as one of the most important scientific hubs in the world today.”

We open our doors to companies and institutions of different sizes to inspire and bring the best minds in the industry together in Basel, which has established itself as one of the most important scientific hubs in the world today.

Matthias LeuenbergerCountry President for Novartis in Switzerland

A catalyst for innovation

The Basel area is home to over 700 life sciences companies, comprised of more than 32,000 employees – including 8,000 for Novartis at the campus alone – making finding the right person to pitch to, or company to partner with, an intimidating prospect. The startup mindset may lead to individuals eagerly trying to sell their idea or technology, without considering its relevance to the therapeutic indication of the other company’s portfolio.

On the other side of the table, big pharma can be slow to engage its smaller counterparts, where speed – as well as access to funding and resources – can be make-or-break factors.  A means to ignite the critical conversations that lead to the discovery of mutual interests is often needed, followed by a way to nurture the relationship into a successful long-term collaboration.

A major factor for the ongoing success of this healthtech hub is access to support from Basel Area Business & Innovation, an independent, non-profit agency that provides assistance with the relocation or expansion of companies. The company has helped over 30 startups settle in the Novartis Campus, as well as hundreds more businesses and entrepreneurs in the cantons of Basel-Stadt, Basel-Landschaft and Jura.

A key aspect of its remit is to provide community management activities on campus – including frequent events, roundtable discussions, pitch sessions and more – to generate networking opportunities. Its DayOne Accelerator has also been vital in helping many startups scale their technologies.

Scaling new heights in Basel

Many of these startups are in the rapidly expanding field of AI, offering products or services through partnerships or software licensing deals that can be applied to pharma pipelines. One notable example is Holmusk – a company originally from Singapore – that expanded its operations to the Novartis Campus to capitalise on the robust life sciences and pharma presence in the Basel area, as well as the wealth of specialised talent. The company uses AI-powered analytics to enrich its large mental health platform ‘NeuroBlu.ai’, helping pharmaceutical companies improve drug development and commercialisation.

The future of healthtech

Pioneering ecosystems such as the Novartis Campus – located in an equally scientifically vibrant city – help to not only accelerate drug discovery and development, but also secure a prosperous future for the region by enticing global players to its shores. The world-class resources, state-of-the-art facilities and varied personnel found there only attract more investment, additional startups and other major pharmaceutical companies, perpetuating the innovative environment that is nurtured by local agencies established to accelerate scientific progress. This has led to a healthtech hub bursting with talent and novel ideas that continues to deliver cutting-edge tools to enhance drug discovery, accelerate time to market and improve patient access to care.

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The post How open innovation in healthtech hubs is fueling the rise of digital healthcare appeared first on Basel Area Business & Innovation.

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How to access the U.S. market with your medical device https://baselarea.swiss/blog-post/how-to-access-the-us-market/ Fri, 10 Nov 2023 12:54:53 +0000 https://baselarea.swiss/?post_type=blog_post&p=152294 In one of our latest Venture Mentoring events by Basel Are Business & Innovation, we invited Nila-Pia Rähle to speak on market access for medical devices and in-vitro diagnostics products in the US.

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| News

How to access the U.S. market with your medical device

26.10.2023

In one of our latest Venture Mentoring events by Basel Are Business & Innovation, we invited Nila-Pia Rähle to speak on market access for medical devices and in-vitro diagnostics products in the US. She is co-founder and president of the board of our partner Effectum Medical and has over 20 years of experience working in the field of medical devices.

Impressions of the event

Meet Effectum Medical

Effectum Medical specializing in regulatory affairs and quality management in the medtech industry. The company serves as a trusted partner for medical device startups and established firms alike, guiding them through the complex landscape of global regulatory requirements.

Two service models serve this mission:

Meet Nila-Pia Rähle

The European challenge

Unlike the FDA’s more interactive approach, the European system is difficult and time-consuming to navigate for startups. This complexity can be particularly daunting for startups that don’t have in-house regulatory expertise.

Nila-Pia mentions two more pressing issues.

Delayed Notified Bodies

Notified Bodies, the organisations designated by an EU country to assess the conformity of certain products before being placed on the market, are currently delayed. It takes anywhere between 13 to 18 months just for the technical documentation review.

Lack of guidance

Unlike the FDA, which provides pre-submission meetings and direct feedback to make sure your application is done right, European Notified Bodies generally don’t offer any guidance prior to your submission. This makes the already complex process even more challenging, leaving your startup to navigate the regulatory maze on its own.

 

The advantages of the United States

The United State’s FDA (Food and Drug Administration) offers a simpler, interactive approach. This provides startups that go to market in the US with distinct advantages.

1. Risk-based approach

The FDA categorizes devices into three classes based on their potential risk to patients.

  • Class I: Low-risk devices that generally don’t require premarket approval and are subject to general controls like proper labeling.
  • Class II: Moderate-risk devices that often require special controls and may need premarket notification (510k).
  • Class III: High-risk, often life-supporting or life-sustaining devices that usually require premarket approval (PMA) involving rigorous testing and clinical trials.

2. Pre-submission meetings

The FDA gives you the opportunity for a pre-submission meeting. This meeting allows startups to engage directly with the FDA to discuss their regulatory strategy, ask questions and receive feedback. It helps you tailor your submission to meet all requirements on the first try, reducing the likelihood of delays due to incomplete or incorrect submissions.

3. Simplified approval process

The FDA makes use of a concept called “predicate devices”. These are existing devices that are already marketed in the US and serve as a benchmark for new devices seeking FDA clearance. If you can show that your new device is substantially equivalent to an existing, already marketed device, you can often bypass some of the more rigorous testing requirements and bring your product to market significantly faster.

How to apply for U.S. market access with your medical device

 

Step 1: Ensure the U.S. is the right market for your startup

Evaluate whether the U.S. is really the place you want to go to market in. Be prepared for a highly competitive medical device market with many established and emerging companies vying for market share. Clinical studies might also be more costly than in Europe.

Step 2: Classify your device

Each of the three previously mentioned classes has its own set of regulatory requirements, with Class III being the most stringent due to the higher level of risk associated with these devices. Understanding your device’s classification will help you identify the appropriate regulatory pathway you’ll need to follow.

Step 3: Consult with FDA

Consult with the FDA through a pre-submission meeting. The FDA offers this service free of charge and it provides an opportunity to discuss your device’s regulatory and clinical strategy. This can help you tailor your submissions more precisely and avoid faulty submissions.

Step 4: Choose the right submission pathway

During this meeting, you’ll also learn what type of application is right for your device:

  • 510(k): Pre-market notification for Class I and Class II devices, used to demonstrate that the device is substantially equivalent to an already marketed (predicate) device.
  • 510(k) Exempt: Some Class I and a few Class II devices are exempt from the 510(k) pre-market notification requirement because they are considered to be of lower risk and have a well-understood safety profile.
  • PMA (Pre-Market Approval): Required for Class III devices, this is the most rigorous type of application involving clinical trials to prove safety and effectiveness.
  • HDE (Humanitarian Device Exemption): Devices that are intended to benefit patients with rare conditions (affecting fewer than 8,000 individuals in the U.S. per year) may be approved without needing to demonstrate effectiveness, but they must prove safety and that the probable benefit outweighs the risk.
  • De Novo Classification Request: For low to moderate risk devices that do not have a predicate, this request seeks FDA classification into Class I or II.

Step 5: Prepare documentation

Preparing all the necessary technical documentation can include your device’s specifications, test results and clinical data, if applicable. If you’re going for a 510(k) submission, you’ll also need to identify a predicate device to demonstrate that your device is substantially equivalent to an existing, approved product. Make sure to also have a quality management system in place, as this is a requirement for all classes of medical devices.

Step 6: Register and submit

Your final step is to register your company and product with the FDA. This is a prerequisite for submitting any type of application for product approval. If you’re not not living in the U.S., you need a U.S. agent to represent your company (they must be able to answer questions from the FDA about your device).

The costs of bringing a medical device to the US market

While some aspects, like pre-submission meetings, are currently free of charge, other steps in the process can be costly. These may include fees for submitting applications, costs for clinical trials and expenses related to compiling the necessary documentation.

While most of those costs vary, the FDA publishes its application costs on its website:

* A small business is defined as a business, including its affiliates, whose gross receipts
and sales are less than $100 million for the most recent tax year.

For the most recent information, visit the FDA’s Medical Device User Fee Amendments.

FDA clearance/approval could help with access in the EU

FDA clearance/approval not only facilitates U.S. market entry but also eases global expansion.

Some countries’ regulating bodies have agreements with the FDA, allowing for easier approval of FDA cleared or approved products. This is very helpful for startups aiming for global expansion as it saves them from undergoing multiple full approval processes.

Switzerland, for example, is currently evaluating streamlining the entry of FDA-approved products, offering a quicker and more cost-effective route to market.

Need help?
If you need help bringing your medical device to market, get in touch with our Venture Mentoring team.

We provide unbiased, professional advice to startups and entrepreneurs, looking to turn their invention into a successful business.

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Paradigm shift in pain management https://baselarea.swiss/blog-post/paradigm-shift-in-pain-management/ Fri, 10 Nov 2023 09:48:54 +0000 https://baselarea.swiss/?post_type=blog_post&p=152140 Pain is a crucial sensation for survival, but it can also drive us to depression and long-term suffering if not managed correctly. In response, researchers are exploring ground-breaking ways to manage pain. Fascinating approaches are already finding their place in forward-thinking healthcare institutions, supported by the healthtech sector, which is booming in multiple locations around Europe, especially in the Basel Area.

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Paradigm shift in pain management

10.11.2023

Pain is a crucial sensation for survival, but it can also drive us to depression and long-term suffering if not managed correctly. In response, researchers are exploring ground-breaking ways to manage pain. Fascinating approaches are already finding their place in forward-thinking healthcare institutions, supported by the healthtech sector, which is booming in multiple locations around Europe, especially in the Basel Area.

Alarmingly, chronic pain affects more than 30 percent of people worldwide, [1] yet current treatments can be ineffective or lead to drug dependence, leaving many individuals in dire need of innovative solutions that will help them find relief. New ways to manage pain – from neuroplasticity training through interactive games to therapies that use virtual reality (VR) – promise to shake up the status quo of clinical pain management in the years to come.

Pain is a complex and multifaceted biomechanism that is experienced differently by each person. Its subjective nature means that it can’t be measured or quantified; a person’s perception of pain is unique and influenced by various factors, including genetics, past experiences, and emotional state. Psychosocial elements – such as mood, stress levels, and support systems – also shape how a person perceives and copes with pain. This complex web of factors has plagued healthcare professionals for a long time, making chronic pain treatment incredibly challenging. Traditional therapies offer temporary relief, but long-term use can lead to dependence and addiction, which is evident with the opioid crisis in countries such as the  US. Many clinicians are therefore looking for alternative treatments, while also seeing the benefits of taking a more holistic approach to the pain management paradigm.

Novel solutions for treating pain

Dr Elan Schneider is CEO and Co-founder of the Israeli company TrainPain – comprised of a team of healthcare professionals, scientists, and technology experts who have developed a neuroplasticity training game for chronic pain. Dr Schneider has dedicated the best part of his career to finding novel solutions for treating pain. He explained: “Pain can destroy a person’s quality of life for prolonged periods, yet there isn’t always a clear correlation between the physical damage in the body and the intensity of pain felt. The latest understanding of pain suggests that neuroplastic changes can heighten the sensitivity of the body’s pain-processing nerves. This means that even minor threats to the body can trigger pain, amplifying these nerve signals and resulting in disproportionate levels of pain relative to the actual harm.

“Despite extensive research in this field, many findings haven’t made their way into clinical practice. At TrainPain, we’ve translated some ground-breaking concepts from neuroscience into tangible solutions. Our method is to train the body’s natural ability to regulate pain by enhancing the neural circuits that naturally turn down the volume of pain-related nerve signals sent to the brain. While this approach isn’t new – opioids and cannabinoids, for example, work similarly to mimic the body’s inhibitory neurotransmitters – traditional medications not only come with side effects, but also fail to promote the body’s inherent learning capabilities for long-term changes in pain regulation.”

Transdiagnostic pain management

The team at TrainPain has taken a transdiagnostic approach to pain management, looking at mechanisms that are common across different types of chronic pain. This could help to meet the dire need for novel therapies for neuropathic pain – including fibromyalgia, complex regional pain syndrome, and phantom limb pain – where current treatments are largely ineffective or insufficient.

Dr Schneider continued: “Various conditions display an overlap, with neuroplasticity in the nervous system being a pivotal factor. Engaging in numerous repetitions of therapeutic tasks can help address these maladaptive neuroplastic changes and promote healthier alterations in the nervous system. To this end, our solution harnesses sensory perception tasks, delivered through video games, to provide the necessary engagement and ensure that patients participate for sufficient time to benefit. This form of training aids learning and induces changes in how sensory neurons activate and communicate.”

Basel: a hub for scaling innovation

TrainPain is one of a handful of companies attracted to Basel, Switzerland, which is now arguably the healthtech capital of Europe. Basel and the surrounding area are replete with highly specialized scientific entrepreneurs and large pharmaceutical players, where growing companies such as TrainPain can be immersed in a forward-thinking environment to foster innovation. The company signed up for the DayOne Accelerator with Basel Area Business & Innovation – a non-profit agency that helps innovative companies develop and expand – to make the vital connections it needed to take its ideas to the next level and, ultimately, reach the patients they are designed to help.

Commenting on the accelerator, Dr Schneider said: “Participating in this accelerator gave us the opportunity to talk with the right people at the intersection of pharma and digital health. We learned a lot about the pharmaceutical industry and its needs, where our solution fits, and how to make important collaborations with healthcare organizations to ensure we are ready for the future.”

Another alum of the DayOne Accelerator is Rescape, a Welsh startup that develops VR solutions for reducing pain and anxiety. Rescape knew about the beneficial ecosystem of the Basel area, which helped the company take its innovation from conception to completion. Matt Wordley, Co-founder and Board Director at Rescape, explained: “We don’t get much exposure to pharmaceutical companies in Wales, so spending time in Basel has been crucial for our development as a small startup. It has allowed us to understand the complexities of the pharma world, and network with the right people. In fact, a couple of the collaborations born out of our time in Basel have really helped us fast-track our business, and a number of other opportunities are still being pursued. The team at Basel Area Business & Innovation has also opened the doors to mainland Europe, helping our VR solutions conform to the EU medical device regulations.”

Virtual reality in healthcare

VR is most often associated with gaming, but its applications are being explored in a variety of industries. In healthcare, a recent analysis of VR and augmented reality in scientific literature found more than 8,000 research papers on the topic, with the most common medical conditions under investigation including pain, stroke, anxiety, depression, fear, cancer, and neurodegenerative disorders. [2] Pain and anxiety management have the largest evidence base for the use of VR in medicine, [3] where distraction through immersion – along with neurophysiological changes – contribute to therapeutic effects. This could lead to novel treatment options for patients with chronic pain, potentially reducing the reliance on opioids. [4] In addition, Rescape is already seeing significant benefits in a more acute setting.

Wordley explained: “The brain becomes ensconced in the environment that it is in, as it is not designed to cope with two realities. With VR, we are basically hacking the brain, so it shelves the pain or anxiety the patient is experiencing, and replaces it with a distracting or relaxing environment. We have found some wonderful results in paediatric patients, especially with children who are stressed or anxious about minor procedures, such as those involving needles. VR can actually help to reduce sedation requirements in children, and potentially eliminate the need for anaesthesia for minor operations. This is a huge benefit to both anxious children and stressed parents, as well as healthcare professionals, reducing the risks and recovery times for patients.”

Wordley continued: “VR is also being deployed in palliative care as a temporary respite for patients – a form of escapism – and in intensive care units (ICUs). A nice example in the latter setting involved a patient who was having around 20 panic attacks per day following an extended ICU stay, where he experienced pain and isolation from the outside world. Within a couple of weeks of using VR, he was having just the odd panic attack, and could be moved to a general ward. However, his story didn’t end there. Not long after being discharged, he needed to get his big toe amputated, but the medical team couldn’t use a general anesthetic because of his health, and it would need to be done using a regional block. This caused him to spiral into a panic attack, until he agreed to use VR to calm his nerves, allowing the operation to continue.”

Summary

Pain management has been troubled by its subjective nature, where simply treating the ‘problem’ doesn’t always equate to therapeutic success. This can leave patients with enduring pain and anxiety, and clinicians with few options. The call for novel therapies to fill the gap in managing pain is being answered with the help of extraordinary innovations stemming from the healthtech sector, which are nurtured in thriving hubs such as Basel. Although there is no silver bullet, neuroplasticity training and VR are now additional tools in the clinician’s armamentarium, allowing them to not only reach for their pharmacopeia, but also turn to technology to help improve the lives of their patients in pain.

References
1. Cohen S, Vase L, Hooten W. Chronic pain: an update on burden, best practices, and new advances. The Lancet. 2021;397(10289): 2082- 2097. doi: https://doi.org/10.1016/S0140-6736(21)00393-7
2. Yeung A, Tosevska A, Klager E, et al. Virtual and Augmented Reality Applications in Medicine: Analysis of the Scientific Literature. J Med Internet Res. 2021;23(2):e25499.  doi: https://doi.org/10.2196/25499
3. Rescape. The Evidence for Virtual Reality in the Clinic. 2021. https://www.rescape.health/virtual-reality-white-paper [Accessed 10 July 2023]
4. Gupta A, Scott K, Dukewich M. Innovative Technology Using Virtual Reality in the Treatment of Pain: Does It Reduce Pain  via Distraction, or Is There More to It? Pain Med. 2018  Jan 1;19(1):151-159. doi: https://doi.org/10.1093/pm/pnx109. PMID: 29025113.

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BOOM Summit in Basel accelerates health technology https://baselarea.swiss/blog-post/boom-summit-in-basel-accelerates-health-technology/ Thu, 09 Nov 2023 15:03:40 +0000 https://baselarea.swiss/?post_type=blog_post&p=152423 The BOOM Summit at Messe Basel in April 2024 will be a completely new kind of healthcare conference. The first edition will be dedicated to trends in health technologies that are set to significantly change the healthcare sector.

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BOOM Summit in Basel accelerates health technology

09.11.2023

The BOOM Summit at Messe Basel in April 2024 will be a completely new kind of healthcare conference. The first edition will be dedicated to trends in health technologies that are set to significantly change the healthcare sector.

The inaugural BOOM Summit will take place in April 2024. The venue will be the events hall at Messe Basel. According to a statement, the event will be dedicated to trends in digital health technologies. It will be “a highlight of the European healthtech calendar”, as well as provide an open forum for the discussions and strategies that are set to transform the healthcare sector.

The event is organized by DayOne, an initiative of Basel Area Business & Innovation, the investment and innovation promotion agency, and the Kenes Group, a leading global provider of medical conferences. The main partner is the Basel-based MCH Group, which is supporting the BOOM Summit as part of its strategy to position Basel as a leading hub for life sciences events. “The aim of the BOOM Summit is to promote collaboration and innovation in the field of healthcare technology,” commented Caoimhe Vallely-Gilroy, Director of Strategy DayOne and conference organiser.

Program offers great variety

The event is aimed at all professionals as well as entrepreneurs, investors and political decision-makers. The program includes expert panels, technology presentations, startup pitch sessions and interactive workshops. According to Dr. Leslie Anne Fendt, who is responsible for an advanced digital health project at Roche in Basel, the BOOM Summit will “bring together the best and brightest minds in healthcare technology and hopefully ensure that the latest and most exciting technologies can flourish”.

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Investors stump up 3.7 million Swiss francs in Onena Medicines https://baselarea.swiss/blog-post/investors-stump-up-3-7-million-swiss-francs-in-onena-medicines/ Fri, 03 Nov 2023 13:34:47 +0000 https://baselarea.swiss/?post_type=blog_post&p=152383 Onena Medicines has secured an investment of 3.7 million Swiss francs. The portfolio company of the biotech startup incubator BaseLaunch will therefore be able to drive the development of its antibodies designed to influence the growth of tumors.

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Investors stump up 3.7 million Swiss francs in Onena Medicines

03.11.2023

Onena Medicines has secured an investment of 3.7 million Swiss francs. The portfolio company of the biotech startup incubator BaseLaunch will therefore be able to drive the development of its antibodies designed to influence the growth of tumors.

Onena Medicines has raised a total of 3.7 million Swiss francs as part of a financing round. The venture capital has been provided by the Basel-based asset management firm Avanteca Partners and Zürcher Kantonalbank, the cantonal bank of Zurich. The biopharmaceutical firm Onena, which is headquartered at the Main Campus of Switzerland Innovation Park Basel Area in Allschwil in the canton of Basel-Landschaft, is a portfolio company of BaseLaunch, the biotech startup incubator active within the Basel biotech cluster.

Onena has a pipeline of promising antibody medicines to treat cancer, which neutralize a new class of growth factors called dual SMAD inhibiting proteins (DSIPs) that are responsible for programming the cancer cells to grow and induce resistance to chemotherapy. “Our partners realize, as we do, the incredible opportunity that lies before us to lead the AI drug discovery field”, comments Neethan Lobo, CEO and co-founder of Onena Medicines, in a press release.

Efficacy already shown

Onena intends to put the investment towards its efforts to provide in vivo proof of concept with its most advanced DSIP program (OMED-2). This is a first fully human antibody that targets an as yet undisclosed DSIP target protein. The company believes this has the potential to impact solid tumors such as melanoma.

Onena’s flagship OMED-1 program has already shown efficacy in breast, colorectal and glioblastoma preclinical models in vivo. Onena uses its deep learning pipelines to humanize and optimize the binding affinity of its lead molecules.

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CSL joins Basel Area biotech cluster https://baselarea.swiss/blog-post/csl-joins-basel-biotech-cluster/ Thu, 02 Nov 2023 13:28:13 +0000 https://baselarea.swiss/?post_type=blog_post&p=152350 The research and development department of the globally active Australian biotech company CSL has moved into a new office in the Switzerland Innovation Park Basel Area on the Novartis Campus in Basel. With this move, CSL aims to tap into the region's great potential.

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CSL joins Basel Area biotech cluster

02.11.2023

The research and development department of the globally active Australian biotech company CSL has moved into a new office in the Switzerland Innovation Park Basel Area on the Novartis Campus in Basel. With this move, CSL aims to tap into the region's great potential.

At the CSL office opening in Basel (from left to right): Christof Klöpper, CEO Basel Area Business & Innovation, Emmanuelle Lecomte-Brisset, CSL Head of Global Regulatory Affairs, Eric Teo, CSL Head of Patient Safety (Photo by Arianna Ramirez)

CSL is expanding its research and development (R&D) network in Switzerland. The global biotechnology company, which is headquartered in Melbourne, Australia, officially opened a new office in the Switzerland Innovation Park Basel Area premises on the Novartis Campus in Basel. The contract with the operator includes 18 workstations.

In a statement, CSL describes the move as a “pivotal milestone in strengthening CSL’s R&D network across Switzerland”. It allows for “flexible and activity-based ways of working” and taps into “the region’s great potential” for collaboration along the drug development process.

Access to Basel Area’s talent pool

“This step is not only extending our long-standing strategic partnerships with key players in biotech located in Basel but ensuring access to the region’s talent pool and exploring further opportunities for collaboration”, commented Emmanuelle Lecomte Brisset, CSL’s Head of Global Regulatory Affairs who is leading CSL’s efforts to strengthen its R&D presence in Switzerland.

In May of this year, CSL opened an R&D laboratory on the Biopôle Campus in Lausanne. In August 2022, the company acquired Switzerland’s Vifor Pharma, which has since operated as CSL Vifor. CSL has also established collaborations with academic institutions in Switzerland, such as the Swiss Federal Institute of Technology in Lausanne and Lausanne University Hospital.

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