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June 2021 Edition
Despite considerable handwringing and soul searching over a perceived lost competitiveness when it comes to domestic market performance – a modest growth rate of 2.8 percent last year coupled with significant delays to drug reimbursement – plucky Switzerland still manages to hold its own as a focal point for innovation and discovery in global medical science. Consequently, the country continues to rank very highly on the radar of both Big Pharma and the international biotech community alike.
“In our eyes Switzerland represents the real deal: namely an early-adopter market landscape spanning R&D, clinical trials and breakthrough innovation. The entire ecosystem functions smoothly and constitutes a leading biopharma hub not just within Europe, but globally as well,” ventures BMS’ general manager for Switzerland and Austria, Remo Gujer. Small wonder therefore that his company has selected the tiny landlocked state as the locus for basing not only a ‘global capabilities hub,’ but two major manufacturing plants and more than a thousand jobs.
“It’s fair to say that this is a true pharma nation where the drug development industry forms a key pillar of the national economy,” agrees Ans Heirman, assistant vice president and managing director of MSD. “Many of the elite drug makers of the world have placed global or regional headquarters here, and that creates a fascinating dynamic to be part of. In our own case, our Swiss footprint acts as the linchpin of our European strategy and is home not only to our regional management function, but also manufacturing an and logistics platforms, and the site of an important research facility,” she adds.
Certainly, the strategic relevance of the life science sector to the Swiss economy appears to be increasing. Nowadays, the pharma industry alone generates a full 5.4 percent of the country’s GDP and this figure rises to an impressive 9.2 percent as soon as indirect effects are factored in.
Equally significant, the industry now accounts for a massive 45 percent of Swit-zerland’s total exports. According to the latest statistics from scienceindustries, while total Swiss exports grew by 78 percent from 2000 to 2020 (from CHF 126.5 billion to CHF 225 billion), the life sciences contribution increased by a remarkable 349 percent within the same time period (from CHF 22 billion to CHF 99 billion), rendering it the foremost driver of Swiss export growth and absolutely critical to the maintenance of a strong balance of trade surplus.
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But what is it exactly about Switzerland, that catches the eye so much and makes it such a unique and alluring prospect for so many life science companies?
Most industry insiders mention the excellent enabling ecosystem that marries a robust manufacturing infrastructure with advanced research competencies and a deep talent pool. From a biotech perspective, the clear advantage is that all the resources and support systems that you may need to call upon are within easy reach. “Switzerland’s clear strength is a well-rounded and deeply embedded innovation culture fuelled by best-in-class technical and scientific universities, top engineering schools and elite research centres,” reflects Nicolas Fischer, CEO of Light Chain Bioscience. “Over the past couple of decades, this has become more pronounced as there has been a proliferation of incubators and accelerators offering unprecedented levels of assistance,” he continues.
Chris Martin CEO and co-founder of ADC Therapeutics very much concurs. “Switzerland is a fantastic place to be running a biopharma company because you’re operating in close proximity to some of Big Pharma’s most innovative players that are right at the top of their game – Roche and Novartis to name just a couple. Then there are also heavyweight contract manufacturers such as Lonza. The infrastructure is world class and there is an overarching willingness to promote innovation at every twist and turn. The Federation clearly understand the value of enticing in high-tech ventures such as biotech and will pull out all the stops to support you and help you become efficient and competitive,” he enthuses.
Predictability is another important asset. “One of the characteristics that really stood out to us was that fact that this is evidently a business-friendly place with a strong work ethic. Essentially, we were looking for a well-governed, stable and reliable environment that would suit our long-term investments well. You get the sense that the authorities appreciate the importance of continuity and consistency and this certainly helps with your business planning,” opines Marc-Olivier Geinoz, founder of Dipharma.
Then, there is the seemingly bottomless talent pool. “In terms of manpower, the level of pharma-specific qualification and skills is quite superb,” insists Laurent Massuyeau, CEO of iQone. “There’s a reason why Switzerland has been at the top of the IMD competitiveness index for so many years in a row! It’s because it’s simply one of the best places in Europe to start a business,” he insists. “For sure, the cost of labour might appear quite pricey at first glance, but when you consider the talent that you are getting in return, the difference is noticeable. People over here tend to be better-qualified, more well-rounded and speak more languages than their counterparts in other European countries. Establishing an international enterprise like this in Europe can be a complicated business without personnel that possess both the technical know-how and the requisite language competencies to fuel global expansion; but in Switzerland it’s actually pretty easy to source such profiles,” he reasons.
And, in an increasingly globalized pharma industry, it’s not just about having a rich supply of top talent already on the doorstep, but the ability to attract the specific specialist human capital you need from around the world. “Historically, Glenmark started its innovation division in Switzerland for exactly this reason,” recalls Alessandro Riva, former CEO of Ichnos, the Indian generics company’s fully autonomous oncology-focused biotech subsidiary. “As an Indian company they basically had to choose between the US and Switzerland and found the latter to be more approachable: equally stacked with talent and the sort of sophisticated, affluent and modern environment right in the very heart of Europe that people will readily be willing to relocate to.”
FOPH Director-General Anne Lévy’s Top Priorities
“Managing the COVID-19 crisis will remain the top priority in the months ahead. In the longer term, the Swiss healthcare system will have to address several challenges in order to continue offering the best possible treatments to the entire population.
“The health status of the Swiss population is very good compared to other countries. However, there is still potential to reduce the risk of developing diseases that can shorten or adversely affect the quality of life. Let me mention just a few examples: smoking still kills nearly 9,500 of our fellow citizens every year; the number of people who are obese has remained stable since 2012; and there is also the increasing prevalence of mental illness which constitutes a major challenge, in particular due to the ageing of the population.
“The Federal Council has adopted a Health2030 strategy that sets out the priorities for health policy over the ten next years. While technological and digital change will remain our top priority, this strategy focusses on three other key challenges: demographic and social trends, preserving high-quality and financially sustainable healthcare coverage and creating opportunities for a healthy life. Each of these four challenges encompasses a large number of objectives to be achieved.”
Meanwhile, for the large multinationals especially, the wealth of skills in both fundamental and clinical research sets Switzerland apart when it comes to conducting R&D. “It’s absolutely no coincidence that a significant part of our clinical trial pipeline gets routed through here because there’s a very keen and vibrant scientific community with highly engaged medical experts. You just don’t find that level of intensity in many countries,” muses Katharina Gasser, managing director of the research-driven neuroscience pioneer, Biogen, and chair of the executive committee of Interpharma, the Swiss association representing originator drug developers.
Christiane von der Eltz, country speaker for Merck Switzerland, which recently announced big investments in its Aubonne and Vevey sites, strikes a similar tone. “Switzerland generally offers attractive conditions and a stable environment for international companies”, she opines. “The country offers an environment favourable to innovation, a good infrastructure, a highly skilled workforce, and good quality of life – which helps to attract and retain talented employees. We expect that these attractive conditions will be maintained in a stable manner over the long term.
“Over the past two years, a number of significant investment projects have been announced for Switzerland. In March 2019, we announced a EUR 150 million investment for the expansion of our biotech manufacturing site in Aubonne. Following this, a EUR 250 million investment was announced in January 2020 for a new Biotech Development Center situated in Corsier-sur-Vevey. In July 2020, we announced an EUR 18 million investment in a new laboratory facility in Buchs that will support Merck’s rapidly growing reference materials business. Besides these transformational investments, we will also continue to invest permanently in our manufacturing sites, in Switzerland like everywhere else in the world, to maintain them at state-of-the-art industry levels.”
Indeed, the strong interplay between the Swiss research community and the pharma industry is rather distinctive. Switzerland’s Friedrich Miescher Institute for Biomedical Research (FMI) – officially the most efficient institution in Europe in terms of successful European Research Council grants and thus considered the gold standard of innovative research in Europe – serves as a case in point. “The FMI was founded 50 years ago with a vision that was not far from what it is today: it was created to provide a pure research and training capability able to anticipate ahead and operate right at the cusp of breakthrough medical science. We are intertwined with the pharma industry, not least because we are funded to a large extent by Novartis, but also because we have made it our mission to generate insights that are translatable and thus very valuable for innovative drug developers, even if we do not complete that translation part of the process ourselves. This means staying ahead of the curve. For instance, if targeted protein degradation is going to be the next big emerging trend in drug development, then we should have been there five years before that,” explains Susan M. Gasser, the institute’s director emeritus.
Ultimately the country’s enduring appeal would appear to derive from an intricate and multifaceted ecosystem that manages to give any innovative life science outfit – from small, disruptive biotech startups all the way up to iconic pharma multinationals – the tools and impetus to thrive and flourish.
While fledgling biotechs might justifiably view the country as a fine nurturing milieu that will offer encouragement, support and the opportunity to grow, well-established brands equally see it as a chance to compete amongst the very best and push their potential to the absolute limits. The sheer concentration of top actors within the same closely knit space creates its own competitive dynamic and raises the bar. Meanwhile, being able to lay claim sizable in-country research presence in such a sophisticated setting confers a certain level of kudos and credibility and can project a powerful message to investors, shareholders and peers alike.
“I would go as far as to say that part of the reason why we are here in such force is the stiff competition from the two major Swiss pharma companies that also possess a top neuroscience portfolio,” acknowledges Biogen’s Katharina Gasser. “We feel that we are on their turf, and that pushes us to go the extra mile, it motivates us to compete at full-throttle and deliver even better execution than might otherwise be the case.”
The sheer richness and comprehensiveness of the Swiss life science fabric also unlocks exciting new possibilities for firms aspiring to operate at the bleeding edge of next generation medical science. “The decision to situate our headquarters in Zurich was the result of a long and carefully thought-out decision-making process,” recalls Tero Silvola, CEO of BC Platforms, a company seeking to revolutionize drug development and personalize care through genomic data discovery and predictive analytics. “We are part of a comparatively new industry born out of the intersection of data with biology, healthcare and the life sciences. Frankly, we needed to be located in a setting where these different sectors were aligning more quickly and where the longstanding silos and barriers between disciplines were being broken down. We consider Switzerland to be precisely that sort of place,” he exclaims.
Bringing Personalisation to Perioperative Medicine
In an industry niche largely overlooked by Big Pharma, Swiss-headquartered Sintetica has carved out an enviable name in the anaesthetics and analgesics space. The company employs more than 300 people, over 15 percent of whom work in R&D, boasts a robust manufacturing prowess, and is increasingly focusing on the development of personalised solutions in its areas of focus.
CEO Miro Venturi, previously Global Head of Diagnostics Biomarkers and Personalized Healthcare at Roche, characterises his work at Sintetica as the continuation of a career-long commitment to personalised medicine. “I have always tried to advance our collective efforts in personalising medical treatments, even when the prevailing wisdom was that all patients had to be treated the same way,” notes Venturi.
He adds, “My challenge today is taking this concept into perioperative medicine, which involves everything that happens to a patient before, during and after surgery. Nearly everyone goes through some type of surgery in their lives and requires personalisation in their treatment journey.”
With ICU and operating theatre doctors having to react very quickly, innovation in the perioperative medicine space needs be “easy to understand, ready to use, and add value to the hospital system,” notes Venturi. The company’s therapeutic areas of focus include epilepsy, neurodegenerative conditions, and ophthalmology and it is also developing non-opioid analgesics that can be used by patients for longer periods without the risk of addiction. Another key field is digital solutions which better allow physicians to track the patient journey.
Manufacturing is also a crucial differentiator. The firm’s Swiss manufacturing sites have a production capacity of 90 million ampoules, five million infusion bags, and over eight million vials; a footprint that was especially relevant during the COVID-19 pandemic, when Sintetica was able to step in and produce large amounts of the key drugs required in Swiss ICUs.
With national sales teams in place in key European markets, and a partnership network elsewhere, Venturi admits that future growth may come via “a mix of organic growth and acquisitions and alliances.” However, whichever expansion path Sintetica chooses, collaboration seem set to be at its core. “Perioperative medicine is a field where partnership is inherently important because several practitioners collaborate to treat the patient at the same time,” concludes Venturi.
Indeed, the Swiss life science sector enjoys a strong track record when it comes to being at the forefront of pioneering science. Nowhere has this been more evident than during the recent Coronavirus pandemic. Technologies developed by local scientists have so far been crucial in the fight against COVID-19, including cloning the virus, cryo-electron microscopy to visualize the spike proteins, and the use of radioactive molecules that bind to receptor proteins to investigate how the virus enters the host.
Janssen Vaccines in Bern, part of the Johnson & Johnson group, has been playing a leading role in the development of a vaccine candidate that successfully navigated Phase III studies earlier this year, while national champion, Novartis, has been spearheading efforts to reprofile existing pharmaceuticals for the treatment of COVID-19, and has joined forces with Zurich-based Molecular Partners to develop DARPin® treatments based on a novel class of protein therapeutics.
Even Swiss contract manufactures have been getting in on the action. Moderna – a US entity which has just opened a European headquarters in Basel, that achieved global renown for managing to finalize the design of its innovative mRNA-1273 inoculation a mere two days after the virus sequence was first made available – has teamed up with Lonza to produce 1 billion doses of the vaccine per year from a state-of-the-art specially purposed facility in Visp. Meanwhile, Swiss-headquartered CMO Adienne has raised eyebrows after being announced as the first European company to be awarded the rights to start manufacturing Russia’s Sputnik V COVID-19 vaccine.
“The Russian Direct Investment Fund (RDIF) contacted us through the Russian-Italian Chamber of Commerce during the selection process of companies in Europe to manufacture Sputnik V. We appeared on their radar because they were looking for acompany with a strong research foundation that could start from the cell all the way to the commercial product. Given that few companies in Europe are able to fit this bill as well as the fact that Adienne has all services integrated in-house, we ultimately came out on top,” proudly explains Antonio Francesco Di Naro, president and founder of Adienne.
“Swiss companies are increasingly involved in global vaccine production collaborations, with Lonza now producing most of Moderna’s vaccine supply for Europe and Novartis assisting with the manufacture of the Pfizer/BioNTech vaccine… Today, Switzerland is among the thirteen most important countries in the world for the production of vaccines,” enthuses René Buholzer, CEO of Interpharma.
Latest generation biologics manufacturing is actually one of the areas where Switzerland manages to differentiate itself from many of its competitors. For example, when it comes to producing vaccines against COVID at speed, Swiss manufacturers like Lonza and Adienne have been able to showcase their superiority.
The issue is that many CMOs have the capability to fill and pack millions of doses, but very few can actually manufacture the drug product,” notes Di Naro. “We need to invest more because vaccines are not manufactured in one month and you need people with expertise to grow cells, do the chromatography, and other steps.
Meanwhile the country is at the epicentre of attempts to reshape drug manufacturing to make it fit for an era where chemically synthesized medicines are increasingly giving way to high complexity biologics. UCB Switzerland, for instance, has spent the past 5 years fine tuning their production processes to achieve a greater level of synergy between development and manufacturing.
“There are notable differences between the fabrication of small molecules and biologics. For a start, the size of investment is fundamentally different, as is the time needed to activate a supply chain. What this means is manufacturing has to be integrated much earlier in the cycle, so as to ensure a seamless and fast transfer and accelerate our speed to market,” reasons Jacques Marbehant, the company’s senior vice president, head of global manufacturing, engineering and health, safety & environment.
“Given the sheer level of sophistication in biopharma manufacturing today, we think there also needs to be far greater assimilation of manufacturing experts into cross-functional positions involving skillsets such as complex data analysis and quality management,” he expounds.
Moreover, despite entering an age of increasingly consolidated production networks, Switzerland continues to feature prominently. “Over the past decade, UCB has moved from eleven manufacturing sites to just four, with two hubs in Belgium and Switzerland representing strategic concentrations of resources and expertise to cover the manufacturing of both large and small molecules. Our external biologics manufacturing network is also managed from Switzerland, while our sites in Zhuhai, Southern China and Saitama, a suburb of Tokyo in Japan, can be better characterized as market entry sites dedicated to their countries,” details Marbehant.
“Manufacturing out of Switzerland in this manner might cost slightly more but continues to serve us well because we can tap into unique knowledge and know-how while benefitting from the extremely high levels of production that you get out here. What’s more the ‘made in Switzerland’ brand carries a special association with quality and precision, which is thoroughly pivotal in our niche,” he adds.
Likewise, companies based out of Switzerland seem to be at the forefront of ongoing efforts to reinvent pharma logistics and supply chain networks. For instance, the Basel-based ‘pharma competence centre’ of Agility Global Integrated Logistics (GIL), one of the world’s top freight forwarders and providers of contract logistics, has been encouraging its clients to enter into much deeper partnerships than the conventional service-supplier relationships of yesteryear.
“Over time, we’ve realised that the closer we can be, the better the services and solutions we can deliver. The more we can act as an extension of the client’s own operations, the greater the value we can bring and that requires being brought in right at the initial inception phase of projects,” recounts Eric ten Kate, Agility’s vice president for global life science.
His company which describes itself as an ‘IT firm that does logistics’ wants to leverage technologies such as blockchain to provide drug makers, payers and healthcare providers with greater real-time visibility of pharma supply chains. “When you order from Amazon, you can see exactly where your products are and when they will be delivered. We believe the life science community should enjoy that very same level of transparency and service from 3PLs. For example, if you take the case of the COVID vaccines that require two doses, companies, governments and patients need to be able to track when someone has taken the first dose and when they would require the second dose. And we all need to be supremely confident that the data is current, accurate, secure and can’t be tampered with. A blockchain is the obvious solution to give us that ability, he argues.
At the same time, a newfound desire to prioritize resilience and repatriate supply chains after COVID-19 exposed frailties in the partnership networks of many pharma firms may well play out in favour of Swit-zerland. “Supply chain resilience has become the new currency of business success. The global pandemic has compelled us to investigate complex risk patterns and start taking mitigating steps so as to guarantee that our supply to patients can be maintained. One of those steps might well be having part of those networks closer to home,” muses Jacques Marbehant.
The Advent of Genericized Orphan Drugs?
On the back of strong year-on-year growth, orphan drugs now constitute around 15 percent of global pharmaceutical prescription spending and this trend looks set to continue with the majority of the known 7,000 rare diseases still lacking approved treatments. Yet, despite the first orphan drugs losing patent exclusivity in the EU more than a decade ago, a commensurate generics market for orphan drugs has been slow to take off.
“Developing a generic of an orphan drug costs as much, if not more, as developing a generic of a blockbuster drug, but with low volumes spread over a market that is geographically very fragmented. Moreover, orphan drugs are not a priority for substitution with many payers, who place far more emphasis on their big expense volume products. As a result, the incentives for generics firms to go into the rare disease segment are often perceived as low,” reasons Marc-Olivier Geinoz, CEO and Founder of Swiss-based Dipharma. In Switzerland, there is even an additional barrier as 15 years patent exclusivity is granted on all orphan drugs rather than the usual ten years.
Yet, despite all of this, Dipharma has still spotted an opportunity in its domestic market. “Rare diseases are only rare when taken in isolation; together there are many of them, and whilst the number of people suffering from each individual disease is very small – typically less than 5 out of every 10,000 people – ¬it is estimated that perhaps around seven percent of the global population could be affected by a rare disease,” explains Geinoz. Indeed, in Switzerland, the number of patients affected by rare diseases is estimated to exceed half a million which more than the volume of people with diabetes (some 4 percent of the Swiss population).
What’s more despite the barriers encountered, Dipharma has hit upon a way to increase the uptake of genericized orphan drugs. “We strive to offer a superior quality, such as for example a superior purity. Purity is especially important because when you take a product for life, who knows how much and what impurities might accumulate in your body and what their effect will be in the long run. By making patients and physicians more aware of issues like this we stand a good chance of changing hearts, minds and behaviours.”
“I do foresee a trend towards regionalizing supply chains,” agrees ten Kate. “In recent years, supply chains have become extremely globalized as drug makers sought to contain costs and procure raw materials cheaply. However, a counter trend is starting to manifest itself. Already the industry has become hugely dependent on China and India for APIs and people are suddenly starting to question whether this is a good idea after all. Companies and even governments are seriously considering regionalizing their sourcing, manufacturing and supply chain and, within Europe, Switzerland stands out for its guaranteed quality, reliability and security.
One company that is now winning plaudits for having resisted the urge to outsource everything to Asia happens to be Novartis’ generics subsidiary, Sandoz. “Unlike some of our more opportunistic international competitors, Sandoz has always maintained a strong manufacturing base in Europe and has integrated supply chains in key areas like anti-infectives and biosimilars. Strong regional manufacturing networks and dual sourcing strategies allow us to avoid putting all our eggs in one basket and this helps us to secure sustainable supply in volatile and critical times such as these. As a market leader in Europe, we are aware of our responsibility to provide access to high quality medicines and continuously invest in localized capacities and capabilities,” confidently declares Jan Tangermann, the company’s country head.
Financing Swiss Healthcare
Switzerland’s public healthcare apparatus is renowned the world over for its sheer quality and the unprecedented levels of choice afforded both to patients and physicians, but long-standing concerns about how to sustainably finance such a system in the modern era risk tarnishing a well forged reputation. Just like in most parts of the developed world, public healthcare costs have been rising exponentially and opinions remain divided on who should be picking up the tab.
“In terms of the Swiss healthcare system itself, I have definitely been struck by how patient-centric everything is. In general, doctors here can choose what they consider to be the best treatment option for a particular patient. Quality of care is tremendous and access tends to be possible some way or another, even for the most innovative of medicines,” muses Katrien de Vos, country president of AstraZeneca. “The big question is what’s the optimum economic mechanism to sustain such standards.”
“Switzerland essentially wants to have its cake and eat it – paying less for healthcare without seeing a corresponding drop in quality. People’s expectations are of course very high, but they are loathe to see their heath payments increase… ultimately we are a rich country that can afford high-quality healthcare and, while some sort of cost-containment measures are clearly an imperative, they need to be implemented in a smart way, which means fairly and not to the detriment of innovation,” argues Interpharma’s René P. Buholzer.
What then does the current financing landscape look like? For a start, basic health insurance is compulsory for all residents in Switzerland. “Currently, there are more than 50 insurers in Switzerland offering plans for this compulsory basic insurance. The basic insurance tends to cover around 40 percent of healthcare consumption and everything beyond that needs to be covered either out of pocket or through additional insurance plans,” explains Pius Zängerle of curafutura, one of the two largest Swiss health insurers’ associations.
“The ecosystem of basic insurance is also very competitive because every Swiss resident is able to change their insurer every year, and every insurer is obliged to release anyone that wants to leave and to accept anyone that wants to enter. Therefore, insurers are incentivized to compete in terms of service delivery and so on,” he adds.
Then, of course, there is the much-contested role of the pharma industry. “Swiss pharma contributes disproportionately to cost containment, more than any other actor in our country’s healthcare system. Switzerland’s Health Minister has stated several times that the pharma industry saves the system more than CHF one billion a year through the regular price reviews; a pretty impressive number considering that pharma represents a mere 12 percent of total healthcare costs,” argues Buholzer.
Meanwhile, many point out that there is plenty of scope for healthcare rationalization and cost savings. “I would say that Switzerland’s inpatient sector is currently over-resourced due to the way the hospital sector is being financed. Cantons currently cover 55 percent of all inpatient costs but zero percent of outpatient costs. This of course incentivizes insurance payers and their patients to prefer inpatient services, which is not ideal because of the high costs associated with hospitalization,” reasons Pius Zängerle.
There may soon be some movement on that front, however. A newly proposed legislation actually suggests standardizes the financing system across outpatient and inpatient sectors, with cantons covering 25 percent of both sectors and insurers covering the remaining 75 percent.
Swiss influence also extends to specific therapeutic areas. The country’s prowess in leading the charge against one of biggest and trickiest public health challenges of our time, cancer, is especially noteworthy. This has been party driven by the manner in which the two most successful and iconic Swiss drug developers – Novartis and Roche – have placed oncology front and centre of their portfolios. “With our recent acquisitions in the field of radioligand therapies, Novartis Oncology is now uniquely positioned to deliver and develop innovation across all four technology platforms in the oncology space; that is radioligand therapies, targeted therapies, immuno-oncology therapies, and cell and gene therapies. To my knowledge, no other company can boast all four platforms in house. This gives us the unique opportunity to explore a combination of these platforms in the future,” enthuses Vincent Gruntz, general manager of Novartis Oncology.
Switzerland’s dominance in oncology is just as forcefully reflected in the singular focus of countless smaller innovative entities such as Ichnos and ADC Therapeutics. The fact that the Swiss pharma industry has taken on such a task speaks volumes about the community’s ambitions and its desire to shape the future of medical science. “The global unmet medical need that exists in oncology is gargantuan despite the numerous innovations of the last three decades in chemotherapy, small molecules, biologics, and cell therapy. The survival curves of many different cancers are still not yet where anyone would like them to be and, for most cancer patients, once their cancer becomes metastatic, there is no plateau in the survival rate. Additionally, there are very few long-lasting complete responses in cancer, which is the first step to curing the disease. Although oncologists have managed to prolong the survival of many cancer patients, have shrunk tumours, and been able to keep the disease under control, we are still far from being able to offer a cure in the majority of cases, so this quest represents one of the defining tasks of the current era of medical science,” reflects former Ichnos CEO Alessandro Riva.
The sheer volume of oncology-related innovations that have come out of Switzerland to date is deeply impressive. Novartis has, of course, led the way in pioneering CAR-T therapy, – whereby cells are taken from a patient, modified and injected back – and the fact that the country nowadays boasts one of the highest densities of centres certified to treat patients with CAR-T therapies worldwide, is perhaps emblematic of the gusto with which the country seems to have embraced such a novel, and often controversial, technology.
Away from the limelight, however, a plethora of other cutting-edge innovations are in the works. Take, for example, ADC Therapeutics, a clinical-stage oncology biotechnology company leading the development and commercialization of next-generation antibody drug conjugates (ADCs) with highly potent and targeted pyrrolobenzodiazepine (PBD) dimer technology. Incorporated in Switzerland back in 2011 the company has managed to file – on average – two INDs per year ever since and has been trailblazing a new front in the war on cancer.
“In a way, antibody drug conjugates are a simple concept. There is the antibody, which binds to a protein that is exclusively or predominantly expressed on the surface of tumour cells. To use an analogy, it acts rather like a guided missile. It finds and binds to the tumour cell, where it becomes internalized, and then the enzymes in the cell release the toxin into the cell, so that it can kill the tumour cell,” explains Chris Martin CEO and co-founder of ADC Therapeutics.
Ichnos, for their part, have chosen to focus upon one of the most transformational approaches for haematological malignancy patients today and potentially in the future for solid tumours. “This mechanism involves what we call immuno-cell engagers and immuno-cell modulators which may enhance the patient immune system to ultimately kill cancer cells,” explains Riva. “In the clinical setting, this approach is already showing itself to be transformational in terms of long-lasting complete response rate and is a strong candidate to move the needle on haematological malignancies. Additionally, we have a proprietary platform which, from an antibody engineering perspective, allows us to build up different molecules around immuno-cell engagers and immuno-cell modulators,” he elaborates.
Light Chain Bioscience, meanwhile, focuses on the identification and development of bispecific and multi-specific antibodies using their proprietary format called the Kappa-Lambda body™ platform. “There is no question that bispecific and multi-specific antibodies represent novel modalities that enable unique modes of action and possibilities for therapeutic intervention against cancer,” explains CEO Nicolas Fischer. “Our contribution has been to develop a multi-specific format maintaining the natural structure of a human antibody to generate drug candidates that will have a higher likelihood of success in the clinic. Our platform achieves this by delivering bispecific antibodies fully retaining the natural sequence and structure of human antibodies, without a single modification. To build and isolate these unique molecules, we rely on the use and properties of antibody light chains,” he clarifies.
With the sheer volume and tempo of innovations taking place, Switzerland has naturally become a magnet for oncology-focused firms from all around the world. Anglo-Swedish drug maker AstraZeneca’s steadfast presence is rather illustrative of this. The company which excels in early curative treatment of lung cancer finds Switzerland an especially fruitful place for cancer-related clinical trials. “Right at this moment in time, we have around 40 on-going in-country clinical trials for oncology and increasingly, we are looking to locate our Phase III trials here based on the sheer quality and accumulation of expertise within the Swiss centres. Although Switzerland might seem a tiny market in the grand scheme of things, because of its strength in oncology, it plays an outsized role in relation to our overall strategy,” confides Katrien de Vos, the company’s country president.
“AstraZeneca’s focus is on some of the most hostile and hard-to treat cancers including lung, breast, ovarian and certain blood cancers and it is absolutely no coincidence that we have set about establishing such a strong commitment with the excellent in-country research groups and institutions to advance clinical and real world data,” she adds.
One key feature of the Swiss oncology space is also the tendency for companies to join forces and pool research and resources to attain shared outcomes. “The advantage that we have in Switzerland with its strong bedrock of companies is that we can advance the field together. No one company can improve cancer care alone; it has to be done by a full ecosystem of different players,” declares MSD’s Ans Heirman.
“We definitely don’t see ourselves as competing with alternative cancer breakthroughs such as cell therapy,” agrees Riva. “That is not what this is about: we are convinced that both approaches can move the needle for patients, both as a mono-approach as well as a sequential approach. Once both approaches are approved, we can envisage a sandwich like scenario where immuno-cell engagers or modulators are administered both as induction to reduce the tumour burden before cell therapy and as maintenance after cell therapy.
Riva also points out that bispecific antibodies offer the opportunity to work at a different velocity; they can be quicker than cell therapies as they offer more flexibility to design new medicines. “As we learn more from cell therapy and from immuno-cell engagers, we also will learn how to categorize the patient populations that may benefit more from one approach. Always, we aim to interlock other approaches; we are not here to compete against other pharmaceutical companies but to fight cancer,” he insists.
That is not to say that the country does not also have its shortcomings. The gap between stellar innovation and ensuring access to novel technology for the domestic population is widening and, if left unchecked, threatens to destabilize a finely set equilibrium that has thus far served the Switzerland so well. One particular pain point being reported by many industry stakeholders is the current length of time being taken to receive decisions on reimbursement.
“In 2020, only 11 percent of new innovative products were reimbursed within the legal 60-day period following Swissmedic approval. This is unacceptable for Interpharma and for patients,” declares René Buholzer.
Moreover, this is an issue that has been coming to a head for some time. “Even back in 2019, originator drug developers were seeing a large backlog of products not being reimbursed,” confirms Biogen’s Katharina Gasser. “11 of the 46 applications were admitted within the official timeframe, over half took longer than 120 days and there is a backlog of 136 new active substances not yet listed on the specialty list. The technical and medical progress that has been made in drug development is really exciting, but the reimbursement procedures simply have not yet caught up and this is having very detrimental consequences.”
Equally concerning are the mechanisms being deployed to price latest generation therapies that don’t neatly align with existing reimbursement criteria. “Today, there are basically two primary mechanisms for drug reimbursement in Switzerland: foreign price comparison across a basket of European countries and therapeutic price comparison. As we move forward, however, particularly as products become more sophisticated and more tailored to individual patients, we will require fresh models,” warns BMS’ Remo Gujer.
Already there are examples of this happening. “Therapeutic cross-comparison reaches its limits when assessing newer and more complex therapeutic approaches. It especially doesn’t work when you bring a completely new treatment option without any comparator therapy on the market, or when you have a combination treatment,” observes Roche’s managing director for Switzerland, Thomas F. Schmidt.
His company has therefore been advocating for an altogether alternative approach. “We have started a project on value-based healthcare with the University Hospital of Basel to look at what creates value for patients along the entire patient journey and how we can take a more holistic approach instead of seeing the patient journey as a series of single decision points. The idea is to generate much more value for patients and increase efficiencies across the system so that overall costs are lower – to everyone’s benefit,” he explains.
Nonetheless Novartis’ experience getting its much-celebrated CAR-T therapy to market is rather revelatory and has shone a light on the current challenges that exist. “Swissmedic gave fast approval but having submitted the reimbursement application for the CAR-T therapy as a drug, we were then made aware during the process that it needed to be applied for as a medical service instead. This requires a fundamentally different route. In the end, we had to find a solution, together with all the health insurance companies and the individual hospitals, which was extremely time consuming and all in all a pretty difficult feat,” recounts Vincent Gruntz. That an inherently Swiss invention should be subjected to such trials and tribulations in its home market hardly sends out a positive signal.
While some might dismiss these reservations as of little consequence in the grand scheme of things given Switzerland’s tiny population and correspondingly small domestic market size, that risks forgetting that what makes Switzerland so special is not one single factor, but the constellation of many factors working together in unison. Upset the fine balance and weaken investor confidence and the effects could potentially be far reaching.
Another concern for many market insiders is the prospect that Switzerland might be getting left behind with respect to digital technologies. “The pharmaceutical sector is going through a technological transformation and it’s not just about novel treatment modalities that can further address diseases with high unmet medical need. It’s also about health data utilisation and it’s imperative to keep pace with this digital transformation,” argues Remo Gujer.
“Switzerland excels in R&D but when it comes to issues like digitalization, electronic data management, and so on it is extremely easy to get left behind… There is an avalanche of healthcare data available out there these days, but frankly not enough is being collected or used in an integrated manner that is interfaceable between the different actors across the healthcare system. We simply must not let this opportunity pass us by,” he counsels.
“On digitalisation, we are already a laggard,” bemoans René Buholzer. “The Bertelsmann Foundation’s index on digital health shows that we are in a bad position compared to other European countries. Countries like Denmark with more centralised systems as well as the Baltic nations that have a more greenfield approach perform well, but so does Canada, another federalised state so we really have no excuse… electronic patient records should have been here a long time ago. Most cantons still have not implemented them.”
Others, such as MSD’s Ans Heirman, have arrived at much the same conclusion that Switzerland risks missing out. “In Switzerland, the data is more scattered and there is not a unified platform. I am convinced that data – not only from clinical trials, but real-world data that shows the uses and outcomes of products in real world patients – is an important element for the future. Data will be key to improving both cancer care and the efficiency of the overall healthcare system,” she thinks. “As an industry, we need to work on connecting the dots and making data available in a safe way for research purposes as well as for healthcare efficiency optimization purposes, from which the entire society benefits.”
Roche’s Schmidt very much agrees. “We want to see a stronger and better digital infrastructure for the collection and analysis of health data, including electronic patient records, interoperability of systems and so on. This is a key element in terms of how we can help develop the overall system and deliver broader access to the right treatments to the right patients at the right time.
Luckily, certain companies are already working hard to help bridge the gap. BC Platforms which strives to become the world’s largest federated data network is one such outfit. “Our role is highly connected to the life sciences, ensuring that the data generated gives clinical decision makers the opportunity to give the right medicine, at the right time, at the right dosage, to the right patient; thereby maximizing treatment outcomes, accuracy and quality. The biggest value that we bring to life science research is related to time. With the blockbuster era receding and the regulatory bar rising, data and technology is crucial to helping drug developers navigate a more complex environment,” explains CEO Tero Silvola.
“Our aim was to ensure that genomic data is utilized as effectively as possible and make precision medicine a reality. The production process of genomic data has gone through a massive change in the past ten years. When we started with BC Platforms, the unit cost for producing the complete DNA sequence for one sample was in the millions of dollars. However, today the price tag is around the same level as an MRI image; below USD 1500 per sample and declining. Therefore, we predict that there will soon be an explosion of integrated genomic and clinical data. Our job is to make sure that service providers such as hospitals can integrate and provide a workflow from these tools to actionable insights as effectively and reliably as possible,” he continues. Doing so, he believes, would create ‘infinity loops’ between the interconnected sectors of healthcare and life sciences. Everything we try to solve in healthcare will serve life sciences, and vice versa, he predicts.”
Ultimately then Switzerland has much to be proud about and continues to display an embedded excellence even during the most turbulent of times. It must not however let itself become the “sleeping beauty” who loses her luster by resting on her laurels. “Right now, everything works pretty well here and we are very well positioned in various competitiveness and innovation rankings, but we perhaps need to wake up and look more towards our most formidable competitors like the US, UK, China, and Israel. While we still offer something special to investors and entrepreneurs who seek to create breakthrough medical science, there is always the risk of complacency setting in,” notes Debiopharm’s Bertrand Ducrey.
“Almost everywhere you care to glance – whether it be the strong academic and clinical research setting, the propensity towards innovation, the robust infrastructure, the deep talent pool or the accommodating political system – Switzerland boasts some fine credentials, but the onus is on all of us to ensure that the country continues to operate to the maximum of its potential,” concludes J&J’s Michael Hübner.
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