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Episode 9: BioNTech and Beyond

- August 2023 -

After the success of previously unknown biopharma company BioNTech in combatting Covid, Germany is back in the spotlight as “the world’s pharmacy.” But what comes next for the sector?

After the success of previously unknown biopharma company BioNTech in combatting Covid, Germany is back in the spotlight as “the world’s pharmacy.” But what comes next for the sector? And how can international health-sector companies profit? We talk to the world’s oldest pharmaceutical company Merck, a serial entrepreneur and a biotech journalist about personal medication, international partnerships and mRNA technology and its potential for fighting cancer.

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Our guests

Das Nutzungsrecht an die Merck Healthcare KGaA über.Bei Veröffentlichungen weisen wir auf die Namensnennung "©Lichtbildatelier Eva Speith, Darmstadt". Dies ist ein eingebettetes Bild | © Lichtbildatelier Eva Speith, Merck Healthcare KGaA

Laura Matz

Laura Matz is the Chief Science and Technology Officer for Merck, Darmstadt, Germany. An executive vice-president, she’s responsible for the corporate innovation teams including the digital office and new digital business models. She has 20 years of experience in semiconductor manufacturing and a decade of experience running semiconductor materials businesses. She has a PhD in analytical chemistry from Washington State University.

 

 

 

Porträtfoto Maike Becker Krüger Dies ist ein eingebettetes Bild | © Maike Becker Krüger

Maike Becker-Krüger

Maike Becker-Krüger studied International Relations at Lake Forest College in Chicago and at Franklin University in Switzerland. This was followed by an MBA from Quadriga University Berlin. She worked directly for state premier of the regional German state of Hessen before taking responsibility for European policy coordination within the national government. Starting in 2015, she has built up the capital city office and the Corporate and Government Relations Berlin department at Merck. Since 2022, Maike Becker-Krüger has been Head of EU & Germany Corporate Affairs.
 

 

Porträtfoto Oliver Schacht Dies ist ein eingebettetes Bild | © Oliver Schacht

Oliver Schacht

Oliver Schacht is a corporate finance professional and expert in the molecular diagnostics industry and CEO of OpGen. He has co-founded several start-up companies in biotech, clean tech, IT and education in Europe and the US and has experience in developing and implementing commercial strategies and financing measures (including two IPOs). He also serves as the chairman of the Board of Internal Council of Biotechnology Assocations and the president of the German industry association BIO Deutschland. He studied European Business Administration in Reutlingen and London and holds a PhD from Cambridge University (UK).

 

Porträtfoto Dr. Georg Kääb, Biocom AG Dies ist ein eingebettetes Bild | © Georg Kääb, @ Biocom AG

Dr. Georg Kääb

Dr. Georg Kääb studied biology in Regensburg and Munich and earned his doctorate in neuroimmunology. After freelancing for the Süddeutsche Zeitung newspaper, he became editor-in-chief and co-managing director at the Association of German Biologists. From 2007 to 2021, he headed the communication of the cluster organization BioM (Martinsried), was managing director of the Biotechnology Cluster Bavaria and spokesperson for BioRegions in Germany. Since autumn 2021, he has headed the editorial team of the biotechnology magazine division at media company BIOCOM AG.

 

Transcript of this episode

Presenter: Hello and welcome to “Into Germany.” The German business podcast brought to you by Germany Trade & Invest, GTAI, the German government’s international business promotion agency. I’m Kelly O’Brian!

Today we start at the speed of light – or to be more accurate “Project Lightspeed”. It was born on January 24, 2020. Back then, most people thought all was well with the world. There was a mysterious, fast spreading disease in Wuhan China. But only a few scientists were worried about that. Among them an entrepreneurial couple in the German town of Mainz:

Uguar Sahin: I did some calculations … and after that I knew: The virus had already spread worldwide.”

“On the weekend we started with our team to work on the development of a new vaccine”

Özlem Türeci: “We approached Pfizer at a very early stage when nobody believed a new vaccine would be needed.”

The voices we just heard are those of two heroes. Dr. Özlem Türeci and her husband Dr. Ugur Sahin helped create one of the first and best coronavirus vaccines on the market thanks to novel mRNA technology. They saw a way of harnessing the potential of this novel technology for preventing Covid 19 – as fast as humanly possible.

Özlem Türeci: “We called our program Lightspeed. That’s the fastest way possible - this was what we aimed for.”

A small cutting edge biotechnology company in the western German city of Mainz proved quicker than scientists from all over the world. Türeci and Sahin’s firm BioNtec teamed with Pfizer to produce one of the two major Western coronavirus vaccines. It put Germany back in the spotlight as “the world’s pharmacy” - a title lost to China, the US and other countries some time ago.

So, what’s next for German biotechnology? It there another BioNtech in the making?

Oliver Schacht: That's a true global champion, a multibillion dollar organization that made a massive impact. But also there is a great number of very successful global biotechs.

Georg Kääb: This was, I think, really a let's say, a hallmark for the also for the German biotechnology on a global scale. But there is more than only Biontec in the German landscape,.

This is what two biotech experts say: journalist Georg Kääb - and Oliver Schacht from Germanys Biotech Industry Association. They’ll discuss the lay of the land and Germany’s thriving startup hubs.

But first we go to a city near Mainz – to Darmstadt. It’s home to the headquarters of the Merck Group – the world’s oldest pharmaceutical and chemical company. Founded in 1668, its still family run and known the world over. In the United States and Canada they operate as EMD and Millipore Sigma.

Laura Matz and Maike Becker-Krüger are here to tell us about the scientific and business side of the company..

So, hello Laura. Tell us a bit about yourself please.

So I'm Laura Matz. I'm the chief science and technology officer for Merck. And that means that I get to work across our three unique sectors in electronics, life science and health care,.

Maike, maybe I hand it over to you.

My name is Maike Becker-Kruger. I had the corporate affairs function for the company, for EU and Germany. So what Laura just just hinted on is sort of my task,.

To position the company right with across all three sectors that we're, that we're engaged in in these not only regulatory but only also political fields and ecosystems.

So, Laura, are we right to think Germany is currently experiencing a biotech boom?

Laura: We've seen a significant acceleration in biotech with the with the pandemic. That was a super interesting time from a scientific perspective over the past several years, as you know, kind of the entire biotech and health care industry dealt with the realities of COVID and how to solve that problem very quickly. And I think, of course, with BIONTECH, but also with the broader capabilities that were needed to support the overall pandemic, of which, of course, Merck was a key, key contributor as well.

And we really saw that companies, academia, governments came together to really solve and drive the problem forward.

Of course, we had to get a vaccination out to the entire population and in record time,.

And I think Germany was one of the countries that really took initiative and ownership to really to really drive that forward.

This is I mean the new buzzword in town. The German speed that we're that we're looking for and not just right for LNG terminals, but also I think in terms of when we look at the biotech that that we're talking about right now, which is absolutely essential, as we've seen in the pandemic,.

The question, of course, we have in front of us as the biotech industry and health industry, is how do we replicate that response in a more normal time.

How do we make sure that we keep that sort of urgency, that collaboration to solve the bigger problems like cancer.

Laura, what was Merck’s role in the combating of the pandemic?

One of the I think the big recent contributors for the mRNA vaccines was that our life science business manufactures the lipid nanoparticles. So these are the products that carry the the RNA for the for the vaccines. And this has been I think we have invested quite significantly. We're a leader in this area and we continue to really develop the future capabilities that will even broaden the opportunity for RNA therapies.

Generally speaking, where is Merck headed? And where is German biotech headed?

Laura: So we're in electronics and specifically focused on semiconductor. So in that area, of course, AI being kind of a key element of really driving many different technological advancements we make, as Mark says, the materials that go into many of the devices that are now being used for the computations on an artificial intelligence in the life science side.

Laura: We're working with all major biotech, academia and pharmaceutical companies to really solve kind of the future health care, health care and biology problems.

Laura: Many of the learnings that we have from health care can go much broader into the agricultural impact as well. Specific gene design for targeting the right kind of modified plants, that's not something that we as Merck we necessarily do. But. I think a lot of the scientific discovery that we're making in the health care and life science base can have a broader impact. And in our broader life science portfolio, we really work with academia across all different scientific sectors to to enable the materials and chemicals infrastructure that that's needed. And so we work very closely with customers to enable those advancements in the food sector, in the energy sector as well.

Maike: Absolutely. I think if we look also into genome editing and the biotech we do there, it's also it makes a huge difference what kind of what kind of GMO division, if you want to call it, that you actually tackle, especially in Germany. If you tackle it from a pharmaceutical side and the advantages that that brings, it's also a different story than if you actually talk about GMOs in agriculture and in food, right?

So I think that the possibilities we have with our ethics board and the ethics advisory panel that we give ourselves in that sense for the pharmaceutical and biotech in that sense, I think can be a really a model and is something that Germany is properly also set up in mirroring this in terms of of an EU and global scale.

Laura: I think the question we have we have in front of us is: How does how does Germany enable those future advancements and still continue to bring all parts of the ecosystem together to solve those scientific challenges? And Maike, I mean, maybe you see this in your government work today, so maybe you can also comment.

Maike: This is obviously something that we bring out to to the political stakeholders and engage with them to say this. And you have, you have a great industry here that is, that is home, that is based in Germany, that has a really good advantage. Also in terms of competitiveness for the single market, if we talk Europe. And how do we how do we bring this forward now?

How do we sort of institutionalize it in a certain German but simultaneously new, un-German way to say we need to, we need to enable.

Right. We we shouldn't be looking for how do we regulate ourselves towards innovation, but how can we actually enable it in a positive mindset? And we've shown that we can do it.

So German regulation is too rigid? But BioNTech was famous for its speed...

Maike: These are these are opportunities that we need to link, if not European, globally. These are these are advancements that are going to be even better, even faster, even more strategic if we join global forces on them. This is this is like viruses, bacteria. They don't they don't stop at the German border and say, I'm going to return to Berlin and see what I can do there. Right. So this is this is something where I think we also need to make sure that whatever ecosystem we're setting up. A has in its tangents, a connectivity to what we have on the European scale and what we have on the global scale. And for us as an international operating company, this is in our DNA anyhow,.

Subsidies are everything. Companies just go where the most free money is… Or am I wrong?

Laura: We've seen this with semiconductor, with the response to where you localizing semiconductor manufacturing and that being driven in Germany, definitely in the EU as well as as well as the US. And the subsidies are important, but also in the context of what kind of capabilities, infrastructure, talent is needed to support and to support those industries. And so it can't be just about subsidies.

It really has to be around what's the total structure to make it impactful for the society.

Interestingly, for me, maybe you can tell from my accent I'm an American. I've been here now for almost a year and Germany has such a rich history of scientific capability, strong academic presence with the universities. And there's really a very important talent population in Germany. And so that is a really strategic advantage.

Maike: If we look at German funding, if we look at European funding, there's plenty there's plenty of not or not fully used untapped pots and buckets of money that that that are that can be put to work. So in some ways it might be a question of refocusing these budgets, but overall they're there.

Laura: It really takes a partnering approach, I think because it's probably not the case that the best minds are only in the US or only in Germany, and that the innovation is how innovation typically happens is a great idea or scientific discovery happens in one place and then it's built upon somewhere else. And so having the right partner in the right ecosystem really becomes critical to drive scientific discovery for the next round of challenges that are being faced.

Maike: Exactly what Laura said. It's about cooperation and it's about connecting. Connecting the brilliant minds together with the scientific basis that we have in Germany.

Okay so partnering on a global scale will be one trend. What else will change in biotech?

Laura: I mean, one thing we didn't talk about was data and kind of the. Policies around around data usage in health care.

One of the trends we see to enable kind of therapeutic advancements in the future is to understand more about the patient population, specifically the impact from from specific genetics, environmental factors. And being able to bring the patient data together in a anonymized and of course, secure way, but also to be able to be utilized by researchers for scientific impact. And this is something we have a specific business called centerpiece, where we're working with medical institutes to enable that secure use of aggregated and anonymized patient data.

We can have confidence in the privacy of individual people's data, but still be able to aggregate and utilize the data for scientific discovery. That maybe wasn't true 20 years ago, but it is today.

That's something that goes hand in hand with policies around data privacy. And various countries have taken different approaches on that. Maike, I don't know if you want to comment on specific Germany policies or process.

Maike: Well, I think when it comes to data Germany also always has a careful to say single role, but definitely a very prominent role when it comes to Data. Normally nobody wants to share his or her data, but as soon as you sort of have a personal need and concentric circles to your relatives and you are actually affected by a disease, you're very willing to share that that data in order to improve therapies. Right?

Laura: Right. You need to know the biomarkers. You need to know the history of the patient. Even for myself, I hope that comes a day where they'll know exactly how much if I have cancer or something, that they'll be able to say this is the exact amount that that you need. So you don't have negative effects, but you also target the cancer cells in the most effective way. And that's where utilizing this data now will help us get to that point in the future.

Well, thank you, Laura, thank you Maike for sharing those insights with us.

Thank you. It was really our pleasure to join you.

Lesson one today: data-sharing is key to personalized medication. And tomorrow’s biotech will be even more international. But before we ponder the implications of that, it’s time for a high-energy round-up of some of the top business stories from Germany.

R and D Record

German government spending on ENERGY research and development reached an all-time high of just under 1.5 BILLION euros in 2022. That’s according to the Ministry for Economic Affairs and Climate Action. Funding was doled out to major corporations and world-leading research institutions, but small to medium sized companies also took home 300 million euros.

Green Steel

Pending EU approval, the German government is looking to put billions into decarbonizing domestic steelmaking. Salzgitter Flachstahl has already been granted more than one billion Euros. And the state wants to funnel over TWO billion to Thyssenkrupp Steel Europe as part of a hydrogen-related Important Project of Common European Interest, or IPCEI.

Heating Transition, Part 1

Three-quarters of newly built residences in Germany now get at least some of their heating from renewable sources. So says the country’s Federal Statistical Office. And more than 60 percent of new residences use renewable systems, including ground or air heat pumps, solar, wood, biogas/biomethane and biomass, as their PRIMARY source of heat.

Heating Transition Part 2

Staying with the topic, municipal utility companies and the state want to see 100,000 additional German homes a year connected to district heating. Only 14 percent of German residences use district heating. That compares with 65 percent in Denmark. Huge projects are underway to this end. The Rheinenergie ultility company, for instance, is building Europe’s biggest-ever heat pump in Cologne.

And finally Silver Screen

National Geographic magazine has commissioned a documentary film about none other than BioNtech’s founders Uğur Şahin and Özlem Türeci. The documentary will be directed by award winner Patrick Forbes. Having helped give the world one of the major vaccines against the coronavirus, the scientific and entrepreneurial couple is now trying to find a cure for cancer…

Presenter: So, you see German biotech can make you not only wealthy, but famous. Here’s a bit of background. Before the Covid outbreak, BioNtec primarily worked on mRNA based drugs against cancer, and they never stopped this research. Now it’s a focus again.

So, can BioNTech achieve a second triumph? Can anyone make a big breakthrough on cancer? Lets ask Oliver Schacht, a German serial biotech entrepreneur.

I think that we proved to ourselves that we can truly build global champions that are multibillion dollar companies. And I think we'll be able to do it again, whether it's an mRNA technology in cancer, whether it's in cell therapy, whether it's CRISPR costs, gene editing, you know, a lot of that science, a lot of that technology was developed in Germany.

So it was no accident that the first vaccine was developed in Germany?

No, this was no accident at all. In fact, it was no accident that it was Biontech. Because if you look at the story and I know both Ugur Sahin and his wife, Özlem Türeci, they were entrepreneurs, you know, before Biontech started, the company sold that. And then when Biontech was founded initially, typical German, very humble, very frugal, small scale financing. But very early on, investors saw the potential of the technology and invested big. If Biontech hadn't already been a significant sized organization with more than €100 million of funding and global partnerships, we should never forget the Pfizer partnership was already in place. They had collaborated for a couple of years prior to COVID. That was the only thing that allowed both Pfizer and Biontech to move at literally lightning speed and literally on a handshake initiated collaboration early on in 2020.

How important was the partnership with Pfizer, with big US-pharma?

That really helped when the resources were made available to then go through this whole process in record time. Pfizer for certainty, for clinical trials, regulatory submissions and global distribution. But also when you look at the scale up story, and that's when you asked, is it an accident that this happened in Germany? No, Germany has some of the oldest, most traditional and most successful vaccine companies in the world. When you look at the acquisition that Biontech made off Bering Werke in Marburg, which is a traditional vaccine plant with hundreds of people, established production facilities, a full team of hundreds of employees, you know, again, taking something that was classic industrial already scaled up and integrating it into a setting with new technology and a new type of vaccine really made this possible. And building this all from scratch would have likely failed, at least not succeeded in this short period of time. So again, this was a combination of big corporate with Pfizer, innovative biotech, with Biontech and traditional vaccine capabilities in Germany with the Marburg facility.

You yourself merged of your German business Curetis with the US company OpGen. Could you tell us a bit about you and your business?

Im a serial entrepreneur in the biotech industry. I started my first biotech 25 years ago in Germany, in Berlin. A company called EPI Genomics, which quickly became a global company with U.S.-German operations spent seven years in Seattle running the Epigenomics U.S. operations and then spent ten years in infectious disease diagnostics with Curetis in southern Germany near Stuttgart until we merged that with a U.S. company option here in Maryland, which is where I'm based now. So I am back in the U.S. set up that trans-Atlantic bridge. And in addition to my day to day job as an entrepreneur, I also serve as the president of the German Biotech Association Bio Deutschland, as well as the chair of the International Council of Biotech Associations here in Washington, D.C..

What’s that company doing today?

We're doing infectious disease diagnostics. So hospital superbugs, not virus testing. We did have a COVID test, but normal times we detect bacteria and antibiotic resistance. So again, the superbug in hospital that kills patients because antibiotics no longer work. We brought our platform to market in Germany and Europe, internationally Middle East, Asia and in the U.S. But we'd always wanted to bring the company to a U.S. stock market listing. Now, when that was not possible initially in 2015, we IPOed Curetis on Euronext in Amsterdam, in Brussels, but then in 2020 we merged it with OpGen here in the U.S. whereby we used Option NASDAQ listing in the capital markets and brought our technology, our products into the combined entity. Today OpGen is the U.S. parent organization NASDAQ listed.

Critics say a US listing is the end of many German success stories… What do you say to that?

We did consciously transfer all of our R&D, all of our manufacturing and all of our international global distribution outside the U.S. into Curetis in Germany from the U.S. because it is cheaper to do it in Germany. It's the best of both worlds. You know, really the talent pool and technology in Germany combined with the capital markets and commercial powers here in the U.S..

Where is your manufacturing site in Germany?

Our facility in Germany is in a beautiful small town called Bodelshausen, right at the foothills of the Schwäbische Alb. You know, you have Schloss Hohenhzollern, Castle, right on the hill, there is a tremendous pool on the hill. There is again of talented medical device manufacturing operators. There was about 60 it's called Medical Valley. There was about 60 medical device and technology companies over there. And we manufactured products here in the U.S. at literally twice the cost in an R&D environment, which in Germany, the facility is not just inspected and audited to European standards. It's been inspected by the U.S. FDA.

Does Germany still have some catching up to do? Compared to the US or China, the German industry is relatively small…

If you compare the German biotech industry to the U.S. biotech industry, of course, we're behind. There is no denying that. We probably have, I don't even know, 20 to 30 publicly traded biotech companies in Germany. There is 900 publicly traded biotech companies here in the U.S.. You're not going to catch up on that. But within Europe, Germany has one of the strongest, definitely broadest biotech industries.

Let’s talk about the German startup community. Is it fit for global competition?

A lot of German biotech companies out of necessity from day one while they get started in Germany with all of the great ingredients of fantastic research, great science, great technology and early stage support immediately take a global perspective. You cannot develop a biotech company, whether it's a pharmaceutical company, developing new drugs or a diagnostics or device company or vaccines. You always have a global market and a global commercial path in mind. So partnerships with big pharma, with big diagnostics, with big vaccine players are always an integral part of our business plans.

Germany used to be the home of big pharma…

Well, we used to be the pharmacy of the world, die Apotheke der Welt, and we lost that status.

A lot of the pharmaceutical industry is clearly dominated by U.S. players. Not too surprising. There is a lot of collaboration, strategic alliances and partnerships between German biotech and U.S. Big Pharma and U.S. big biotech.

In which sectors do you see companies in Germany that have the potential to become the next BioNtech?

There is no particular sector. We've got great therapeutics companies, we've got great diagnostics companies. If you look at the large one of the large players in cryogenics, you know, they're a research product as well as a diagnostics company comes out of Germany.

There is a great number of very successful global biotechs, the likes of Kiagen, Evotec, Morphosys, and then hundreds of startups. In a lot of cases that newer generation, which Biontech is a part of companies like immatics or Inflarx or Icarus. There's a lot of success stories there that have been built over more than a decade with sufficient capital to really get to critical mass.

Here’s a general question. Is German biotech more about bio or about tech?

Biotech goes well beyond human health. We've got great biotechnology companies and startups in areas such as industrial biotech for enzymes and manufacturing processes like brain. We've got fantastic startup companies in the novel food area. Food and food security will be one of the leading sectors. Technologically, I think we have definitely the potential to build the German biotech industry from its current base, where we have, you know, literally more than more than 400 biotech companies in Germany into a universe of biotechs that will have more than just a handful of BioNtecs.

What needs to be improved for Germany to keep growing its biotech sector?

We've got all of the fundamental ingredients of success. Let's just get better, faster, more agile. Why is it not possible in Germany to start a company digitally within 24 hours? Here in the U.S., you can start a company literally in 24 hours. And several European countries have demonstrated that that's possible as well.

You have got to get faster. You have got to get leaner.

Well, we’ve already heard of the new German speed while talking to Merck. But how do we get startups to grow big?

We're really good at basic research. Fantastic research institutes were really good at starting companies. Where Germany continues to struggle is the scale up. And that's, in my view, where potential collaboration or even strategic business transactions between German biotech and international, especially U.S. companies, come into play.

Any hot tips for us?

There's a whole universe beyond classical sort of therapeutics biotech and you know, they're coming up by the day. There's probably by now two dozen. A lot of them still very small, very early stage startups. And again, part of the struggle, some of these companies then had to look to markets such as Singapore for a first product approval,.

We've got to be willing to not just invent cool technology and bring it from academia into startups. We've got to be willing to then scale up and develop products with those technologies for the German and European markets as well.

And I think if we do that, then we'll have more companies and above all, we'll have more successful companies with true unicorn multibillion dollar companies that make a real impact on patients lives and energy transition at large.

Thanks, Oliver.

So the ideas and the ecosystem are first rate in Germany, but young companies need help scaling up. To go into more detail on that, let’s bring in Georg Kääb.

Hi Georg, what’s your background?

I studied biology a long time ago, working also in a lab. I changed the lab space rather quickly with the communication and journalism. And now I'm a journalist, the managing editor of the magazine Transcript, which is a very traditional German magazine for biotechnology, almost 25 years coming from the media house biocom.

Can you give us a short overview of what the German biotech landscape looks like?

We have around 770 or so biotechnology companies in Germany and around 200 or so of them are service providers and technology providers. And what are these companies doing? Very different things. Some of them have a device or an essay where you can test your drug candidate. Whether this is really functioning as you want it, whether this is really binding to the receptors you want to tackle, whether the interaction is good or very good or better than ever before, whether this compound could be toxic for the patient and things like that. So you have to do a lot of tests. And there are many companies around, many of in Germany, that have developed very fine tuned analytic tools or they have a device, for example. I also always come to the company in nanotemper from Munich, which is a small company, but they have a device where you can measure the interaction of proteins and this helps to increase your success rate of working with the right compound in your drug development phases.

To what extent is German biotech attracting investors?

The pockets of the investors are rather full at the moment. And we see a lot of very interesting and high ranked financing rounds for also startups or early phase development. So, for example, T knife in Berlin closed a very huge financing round, some months ago or two. They are working in the space of cell immunology. Cell therapy with tcell engineered by that technology. And we also have a company like Two Bullets in Martinsried, Munich. They also closed very huge financing rounds with international investors, mainly from the U.S., I think 60 million or so in a very early financing round. And they have another approach. They have a technology to add a special toxin to an antibody. So not only the antibody kills a cancer cell, but also the toxin, let's say, improves the attack against a cancer cell. And so the whole field of so-called ADC antibody drug conjugates is in a in a huge hype in the moment. So you see huge financing rounds all over the globe. But also many of those interesting companies are sitting in Germany.

Oliver Schacht just pointed out that German biotechs have difficulties scaling up. They need partners. Do you see this as a problem?

All the other German smaller biotechs have at least at one step in their development and in one phase of the clinical trial, they have to have an international collaboration partner. There is no German biotechnology or there is no American biotechnology or there is no whatsoever biotech, because this is a global network effort, let's say. So if you have a interesting drug, you want to develop it and you have the interesting disease you want to tackle, then you have to have a international very good collaboration with the clinical sides, also with other pharma partners, with all of the regulators. And this is just in the next minute. It's an international business and an international development.

Why do entrepreneurs and companies choose Germany as a base?

Location is important because it's a whole ecosystem. you need for really having success with your company. It's not only having the space where you can work and having employees and a team, of course, but you also have to have the ecosystem of the all the consultants and the lawyers, patent lawyers, regulators, everything. Best would be to have them close by for advice and how to be successful in the next steps. And this is why you have these hotspots over the globe where really it's happening the most in biotechnology. You have the East Coast in the U.S., you have the West Coast, you have some spots in Europe. I think in Germany, there are some spots where you also have a good scientific basis where the innovation come from or the idea comes from.

And what are Germanys assets? Let’s hear your pitch!

You have really good locations in Germany all around the large scientific universities and university hospitals or the Max Planck and Fraunhofer Institutes. I think this is really special about Germany, that we have this very broad and very excellent scientific backbone.

We are in a good situation, that we have this scientific background, we have the entrepreneurs, we have the money, and we can really try to invent new things for the burden of diseases like cancer, like, uh, Alzheimer neurodegenerative diseases,.

And then this has to become an innovation and innovation. Is it only when it comes to the market and really ahead. So and this is only in the pharma world, when you get the approval, then your idea is really and a change for the patients.

BioNtech announced that they will do their trials for cancer drugs in the UK. Is that due to strict regulations here? Does it take longer to get approval? Or why would they move the trials away from Germany??

You have always this discussion about regulatory frameworks and where is, let's say, for example, the clinical trial best set up, where is the approval fast and things like that. But the differences of the let's say, the Western world regulatory bodies is not so huge. And it is of course more than natural that a company like Biontech who wants to be a frontrunner just also takes the chance to be working with a government which is now no longer being part of the EU. So you have to have your own negotiation with this government if you want to work with them.

This has nothing to say that they are leaving Germany or so.

This huge success of Biontech with the vaccination program in mRNA was really a collaborative effort with together with Pfizer,. Where they really showed that with a vision and a strong commitment of everybody. Many actors playing working on this topic, one really can have success in a very short time. And. this was, I think, really a let's say, a hallmark for the also for the German biotechnology on a global scale. But there is more than only Biontech in the German landscape,.

Well thank you, Georg, we’ll definitely look out for new BioNtecs… And with that we’ve ALMOST come to the end of our podcast…

But before we say goodbye, we’d like to tell you a bit about HOW GERMANY WORKS.

How do drugs, medications and medical technologies get approved in Germany? There are a number of ways. They depend on things like the sorts of innovation involved and whether the products are to be marketed solely in Germany or elsewhere as well. The national authority is the Federal Institute for Drugs and Medical Devices. For the authorisation of certain drugs, in particular medicines with new active substances for severe diseases, the centralised European authorization procedure must be used. Approval is granted by the European Medicines Agency. That was the case with the BioNTech/Pfizer coronavirus vaccine. The European procedure can also be chosen optionally. It’s just one way in which Germany is trying to speed up procedures.

Presenter: And that’s HOW GERMANY WORKS.

Ok that’s it for this episode. Do you want to become a biotech pioneer working on new healthcare remedies? Germany Trade & Invest can offer you support in making your scientific breakthrough in Germany. At no cost because we’re a government agency.

Get in touch at gtai.com.

We’re also keen on your opinions, suggestions and questions. Please leave a comment in your favorite podcast app or drop us a line. You’ll find all the details in our show notes.

So, for now: stay well. Till next month, thanks for listening, “Auf Wiederhören” and remember: Germany means business.


 


 

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