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Manufacture Technology and Equipment, Biosimilars, Bioprocessing - Upstream & Downstream, Trends & Forecasts

The Future of Biopharma – Big Needs and Smart Solutions

sponsored by Cytiva

In this final article of the series – based on the “Bioprocess Days” event in May 2019 – we interview Günter Jagschies, Senior Director, Strategic Consumer Relations at Cytiva, to discuss the evolution of the biopharma industry. The take home: we must never forget unmet needs when developing new medicines.

Why do you find the biopharma industry so inspiring?

One of my personal areas of study and research is the global healthcare situation, particularly the economics and affordability of healthcare. I am passionate about biopharma’s role in bringing forward new treatments and solutions for the biggest healthcare problems. The industry has made incredible advances – and this is what motivates me day to day. We work with many different pharma companies, so are involved with a huge percentage of drugs that come to market. I always wanted to be a biochemist and I was very drawn to biopharma. I’ve never looked elsewhere and I’ve never worked for any other company either. Today, I have an ambassador role for the business. I do a lot of traveling, giving customer seminars, offering advice, speaking at conferences, and publishing articles. It’s really exciting to share knowledge in this way.

What are the biggest advances to come out of the biopharma field?

When I started out in the industry, biopharma was just starting with insulin and the first proteins. For many years, there was only one insulin drug available and then slowly the others started to come through. And now there are many different options for patients! The industry has also diversified from smaller proteins made in bacteria to incredibly large, complex constructs and viruses. And the revenue coming into the industry is now huge.

Manufacturing technologies have also come a long way. There is now increasing use of single-use systems and hybrid technologies, but I think that it is the increases in the productivity of bioreactors that have had the biggest impact. In the last five years, we have gone from titers of around 5 g to 50 g per liter. Five years ago, no one would have thought such high titers would be achievable. Now, it is possible to get the amount of product required from one bioreactor, which opens the door to smaller facilities with a lower CapEx.

What is your vision for the future of biopharma facilities?

My vision for the future is smart and small – with increased flexibility and productivity. Digital tools will play an important role in the factory of the future, integrating all aspects of process monitoring and allowing manufacturers to make rapid decisions or corrections in real time. Biopharma facilities will also be small, working either with just one product in a large quantity or with multiple products, and most likely using connected processing.

Where do the main opportunities lie in the field?

Unmet medical needs should be the focus. There are still many diseases that have no treatments at all, so there are plenty of opportunities for companies to develop new drugs to treat the symptoms of certain diseases, or even cure the disease completely. Today, with the advent of cell and gene therapies, there are so many more options when it comes to developing treatments. We also shouldn’t forget new vaccines – prevention is always better than cure!

The biggest opportunities lie in some of the most difficult areas: cancer, Alzheimer’s, Parkinson’s and even diabetes – which is still not fully understood. The industry should not give up on these challenging fields because there will be huge rewards for the companies that make an impact on any of these diseases.

Which challenges will require the most focus?

The greatest challenge now is the affordability of the new medicines developed. In the press and media, there are new stories every week about how expensive some of these drugs are. On one hand it may cost $1000 per year for insulin treatments, on the other hand there are therapies costing over $500,000 per patient, per year. It’s obvious that few people (or governments) can afford that. We need to find a way to bring the price down. Some of this may come from new advances in manufacturing, but it may also be that the industry’s business models need to change – perhaps being paid for success. And that’s not easy because it goes against corporate dogma. But some companies are willing to embrace new ideas; Novartis, for example, demonstrated its openness for new payment models with Kymriah and has been exploring an outcomes-based payment model for the therapy in some countries. I don’t think it is quite clear yet exactly how payment models like this will work in broader patient populations, but it’s a step in the right direction. It should also be noted in this context that the pharma industry is not the only driver of healthcare costs – there are many other factors that impact the situation, such as hospital systems, insurance and general complexity in terms of how healthcare is delivered.

Ultimately, many medicines are only available to a very small percentage of the global population. We need to aspire to treat every patient in the world – and that means we need some good solutions to the affordability challenge.

Patients Need Better Biosimilars

When it comes to meeting unmet needs, biosimilars have a huge role to play, as they introduce competition to the market that can help to bring down the cost of expensive biopharmaceuticals. However, there is also an argument that biosimilars are not enough – why not update and improve on existing biologics with biobetters? Another speaker at the “Bioprocess Days” event was Soon Jae Park, CEO of Alteogen, who gave insight into the challenges of establishing a biosimilars business in South Korea.

Have you always worked with biosimilars?

After studying for my post-doc in the US, I joined LG Life Science, which was, at the time, known as LG Chemical. The company was the first in Korea dedicated to biological drugs – both new biological entities and biosimilars. I was one of the early members of the company and, during my time there, I worked on many biosimilar programs. We were one of the first biosimilar companies in the world and we obtained European approval for a human growth hormone biosimilar in 2006.

I started Alteogen in 2008 with Hye-Shin Chung – and she is our Chief Scientific Officer today. Our focus is on next-generation biobetters with improved efficacy.

What main challenges have you faced?

A few years ago, Korean biotech companies could not get enough funding because there was a perceived lack of value in the country’s biotech. This also impacted us – the slow supply of funding made it very difficult to accelerate our program! Fortunately, the situation is quite different today and there is a lot more venture capital funding available for biotech – in fact, it’s one of the top sectors for investment and is also attracting investment from overseas.

How can biosimilars be made better?

We focus on three areas: long-acting biobetters, proprietary antibody-drug conjugates, and antibody biosimilars with complexity. We have developed some special technologies to help us. Our NexP Fusion Technology, for example, increases the half-life of any biologic using DNA recombination and human A1AT, and means that the drug needs to be administered less frequently. We also use our NexMab ADC Technology and Hybrozyme Technology.

What do you enjoy most about the sector?

A friend of mine develops smartphones but, after six months, a smartphone is out of date. Things can change very quickly and it can be challenging to continually innovate in such a competitive landscape. Pharma and biotech have much longer timelines but it means that even if there are setbacks in the middle of the pathway, there can still be room to recover. Of course, sometimes it takes too long to develop something in the biotech world but the important part is that there is an end goal in sight. Eventually, we will arrive at that goal. And if you enjoy the journey then it’s a very good sector to work in!

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About the Authors
Günter Jagschies

Senior Director, Strategic Consumer Relations at Cytiva

Soon Jae Park
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