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Business & Regulation Small Molecules, Formulation, Contract Development Services, Contract Manufacturing Services

Chemistry, Conjugation and Management: Lessons Learned with Bernhard Paul

The diverse applications of chemistry are inspiring

Chemistry is a subject that always came naturally to me when I was in school – I didn’t have to try very hard and yet I seemed to be good at it! I also found chemistry inspiring because there are so many real-world applications. It seemed clear that this was the right subject for me, so I studied chemistry at the Graz University of Technology in Austria, which is where I am from. After graduating, I had the opportunity to do a PhD in Florida – the combination of chemistry and sunshine sounded like a good one!

As I reached the end of my PhD, I came to the turning point that all young scientists face: an academic career or an industrial career? I’d experienced a lot of the academic side during my studies, but what interested me most was the application of chemistry to real-world problems. Medicine is particularly inspiring and rewarding because of the connection with patients and the potential to improve people’s lives – this lured me to my first role in industry at a custom research organization (and continues to inspire me today). It was fast paced and exciting, and I was able to contribute to a number of different projects in a very short time span. I worked with many different customers and partners on a diverse set of molecules (both innovator and generic), ranging from early stage process development, all the way through to commercial products. Looking back, I think that working at a custom research organization was the best introduction to – and education of – the pharma industry that I could have asked for.

In a complex world, outsourcing is essential

I later joined a biotech company in the Boston area where I helped oversee API process development and outsourcing. The company focused on a wide range of diseases – among other things we looked at improving the quality of life for patients with chronic diseases. It gave me a great perspective on how outsourcing and manufacturing work. Today, I am the general Manager for Johnson Matthey’s European Custom Pharma Solutions business and I often look back on my early experience in Boston, when I was the customer, to think about how we can provide the best customer experience – I think about how I would have felt about certain things at the time and what was important to me.

I joined Johnson Matthey about seven years ago, initially with responsibility for chemistry development and then, later on, developmental manufacturing. Subsequently, I was promoted to the general manager position of the Pharma Services business. It’s been interesting to have been on both sides of the fence. Some people talk about biopharma companies and outsourcing providers as different worlds, but ultimately they are linked closely together, while facing different challenges. The most successful relationships I have seen are when outsourcing providers are considered as partners rather than just vendors, which brings a collaborative approach to solving problems and overcoming challenges. Drug development is becoming ever more complex, so having all the right expertise in house can be difficult; outsourcing certain parts makes sense and having a strong partner can make all the difference.

Management is about soft skills

My scientific education gave me the hard skills in science, but management has required a softer skillset. I think that every scientist transitioning from a scientific to a management role has a number of hurdles to overcome. But it’s important to remember that although it may seem difficult at first, management and leadership skills can be learned, just as chemistry and physics can be learned.

My interest in management actually stems from a project I worked on as an undergraduate, when I had the opportunity to collaborate with a group of doctoral students who were doing their PhDs. When I first joined that group they outlined their vision, clearly explained my part of the overall project, and empowered me to make independent decisions. I found myself incredibly motivated and inspired as a result. The experience made a big difference to how I look at management and leadership. The students made a real effort to show me what value my work would have, how it fitted into their research, and how it would help make a research product come to life. Seeing the big picture and how it all fitted together was tremendously inspiring and ever since then I’ve tried to inspire people in the same way.

For those wanting to move into a management role, I would say it’s really important to learn as much as possible about a wide range of areas. Scientists often become experts in a very narrow technical field, but for management you need general expertise in technical and non-technical areas. I also think it’s essential to learn about the challenges that other groups within the company are facing, and to look at problems with a much more strategic view.

Finally, the biggest lesson I have learned over my career so far is that people are an organization’s most valuable asset. I’ve had the privilege to work with incredible people and one of my most important roles is to identify talent and ensure that people remain engaged and challenged. This should be a priority for any leader.

The majority of therapies in development today are still small molecules and the field is not standing still.
Small molecules continue to be a success story for the industry

I have spent most of my career working with small-molecule APIs. At the moment, there is a lot of talk about biologics – and rightly so. There are many exciting advances blossoming in the biopharma field, not to mention the huge growth. But these biologic innovations sit alongside small molecules, which remain hugely important. The majority of therapies in development today are still small molecules and the field is not standing still. Small molecules are becoming larger and increasingly complex, and often show remarkable efficacy. For example, many of the new drugs that treat Hepatitis C are incredibly efficient small molecules and there are many other recent small-molecule success stories in the industry.

However, the increasing complexity of today’s small molecules is leading to challenges in bioavailability and solubility. Innovative thinking is needed to overcome these issues and, as a result, there has been a lot more focus on materials science, such as the physical form and properties of an API, and how these can be controlled to ensure bioavailability. A number of new formulation technologies and approaches are being developed that should help in this area. Co-crystals are also receiving a lot of interest, mainly thanks to recent encouragement from regulators.

Over the last few years there has also been a lot of attention paid to drug conjugates. For these types of therapies, one combines a small molecule, which is usually very potent, and a polymer with a targeting ligand or an antibody that helps deliver the molecule to the best place. These products present unique challenges, having highly complex small molecules requirements, yet also needing many of the same advanced analytical techniques applied in large molecule manufacturing. The lines between small and large molecules are becoming more blurred.

Continuous processing is here to stay, but isn’t the solution to everything

One of the most exciting advances in terms of API manufacturing is continuous processing – I’m seeing a lot of demand and questions around this. It’s not new – the first wave of interest in the pharmaceutical industry was quite a while ago – but we are now seeing a surge thanks to new technologies and the fact that regulatory bodies are encouraging the industry to explore the potential. However, the volumes we work with in the pharma industry are relatively small compared with other industries – and continuous processing has traditionally been associated with high volumes. Being able to adapt continuous processing to the unique needs of our industry will allow us to deal with certain chemistries more effectively, particularly those involving unstable intermediates or hazardous reactions. I think the key is to bear in mind that not every stage of every process is suited for continuous. It’s important to be selective about where you use it and to examine where it could have a real impact – and what problems it can potentially solve.

There is growing interest in biocatalysis

Another big trend in small molecule development is green chemistry, particularly biocatalysis, which stems from recent advances in genetic engineering, analytics and molecular biology. Biocatalysts, like all catalysis, increase the speed at which a reaction takes place, but can often require only mild operating conditions and less solvent usage. They also have high selectivity, which can reduce side reactions and make them more environmentally friendly. As with continuous processing, biocatalysts aren’t suitable for everything, but are definitely a great tool to have in the toolbox. When it comes to synthesis, the most important factor is to always choose the right solution for a problem – whether it’s a biocatalyst, a chemo-catalyst, or something else. It’s difficult to argue against the fact that catalysis is the most effective way of doing chemistry, given that a single catalyst molecule can rapidly process thousands or even millions of substrate molecules in each reaction. It’s a very efficient way of making or breaking chemical bonds.

Challenging times lie ahead, but the industry must continue to focus on quality

We are experiencing a dynamic time for the industry. Important political events that occurred in Europe and the US in 2016 will certainly have an impact on the drug industry, and there are also increasing conversations and arguments around drug pricing and the cost versus benefit of new drugs. There are definitely some difficult discussions to be had – and I’ve no doubt that these will continue throughout 2017 and into 2018 and beyond. I also expect the high levels of industry consolidation that we’ve seen in recent years to continue, both on the innovator side as well as the contract manufacturing side. From the point of view of a contract manufacturing and development organization, I think it will be important for service providers to offer a wide range of solutions, and to be nimble and agile enough to respond to problems quickly.

I also value out-of-the-box thinking – and so I’m very interested in open innovation. There are many challenges in drug development that cannot be faced alone; a platform that allows outsiders to bring in their ideas and encourages collaboration can only be a good thing. At Johnson Matthey, we encourage this with our open innovation program called eXovation. The first round of applications closed recently and I’m looking forward to seeing the results.

Whatever events occur to shape our industry, we shouldn’t forget that our main focus should always be on quality since that ultimately assures patient safety. Increasingly, there are companies that are not meeting the necessary quality standards, particularly when it comes to supply chains (although transparency and traceability are on the rise). Only companies that consider safety, quality and compliance as their core values will be successful in the long run – no matter what other changes befall the industry.

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About the Author
Bernhard Paul

Bernhard Paul is General Manager European Pharma Solutions, Johnson Matthey.

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