Providing the tools and solutions

What do you see as the changes which have had the biggest impact on the market over the past 21 years and how has Thermo Fisher met them?

The most significant change has been the shift from the development of small, more broadly acting molecules to large, complex biologics which act with high specificity and potency. From an analytical perspective, in every pharma company 20 years ago there was what was known as a core services laboratory. Today we see more of an at-source demand where bioanalysts are focused on getting answers faster, and on transforming high numbers of samples into immediate, meaningful, knowledge. Over this period, we have risen to the challenge of providing solutions to unravel the increasing complexity of biologics – and we continue to work on the simplification of these powerful technologies.

Most recently, we have seen a huge change in bioproduction strategies and in manufacturing as a whole, where analytical technologies – once reserved for offline analysis by chemistries, manufacturing and control (CMC) groups – are being implemented in an online production environment.

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Growth in the Asia-Pacific market has also been significant – today comprising almost 40% of our overall business for chromatography and mass spectrometry. Such growth is driven by increased biosimilar manufacturing, alongside a significant existing generic pharmaceutical market. To best serve the expanding eastern pharma market, we continue to build and adapt our teams in these regions.

Thermo Fisher Scientific has grown over the years, with a stream of acquisitions across various life science sectors and product categories. With the purchase of Patheon, has the relationship between equipment suppliers and CMO/CDMOs changed, and do you see the potential for more mergers?

By combining Patheon’s capabilities in drug development and manufacturing with our clinical trials packaging and logistics expertise, we will be able to provide an end-to-end solution for our biopharma customers – from initial drug formulation to clinical trials support, to commercial production.

There are huge opportunities for us to collaboratively develop differentiated workflows, products and services. We hope to be able to consider pharmaceutical manufacture more holistically; streamlining work streams, creating a greater return on investment for our customers and significantly reducing the time-to-market for new drugs, potentially saving lives that could have been lost while waiting.

Many small-medium biotech sponsors who outsource to Patheon are looking for one-stop-shop solutions providers. It has recently been shown that great efficiencies can be gained for sponsors who employ single-source outsourcing partners, versus a multivendor development Dr John Rontree, Senior Director of Marketing, Pharmaceuticals and Biopharmaceuticals, Thermo Fisher Scientific and manufacturing model.¹ Thermo Fisher Scientific is uniquely positioned to provide these solutions and services due to the breadth of our portfolio.

Looking ahead to the next few years, what do you think are likely to be the main opportunities and challenges affecting the industry and how is Thermo Fisher geared up to meet them?

I believe one of the biggest changes to come will be seen in quality assurance/ quality control (QA/QC). There is a huge shift towards the implementation of singleuse biotechnologies, continuous (leaner) manufacturing outfits and the need for advanced process analytical technologies (PAT) for ‘real time lot release’.

As a company, we already provide the tools and solutions to address many of these changes. One specific example that comes to mind is the application of ultrahigh performance liquid chromatography (UHPLC) and high resolution accurate mass (HRAM) mass spectrometry (MS) in the late drug development, manufacturing, formulation and QA/QC environment. This is an area in which we are pioneers. The so-called ‘multi-attribute method’ (MAM) has been directly driven by the biopharma industry and is being developed and adopted at an unprecedented pace. There is certainly a growing pressure to make highend analytical technologies more portable, simpler to use and smaller in size to better fit within the manufacturing environment.

Another challenge this raises is the need for more ‘global’ workflows and ‘platform technologies’ that can easily be re-purposed from one drug molecule to the next. A significant amount of time, money and resource is spent in the area of method development. We are partnering with the National Institute of Bioprocessing Research and Training (NIBRT) in Dublin, Ireland, to address this particular bottleneck – to bring fit-for-purpose, freely available methodologies which are applicable to a range of monoclonal antibody-based therapies, directly to our customers.

Longer term, how do you see the future for the sector and what is the role of companies such as Thermo Fisher in creating that future?

The ability to share, manage and unlock the knowledge in big data is a major opportunity for the pharmaceutical sector. Our goals are well aligned with this – and the opportunities presented by cloud-based strategies. Our ambition is to become the leading digital science company, through expansion and development of our digital capabilities. Digital has the potential to change the way our customers work – providing them with unmatched capabilities for commerce, services and innovation, so driving productivity and ultimately power science. We have already created a ‘digital transformation office’ that will provide strategic alignment to connect our digital offerings into a common platform and we will form strategic partnerships to help strengthen our digital offerings.

If there was one thing you could change within the sector, knowing what has happened in the past 21 years, what would it be?

I personally believe that we could, as an industry, be more collaborative. Notwithstanding the challenges of intellectual property (IP), there are so many opportunities to advance the analytical tools and strategies to the benefit of the life science industry as a whole. We are now starting to see exciting strategic partnerships form, focused on the creation of solutions to problems that no one company alone could tackle. Examples include the Emerging Technologies Consortium (ETC), the BioPhorum Operations Group (BPOG) and the recently announced Partnership for Accelerating Cancer Therapies (PACT) from the National Institutes of Health (NIH).

Such initiatives bring both the big pharma companies and ourselves as instrumentation vendors/solutions providers together, to work through specific problems and industry challenges. Such collaborations will facilitate the provision of superior, next-generation, solutions for the pharma industry, and ultimately better medicines, faster.

Reference

1. www.twst.com/update/thermo-fisher-scientific-inctufts- center-for-drug-development-study-quantifiesmultimillion- dollar-benefits-of-using-single-sourcepharma- drug-development-and-manufacturingmodel/

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• Employing approximately 65,000 employees globally
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