Ellen Lambrix and Adam Coughlin from Bristows' Commercial IP team attended the BioIntegrates conference in London on 16 May 2023. With attendees from across the biotech sector (including founders, start-ups, academic institutions, investors, CROs and CDMOs), the event prompted some wide-ranging discussions on a variety of issues and challenges currently faced by the sector.
As the BIA has previously reported, UK life science and biotech financing has got off to a slow start in 2023 in comparison to recent years. Perhaps unsurprisingly the current challenging funding environment wasn't far from everyone's minds. One of the big themes of the day was identifying the "pinch points" that companies in the sector are experiencing and strategies for addressing those. In fact strategy, and the importance of having one, was a theme that was woven throughout a number of the sessions of the day. Here we summarise some of the key strategic decisions that biotech companies are currently facing.
For companies who are fundraising, deciding who to take investment from is an decision that can shape the future strategy of the company. As well as getting the valuation and deal terms right, speakers discussed the importance of finding investors whose strategic vision is aligned with that of the company. Investor support and alignment can be particularly important for companies who find themselves at a fork in the road choosing between different business models or partnering strategies. This decision can be particularly acute for companies in the emerging TechBio sector, as two tribes of investors are emerging. Specialist biotech investors (more used to longer development times and higher regulatory hurdles) are facing competition from investors who have traditionally focussed on the tech sector (more used to investments that turn a profit quickly). You can read more on this issue in our article "TechBio investment scene: two tribes go to war?" by Claire Smith and Marek Petecki.
Despite agreeing that investor choice is important however, panellists also acknowledged that cash is still king and, particularly in today's challenging funding environment, not all companies have the luxury of choosing between multiple different investors. In order to survive in these leaner times, there are therefore a number of other key strategic decisions that biotech companies will need to make.
According to McKinsey & Company, between 2019 and 2021, two thirds of global VC investment in therapeutic-based biotech companies went to start-ups with platform technologies. So it's clear that having a platform can be incredibly valuable. Give the growth in areas such as cell and gene therapy, mRNA and genome editing (including the focus on development of innovative delivery systems for those technologies), together with the rise of AI and machine learning enabled drug discovery, it's easy to see why so many companies are focussing on development of platform technologies.
One question facing biotech companies is how to put platform technologies to best use. On the one hand, a platform could be used to build a pipeline of therapeutic products (e.g. a drug discovery platform used for the identification of antibodies targeting a range of different indications). In this case, the platform could be kept for in-house drug discovery only, with the company's primary focus being on the development of its product pipeline. On the other hand, a platform could be used to generate revenue itself (e.g. by offering it as a service to others, or licensing it out). In this case the platform becomes the product. A hybrid model is also possible.
“Platform” is also a broad concept which covers a large range of technologies and, to a large extent, the right business model will depend on what the platform technology is. The choice of business model will dictate where a company focusses its finite funds and attention so this will be a key decision for a company with a platform to make.
Building a robust IP portfolio to protect the products and/or services offered by a biotech or techbio company is crucial. IP can be one of the most valuable assets of a biotech company; protecting a company's competitive advantage and market position and also, potentially, acting as a revenue source for companies which pursue licensing and partnering strategies. Investors are also likely to want to interrogate a company's IP strategy before committing funds.
While patents are likely to be at the forefront of mind, a strong IP strategy will include a broader range of IP rights. In some cases, a company may decide it is more valuable to keep certain discoveries and assets confidential rather than seeking patent protection (e.g. for complex, hard to replicate manufacturing techniques, or valuable curated data sets). Also, patent protection will not always be relevant. In an increasingly data driven world where more companies are using AI and machine learning tools, other IP rights such as copyright and database rights will also be important. Particularly for new biotech companies, having an early understanding of the scope and variety of IP rights available and how they each be used to maximise protection is key.
There comes a time in the lifecycle of most biotech companies when the prospect of partnering with other companies comes into focus. Partnering with a big pharma company is a well trodden path for biotech companies and successfully done can be valuable source of revenue (e.g. via upfront payments, royalties and milestones) and can validate the biotech company's technology. However, partnerships need careful planning and management and decisions on when to partner, who with and how much to give away are not easy. Biotech companies with a platform technology also need to plan carefully when entering into partnerships as there are a number of points to be considered, particularly when it comes to granting and defining exclusivity. Claire Smith and Louisa Jacobs wrote about IP ownership issues arising from collaborations involving a platform technology here.
Finally, partnering doesn't always mean licensing and collaboration deals with big pharma. A key relationship for many biotech companies will be with a CDMO. Biotech development is complex and scale up isn’t linear. Given the complex manufacturing processes and technology needed for many biotech products it can make sense to outsource some or all the development and/or manufacture to a CDMO. But with the industry experiencing capacity constraints and competition for slots coming from large biopharma companies, it may be difficult for a small biotech company to find the right CDMO partner to meet its needs. Panellists at BioIntegrates focussed on the importance of communication and building strong collaborative relationships with CDMOs. Of course any key commercial relationship should also be underpinned by a robust contract (especially crucial when things don’t go to plan).
Despite the current challenging fundraising environment faced by the UK biotech sector, this year's BioIntegrates event felt (cautiously) optimistic. Companies might be feeling the pinch in some areas but innovation is still happening at pace, milestones are still being achieved, relationships are still being built and, for companies with the right technology and a clear strategy, investors are still investing.