Dr Despoina Filiou is a Senior Lecturer in Strategy who joined the OU Business School in April 2020. She is a member of the Strategic Management and Leadership Research Cluster.
The Pfizer-BioNTech vaccine received regulatory approval for emergency use from the Medicines and Healthcare products Regulatory Agency (MHRA) on 3 December. This came only months after a team of researchers led by Professor Zhang Yongzhen in Wuhan in early January made the genome sequence of Covid-19 publicly available.
This led to unprecedented efforts to develop test kits, to test existing compounds against the virus and accelerated investments in messenger RNA (mRNA) technologies to discover a vaccine. Up to the time when the World Health Organisation (WHO) declared the pandemic in early March, mRNA technologies have had no proven commercial potential but held the promise of leading to novel therapeutic discoveries, such as personalised medicine and vaccines for cancer.
Sharing the genome sequence in open platforms initiated a concerted effort within the scientific community worldwide to share research results and data on infection rates and progressed our understanding of the virus and its impact on human health. It supported BioNTech and Moderna to be the first two companies that used mRNA technologies to take vaccine candidates to final stages of clinical trials. Other companies intensified efforts on vaccine discovery but when research was based on established technologies, such as viral vector (the Oxford-AstraZeneca vaccine), it led to candidates of lower efficacy, requiring more complex development processes.
Both BioNTech and Moderna managed to access funds to pursue their research through collaborations with established pharmaceutical companies, the national institute for health and government funding. The Pfizer-BioNTech collaboration led to a breakthrough vaccine, the first ever mRNA-based product to get MHRA approval and to be administered soon after to vulnerable groups in the UK. Pfizer-BioNTech’s response to the pandemic was immediate, with the collaboration announced on 17 March to allow the partners to coordinate multi-site and country clinical trials.
The two partners are building on an existing collaboration, established back in 2018, when Pfizer started working with BioNTech, to explore mRNA technology for developing vaccines for cancer based on personalised medicine principles. Pfizer is not the only established pharmaceutical firm that BioNTech collaborates to meet the worldwide demand for inoculation. The complex regulatory processes for drug approval pose hurdles for newly-established firms in this sector as they lack experience; BioNTech has no products to market. On 16 March, BioNTech announced its collaboration with Shanghai’s Fuson Pharma to conduct stage 2 clinical trials in China, to assess the safety of the vaccine candidate and to support future Biological License Application (BLA) protection and subsequent production in the country.
This small window to BioNTech’s collaborative strategy shows the complexity of collaborations required for a fast response to the pandemic and faster time to market. BioNTech is not only collaborating with established pharmaceutical firms to develop and market its vaccines. It has a range of agreements with other organisations that hold patents in mRNA related and enabling technologies, giving BioNTech the license to use technologies at the frontier of research in its field.
The Pfizer-BioNTech case reflects the broader and diverse strategies for collaboration of newly formed and established firms in the bio-pharmaceutical sector. Since the 1980s, during the early stages of biotech development there is a wave of collaborations in the sector. The vast range of applications of mRNA technologies cannot be exploited by individual firms alone, which often lack all the requisite capabilities.
My research on the early stages of the bio-pharmaceuticals sector has shown that newly-formed biotechnology firms do become more innovative (in terms of patents) when they form alliances to exploit and commercialise their technologies with the support of a large pharmaceutical firm’s capabilities and expertise on development, manufacturing and marketing (Filiou, 2021). This same research shows that pharmaceuticals firms may experience inefficiencies when integrating new technologies with established product lines and this may even negatively impact on their innovativeness in the short term.
Covid-19 brings to the fore the role of openness and alliances in innovation. Sharing risks and costs of research in emerging technologies with no short-term commercial potential can pave the way to path-breaking solutions to new problems. For those interested in researching openness and innovation in this but also in other sectors, or in exploring how personalised medicine and the use and processing of patient data can revolutionise innovation, look out for our upcoming PhD studentships at The Open University Business School.