FST JOURNAL

Partnerships can achieve great things. In 2020, a partnership was established between academic groups at the University of Oxford that already knew each other and worked together, as well as a big pharma partner in AstraZeneca. This is a very good model for partnerships in the future when results are needed quickly, but also at scale.

Academia can be fast and flexible. There are many sources of expertise available in-house, networks of academic collaborators in the UK and in other countries which can be drawn upon immediately. Unusually in this case, the university was not just involved in the very early development of new ideas. Oxford has its own Good Manufacturing Practice (GMP) facility which can make vaccines to take into clinical trials. It has its own clinical trial centre and a great deal of experience in developing manufacturing processes and conducting clinical trials.

By 23 April 2020, the vaccine had been manufactured to GMP ready for clinical trials, all the necessary approvals had been gained and the clinical trials started. Oxford led Phase One, Phase Two and Phase Three clinical studies in the UK, Brazil and South Africa.

Taking things further

To achieve a good transfer of ideas from academia into pharmaceutical companies, it is necessary to take things past the idea stage: if academic work is transferred at a very early stage, it often moves very slowly when it gets into a company.

This case was different because the academic partners had taken it a long way through development, there was a scalable manufacturing process, we were generating clinical trial data, and therefore it was much easier for a large pharma partner to step in and take it from there.

Not every university or academic group will have access to such facilities, particularly in other areas of drug development. Yet the UK does have the possibility of creating a series of hubs in GMP manufacturing and linking these to clinical trials. This would allow academics to get their early phase work further on in the development process; and that is what is needed. By collaborating and by facilitating access into GMP manufacturing and then clinical trials, more value can be generated from the vast amount of work that is done in academic groups (which otherwise may not move out of the university lab and into the clinic).

So there really needs to be greater emphasis on projects moving further along the development pathway while still in academia. That goes hand in hand with creating new processes and perhaps new approaches to clinical trials.

The Oxford AstraZeneca Covid-19 vaccine was the results of a successful partnership between academia and industry.

 Of course, a university cannot carry out the large-scale manufacture and the preparation of global regulatory submissions that are needed to license a vaccine which will be used across the world. So we had to move from a hands-on, small-scale approach to a large-scale systems and logistics approach within AstraZeneca.

Combining the advantages of the academic approach with those of Big Pharma was what enabled us to move quickly in 2020. For academic groups, though, there is the challenge that funding is becoming more short term: often three year grants, although it may take a year to apply for them. Large teams for manufacturing and clinical trials were really essential in 2020, but it is increasingly difficult to maintain them in the face of such short-term funding.

Technology funding

I have been working in outbreak pathogen vaccine development for some time and had been trying to get vaccine technology development and vaccine manufacturing enhanced many times before 2020. Yet it was never possible to gain funding for the technology that underpins the development of the different vaccines that we then worked on. Funding has been available for specific vaccines against specific diseases. But to fund the underlying technology itself: there were no suitable calls for proposals to apply for. So although we had the ideas, we were not able to put them into practice.

Another issue involved the production of doses for clinical trials. They were made by four different companies, each with a different process and assays. This was a major difficulty for the clinical trials, which would have run much more quickly and smoothly had an extended and modified Clinical Biomanufacturing Facility (CBF) and the Vaccine Manufacturing and Innovation Centre (VMIC) already been up and running. They were really needed then.

Finally, having a clear and shared goal achieves a great deal. Grant applications are increasingly large and complex. Yet last year, we went from concept to 700 million vaccine doses released for use in 172 countries in less time than some academic funding applications now take.

Our plans were constantly being developed every day – literally! Budgets were reactive, we did report actual spending, but the plans changed. Often, we did not have agreed budgets for specific funding in advance. The decisions were made by those leading the work, not by external consultants to funders who often have a large amount of influence despite not doing the work themselves.

The UKRI rapid response scheme achieved a good balance between information gathering and speed. This meant that we could provide the appropriate amount of information needed to release funding to move the programme forward.

In conclusion, establishing and maintaining expert teams in academia should be prioritised over the award of small, short-term grants which make team-building very difficult.