Decisional tool to aid portfolio selection decisions into new biotherapeutic modalities

The research entails using decision-making modelling techniques to assess the costs, rewards and risks associated with the introduction of new biopharmaceutical products into a company's portfolio, specifically in this case AstraZeneca. Much of the work will involve applying these modelling techniques to novel therapies that treat serious and life-threatening illnesses. Some of the key aims and objectives of this project are to create a tool to evaluate the process economics of some of these newer therapies against AstraZeneca's current product portfolio. The benefit of this is that it will allow for a comparison and inevitably identification of how best approach the manufacture of these new therapies, in the most cost-effective manner possible, so as to reduce the cost of the therapy to patients. It also will allow for this identification to happen earlier on in the process development, enabling a reduction in the typical drug development timescale, thus allowing it to be available to patients sooner. Fundamentally, the overarching aim is to put in place a tool that successfully incorporates multiple criteria (including economic considerations and operational considerations) to identify and optimise the composition of AstraZeneca's drug portfolio.

The work carried out in this project has the potential to be applied to a variety of biopharmaceutical product portfolio situations, whereby other companies that wish to develop vital therapies to rapidly and efficiently treat patients can utilise some of the tools put in place. This will allow for early identification of the options, thus ensuring the therapies are marketed (and so can be used) quicker and are more cost effective than before.

The CDT has a proven track record of delivering impact from its research and training activities and this will continue in the new Centre. The main types of impact relate to: (i) provision of highly skilled EngD and sPhD graduates; (ii) generation of intellectual property (IP) in support of collaborating companies or for spin-out company creation; (iii) knowledge exchange to the wider bioprocess-using industries; (iv) benefits to patients in terms of new and more cost effective medicines, and (v) benefits to the wider society via involvement in public engagement activities and impacts on policy.

With regard to training, provision of future bioindustry leaders is the primary output of the CDT and some 96% of previous EngD graduates have progressed to relevant bioindustry careers. These highly skilled individuals help catalyse private sector innovation and biomanufacturing activity. This is of enormous importance to capitalise on emerging markets, such as Advanced Therapy Medicinal Products (ATMPs), and to create new jobs and a skilled labour force to underpin economic growth. The CDT will deliver new, flexible on-line training modules on complex biological products manufacture that will be made available to the wider bioprocessing community. It will also provide researchers with opportunities for international company placements and cross-cohort training between UCL and SSPC via a new annual Summer School and Conference.

In terms of IP generation, each industry-collaborative EngD project will have direct impact on the industry sponsor in terms of new technology generation and improvements to existing processes or procedures. Where substantial IP is generated in EngD or sPhD programmes, this has the potential to lead to spin-out company creation and job creation with wider economic benefit. CDT research has already led to creation of a number of successful spin-out companies and licensing agreements. Once arising IP is protected the existing UCL and NIBRT post-experience training programmes provide opportunities for wider industrial dissemination and impact of CDT research and training materials.

CDT projects will address production of new ATMPs or improvements to the manufacture of the next generation of complex biological products that will directly benefit healthcare providers and patients. Examples arising from previous EngD projects have included engineered enzymes for greener pharmaceutical synthesis, novel bioprocess operations to reduce biopharmaceutical manufacturing costs and the translation of early stem cell therapies into clinical trials. In each case the individual researchers have been important champions of knowledge exchange to their collaborating companies.

Finally, in terms of wider public engagement and society, the CDT has achieved substantial impact via involvement of staff and researchers in activities with schools (e.g. STEMnet), presentations at science fairs (Big Bang, Cheltenham), delivery of high profile public lectures (Wellcome Trust, Royal Institution) as well as TV and radio presentations. The next generation of CDT researchers will receive new training on the principles of Responsible Innovation (RI) that will be embedded in their research and help inform their public engagement activities and impact on policy.