Targeted Healthcare – Accelerating from one-size-fits-all to Personalised Medicines

Future Targeted Healthcare Manufacturing Hub

Targeted biological medicines are more effective than traditional treatment because they are designed to target sub-populations or even individual patients. It is a fast-growing field of science that represents both a huge public health and business opportunity for the UK, which has a global lead.

 

Hub Directors, Professor Nigel Titchener-Hooker FREng, Dean of UCL Faculty of Engineering Sciences, Professor Suzanne Farid FIChemE and Professor Paul Dalby FRSC

Above: The FTHM Hub’s partner organisations, at April 2022

Above: Cancer fighting T-cell. Credit: iStock.com/cgtoolbox

The Future Targeted Healthcare Manufacturing (FTHM) Hub is addressing the manufacturing, business and regulatory challenges to ensure that new, personalised medicines can be developed quickly and manufactured at a cost affordable to society.

Our vision is three-fold:

To be the first globally recognised consortium for the creation, delivery and dissemination of innovative manufacturing research

To provide the manufacturing infrastructure and capabilities needed to enable UK manufacturers to exploit advances in personalised medicine

To enhance UK competitiveness with research that enables cost-effective, robust manufacture, supply and delivery

The FTHM Hub brings together a network of academic, industrial and sector partners to deliver the vision. The academic team brings multidisciplinary expertise from across UCL (lead), Imperial College, Loughborough, Manchester, Nottingham and Warwick. This is supported by industrial and sector experience from a user-base of 45+ partners, comprising leading manufacturers and suppliers, large global companies, SMEs, government-industry associations, charities and the Catapult centres.

The enabling research programme
is structured under two Grand Challenges:

Grand Challenge 1: Digital decisional tools for transforming supply chain management for personalised medicines

Grand Challenge 2: Digitally driven manufacturing and analytical platforms for personalised medicines

And five intersecting key themes:

Cell and Gene Therapy Manufacture, Cell-Free Synthesis, Digital Decisional Tools, Formulation and Analytics, Regulatory Strategies, and Reimbursement and Policy.

Initially, the research programme focused on developing manufacturing capabilities for stratified proteins (e.g. Antibody-Drug Conjugates) and personalised cell therapies (e.g. CAR T-cell therapies) for cancer treatment. To reflect the changing landscape, this evolved to support a broader set of modalities, including viral vectors for gene therapies and nucleic-acid based therapies and in addition, new underpinning themes on digitalisation and analytics.

Personalised medicines, including cell and gene therapies, have enormous potential to transform the lives of patients in the UK and across the globe. To realise this potential, health systems must be ready for these new innovations and understand how best to support them.

The Hub has developed a programme of policy outreach to build and strengthen relationships with healthcare providers and key policy stakeholders in the life science sector to help understand the challenges and opportunities offered by personalised medicines and contribute to a prosperous UK.

Stakeholders we have engaged with include Central Government and Government bodies, as well as influencing organisations: NHS England and Improvement, Medicines and Healthcare products Regulatory Agency, HM Treasury, The National Institute for Health and Care Excellence, and BEIS Office for Life Science, to name but a few.

Learn more at www.ucl.ac.uk/biochemeng/hub

Success Stories

1. The Bio Industry Association and Oxford Biomedica worked with UCL on the economic risks of not considering scalable processes early on in development for gene therapies. The resulting insights were used to support a pan-UK business case to increase gene therapy manufacturing capability and capacity in the UK.

2. Cancer Research UK and UCL collaborated on an evaluation of alternative production methods for plasmid DNA that is in high demand given the rise of gene therapies and vaccines. A novel cell-free reactor configuration was shown to generate a substantial yield improvement. This promising finding will form the basis of future development in the cell-free technology space.

3. The Hub was invited to contribute expertise to a G7 100 days Mission roundtable hosted by the UK Government Chief Scientific Advisor Sir Patrick Vallance. Insights relating to the goals for developing new monoclonal antibody therapies during a pandemic helped the government set evidence-based cost targets for this type of therapy.

4. The Hub’s work on co-formulation stability for antibodies (December 2020) was ahead of the curve, and on the critical path for industry, as only in April 2022 has the first co-formulated antibody approval been made. Clearly this is a new growth area for cancer therapies.

“The Hub has developed a programme of policy outreach to build and strengthen relationships with healthcare providers”

Below: Protein separation and analysis equipment, UCL Biochemical Engineering