National Hub for Advanced Long-acting Therapeutics (HALo)

CONTEXT: In high-income countries like the UK, almost all of the common approaches to treating acute and chronic healthcare conditions are based on medicines that need to be taken every day or several times per day. Treatments for high blood pressure, diabetes, high cholesterol, asthma, and depression, are all based on daily doses of drug, delivered via tablets, liquid medicines, or inhalers. Unfortunately, many medicines fail to deliver their intended benefits due to missed doses and many prescribed medicines are thrown away. Missed doses create a range of additional complications, from a lack of efficacy, through to the development of pathogen resistance. These complications can negatively impact individual patients, in some cases leading to their death, and have the potential to negatively impact whole populations. There is a proven alternative approach, called Long-Acting Therapeutics (LAT), which deploys drugs in a different way. A single administered dose safely delivers the right amount of drug over very extended periods of time from weeks to months. These approaches have been highly successful in the management of HIV and mental health disorders, and recently this team have shown the potential to protect against malaria infection. The scope for LATs is considerable and many diseases have no LAT option, and global health efforts are targeting many opportunities. Market research has consistently shown a high degree of patient enthusiasm for LATs. For doctors, this approach can greatly simplify the way they administer drugs, improve clinical outcomes, reduce environmental exposure, and reduce the costs of healthcare provision. But LATs cannot be introduced trivially. To fully exploit their potential in the UK, a concerted investment in science, technology, regulatory pathways, clinical manufacture, and utilisation is required. Developing appropriate LAT medicines also requires a detailed understanding of public and patient perspectives and the acceptability of LAT approaches. VISION: Our vision is to create a UK National Hub for Advanced Long-acting Therapeutics (HALo), based at the University of Liverpool’s (UoL) Centre of Excellence for Long-acting Therapeutics (CELT) with initial satellite activities in 3 leading UK Universities (University of Nottingham, Queens University Belfast, and the University of Manchester). The Hub will advocate for new LAT development to maximise opportunities from a UK perspective, address key technology questions, establish LAT awareness across public, patient, and clinical groups and ensure patient involvement in future LAT development. AIMS & OBJECTIVES: HALo will conduct world-leading physical science research to advance LATs and will also advocate strongly for a national strategy on LATs. We will also create a national translational ecosystem to enable scale-up of industrial and academic LAT candidates from pre-clinical proof-of-concept through a UK-wide manufacturing base capable of production of GMP medicinal LA products and a regulatory environment to enable rapid clinical evaluation. PARTNERSHIP: HALo has established a partnership with numerous pharmaceutical companies (start-ups to multinationals), contract development & manufacturing organisations (CDMOs), formulation ingredient manufacturers and some of the largest hospitals in the UK. We will create patient, CDMO and industry forums with additional partners to advocate strongly for a national strategy and ensure the UK benefits from the economic and healthcare potential of LATs. Future national healthcare provision will require LATs to overcome unmet clinical needs not addressable using conventional medicines. HALo will address key technology questions, establish LAT awareness, and ensure patient involvement in future LAT development.