Bath is the first institution outside the United States to receive funding from the US Food & Drugs Administration (FDA), for a major new research collaboration that will strive to open up the pharmaceutical drugs market and enable the design of better and cheaper medicines.
The research consortium, ‘Research in Medicines Design’ (ReMedDes) will lead projects to understand and improve how different locally acting drugs (skin, nasal, inhaled) are delivered and absorbed by the body, with the potential for global impact across healthcare.
Current projects, in which members of the research team are involved, include creating the next generation of orally inhaled and nasal products that will tailor delivery of medicines in the treatment of asthma and allergic rhinitis, and improving the current inefficient delivery of drugs to both the skin and nails, enhancing treatments for diseases such as psoriasis and onychomycosis.
By designing generic copies formulations of drugs, for which patents have lapsed, the researchers also hope to be able to dramatically reduce medicine costs in the UK and abroad.
To date, the availability of generic drugs has been limited because it has been difficult to formulate products with exactly the same, or ‘bioequivalent’, effects: i.e the same therapeutic efficacy and safety on the body as the innovator’s formulation. But the ReMedDes team is using its expertise to ensure that bioequivalent medicines are just as effective as the original versions.
Work in this area has already included an understanding of how the leading respiratory product, Advair™ a combination of a corticosteroid and a long-acting β2 agonist, is absorbed and eliminated by the body differently, dependent on which part of the lung to which they are delivered.
Collaboration between ReMedDes and the FDA marks the first time an institution outside the United States has received funding from this regulatory agency, aligning the research closely with new priorities under the Affordable Care Act (‘Obamacare’) and funding Under the Generic Drug User Fee Amendments (GDUFA) law of 2012.
Professor Richard Guy of the University’s Department of Pharmacy & Pharmacology explained: “Our overall objective is to undertake research that facilitates the creation of better and less expensive medicines. The approach uses multi-disciplinary research to improve formulations to increase the rate and extent of drug absorption at its site of administration”.
Over $1,200,000 of FDA-funding complements additional high-profile funding partnerships for ReMedDes with major pharmaceutical companies, including GlaxoSmithKline, Pfizer and Genentech.
Commenting on the significance of the new consortium, Professor Richard Guy added: “Ultimately, the strategy is to develop a suite of in vitro experimental research tools and in silico (mathematical) models, to direct the rational design and optimisation of high-performance pharmaceutical formulations.”
Academic researchers involved in the ReMedDes initiative are: Professor Rob Price, Dr Nikoletta Fotaki, Professor Richard Guy, Dr Begoňa Delgada-Charro, Professor Randy Mrsny, Professor Eddie French and Dr Paul de Bank.
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