The Medicines and Healthcare products Regulatory Agency (MHRA) has today published its fourth case study detailing how the regulator has helped researchers at the Jenner Institute, University of Oxford take a step closer to developing an effective vaccine against the global killer Malaria.
Through engagement with the University of Oxford our Innovation Office has helped contribute to the development of a viral vector, which is used as a carrier of genetic material to help treat a specific disease.
MHRA helped facilitate the strategic project planning by introducing Jenner Institute researchers to the relevant agency teams at the correct times. These included colleagues in the clinical trials teams, the good manufacturing practice (GMP) inspectorate, the pharmaceutical assessors and the toxicologists.
Innovation Office colleagues also reviewed the risk assessments and the descriptions provided on the vaccine in the information package. Finally, MHRA helped by sending accurate constructive feedback. This was particularly helpful in aiding researchers to progress their project quicker.
MHRA Director of Licensing, Dr Siu Ping Lam, said:
“Viruses evolve and new vaccines need to be found to stop or inhibit their spread. It is important to ensure that academic institutions across the UK and beyond, continue to innovate in their approaches to developing vaccines and medicines that can tackle threats from emerging viruses and improve the lives of people throughout the world. At MHRA we understand this and work hard to ensure institutions can come to us and get the very best scientific and regulatory advice, guidance and expertise at every step of the clinical product development lifecycle.”
Eleanor Barrie, QP, Clinical BioManufacturing Facility, the University of Oxford said:
“We needed to work quickly to find the answers to questions that would help us develop an effective programme of research. The experts at MHRA were quick to recognise our innovative approach and worked with us closely at a number of vital milestones, which in turn helped us bring this breakthrough to the fore.
“This work could have a huge impact on public health. Using this approach, researchers at Oxford University have developed a panel of novel vaccines for early phase studies in the treatment of malaria and other diseases including HIV, TB and flu.”
- This case study is the fourth in a series to be released by the Innovation Office at MHRA. The series has been developed with the Medicines Manufacturing Industry Partnership (MMIP). MMIP, which was launched by the Association of the British Pharmaceutical Industry (ABPI) and the BioIndustry Association (BIA) earlier this year, and brings the UK’s medicines manufacturing industry together to create an attractive and innovation-rich environment to drive UK competitiveness and to build international recognition in medicines manufacturing. This particular case study has been developed with the support of the BioIndustry Association (BIA) Manufacturing Advisory Committee (MAC), which supports the UK commercial bio-medicine manufacturing community by providing an experienced voice to address issues relevant to the biologics, vaccines, cell and gene therapy sector, and to cross-pollinate expertise and best practice. View the case study.
- The Innovation Office, launched in March 2013, is one of the ways MHRA supports the Prime Minister’s life science’s strategy. This strategy calls for the encouragement of life science industries as a future growth area for the country. It is designed to help companies overcome barriers and it creates incentives for the promotion of healthcare innovation.
- Malaria is a disease that is found in over 100 countries and led to the deaths of 627,000 people in 2012 (World Malaria Report, World Health Organization (WHO), 2013).
- Contact the MHRA Innovation Office for enquiries.
- MHRA is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. Underpinning all our work lies robust and fact-based judgments to ensure that the benefits justify any risks. MHRA is a centre of the Medicines and Healthcare Products Regulatory Agency which also includes the National Institute for Biological Standards and Control (NIBSC) and the Clinical Practice Research Datalink (CPRD). MHRA is an executive agency of the Department of Health.