CAPACITY 2023

The challenge

Globally, rapid progress is being made in the development of molecular and cellular treatments, including for infectious diseases. Conventional pharmaceutical development focuses on small chemicals, but newer generation treatments aim to manipulate gene activity or are based on the use of cells as therapeutic agents.

Although often expensive to develop, molecular and cellular treatments have advantages, in some cases including the potential to be curative, avoiding the need for long-term treatment. In the long run, they could therefore be cost-saving.

Despite their potential, molecular and cellular approaches have made little inroads into sub-Saharan Africa. Increasing clinical research activity in this area will require a range of actions, including raising awareness, developing safety-monitoring systems appropriate for these new technologies, and building knowledge and capacity within the African research community. They also raise specific ethical issues, which will require capacity building in regulatory and ethical review capacity. 

The project

Researchers in Uganda and Tanzania are beginning to explore the potential application of molecular and cellular therapies to diseases that have a significant regional impact. Focusing on Uganda, the CAPACITY 2023 project is carrying out a range of activities to create an environment where clinical studies involving these new technologies can be safely and ethically carried out. The lessons learned will be transferable to other sub-Saharan countries. 

Key activities include:

• Working with a range of stakeholders to develop regulatory frameworks for clinical studies involving gene therapy or other molecular and cellular technologies.
• Strengthening the capacity of regulatory agencies to oversee such studies, for example, through short-term training of regulatory staff and placements in bodies with experience in these areas.
• Building the capacity of researchers and clinicians in the use of gene therapies and other molecular and cellular technologies, leveraging the experience already gained in pioneer countries.
• Developing guidance and organising training to strengthen pharmacovigilance systems specific to these new technologies. 

Impact

The CAPACITY 2023 project is helping to establish a foundation for an increased focus on gene therapy and other molecular and cellular medical technologies in sub-Saharan Africa. It will:

• Enhance technical skills in these emerging areas of research.
• Build institutional capacity in gene therapy and other molecular and cellular technologies.
• Provide a robust regulatory framework to ensure effective oversight of clinical studies involving such novel technologies.
• Enable additional countries to learn from Uganda’s experience.

In summary, the project’s work will provide a major impetus to research on molecular and cellular technologies in sub-Saharan Africa, which hold enormous promise but have so far not received the same level of attention as in other parts of the world.