A PANTHER in the room…

The PANdemic Preparedness PlaTform for Health and Emerging Infections’ Response (PANTHER) is a new international collaboration aiming to establish a platform for rapid initiation of clinical studies in the event of a new pandemic.

The sponsored satellite symposium, chaired by Professor Francine Ntoumi (Republic of Congo), Executive Director of the CANTAM2 EDCTP Network of Excellence and Coordinator of the PANDORA-ID-NET pandemic preparedness network, provided an overview of the key aims of this new African-led platform.

What could 80% ready tools look like?

Dr Nathalie Strub Wourgaft, PANTHER (France), suggested that extensive preparations could be made in advance of a pandemic to ensure that clinical studies could be rapidly launched in an emergency situation to evaluate potential new interventions – “a swift and efficient response based on research,” as she put it.

Several global and regional bodies are engaged in priority-setting exercises. Clinical evaluation activities will have disease-specific as well as generic preparedness aspects. Key needs include a target product profile, with a public health perspective, while PANTHER will have a particular focus on phase II studies to generate timely efficacy data. Access conditions will also have to be addressed.

Timely trials could be facilitated by tools such as approved master trial protocol templates, with disease-specific and country-specific appendixes. Standards could be agreed for data collection, management, and data-sharing agreements.

Preparing for phase 2 clinical trials: the need for more phase 1 units in Africa

Dr Salim Abdulla, Ifakara Health Institute, Tanzania, suggested that lessons could be learned from the COVID-19 pandemic, for example the ANTICOV platform, which evaluated several possible treatments. The aim, he suggested, was to build on what already existed, rather than reinventing the wheel.

Key needs include standard protocols, standardised procedures, and well-networked teams able to carry out phase II trials of new or repurposed interventions to generate evidence on efficacy and safety in African populations.

Salim also made the case for enhancing phase I trial capacity in Africa. Phase I trials may be needed because of the extensive genetic variability in African populations, as a route to faster access, and to facilitate rapid dose adjustment studies and assessment of safety in target populations. This capacity could support first-in-human trials, pharmacokinetics/pharmacodynamics studies and bioequivalence studies – important if manufacturing capacity continues to grow in the region.

Preparing for a new flu pandemic: yes we can

Dr Bernards Ogutu, Kenya Medical Research Institute (KEMRI), Kenya, suggested that the next pandemic could well be another respiratory pathogen, possibly influenza. The burden of flu is probably underestimated in Africa and there is a constant risk of avian flu spillover to humans.

A phase II trial platform could be used to assess potential treatments, using efficient adaptive designs, including umbrella trials involving different respiratory conditions, once diagnosed. Key considerations include appropriate choice of endpoint (as clinicians, public health specialists and regulators may have different perspectives), development of multiplex point-of-care diagnostics, better integration of surveillance and clinical care, and ensuring that activities are feasible at the community level

Could regulators be better prepared?

Finally, Dr Margareth Ndomondo-Sigonda (Ethiopia), an advisor to AUDA-NEPAD, highlighted some of the key issues of relevance to national, regional and global regulators.

A key activity will be to discuss and agree tools and pathways in advance with regulators, to avoid delays during a pandemic situation. This can build on pathways already established at different levels to accelerate clinical evaluation and licensing in emergency situations.

Several initiatives, for example involving the Africa CDC, AVAREF and AUDA-NEPAD, are already working to build national regulatory capacity, strengthen collaboration across countries, harmonise activities and avoid duplication of efforts. Different approval pathways have been identified dependent on whether or not an intervention has been approved by a stringent regulatory authority or has achieved WHO prequalification.

In addition, one goal of the new African Medicines Agency is to strengthen national regulatory authorities (NRAs) and research ethics committees – more than 60% of NRAs are currently at maturity level 1. Nevertheless, those at maturity level 3 coud be leveraged to accelerate approvals in the region with effective partnerships and reliance mechanisms.

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