DNDi and Medicines for Malaria Venture (MMV) have launched a Joint Regulatory Platform—an innovative, open, and collaborative framework through which the two non-profit medical research organizations are pooling resources and sharing expertise to accelerate the development of new medicines for underserved populations.
Fabienne Benoist is Head of the Joint Regulatory Platform.
Fabienne, could you explain what this Joint Regulatory Platform is and what activities it is undertaking?
This is a pioneering programme launched by DNDi and MMV to pool their resources and expertise in regulatory sciences.
We want to increase our impact, prevent duplication of effort, speak with one voice to regulatory authorities and stakeholders, and shorten drug registration timelines—with the ultimate goal of accelerating the development and access of new medicines.
This collaboration is not limited to market authorization of new drugs. It encompasses a wide range of regulatory activities, including clinical trial applications, interpretation of the evolving regulations, and design of our regulatory strategies.
Our work also focuses on treatment guidelines because obtaining strong clinical results and securing registration for a new drug is not enough. If national treatment guidelines for the associated disease are not updated accordingly, patients will still be unable to access the new drug.
The platform operates on two levels. The first is at the programme level, where partners discuss regulatory strategies and how best to develop their products, ensuring they have the right clinical data and the right expertise so that the resulting prescribing information reflects patient needs as accurately as possible. The second is at the broader ecosystem level, where partners pool their knowledge and coordinate collective advocacy efforts.
We are already pooling efforts on many fronts. For example, we participate in WHO regulatory meetings where we can share our experience and the solutions we have found to common challenges. We have also set up a regulatory newsletter to share the latest regulatory intelligence within our organizations, including new guidelines, advances in procedures for running clinical trials, and country-by-country regulatory changes.
Could you briefly explain what regulatory science is?
Many people still think of regulatory activities as simple paperwork and compliance, but our work is far more encompassing and strategic.
We use the term ‘regulatory science’ because a thorough understanding of the scientific principles underlying drug development is essential for assessing data, preparing regulatory dossiers, and interacting with health authorities. Regulatory science encompasses the evaluation of the evidence required to support a new drug application before clinical trials can begin and before market authorization can be granted. This includes reviewing preclinical, clinical, and chemistry, manufacturing, and controls data that demonstrate a drug’s safety, quality, and efficacy.
This is highly complex, and we need to make sure that regulations fit the science, not the other way around.
This can be particularly challenging in the field of neglected diseases, where there is often little guidance or few established guidelines. We must find solutions and engage with all regulators and policymakers in a rapidly evolving space.
What prompted DNDi and MMV to pool their resources in this regulatory area?
Globally, the regulatory system is highly fragmented. If you want to register a drug or conduct a clinical trial for the same drug in three different countries, you may face three different sets of requirements and three different regulatory frameworks. The necessary regulatory work can be daunting.
This is why it is so important to come together. Bringing PDPs to the table with partners, policymakers, and regulators makes our collective voice far more impactful.
Whether successes or setbacks, DNDi and MMV have accumulated a wealth of experience to share.
This sharing is more important than ever in the context of a regulatory space that is evolving rapidly.
For example, the recently established African Medicines Agency will play a major role in harmonizing regulatory requirements across the continent and improving regulatory capacity. When we met with the Agency’s Director General, Dr Delese Mimi Darko, to introduce our Joint Regulatory Platform, her response was very enthusiastic. She said that engaging with coordinated partners who speak with one voice makes collaboration much easier.
Joining forces is also a smart move in the context of the current global health crisis, where funding and resources are increasingly constrained. As some globallobal pharmaceutical multinationals strategically reevaluate engagement in infectious disease R&D, fewer regulatory experts are working in this field. At the same time, most drug manufacturers emerging in low- and middle-income countries are still establishing their regulatory expertise.
We need to fill these gaps.
Pooling our resources, avoiding duplication, and speaking with a stronger, unified voice are compelling solutions. And it all comes back to one thing: bringing medical innovation to patients who need it most.
Photo credit: Mamadou Diop, DNDi
