Networks as Incubators of Excellence
A humanistic vision for advancing regulatory science
Learning from a plumbing problem
It was a Sunday morning at the end of August. The sky was blue, the sun was bright, and I looked forward to a leisurely day in my hammock. Unfortunately, I soon discovered that my sewer was clogged. Did I mention it was a Sunday morning?
After multiple calls to our list of plumbers, the best arrangement I could make was an appointment for the following Thursday—not very helpful. I started working on my network of friends and found a guy who knows a guy whose business deals solely with plumbing emergencies. Two hours later, the problem was solved—and Sunday was saved.
In my plumbing emergency, beyond the priority of clearing the drain, the plumber had useful things to say about frequently encountered causes of blockages, things to look out for, such as visits by grandchildren, and the importance of preventive maintenance—valuable information for minimizing the risk to future Sundays.
Networks of friends or colleagues with diverse expertise and interests are potent sources of suggestions for handling difficult situations, securing advice on challenging problems, and connecting with experts during unexpected emergencies. Over time, as experience with network members grows, particularly trust-worthy individuals are identified and become the focal points for discussions and remedies.
Networks as incubators of excellence
During my collaboration with scientists and regulators in Africa, I learned about the importance they place on networks. They rely on them for advice and expertise and actively seek ways to develop and enhance them. They readily recognize networks as sources of strength and opportunities to identify weaknesses that can be improved over time.
For example, Uganda is a member state in the East African Community (EAC), a regional economic community that promotes cooperation among member states in political, economic, and social spheres of interest. The EAC has also facilitated the development of specialized networks, including the East Africa Community National Medicines Regulatory Authority (NMRA). The harmonization program implemented within this network aims to enable access to quality essential medicines, vaccines, and medical devices by aligning regulatory requirements, guidelines, standards, and tools across the network.
These regional networks serve as incubators for enhancing skills, cultivating trust among members, and fostering the confidence necessary to address complex challenges. Equally significant, they serve as the building blocks for creating central organizations, such as the African Union and, in regulatory science, the African Medicines Agency.
The African Medicines Agency's (AMA) purpose is to serve as a resource for strengthening regional networks by developing recommendations and programs to deepen the NMRA's regulatory capacity maturity level.
This is key because the NMRAs remain the foundation for conducting regulatory activities on the continent.
The AMA supports the regional harmonization process, coordinates joint assessments to reduce duplication of effort across the NMRAs, and provides support where expertise and knowledge gaps exist.
The formal and informal nature of networks
The World Health Organization (WHO) has been instrumental in enhancing regulatory science in Africa. The WHO publishes the Global Benchmarking Tool for National Regulatory Authorities (NRAs) to promote self-assessment of regulatory systems' maturity levels.
The benchmarking methodology allows WHO and regulatory authorities to pinpoint strengths, address weaknesses, and track progress.
The WHO also encourages African regulatory agencies to adopt regulatory reliance as a best practice for conducting regulatory reviews. The reliance process allows less experienced agencies to utilize the work completed by more experienced regulatory agencies to assist in their decision-making process.
The formal aspect of the reliance process is focused on the national drug authority's decision-making process. It benefits less experienced agencies by minimizing duplicate and unnecessary efforts and accelerating the decision on whether to grant market authorization. It operates within the regulatory authority's framework, ensuring the regulatory review process aligns with the laws and regulations governing the National Drug Authority.
Reliance in this context also includes an informal aspect.
Due to the varying levels of experience across the regulatory evaluation committees, reviewers depend on each other's expertise and past experiences to improve their ability to conduct high-quality regulatory reviews more efficiently. This creates a forum for discussing, questioning, and addressing concerns about the effect of clinical characteristics on the expected safety and effectiveness of a new drug.
Probing dissenting opinions and exploring data gaps are crucial catalysts for strengthening the skills of scientists and regulators and expanding the network's capabilities. More mature NMRAs can pass along best practices, expertise, and institutional knowledge by working together on joint activities, such as product assessments. These interactions allow the scientists and regulators in the NMRAs to build trusting relationships and gain confidence in the proficiency of their activities.
The role of networks in advancing regulatory science globally
Well-equipped regulatory agencies such as the FDA and EMA collaborate with external networks of clinical and scientific experts to address areas of uncertainty during regulatory review and make decisions in the presence of conflicting evidence.
Regulatory agencies in LMICs have embraced regulatory reliance as a best practice and cooperate by sharing expertise and work activities during joint reviews. In both scenarios, sharing knowledge and expertise improves the quality of the review and the level of competence across the network.
What if we were to construct a network of these existing networks to systematically capture and share the ongoing discussions and questioning within the separate networks?
As noted by Anne-Marie Slaughter in The Chessboard and the Web: Strategies of Connection in a Networked World:
What if we could help create networks with much more understanding of how to structure and support them in ways that would maximize their resilience, capacity for action, and ability to scale?
The separate networks already exist, and as the global representative of pan-African interests, the AMA could serve as a bridge to connect with the networks of well-resourced regulatory agencies, e.g., EMA, FDA, and WHO, as needed for sharing technical opinions, guidelines development, and data on product assessments and inspections.
Networks as a tool to promote a culture of holiteracy
A critical aspect of working within networks requires more attention.
Exposure to different perspectives regarding the relative risks and benefits of a new drug inevitably improves the quality of the evaluation and strengthens product labeling. However, these perspectives can also lead to increased uncertainty.
Questioning and discussing dissenting opinions and perspectives will inevitably raise awareness of issues that can affect risks and benefits while offering no clear path to resolution. Nevertheless, gaining a better understanding of concerns is the first step to formulating new approaches to dealing with this uncertainty.
For example, connecting people and institutions across these networks to share discussions and questions about the implications of gaps in a New Drug Application could aid in the development of more comprehensive conceptual frameworks that encompass both existing knowledge and emerging hypotheses. This would also bring attention to known and previously unrecognized gaps in data.
Systematically capturing and considering the discussions across networks would significantly enhance the short-term benefits of better labeling. Furthermore, it could substantially affect the design of pharmaceutical research and development programs and the regulatory approval process in the long term.
The benefits of using technology and communication tools to forge a network of networks could go beyond the already realized beneficial impact on scientists, regulatory agencies, and the patients in their constituent populations.
This diverse network of scientists and regulators, supported by a systematic framework for questioning, synthesis, and knowledge-based decision-making and motivated by curiosity, could enhance human potential and establish a culture that values and exhibits holiteracy in policy-making and global health research.
Writing about collective intelligence, Geoff Mulgan highlights the humanistic significance of focusing on building and sustaining networks:
The question we should be asking is not whether this will happen but rather how we can shape these tools so that they shape us well, enhancing us in every sense of the word and making us more of what we most admire in ourselves.