EMA Executive Director Discusses the Future of Innovation and Regulation
On 16 October at the 2024 ISPE Annual Meeting & Expo in Orlando, Florida, USA, Emer Cooke, European Medicines Agency (EMA) Executive Director and chair of the International Coalition of Medicines Regulation Authorities (ICMRA), discussed innovation and regulation in a fireside chat with moderators Ciby Abraham, PhD, Senior Director and Group Manager, Project and Product Leadership in CMC Regulatory Affairs, AstraZeneca,; and Sarah Pope Miksinski, PhD, Executive Director, CMC Regulatory Affairs, Gilead Sciences, Inc.
To open the discussion, Miksinski asked Cooke to share the biggest concerns on her mind, including what keeps her up at night.
Cooke framed her answer first in terms of opportunities. The COVID-19 pandemic inspired unprecedented international collaboration among regulatory agencies, proving that cooperation between agencies pays off. Now, she said, regulators have the opportunity to maintain that momentum and ensure that agencies can routinely and efficiently share information and align their processes. They have the opportunity to ensure that they are ready in case of future pandemics, with systems in place for things like post-approval changes, clinical trial protocols, and remote hybrid inspections.
Cooke shared that what keeps her up at night is how many of the factors that contribute to problems like drug shortages are not directly controlled by regulators or manufacturers. The global supply of medicines is also subject to trade and market forces and consumer preferences. Solutions will need to involve additional stakeholders, including patients, distributors, healthcare workers, and pricing and reimbursement bodies.
Abraham asked whether the EMA is involved in any efforts to bring additional stakeholders to the table. As an example, Cooke described the EMA’s efforts to alleviate shortages of GLP-1 medicines, particularly a workshop that included members of the diabetes and weight loss communities as well as pharmacists and industry personnel.
Miksinski then asked Abraham how he would answer the original question, prompting him to provide an industry perspective on what issues kept him up at night and what opportunities he sees. Abraham echoed Cooke’s concerns about avoiding drug shortages and emphasized the challenge of post-approval changes. Post-approval changes can take three to five years, he noted, which strains the ability of suppliers keep up with demand.
Abraham followed with a question about how to foster and support innovation. Currently, he shared, when drug companies develop a new technology or modality, they must go through separate regulatory processes in every country, which can slow or stall progress. He also asked Cooke for her thoughts on making new advances accessible to different markets that vary in their capabilities and resources.
Cooke acknowledged the issue, and she assured her audience that regulators also want to facilitate innovation in drug development and manufacturing. She shared that regulatory agencies are working to reduce those hurdles for industry and ensure new technologies can benefit as many people as possible, with strong models developed by the EMA and the US Food and Drug Administration (US FDA) in particular. The EMA Quality Innovation Group (QIG), the FDA CBER Advanced Technologies Team (CATT), and the FDA Emerging Technology Program (ETP) are working closely together to harmonize their requirements and processes. In addition, ICMRA has completed pilot projects involving multi-agency collaborations, and changes approved through those pilots have since been approved by many other countries.
Cooke noted that she was participating in the ISPE fireside chat virtually because she was in India attending a meeting of the International Conference of Drug Regulatory Authorities (ICDRAs), where regulators from around the world were discussing those same issues of innovation, work sharing, and reliance.
Cooke and Abraham briefly discussed how the US FDA and the EMA could expand their collaborations to include more participation from other health authorities. Abraham asked about the possibility of companies submitting a single application for a new technology that would be reviewed collaboratively by multiple agencies, and Cooke noted that that had happened during the pandemic. She mentioned there were opportunities to continue that work and make it more systematic, although it would have to take resources into account.
Miksinski pointed out that resources are an issue for companies too, as she discovered when she moved from the US FDA to industry. She noted that when she suggested working with the US FDA’s emerging technology platform, she was surprised to encounter pushback from colleagues at her company who feared that would involve too much of a resource investment. Could such barriers be overcome by emphasizing the long-term benefits of such collaboration? In response, Cooke urged companies not to shy away from engaging with regulators to push for worthwhile technologies.
Next, Abraham asked Cooke about the ICMRA pilot projects. Cooke spoke highly of the two projects, which involved collaborative assessments by multiple regulatory authorities including the US FDA, the EMA, Swissmedic, the Pharmaceuticals and Medical Devices Agency (PMDA), and Health Canada. For one of the projects, the agencies worked together on five post-approval changes, providing approvals in just 120 days. The other pilot project involved hybrid facility assessments. The pilots were successful, shared Cooke, but they were also challenging, and efforts are underway to make such joint assessments easier in the future through initiatives such as developing a shared technology platform.
Abraham asked what plans ICMRA had for the future, and whether those plans included work on rare or ultra-rare diseases. Cooke clarified that the role of ICMRA is to provide high-level strategizing and leadership, with the heads of agencies joining forces to launch initiatives. She also shared that ICMRA recently completed a workshop on ultra-rare diseases and was waiting on a report from that workshop before determining what forum would be best suited to take over the work.
Miksinski then turned the discussion to the barriers that stand in the way of global harmonization. What’s the EMA’s perspective on overcoming those barriers, she asked, and how can industry help?
Cooke urged industry to be “informed, engaged, transparent, and proactive.” She believes many problems are related to lack of trust between regulators and industry, and building that trust will be important. It would help if companies could submit the same dossiers, she added, or be very clear about why dossiers differ.
In response to queries from Abraham, Cooke discussed progress toward a shared technology platform that regulatory agencies can use to collaborate and communicate with each other and with industry. A task force under the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is exploring the requirements and feasibility of developing such a platform, she explained.
Finally, Miksinski asked Cooke if she had any questions of her own. Cooke reiterated that regulators and industry should ideally be working together on the same side and asked what barriers might be standing in the way of transparency and openness.
In answer, Abraham described the challenge companies face when they receive many different questions from different regulatory agencies, including from regulators who may not have the technical background to address the core issues at hand. Miksinski returned to her point about the resources companies invest to prepare for communication with regulators. Even when the discussions are supposedly informal, companies pour huge amounts of time and energy into ensuring they can present their material as well as possible, which can make the process intimidating.
In response, Cooke described new listen-and-learn focus groups by the EMA. The focus groups are designed to be a safe space where questions can be asked and feedback offered, without the need for final answers or intensive preparation. To conclude, Cooke highlighted the value of having confidence in one’s work and communicating it openly and authentically.
Disclaimer
This is an informal summary of a presentation on 16 October 2024 at the 2024 ISPE Annual Meeting & Expo in Orlando, Florida, USA. It has not been vetted by any of the agencies or regulators mentioned in this article, nor should it be considered the official positions of any of the agencies mentioned.
