Key insights from RAPS Convergence 2025

The RAPS Convergence 2025 conference highlighted challenges in today’s healthcare industry, including educational, logistical, geographical and financial barriers. Sponsors face time to market pressures, and we know Agencies are agreeable to striking the right balance between patient access and safety of new drugs; however, programs for expedited access require continual efforts. The conference emphasized the significance of the patient experience, options for accelerated approvals in both domestic and global settings, insights to navigate the evolving FDA landscape, as well as how to implement artificial intelligence (AI) in regulatory affairs.

Transformative patient role in product labeling 

One of the amazing takeaways from this conference was observing the transformative shift in the patient’s role. Patients have always been at the heart of what we do in the pharmaceutical realm, with the focus on pursuing timely availability of new products to those who need them most.  Now, patients have an opportunity to take on a more active and central role by having their share of voice in product labeling–a quantum leap. We are encouraged to see such great initiatives at the FDA and EMA to embed the patient experience data directly in labeling–“Bringing the Patient Voice to the Health Authorities.” It has the potential to encourage more participation in clinical trials, and the patient has an opportunity to see how their clinical data and real-time experience of their medical condition, including rare and ultra-rare diseases, can be utilized in submissions to regulatory authorities and translated into labeling that is representative of their experiences. A call to action was made to the industry to make labeling more user-friendly, potentially developing a separate patient label that is simpler to read, understand, and utilize, thereby putting the patients’ needs at the forefront. 

Expedited regulatory pathways: Opportunities and challenges

The industry has embraced the expedited regulatory pathways for unmet medical needs currently available through Health Canada, FDA and EMA. A key concern of the industry is the divergence, rather than convergence, of submissions across the agencies. Looking closer at the conditional approval pathway in Canada (Notice of Compliance with Conditions), this pathway enables earlier access to drugs that address unmet medical needs for patients. The conditional approval pathway is based on preliminary data (perhaps a single Phase II or III study using surrogate endpoints) and the Manufacturer must commit to undertake additional studies to verify the clinical benefit. This program does have potential challenges, as it can be difficult to design and conduct confirmatory trials to verify the clinical benefit of the drug. Factors such as a change in clinical endpoints, population changes, or recruitment challenges can impact the ability to complete the post-market commitments required for full approval. Manufacturers need to consider factors including the timeline differences to gain full approval and the competitor space to determine if conditional approval is the best pathway to ensure long-term approval of the health product.

Balancing transparency and confidentiality in FDA decision-making

A key change in the evolving FDA landscape is the initiative to enhance transparency and provide greater insight into its decision-making process regarding drug approvals through the public release of CRLs. This is an impactful change for manufacturers. The transparency is a positive step forward to increasing visibility to drug developers on the common deficiencies that pre-empt the agency’s approval of new drugs and potentially reducing the time to get new drugs to market. On the other side of the spectrum this may unfavourably impact the industry if CRLs, and potentially the responses to CRLs, are issued in real time and companies don’t have the opportunity to protect the public disclosure of proprietary and confidential business information. The consequential impact on regulatory decision-making and approval of dossiers under review in other regulatory jurisdictions cannot be underestimated.

The role of AI in regulatory affairs

AI is proving invaluable in regulatory affairs by organizing and analyzing data, which can expedite submission preparation, improve timeliness of agency responses and accelerate product approvals. While AI offers significant benefits, it also demonstrates that human knowledge and decision-making are essential to input the appropriate data, provide relevant context, and define prompts for the required output.

How Innomar Strategies provides support

Innomar Strategies is your trusted partner to bridge resource gaps and overcome challenges in the healthcare industry, from navigating regulatory hurdles, to submission preparation and commercial product launches. Our comprehensive services span the entire product lifecycle, from pre-submission regulatory strategy to market access. By addressing educational, logistical, geographical, and financial barriers, Innomar helps enhance access to health products in Canada and the US, ultimately improving patient experiences across the continuum of care.

About the authors:

Danielle Mason is a Director, Regulatory Affairs at Innomar Strategies, where she provides regulatory consulting support for health products (including pharmaceuticals, biologics/biosimilars, and combination products) for the Canada and US markets; and she has also consulted for medical devices. In a secondary role as a Quality-Regulatory-Safety (QRS) Project Manager, Danielle liaises with the internal/external teams to ensure cross-functional activities are aligned and product activities comply with regulatory requirements.

Maria Perrotta is a Director, Regulatory Affairs at Innomar Strategies where she provides regulatory consulting support across diverse health product portfolios. She is a Regulatory Affairs leader with more than 25 years of experience in the biopharmaceutical industry, in global regulatory affairs, regulatory policy, quality assurance, compliance, clinical research and professional education. With experience in multiple therapeutic areas including HIV and Oncology, she has successfully led local and global regulatory submissions and navigated health authority interactions primarily with Health Canada, US FDA and EMA.