ransformation is defined in the Cambridge Dictionary as “the process of changing completely the character or appearance of something in order to improve it.” This definition will also tell you that transformation is a noun — but it is much more. As industry continues to extend the frontiers of science, the interactions and information exchange between regulators and the regulated is relatively unchanged. A paradigm shift from a document-centric mindset to a data-driven approach is needed to get therapies to patients more quickly and efficiently. It is time to turn digital transformation into a verb by reimagining the way these entities collaborate and exchange data.

A Turning Point

• The Food and Drug Administration (FDA) modernization action plans and the informatics components in the Prescription Drug User Fee Act
• The European Union Cloud Strategy
• The International Coalition of Medicines Regulatory Authorities’ (ICMRA) collaborative hybrid inspections pilots.

Additionally, initiatives like FDA’s Project Orbis, the ACCESS Consortium, and the Reliance Review Model demonstrate how collaboration between global regulators is reaching new levels as early therapeutic access and a stable supply chain continue to be top of mind.

While these programs are integral first steps, industry needs a harmonized paradigm shift across geographies where real-time communication and coordinated engagement occurs, and where data is standardized, aggregated, and dynamic, to reach optimal efficiency.

Paving the Way for Regulatory Progress

• Real-time coordination, in multitenant spaces, for efficient and secure collaboration between HAs and life sciences organizations (LSOs), eliminating the need for laborious document exchange and duplicative work
• Exchange of unstructured and structured source data within these multitenant spaces to reduce stakeholder reliance on narrative-heavy content
• Inclusion of privacy, security, traceability, and data integrity capabilities to mitigate known barriers to adoption.

Industry has reached an inflection point where maintaining the status quo is no longer tenable. The average cost to bring an asset to market has risen to pre-pandemic levels but average peak sales forecasts have dropped. When coupled with the recent resource-intensive effort by global HAs to respond to COVID-19, they demonstrate that both sides of the life sciences/regulatory ecosystem would benefit from a global paradigm shift. However, a transformation of this magnitude comes with many regulatory considerations.

First, global collaboration requires harmonized data standards. Reputable consortia are leading policy efforts to define or harmonize key data standards to bridge the gap in adoption and maturity across geographies. Specifically, the International Organization for Standardization, Identification of Medicinal Products, and the International Council for Harmonisation are working to develop and adopt standards to ensure reliable and consistent data exchange.

There should also be an understanding that the ecosystem must utilize the most advanced digital solutions while accommodating current and future regulations across varying levels of HA maturity. This understanding of diverse stakeholder needs is critical, especially when it comes to developing flexible and scalable solutions that deliver on known requirements yet are secure enough to comply with evolving international guidelines.

Additionally, to truly realize this important paradigm shift, the ecosystem must come together. HAs, LSOs, regulatory/trade associations, and others must collaborate to successfully realize a future state of digital transformation and regulatory harmonization. Innovation in this space takes trust, transparency, and digital fortitude.

Responsible Innovation

• Project Orbis will provide a framework for concurrent submission and review of oncology products among international partners by facilitating complex, scientific, real-time collaboration. Each “tenant,” or participating organization, will have access to a secure space that offers capabilities including structured content parsed using artificial intelligence, project management capabilities, regulatory review collaboration tools, information request management, and a question-and-answer library. Collectively, this POC will form the foundation for other work-sharing and reliance programs in support of regulatory harmonization and convergence. This POC is expected to be ready for use in 2024 and solidifies the potential for consolidating more regulatory interactions into a single cloud environment.
• Labeling Negotiation will build upon Project Orbis, utilizing core platform capabilities to parse structured content and enable real-time regulatory collaboration. Labeling Negotiation will also demonstrate functionality such as co-authoring, version control, and strict tracking of comments and textual/format changes. These capabilities will offer the transparency needed to support multiple cycles of labeling revisions between an LSO and HA while preserving privacy and data integrity.
• Data Exchange (DataX) will enable complex and tabular data, such as content found in Module 3 of the common technical document (CTD), to flow in and out of the platform to foster collaboration and sharing in regulatory interactions. DataX capabilities will include a bidirectional, continuous data-driven process, upstream ingestion, and real-time exchange of structured data between LSOs and HAs. This functionality will be combined with the ability to view, securely export, and analyze data.

While the initial focus is on structuring and standardizing content, facilitating simultaneous collaboration, and other forms of information and data exchange, the ultimate goal is a single dossier in the cloud. Transformation does not just exist in the future but also relies on actions we can take today. Digital transformation occurs where collaboration, efficiency, and evidence generation converge. As an ecosystem, we must remain steadfast in our advocacy and investment to harmonize efforts and deliver numerous 21st century cures.