Digital Technology Week: Digital technology potential in Regulatory Affairs

As previously discussed, digital technology adoption has occurred more quickly in manufacturing and financial services but is also being applied in the healthcare sector.

The gradual evolution

Digital technology's integration into the regulatory industry is proving to be a gradual evolution rather than a sudden revolution due to the conservative nature of the profession and function. 

The progression to digitally enabled regulatory affairs is also dictated by the dynamics within each pharmaceutical company as the drivers for change often arise from corporate initiatives rather than function-specific.

Whilst digital technology adoption in regulatory affairs is nascent, it is the next 10 to 15 years that are expected to witness significant transformation. 

The opportunities for technology enablement seem huge if the full potential is realized, but the established use of such tools is untested and unproven in regulatory circles.

Current regulatory processes and systems

The existing regulatory activities follow a structured process, ranging from data acquisition to generating comprehensive dossiers for various purposes, such as health authorities' discussions, submissions, and renewals. 

This process forms the basis for integrating digital technologies seamlessly into regulatory activities.

The extent of technology introduction has been that of RIM or Electronic Data Management Systems (EDMS). 

Such commissioning and implementation projects have been significant undertakings for most companies, particularly those that require customization, and so this has taken years. 

With this experience of such implementation and prior experience with software introduction, the prospect of emerging and untried technology fills many regulatory leaders with dread!

The crucial role of data

As an information and data-driven function, regulatory affairs would appear to be a suitable candidate for a digital revolution. 

The challenge is the large volume of data held in a variety of repositories. Addressing the critical aspect of data sources, particularly in the pharmaceutical industry, presents a significant challenge.

Artificial intelligence (AI) tools are actively involved in comprehending data patterns, drawing information from diverse repositories, and advancing data generation. 

However, the manipulation of information through regulatory processes is critical to ensuring a regulatory submission that reflects the applicants’ intentions. As technology remains unproven to complete such tasks reliably the barriers to widespread adoption are significant.

Generative AI in regulatory affairs

Generative AI, akin to chat systems, operates on principles like large language models, including GPT. 

GenAI enables documents to be drafted from source data in an automated manner. CTD sections, clinical documentation, and labeling are all candidates for such technology.

Companies are experimenting with technology systems akin to ChatGPT and OpenAI recognising there is a long road of development and validation ahead. 

Understanding the nuances of data sources and the generation of content is vital when dealing with generative AI in regulatory affairs and the output must be carefully checked and reviewed before these can be considered anywhere near submission ready.

Automating Health Authority assessments

Developments in this space include automation of health authority questions and responses that enable tasks such as reading correspondence, extracting commitments, and managing databases to be automated, replacing manual processes. 

This is not a new technology as it has been used in financial services (e.g., invoice processing) for many years. 

The advantage of a digital system in this space, in addition to removing administrative activity, allows companies to mine such data to produce responses to new questions in the future.

Industry-wide platform

Accumulus Synergy, a not-for-profit organization, has been exploring the application of digital technology as a means of leveling the playing field for industry and health authorities alike. 

This organization is supported by a wide variety of stakeholders and has recently announced a new sharing platform that may provide the basis for future technological advancement. 

Until now, industry standardization has been driven by demand for specific tools or RIM systems, so this development remains of significant interest.

AI's broader implications

AI's potential extends beyond comprehending data points within a dossier to gaining insights into a company's experiences and the entire industry. 

The considerations for the use of such technology a far far-reaching and could leave corporations exposed if not treated with care.

The AI systems that are in use manage data through the cloud and so where the information is held and manipulated must be checked. Security of sensitive data is paramount in both the upload to the given system, but also how the data are manipulated and then where the output is stored once the transaction is completed. 

As a comparison, well-known tools such as ChatGPT and Google Translate are open source which means once data are uploaded these are in the public domain. As a result, many organizations including G&L, prohibit such use with any sensitive data.

The second implication for AI is the nature of the algorithms used to manipulate, structure, or characterize data. Care must be taken to check whether any machine learning occurs to alter the algorithm as data is processed. It is important to ensure that the output remains consistent, validated, and predictable regardless of the subsequent review process.

Another implication for embedded tools is how data are accessed. If a cloud-based AI tool is used to draw from corporate data systems, there should be a clear understanding of how this is done and the jurisdiction of access. 

For example, a CTD module 3 LLM GenAI tool that has access to manufacturing and LIMS systems, what controls over specific product access or wider systems is important to understand.

These examples, whilst not exhaustive, hold significant and inadvertent implications.

Transformative journey: a work in progress

The ongoing evolution of these processes is a work in progress, acknowledging the technology's early stages.

Despite being in these early days, the outlined steps showcase the potent impact of automation on current practices. As we navigate through these stages, the potential for enhanced efficiency becomes increasingly evident.

Implications for regulatory

Regulatory activity is likely to be transformed in the decade to come, but the role of professionals is likely to continue to play a key role in drug registration, offering strategic inputs, and ensuring the desired submission meets the needs of the applicant organization. 

The key to the continuing importance of the regulatory professional lies in adapting to changing dynamics, ensuring the regulatory remains agile and valuable in the face of technological advancements.

The rate of adoption of technology across the industry remains a big question. The vast range of company sizes and complexity is likely to dictate the rate of development and potential benefits within such organizations. 

In addition, the same questions apply to worldwide regulatory agencies – from experience with submission formats and the ability to accept standardized electronic submissions still is a challenge.

How we are addressing digital technology at G&L

At G&L Healthcare Advisors, we are committed to staying at the forefront of innovation in the provision of our industry-leading services.

We provide regular learning sessions to navigate the evolving tech landscape, dispel myths, and foster a better understanding of its impact on regulatory affairs.

We have a dedicated technology group tasked with identifying, testing, and validating the use of digital tools that will help our staff and clients.

We are undertaking trials with technology specifically targeted at regulatory affairs applications. It is important to focus efforts on technology with impact rather than the next shiny new thing!

We will continue to educate our teams and clients alike as we believe that the narrative of technology in our profession should be developed.

Get involved!

We would like your thoughts and perspectives in this area. Are you keen to see regulatory affairs transformed by digital technology? Or are you skeptical of the perceived benefits? How do you believe the industry will change? For the better or worse?

For more information visit our website or arrange a call with one of our experts.

Paul Kuiken is Vice President of Advisory Practice at G&L Healthcare Advisors.