With an even greater focus on technology and automation anticipated in 2024, maintaining regulatory compliance in an increasingly complex drug research and development continuum presents certain challenges. Automation such as generative AI stands to bring significant change in the industry, however a greater understanding of the impact and change it will bring is imperative. Companies will need to evaluate the effectiveness of different technologies and approaches to regulatory processes and identify where artificial intelligence can be applied and where its limitations lie. 

IQVIA SMEs in the areas of Medical Information, Safety, Regulatory and Quality, Pharmacovigilance, Product & Strategy, offer perspectives on what to expect in the coming year, inroads, and opportunities.

Simon Johns, Director, Medical Information and Marketed Product Safety, IQVIA: 

The ever-increasing volume of Medical Information case inquiries will continue into 2024, particularly as it is essentially the only inbound communication channel for pharmaceutical organizations. Companies will rely on artificial intelligence (AI) to manage this growth. Although AI is not a new concept within the pharmaceutical field, the development of new systems and tools such as generative AI (GenAI) will prompt organizations to reassess current applications to automate historically manual operations.  
 

2024 will bring a shift towards multi- or even omni-channel models, especially within the Medical Information space, to maintain communication channels for both healthcare professionals and patients. AI will emerge as an extremely beneficial tool in this area as AI agents will be leveraged for things like warm transfers. If a call center is experiencing a surge in calls, AI chatbots can provide backup for human agents. When necessary, the AI-based system can then transfer calls for human agents. 
 

Fully automated processes will be gradually integrated into processes, and though some believe AI will replace human agents, it will be an assistive tool to enable faster response and reduced agent burden. In 2024, organizations will begin to see the benefits of AI-integrated processes. 
 

Alisa Hummings, Senior Director and Head of Medical Information and Local AE Intake Services, IQVIA: 

Pharmaceutical organizations will push for more AI implementation in 2024. Simpler, smaller processes will be optimized first, allowing for additional time to be dedicated to tasks that require higher levels of human expertise. Although there will not be an overhaul of processes to allow organizations to integrate AI into all operations, tasks that require more manual effort will be automated.  
 

Tools like GenAI show great promise for the pharmaceutical industry, but we must be certain that these automated systems will benefit the company, ensure regulations are met and fulfill industry demands.  
 

Changes in legislation, and the subsequent implications for the industry, will be major roadblocks for organizations to understand and anticipate the expectations from local inspections. Alongside local legislation providing regulatory guidance, local inspectors may also have specific, strict feedback. As 2024 moves forward, organizations will rely on local contacts that fully grasp the specific intentions of authorities in the country they represent. Furthermore, companies will recognize the critical role of documentation and technologies that track legislation changes and updates across borders. This will ensure minimal impacts to workflows, risk management strategies and aggregate reports. 

GenAI

Cham Williams, Associate Director, Safety, Regulatory and Quality Solutions, IQVIA: 

Automation and technology will be a major focus for the regulatory industry in 2024. To maintain compliance with increasingly complex regulations, organizations will rely on more automated processes for their operations. 
 

GenAI for labeling processes is widely anticipated, but building trust within the technology will take time. This innovative automation holds much promise for generating and translating content, but human review and validation will remain necessary. We will see more exploration into the potential applications of GenAI in the coming year, but there will not be a full integration into labeling operations. 
 

Change management, content editing and artwork creation are among the processes at the forefront of completely integrated automation, and additional forms of automation are poised to shift the playing field. We will begin to see AI and natural language processing (NLP) emerge as tools to capture and identify regulations or competitor information. As the use cases develop and expand, 2024 will bring increased automation within regulatory operations. 
 

Structured content authoring will also be a priority for companies, as they recognize it as a viable solution for variation and deviation challenges. This flexible source format, based on the defined and enforced consistency of information organization within documents, will be top of mind as companies see the need for breaking up or componentizing existing documents. Many will begin their long journey to structure content authoring in the coming year.   
 

Michael De Jong, Vice President, Global Head, Pharmacovigilance Technology Solutions, IQVIA:
Organizations will widely seek to incorporate GenAI into pharmaceutical safety processes in 2024, though it is unlikely this technology will become fully integrated into pharmacovigilance operations. Rather than full implementation, there will be an immense growth of knowledge around GenAI’s capabilities and potential to improve safety processes in the future. These tools have the potential to disrupt the industry, but a deeper understanding of the changes and impacts is necessary to build trust in the technology. Pharmacovigilance teams must be able to rely on the accuracy of the AI, but the inaccuracies and potential biases create a major barrier to fully achieving the benefits. GenAI is sure to transform pharmacovigilance, but this will take more time to develop beyond 2024.
 

The significant amount of data inaccuracies and inconsistencies currently within safety databases, despite quality checks, causes issues for many organizations. As the volume of cases requiring manual review increases, companies must reevaluate the current human model and associated growing costs compared with the accuracy of AI. Data entry and medical assessment errors may lead to inaccurate assessments of product safety profiles, and more organizations will look to technological solutions to reduce these inaccuracies, minimize costs and enable safety teams to focus more on risk management activities instead of transactional data entry activities.
 

Michael King, Senior Director, Product & Strategy, IQVIA: 

The excitement around the innovative application of AI tools, including large language models (LLM) and NLP is well deserved; however, organizations will begin to acknowledge that their success does not hinge on the latest and greatest technologies alone. Companies will realize the limitations of this technology as they look to apply cost effective solutions to industry operations and customer-facing activities. Variables such as regulations, the availability of industry data for AI model training and commercial viability of these solutions will mold the effectiveness of the uptake of these technologies in the life sciences field.  
 

The proper implementation and utilization of automated technologies will focus on producing the most effective outcomes for patients in a cost-effective way for the company. The focus on the people and process portion of technological innovation, as well as improved interfaces between these parties (i.e. usability, trustworthiness and human surveillance), will result in better outcomes for both companies and patients in 2024.  
 

Quality management within life sciences is becoming more complex; companies are pushed to deliver improved results with constrained resources, driving the need for more efficient, effective and compliant business operations with controlled investment in head count and operational systems. We will see organizations approach this challenge with the provision of a combination of consulting services, outsourced services and technology, a dependency on which may vary from company to company and over time as an organization evolves. The true value of quality management lies in the capacity to combine these services in a modular, scalable way to meet current opportunities and to adapt over time as an organization expands, rather than solely through a one-off deployment of innovative software or technology without an understanding of how this should be applied to processes and utilized by their professional teams.