Authors:
- Alisa Hummings – Senior Director and Head of Medical Information and Local AE Intake Services
- Simon Johns, Director, Medical Information and Marketed Product Safety
- Michelle Gyzen – Senior Director, Regulatory Affairs and Drug Development Solutions (RADDS)
- Michel Denarié, Senior Principal, Regulatory Affairs and Drug Development Solutions (RADDS)
- Archana Hedge – Senior Director, Integrated PV Solutions, IQVIA
Coined as “Generative AI’s (artifical intelligence) breakout year,” 2023 brought explosive innovation to the pharmaceutical field. The industry began to look towards advanced solutions and automated processes to keep up with the rapidly advancing technological landscape, and regulatory affairs, medical information and pharmacovigilance were no exception.
When it comes to safety and regulatory compliance, organizations can anticipate automated technologies to be at the helm of advancement, but what will this look like in 2024?
Managing local expectations
Pharmaceutical companies will push for further use of AI in 2024, especially for simpler, smaller operations. The first things to be optimized will be these “low hanging fruit” procedures. There will not be an overhaul of processes in the coming year, but there will be automation duties that require larger amounts of manual effort.
Although generative AI has a lot of potential, it must be certain that using automated processes will benefit the company, satisfy industry needs and ensure regulations are followed.
Changes in industry legislation, alongside the subsequent impacts on the entire industry, will bring major challenges in understanding and managing expectations from local inspections. Although local legislation may provide regulatory guidance, local inspectors typically provide stricter feedback. This pattern will continue into 2024, and organizations will rely on local contacts who have a complete understanding of the intentions of authorities in each country they represent. Furthermore, organizations will understand the crucial role of documentation and technological tools that support tracking changes in legislation across borders. This ensures minimal impacts to workflows, risk management plants or aggregate reports.
Keeping up with Medical Information
In 2024, the volume of Medical Information (MI) case inquiries will continue to expand, particularly as it remains essentially the only inbound communication channel remaining for pharmaceutical organizations. AI will be a helpful tool to manage this growing case volume.
The introduction of new tools and systems will push organizations to reevaluate current applications to automate historically manual, time- consuming tasks.
Multi or even omni channel models will be relied on to ensure that patients and professionals have access to means of communication with pharmaceutical organizations. The first application will be in the form of AI chatbots to foster warm transfers. When a call center experiences surges in calls and all human agents are otherwise occupied, these AI-empowered agents will step in as backup. Once a human agent is available or deemed needed, these will be able to transfer the call over. Rather than a replacement, AI will be a tool for agent assistance and quicker response.
Regulatory affairs – slow but steady
AI tools show much promise for the regulatory industry, but many regulatory professionals are not fully prepared for the challenges that may arise. Adoption can bring considerable risk and deep compliance implications. Human efforts will continue to be the greatest asset in the journey to automation for validation and compliance.
Global health authorities will need to respond accordingly as new automated systems and technologies are developed. Within the next few years, there will be greater collaboration and consolidation of how health authorities accept submissions. There will also be a large push for component content management and the potential reinvention of the electronic common technical document (eCTD).
The combination of AI, machine learning and large language models will be very promising to assist in deciphering and managing health authority communications. Organizations will be able to efficiently respond to health authority queries by levering existing information and organizational intelligence.
In general, the regulatory industry is hesitant to adopt innovative technologies. However, the past year brough a new appreciation and understanding of AI’s optimization capabilities. Organizations will take a more thoughtful approach to implementing automation into the regulatory field, focusing on change management and staff repurposing and retraining.
Clinical trials look towards diversity and optimization
In 2024, clinical trial sponsors will focus even more on implementing diversity plans. Patients must be representative of the population, but implementing these plans must be approached cautiously in order to stay compliant with health authority expectations.
FDA project optimizations, such as Project Optimus within oncology, are a recent trend that will spread to other therapeutic areas. In fact, there has been a push for organizations to find the optimal therapeutic drug dose rather than just evaluating the maximum efficacy. This could soon be a de facto requirement, lengthening the trial process and raising costs beyond just the field of oncology.
Organizations will begin to integrate technologies like AI and natural language processing (NLP) for indication prioritization optimization and efficiency. This will reduce the amount of manual time and effort spent on data analysis, enabling senior team members to concentrate on the tasks that require a high level of expertise. This integration will happen slowly but steadily as validation is required for accuracy.
Prioritizing pharmacovigilance
Though tools such as generative AI are still in the initial stages of development, the potential impact to pharmacovigilance operations is expected to be expansive. In 2024, there will be more automation built into existing workflows rather than serving as a stand-alone aid to provide recommendations, suggestions or alternatives for potential safety reports. As with the regulatory space, human expertise will not be replaced but rather supported with advanced technology.
Pharmaceutical organizations must recognize that efficiency does not override patient safety, compliance or regulatory standards.
The interest in combined safety services and technology will grow in the coming year as patient safety remains the main focus of the industry. Organizations may look to complete this integration quickly, but detailed roadmaps and plans are required. An instantaneous approach will not be sustainable, nor will it be feasible.
2024 will be a year full of growth, innovation and learning within patient safety, regulatory compliance and the entire clinical space.
As the industry pushes for more optimization and efficiency, there will be increased reliance on a variety of automated technologies. Though the implementation of tools such as generative AI may be daunting, a well-planned approach will be necessary to improve operations overall.
The Editorial Team at Healthcare Business Today is made up of skilled healthcare writers and experts, led by our managing editor, Daniel Casciato, who has over 25 years of experience in healthcare writing. Since 1998, we have produced compelling and informative content for numerous publications, establishing ourselves as a trusted resource for health and wellness information. We offer readers access to fresh health, medicine, science, and technology developments and the latest in patient news, emphasizing how these developments affect our lives.
