Why Drug Safety is Ripe for an AI Revolution
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Pharma Tech Outlook: Pharma Tech Magazine

Why Drug Safety is Ripe for an AI Revolution

Janice Chang, Executive Vice President, TransCelerate BioParma Inc

Robotic Process Automation (RPA) and Artificial Intelligence (AI)have transformed many industries by improving operational processes, strengthening data analytic capabilities, and streamlining workplace efficiency. These Intelligent Automation technologies have the potential to significantly enhance research and development (R&D)through the elimination of tasks that are high effort, repetitive and transactional in nature, and are subject to human error. However, compared to other business sectors—like finance— implementation of these technologies has not been as widespread and systemic in the pharmaceutical R&D space. This gap is partially due to a wide variety of global regulations and uncertainty around the validation of these technologies, which creates substantial barriers to adoption.

There is a critical need to reimagine how we innovate, develop, and deliver medicine to patients. The COVID-19 pandemic has accelerated the desire and need for change. As leaders in our industry and as patients ourselves, we must not settle for the status quo. Changes in how we work, how we collaborate, and how we leverage technology are no longer optional.

As an R&D consortium and non-profit entity, TransCelerate BioPharma is an established organization that brings together biopharmaceutical sponsors, investigative sites, patient groups, technology vendors, and regulatory stakeholders on a global level to accelerate and improve R&D. Core to our mission is ensuring we put patients front and center in the design and execution of clinical trials.

A key focus area of ours focuses on identifying how intelligent automation can be used to support the improved execution of pharmacovigilance (PV) activities and processes. The aim is to assess potential and realized impact and risk, collaborating with global health authorities, and developing tools and guidance to mitigate risks proactively with the assistance of automation technology.

"As intelligent automation is further deployed, companies will gain better access to more consistent data at a more rapid pace,enhancing safety signal detection and risk management "

Our Intelligent Automation Opportunities in Pharmacovigilance (IAO) Initiative intends to evaluate and identify opportunities across the PV domain to implement rules-based automation (e.g., RPA) and AI-based automation (e.g., machine learning, natural language processing) where we can provide maximum impact and value (e.g., faster insights, better understanding of product benefit-risk profile, etc.).

While there are many opportunities for automation across the various PV processes, we have focused first on individual case safety reports (ICSR), a report created by the information provided by a patient, health care professional, or caregiver to describe a patient’s adverse experiences related to the administration of a medicinal product. Pharmaceutical companies are required to collect and curate these cases and use them to both report to Health Authorities and also to better understand the safe use of their products. The ICSR process is resource-intensive and has a risk of inconsistency that is inevitable with manual data processing, making it a prime candidate for automation. Using automation will enhance both consistency and quality during case intake, case processing, and case reporting. As intelligent automation is further deployed, companies will gain better access to more consistent data at a more rapid pace, enhancing safety signal detection and risk management. With better and more timely data, sponsors can get drug safety insights distributed to providers and patients more quickly. Additional value can be found through the development of collaborative partnerships with technology vendors and academia.

The Interactive ICSR and Automation Technologies Tool (IATT) was developed to show each step within the ICSR process, allow users to assess their organization’s processes, formulate business cases, and communicate automation priorities and decisions to both internal and external stakeholders. These activities can then better inform organizations on applications of intelligent automation within their PV practice.

We are seeing technology companies leveraging TransCelerate’s published tools and papers to help inform them as they innovate in AI technologies. We have also heard great interest and support from regulatory bodies to further dialogue with TransCelerate as we look to co-learn and evolve this space going forward. All are indications that the ecosystem is ready for change, and we are in the journey together.

Intelligent automation offers significant potential to reduce cycle times, improve quality, create efficiencies, and reduce costs, all of which lead to less investment in data processing and more into data insights and decisions to better allocation of resources and can improve patient outcomes. This, in turn, contributes to the improvement of public health.

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