Artificial intelligence has the potential to deliver new solutions to the regulatory world.
Rising workloads, digital data, and complex regulations all make the case for regulatory to explore what artificial intelligence can offer. Industry professionals are eager to learn more about AI’s capabilities and how these can be applied to specific workflows. This knowledge is building the foundation for approaching - and trusting - AI as a way to enhance both new and long-standing processes.
Regulatory Educational Series: AI Under the Hood with VP of ML Sandra Carrico
DIA Regulatory Affairs Community Intelligent Automation Working Group
Recently, Sorcero had the opportunity to join two industry groups to discuss artificial intelligence and its applications to regulatory affairs. These educational sessions provided a step-by-step overview of artificial intelligence with Sorcero VP of Machine Learning Sandra Carrico, the inventor of Mixed Formal Learning. Prior to Sorcero, Sandra was Principal AI Architect at Anthem where she led the TeleHealthOS product and prescription prior authorization improvement project. She also served as VP of Engineering at a number of startups following her engineering management and R&D positions at AT&T Bell Labs and AT&T Labs.
On May 18th, the DIA Regulatory Affairs Community Intelligent Automation working group hosted a session on artificial intelligence, NLP (natural language processing), and language intelligence with Sandra Carrico.
The goal of this lecture was to empower regulatory with an informative “under the hood” look at artificial intelligence in order to engage in deeper discussions with IT departments, and in turn, craft and apply high-impact solutions to the regulatory workflow.
San Diego Regulatory Affairs Network (SDRAN) Presents: AI Under the Hood
The San Diego Regulatory Affairs Network (SDRAN) also hosted a webinar with speakers Sandra Carrico and Sheila Mahoney-Jewels, Regulatory and Clinical Operations Expert on May 18th. The webinar, "AI Under the Hood: A Step-By-Step Guide to How Language Intelligence Works, What it Means for Regulatory, and an IVDR Use Case” provided:
- Step-by-step guide to Language Intelligence
- Practical applications of AI for regulatory
- Real-world IVDR use case
Why artificial intelligence, and why now?
Literature search is key to establishing clinical evidence, but it can be a herculean task, even for the most experienced MDs and PhDs. The global quantity of peer-reviewed content proliferates each day, and regulatory professionals can realistically only manually review about 20-25% of available literature. Simultaneously, new regulations are altering existing workflows.
For example, the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) has brought an 80-90% increase in Notified Body (NB) review. As a result of these shifts, the spotlight is placed on long-standing traditional approaches. In today's modern world, technology is often sought to lift some of these burdens.
In particular, an advanced form of artificial intelligence (AI) designed for the life sciences known as Language Intelligence (LI), is a notable solution. Language Intelligence can process large volumes of scientific content from all literature sources with 100% sensitivity and 95% specificity. This frees MD/PhDs from the laborious aspects of the process so they can focus on analysis.
These solutions are novel, but that is not the full story.
In the “AI Under the Hood” sessions, VP of ML Sandra Carrico relayed the history of language intelligence, going all the way back to the ciphers of the 9th century. From leaps forward during the period spanning from WWII to the mid-1960s, on to BioBERT, and even yesterday’s real-world lessons, artificial intelligence has foundational roots across disciplines. Today’s latest developments are not singular rarities, but the results of many experts along the way.
It's becoming more clear that regulatory affairs could play a key part in paving the developments to come. Within many organizations, regulatory may lead the way when it comes to AI implementation. The more these professionals know about AI, the better they can ensure it aligns with overarching goals and strategies. Regulatory can also begin to differentiate between offerings, as not all AI is created equal. Also, they can trust that the right AI will be a partner that augments - not replaces - the deep expertise of the profession. This is where the true potential lies.
You can also learn more about artificial intelligence in our free 10-page AI in Medical Affairs and Regulatory Affairs 2022 Trends White Paper.