As the EU IVDR deadline approaches, artificial intelligence (AI) is a circulating topic around the regulatory world as a potential solution to managing new requirements. But, what exactly is artificial intelligence? How can it be applied to real-world regulatory use cases and workflows? Is there any reality to the claims being made?
Presented by the San Diego Regulatory Affairs Network (SDRAN), Sorcero VP of Machine Learning Sandra Carrico, inventor of Mixed Formal Learning, and Regulatory & Clinical Operations Expert Sheila Mahoney-Jewels MBA will speak in a virtual webinar on Wednesday, May 18th to break down the reality of artificial intelligence, discuss how it can be applied to regulatory, and share an IVDR Use Case.
San Diego Regulatory Affairs Network (SDRAN) Monthly Program
AI Under the Hood: A Step-By-Step Guide to How Language Intelligence Works, What it Means for Regulatory, and an IVDR Use Case
Program Speakers:
Sheila Mahoney-Jewels, MBA
Regulatory and Clinical Operations Expert
Sandra Carrico
Vice President of Machine Learning at Sorcero
Event Agenda
DATE: Wednesday, 18 May 2022
TIME: 6:00 – 6:05 PM PST Welcome and Announcements
6:05 – 7:05 PM PST Program Presentation
7:05 – 7:30 PM PST Q & A
LOCATION: This is an ONLINE event on Zoom virtual platform
Click here to register for this event.
Program Details
The long-awaited EU IVDR deadline is approaching, and with it, comes a much greater burden on diagnostics companies, particularly an 80-90% increase in Notified Body (NB) review. Literature search is a primary means of establishing clinical evidence. However, it is a laborious task conducted by premium resources (MDs, PhDs) who, even at maximum productivity, can usually only review 20-25% of available literature.
Against this backdrop is the sheer increase in available data to review. No longer are a handful of primary journals considered. The universe of peer-reviewed content has increased dramatically in recent years not only in all major geographical hubs but all over the world. It is an abundance of research, but also a daunting challenge for manual review. Arguably, as digital data increases, long-standing traditional approaches, i.e., manual reviews, will be increasingly challenged.
Language Intelligence, an advanced form of artificial intelligence (AI) designed for the life sciences, is a solution that quickly and easily reviews 100% of the literature, eliminating the laborious aspects of the process and enabling MD/PhDs to analyze the results.
Objectives:
Join us and learn:
- What is Artificial Intelligence (AI)?
- What is Language Intelligence (LI)?
- Step-by-step guide to how Language Intelligence works
- What this new technology means for regulatory
- Inside an IVDR use case
Speaker Biographies:
Sheila Mahoney-Jewels, MBA, is a regulatory and clinical operations SME (subject matter expert), who has spent almost 25 years at the intersection of sponsor operations and the life sciences R&D technology and professional services vendor ecosystem. Sheila’s main passion is facilitating innovation. In addition to regulatory and clinical, Sheila has acquired direct experience with and visibility into all aspects of drug development: pharmacovigilance, biostatistics, data management and statistical programming, medical writing, supply chain, quality, discovery, toxicology, manufacturing, market research and other aspects of commercialization. Sheila’s industry-recognized thought leadership efforts include Co-Founder and Co-Chair of the Drug Information Association’s Regulatory Information Management Working Group, Regulatory Team Lead for the Framework for Paper Destruction v2.0, CoFounder, Chair of the Diversity & Inclusion Working Group, Center for the Transformation of Work- in alignment with the Laboratory for Innovation Sciences at Harvard. Sheila was elected to Pharmavoice’s Top 100 Most Inspiring, 2019 Entrepreneur Award. Sheila holds a BA in Environmental Studies (major: Evolutionary Biology, minor: Public Policy) from Smith College and an MBA from Columbia University.
Sandra Carrico is an innovative executive in the field of machine learning. As Vice President of Machine Learning at Sorcero, Sandra leads the shipping of machine learning solutions that move the state of the art forward. Her approach to developing a mathematical representation of language enables a multitude of machine learning natural language solutions in the life sciences. 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. Sandra invented Mixed Formal Learning, an architecture for the development of efficient machine learning solutions that relies on formal mathematical models at Glynt.ai. The Glynt algorithm currently reports less than a 1% error. She has patents that cover multiple software areas. She holds an MS in Computer Science from the University of Illinois Urbana-Champaign and a BS in Electrical Engineering and Computer Science from Northwestern University. Sandra is a majority owner in DealCloset, an organization that shares substantial revenue with Habitat for Humanity and Second Harvest Food Bank. She enjoys snowboarding and hiking.
Registration Information:
Online registration ends Tuesday, 17 May 2022.
SDRAN Member: $10.00
Non-Member: $15.00
For Questions Email: Programs.committee@sdran.org
More information can be found here on SDRAN's event page.
