APR March 2024 - 56

»
FORMULATION AND DEVELOPMENT
»
How Pharma Companies Are Solving Regulatory
Challenges with AI-based Technology
Jane Reed
Director Life Science Safety Regulatory Quality
IQVIA
Too often, the traditional document-centric approach for solving
regulatory compliance issues taken by pharmaceutical companies
creates barriers in terms of efficiency, collaboration, and compliance.
Because pharma is one the world's most regulated industries -
with continuously evolving frameworks, guidelines, and reporting
requirements - drug developers must keep pace with regulatory
changes to avoid compliance issues.
Many of the issues involved with pharma's traditional approach to
maintaining compliance stem from the heavy manual and repetitive
workflows that are involved. For example, tasks such as developing
regulatory submissions, keeping labels up to date, understanding
guidelines, and maintaining compliance with constantly shifting
regulations require regulatory teams to access and analyze critical
data scattered across vast amounts of documents.
Pharmaceutical companies expend a significant investment on these
activities in in the form of time, money, and effort, which add up on
the cost side of the ledger but do little to enhance revenue. As a result,
regulatory teams are looking for digital transformations that will help
them evolve from the traditional document driven-approach to more
modern, data-driven methods.
Through
digital
transformations,
innovative
technologies
and
systems can help regulatory teams discover essential data within
regulatory documents, then extract and standardize this information
for use in downstream processes like reporting, labeling, master data
management, or structured content authoring.
To accomplish these objectives, leading pharmaceutical teams are
looking to artificial intelligence (AI)-based technologies to automate
processes, improve efficiency, and ensure accurate reporting. One
of these notable technologies is Natural Language Processing
(NLP), which uses algorithms to " read " through unstructured text,
then transform it into structured data that is suitable for analysis
and visualization.
56 |
| March 2024
NLP: What It Is and What It Does
for Pharma
NLP is a subset of AI that pertains to how computers and human
language interact. In lay terms, think of it as computers gaining the
ability to understand, interpret, and generate natural language. With
NLP, computers can process, analyze, and derive meaning from human
language from a wide range of text inputs, including emails, social
media posts, reports, and reviews, in a way that is similar to humans.
Those capabilities are very beneficial to pharmaceutical companies'
regulatory teams, in particular, which frequently must comb through
substantially
large collections
of documents
to discover new
information and answer specific research questions. NLP enables
teams to identify facts, relationships, and assertions that may otherwise
remain buried among hard-to-scrutinize mounds of unstructured data
within regulatory documents and other sources of key data.
Once converted to a structured format, this information can be
integrated into databases, data warehouses, or business intelligence
dashboards and is incredibly valuable for a wide range of use cases
pertaining to descriptive, prescriptive, or predictive analytics.
NLP is not a new technology, but it has become widely used in recent
years in consumer products, such as Siri, Alexa, and Google's voice
search. More recently, the emergence of Generative AI built on large
language models (LLMs), such as ChatGPT, has generated new interest
in applications of NLP in a broad range of disciplines, such as medical
research, customer care, fraud detection, and risk management.
As it relates to the pharmaceutical industry, NLP has become an
indispensable tool aiding in drug discovery, development, and
commercialization, largely because it significantly outperforms
previous methods of search and information discovery. For example,
traditional methods of search merely point to the location of

APR March 2024

Table of Contents for the Digital Edition of APR March 2024

Message from the Editor
Editorial Advisory Board
BIOPHARMACEUTICALS - Getting to GMP-Quality Biotherapeutics From Today’s Bench-Scale Continuous Manufacturing Systems: A Gap Analysis
MICROBIOLOGY - Critical Behavioral Attributes and the Application of COM-B Framework in Aseptic Processing
FORMULATION AND DEVELOPMENT - Use of AUC in AAV Analysis in a GMP Setting
FORMULATION AND DEVELOPMENT - Precision Medicine in Clinical Trials: A Statistical Perspective
An Interview with Dan Smithey, PhD President & CEO, Serán
FORMULATION AND DEVELOPMENT - Still Early Days for AI in Drug Discovery...Says Who?
QC Corner - Enhancing Material and Equipment Availability in Production Isolators
BIOPHARMACEUTICALS - Technologies for Aseptic Filling: The Choice is Clear
Vendor Viewpoint - Data Integrity and Rapid Micro Methods: Transforming to a Modern Microbiology Lab
MICROBIOLOGY - Bacterial Spore Formers in Disinfectant Efficacy Testing
Partner Perspective - Nanoparticle Technologies: Enablers for Ocular Drug Delivery
DRUG DELIVERY - Your Nails and You
DRUG DEVELOPMENT - Battling Exorbitance: High Costs in Sickle Cell Gene Therapies and the Imperative of Global Patient Registries for Equity
FORMULATION AND DEVELOPMENT - How Pharma Companies Are Solving Regulatory Challenges with AI-based Technology
Event Preview - CPHI North America
Event Preview - Excipient World 2024
P.I.N. Points
Advertiser's Index
APR March 2024 - CoverTip01
APR March 2024 - CoverTip02
APR March 2024 - Cover1
APR March 2024 - Cover2
APR March 2024 - 1
APR March 2024 - 2
APR March 2024 - 3
APR March 2024 - 4
APR March 2024 - 5
APR March 2024 - Message from the Editor
APR March 2024 - Editorial Advisory Board
APR March 2024 - BIOPHARMACEUTICALS - Getting to GMP-Quality Biotherapeutics From Today’s Bench-Scale Continuous Manufacturing Systems: A Gap Analysis
APR March 2024 - 9
APR March 2024 - 10
APR March 2024 - 11
APR March 2024 - 12
APR March 2024 - 13
APR March 2024 - MICROBIOLOGY - Critical Behavioral Attributes and the Application of COM-B Framework in Aseptic Processing
APR March 2024 - 15
APR March 2024 - 16
APR March 2024 - 17
APR March 2024 - 18
APR March 2024 - FORMULATION AND DEVELOPMENT - Use of AUC in AAV Analysis in a GMP Setting
APR March 2024 - 20
APR March 2024 - 21
APR March 2024 - 22
APR March 2024 - 23
APR March 2024 - FORMULATION AND DEVELOPMENT - Precision Medicine in Clinical Trials: A Statistical Perspective
APR March 2024 - 25
APR March 2024 - 26
APR March 2024 - 27
APR March 2024 - An Interview with Dan Smithey, PhD President & CEO, Serán
APR March 2024 - 29
APR March 2024 - 30
APR March 2024 - FORMULATION AND DEVELOPMENT - Still Early Days for AI in Drug Discovery...Says Who?
APR March 2024 - 32
APR March 2024 - 33
APR March 2024 - QC Corner - Enhancing Material and Equipment Availability in Production Isolators
APR March 2024 - 35
APR March 2024 - BIOPHARMACEUTICALS - Technologies for Aseptic Filling: The Choice is Clear
APR March 2024 - 37
APR March 2024 - 38
APR March 2024 - 39
APR March 2024 - Vendor Viewpoint - Data Integrity and Rapid Micro Methods: Transforming to a Modern Microbiology Lab
APR March 2024 - 41
APR March 2024 - MICROBIOLOGY - Bacterial Spore Formers in Disinfectant Efficacy Testing
APR March 2024 - 43
APR March 2024 - Partner Perspective - Nanoparticle Technologies: Enablers for Ocular Drug Delivery
APR March 2024 - 45
APR March 2024 - 46
APR March 2024 - 47
APR March 2024 - DRUG DELIVERY - Your Nails and You
APR March 2024 - 49
APR March 2024 - 50
APR March 2024 - 51
APR March 2024 - DRUG DEVELOPMENT - Battling Exorbitance: High Costs in Sickle Cell Gene Therapies and the Imperative of Global Patient Registries for Equity
APR March 2024 - 53
APR March 2024 - 54
APR March 2024 - 55
APR March 2024 - FORMULATION AND DEVELOPMENT - How Pharma Companies Are Solving Regulatory Challenges with AI-based Technology
APR March 2024 - 57
APR March 2024 - Event Preview - CPHI North America
APR March 2024 - 59
APR March 2024 - Event Preview - Excipient World 2024
APR March 2024 - 61
APR March 2024 - P.I.N. Points
APR March 2024 - 63
APR March 2024 - Advertiser's Index
APR March 2024 - Cover3
APR March 2024 - Cover4
https://www.nxtbookmedia.com