APR March 2024 - 57

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documents, tasking human researchers with the issue of potentially
spending hours of time to read through large amounts of individual
documents to pick out necessary data.
Finally, NLP is particularly well-suited for healthcare data discovery due
to the prevalence of unstructured data in the industry, from electronic
health records to medical images to social media posts. Overall,
pharmaceutical companies have used NLP to boost the accuracy
and efficiency of the drug development lifecycle by unlocking key
information from the many unstructured data sources that are relevant
to the industry.
NLP and Compliance:
A Winning Combination
NLP delivers value to drug developers across a variety of purposes
within regulatory affairs by speeding regulatory affairs and
compliance, boosting labelling processes, standardizing regulatory
data, mapping to master data management systems, and driving
digital transformation in regulatory processes.
NLP offers benefits in many areas, including the following three major
regulatory disciplines:
* Regulatory labeling: Access to drug labels from prominent
regulatory authorities is important to help labeling teams
find reference information for disease and symptom terms,
contraindications, adverse events, and special populations.
* Regulatory intelligence: Access to the landscape of regulatory
updates, with integrated data flows to consume textual
documents, both internal (such as corrective and preventive
actions) and external (such as regulatory guidelines and FDA
letters) is essential for regulatory teams.
* Regulatory mapping: Compliance teams need a means of
finding key data attributes from unstructured text documents
and mapping that data to standards, such as Identification of
Medicinal Products (IDMP), a set of international standards that
define the rules that uniquely identify medical products.
NLP in the Real World:
Three Use Cases
The following use cases demonstrate some real-world examples of
how life science companies use NLP to support regulatory operations:
Internal and external risk management: A large pharmaceutical
company's product development team sought more efficient ways
of understanding internal and external risk management information
to optimize the formulations, commercial supply, and post-market
regulatory compliance of its products.
The team created a data lake to capture important internal and external
feeds. External feeds included FDA warning letters, biological license
applications review reports, white papers, and industry benchmark
repositories, while internal feeds included deviations, corrective and
preventative actions, risks, and response to regulatory questions.
The initiative relied on NLP to structure and generate the data by
extracting critical concepts, relationships, and sentiments from the
sea of information. User-friendly visualizations enable team members
to drill down and navigate the information, driving wider use of the
technology among the team. These internal and external data flows are
updated automatically to deliver scalable reporting of the regulatory
landscape, featuring key risks and recommendations to act upon.
Semi-automated regulatory intelligence tracking: Regulatory
and compliance teams often employ manual approaches to monitor
regulatory authorities, such as requiring team members to check
relevant regulatory websites and subscribe to emails to remain
informed of changes to guidelines.
While the process does generate needed intelligence to uncover
concerns, deadlines, events, and regulatory decisions for compounds
of interest, it is a costly and resource-intensive approach.
To overcome the limitations of manual processes, one leading
agrochemical company used NLP to develop a workflow to semiautomate
information acquisition and summaries. The company
integrated NLP with LLM technology to create a regulatory intelligence
assistant, which provided team members with user-friendly questionand-answer
access to updated regulatory information, safety alerts
and risk categorization for compounds of interest.
Access to drug labels for more effective authoring: A leading
drug developer is using NLP to more efficiently explore and classify
drug label data, helping its global regulatory affairs team overcome
challenges associated with identifying and accessing label content
from diverse sources in multiple languages.
To accomplish this goal, the company use an NLP-powered labeling
intelligence hub, which synthesizes drug label information across key
sources such as the FDA and EMA. The hub enables users to compare
specific labels through an interactive view and access digitalized and
original documents directly. The tool has helped the team streamline
processes associated with developing new labels and updating
existing ones, expediting regulatory approval.
Conclusion
Regulations are continually shifting and evolving so it's important
for pharmaceutical companies to adapt their approaches to assist
with regulatory review and compliance. In the past, many in the
industry relied on traditional search methods to uncover essential
regulatory data, but with new advances in AI-based technologies
such as NLP, there are options that can replace the inefficient,
laborious, and error-prone methods. NLP transforms internal
and external data into high-value, actionable insights, enabling
regulatory teams to unlock important supporting evidence to
rapidly address critical business issues.
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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
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