2 PQRI 2021 - KASA Update Rosencrance FINAL v1

An Overview of FDA’s
KASA System
Susan Rosencrance, PhD

Director, OLDP/OPQ/CDER/FDA
Chair, FDA KASA Steering Committee
Introduction
Background • In the Office of Pharmaceutical Quality (OPQ)
we evaluate how a drug is formulated, how it
is manufactured, and the facilities used in the
manufacturing process to ensure a safe and
effective medication is being delivered to the
intended population.
• We also look at formulation and

Quality manufacturing changes made after a drug is
approved to ensure quality is maintained
throughout the product’s lifecycle.
2
Introduction
Background • For a regulatory assessment focused on
quality, a lifecycle approach that
underscores good knowledge management
is essential.
• And to be most efficient its important we

take advantage of modern IT tools and
platforms that emphasize structured data*
and the ability to capture critical
information.
* Structured data is highly specific and is stored in a predefined format so that its easily searchable, whereas unstructured
data is a conglomeration of many varied types of data that are stored in their native formats making it difficult to collect,
process, and analyze 3
Current Challenges to Assessing Quality
External Challenges:
• Volume of INDs, applications/supplements for new and generic

drugs, plus biologics;
• Expectations related to user fee programs; and
• Being accountable to the Commissioner, Congress, the
pharmaceutical industry, and the public.
4
Internal Challenges:
• Regulatory assessments • Encumbers best practices for

traditionally based on knowledge sharing and
X
freestyle narratives (or managing critical information
unstructured text) and a across a product’s lifecycle.
summarization of
application information • An outdated approach that
with cut/paste data hinders the use of modern
tables. technology and our ability to
maximize efficiency.
5
• The risk assessment and evaluation of the

applicant’s mitigation approaches gets
dispersed in lengthy text;
A narrative
• Knowledge management becomes
based quality cumbersome and the assessor’s ability to
assessment compare relative quality and risk across
drug products and facilities is hindered;
means
• The quality assessment becomes subjective
and based on the assessor’s expertise and
knowledge at hand which can lead to
inconsistent application of quality standards
6
Advancing Forward
We recognize the need to modernize
(20th → 21st century technology)
Move from narrative information to structured

data* in order to best capture/manage knowledge
* Structured data is highly specific and is stored in a predefined format so that its easily searchable, whereas unstructured
data is a conglomeration of many varied types of data that are stored in their native formats making it difficult to collect,
process, and analyze 7
Advancing Forward
The KASA System:

A data-based platform
N B
for structured quality
G
E
N
E
W
I
O assessments and
E L
R
I
D
R
O
G applications that
U
supports knowledge
C I
S G C
S S
management and
advanced analytics
KASA = Knowledge-aided Assessment and Structured Application

8
Objectives of the KASA System
The KASA system is being designed to:
1. Capture and manage knowledge

during the lifecycle of a drug product
2. Include established rules and

algorithms to measure the risk
associated with how a product is
designed and manufactured;
9
Objectives of the KASA System
The KASA system is being designed to:
3. Perform computer-aided analyses of
applications for a comparison of
regulatory standards and quality risk
across the repository of approved drug
products and facilities
4. Provide a structured assessment that

radically eliminates text-based narratives
and summarization of information from
the applications
10
An IT template allows FDA to capture
critical assessment information as
highly specific structured data in a
predefined format
11
The KASA Tool
The knowledge captured in KASA:
• Promotes objectivity and consistency in FDA’s
regulatory assessments by providing a broad view of
critical real-time information across the repository of
FDA approved drugs (e.g., controls on impurities across a
drug product line from brand to generic)
• Aids in identifying outliers in applications and facilities
so that emerging problems can be addressed quickly
(e.g., the need for inspection based on assessed
manufacturing capability)
• Improves overall efficiency and excels regulatory
decision making by assuring drugs dependably meet
high quality standards
12
What KASA Means for the FDA Quality Assessor
This is a more
efficient tool
for the
assessor
KASA captures and manages

knowledge and facilitates access
to internal data
13
The Development Process
• The first KASA prototype developed in 2016 was implemented in the
generic space given the large volume of submissions.
• Multiple iterations and improvements were made and tested
throughout 2017-2019
• Throughout 2020-21 FDA worked to transfer KASA to the cloud where it
is stored on FDA servers under a FISMA high environment, the strictest
level of control to ensure protection
• Moving forward there are plans to expand KASA to:
• Drug substances
• New drugs (INDs and NDAs)
• Post-approval changes (i.e., supplements)
• Biologics (BLAs and biosimilars)
14
The Future KASA System
= Knowledge-Aided Assessment
KASA (represents the internal piece)
Knowledge Management
= Structured Application
Generics New Drugs Biologics
(represents the external piece)
Two separate but linked initiatives that

Knowledge-Aided Assessment and
Structured Application
will facilitate the “SA” part of KASA:
• ICH M4Q (R1)
• PQ-CMC
ICH M4Q PQ-CMC

• Provides recommendations for applicants • A term used to describe
preparing the quality section (Modules 2 and 3) of manufacturing and quality control
a drug application information submitted to FDA in
• First drafted in 2002 by the International support of drug applications
Conference of Harmonization (ICH) • Actively establishing electronic
• Planning a revision process that advances the standards (data elements and
format of quality information to a structured terminologies) that will facilitate
format for easy access, analysis, and knowledge the FDA’ transition to a
management by regulatory bodies across the streamlined electronic review
globe environment
• Will facilitate a structured regulatory assessment
in FDA’s KASA system
16
KASA Structured Application

Knowledge Management
Generics New Drugs Biologics
What information is submitted? ICH M4Q

How is information organized?
revision
Knowledge-Aided Assessment and
Structured Application
Electronic data standards PQ-CMC
integrated set of tools and framework to aid content and organization of submission
regulatory assessment and knowledge and electronic data standards
management
The End Game
Leads to quality
Structured data drugs that are reliable
FDA is making IT throughout their
and knowledge
advancements to lifecycle
management will
modernize how
ensure consistency
regulatory
and objectivity in
assessments are
regulatory
conducted
decision making
18

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An Overview of FDA’s

Susan Rosencrance, PhD

• We also look at formulation and

• And to be most efficient its important we

• Volume of INDs, applications/supplements for new and generic

• Regulatory assessments • Encumbers best practices for

• The risk assessment and evaluation of the

Move from narrative information to structured

The KASA System:

KASA = Knowledge-aided Assessment and Structured Application

1. Capture and manage knowledge

2. Include established rules and

4. Provide a structured assessment that

KASA captures and manages

Two separate but linked initiatives that

ICH M4Q PQ-CMC

KASA Structured Application

Generics New Drugs Biologics

What information is submitted? ICH M4Q

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