Transcript Presentation Title

KEY CHALLENGES IN
PHARMACOVIGILANCE
CHALLENGE: HOW TO STANDARDIZE PROCESSES AND DATA
MANAGEMENT
 Development of a common platform
across different geographic locations,
functional groups, product lines.
 Integration of data — a single
database to include data across the
entire product life cycle (pre and postmarket). Challenge: multiple databases
may contain similar information but are
not linked/linkable to each other.
 Implementation of work flow
management technology — identify
and distribute information to
stakeholders according to a
predetermined set of rules. Ensure only
the appropriate employees receive the
data required to inform the decisions
they are authorized to make.
“We don’t view drug safety from a postmarket or premarket
perspective but, rather, as a continuum from the time the
compound is identified and the time of animal studies on
through when companies are hoping to get approval...”
Alan Goldhammer, Associate vice president of regulatory affairs
for the Pharmaceutical Research and Manufacturers of America
(PhRMA) (source: PWC report)
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CHALLENGE: IMPLEMENT PROACTIVE RISK MANAGEMENT
 Development of a risk management action
plan — establish risk scoring and mitigation
processes to evaluate external risk factors
(regulatory, reputation, product liability) and
internal (portfolio, strategic and financial risk).
 Implementation of data mining techniques
— assess the patterns, time trends and events
associated with drug-drug interactions.
 Dashboard — summarize safety information
across the product portfolio in real time. Identify
the types of data that should/should not be used
in drug safety decision making.
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CHALLENGE: RUN PV OPERATIONS COST EFFECTIVELY
 Growing amount of data causes
important safety signals to be missed
— how to deal with the data storm?
 Outsourcing may be done at product
level resulting in mixed vendors and
models.
 Signal identification must not be lost
due to segmentation of the analysis by
different parties.
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10,000,000
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30,000,000
Embase, October 2014
‘Cost savings of 30–40% can be achieved through
outsourced pharmacovigilance activity’
http://www.pmlive.com/pharma_news/outsourcing_phar
macovigilance_352870
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ADDRESSING THE
CHALLENGES IN
PHARMACOVIGILANCE
OUR MISSION IN PHARMACOVIGILANCE
Elsevier provides the capabilities necessary
for Pharmacovigilance and Drug Safety groups
to be more efficient, stay compliant and
mitigate risk
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OUR FRAMEWORK
•Automated
Literature
Monitoring
•Regulatory Data
for Risk
Mitigation
Strategies
•Integration with
case reporting
systems and
audit trails
Output
Analysis
Case Input
Case
Output
Case
Processing
1) Avoid missing
critical information
2) Save time with
better article
pipeline management
3) Connect literature to
broader ecosystem
•Automated
Literature
Triage
4) Manage risk of latestage failure
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EMBASE
THE WORLD’S MOST COMPREHENSIVE BIOMEDICAL RESEARCH TOOL
Reliable and authoritative content to help the drug and drug-related
research community advance new biomedical and pharmaceutical
discoveries.
Confidence
Find all relevant articles that may
not otherwise be found by using
alternative databases
Deep Biomedical Indexing
•
All relevant, up-to-date,
biomedical information from the
research literature
SOURCE
TEXT
MINING
Effort / tools required
•
EMBASE
SCOPUS
PUBMED
Precise Retrieval
•
Deep and focused research using
the most powerful retrieval tools
GOOGLE
0%
50 %
Percentage of relevant articles retrieved
100 %
EMBASE VS. MEDLINE (CONTENT)
INCLUDES ALL MEDLINE CONTENT PLUS MUCH MORE
Embase
Unique
Embase &
Medline
Medline on Embase
5.9m
11.8m
8.3m
2600
3000
2500
• Over 2600 journals not
indexed on MEDLINE,
especially from countries
outside North America
• Over 300,000
conference abstracts
from 1000 conferences
each year (since 2009)
• In-depth drug and
medical device indexing
based on the Emtree Life
Science thesaurus, which
has over twice as many
terms as the PubMed
(MEDLINE) thesaurus
(MeSH)
EMBASE A&G 101 SALES TRAINING, MARCH 2014
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BIOMEDICAL SCOPE AND COVERAGE
EXTENSIVE COVERAGE OF PEER-REVIEWED BIOMEDICAL LITERATURE
Pharmacology & Taxicology 12%
General Clinical Medicine 11%
Genetics, Biochemistry & Molecular Biology 10%
Neurology & Behavioral Medicine 8%
Microbiology & Infectious Disease 7%
Cardiology & Hematology 6%
Psychiatry & Mental Health 6%
Oncology 5%
Healthcare Policy & Management 4%
Allergy & Immunology 4%
Pediatrics 4%
Endocrinology & Metabolism 3%
Obstetrics & Gynecology 3%
Biomedical Engineering & Medical Devices 3%
Anesthesiology & Intensive Care 3%
Gastroenterology 2%
Respiratory Medicine 2%
Nephrology & Urology 2%
Dermatology 2%
Other topics 28%
Including public health, basic biomedical
science and topics included from MEDLINE
EMBASE A&G 101 SALES TRAINING, MARCH 2014
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QUOSA
IMPROVING BIOMEDICAL LITERATURE SEARCH AND RISK MONITORING
A combination of software and services
that allows customers to reduce risk,
remain compliant and ensure that
workgroups have the latest scientific
literature

Pharmacovigilance — Monitor
literature for adverse drug events

Medical Affairs — Collect and share
the latest information for Key Opinion
Leaders and healthcare providers

Medical Devices — Conduct postmarket surveillance for adverse
events reporting and pre-market
approval

Information Management — Collect,
organize and share key documents for
your stakeholders
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SANOFI ADOPTED QUOSA AND EMBASE FOR THEIR
LITERATURE REVIEW
October 22, 2013
Elsevier, a world-leading provider of scientific, technical and medical information
products and services, today announced that Sanofi, one of the world's leading
pharmaceutical organizations, has implemented QUOSA's literature
management tools to automate adverse event monitoring.
Users:
Information managers, CRO, Pharmacovigilance (PV)
Challenges:
• Existing systems for alerts and content management were not efficient or
scalable
• Under threat from the regulator
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EMBASE & PHARMAPENDIUM
IMPROVING BIOMEDICAL LITERATURE SEARCH AND RISK MONITORING
A single drug search in Embase seamlessly
links to PharmaPendium to deliver:

Comprehensive information that
better informs a risk management /
pharmacovigilance strategy

Drug safety information reported in
the literature

FDA/EMA approval and drug review
reports that provides insights into
historical regulatory precedents

A direct link to preclinical and
clinical observations and reported
adverse events (AERs) to better
monitor and anticipate safety risks
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EMBASE + QUOSA: AUTOMATING POST-MARKET LITERATURE
SURVEILLANCE
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An information specialist
develops a comprehensive
search strategy for a drug
in Embase
The search strategy is
tested, validated and
regularly maintained (at
least 3 times a year)
The information manager
sets up a daily or weekly
alert containing the search
strategy
Alert results are
automatically loaded into
QUOSA, deduplicated, fulltext retrieved and stored in
specified folders
Quosa enables further
annotation and indexing,
‘internal alerts’ and text
analytics
PV / regulatory specialists
receive only relevant full
text, annotated and
deduplicated, pre-analyzed
full text records to review
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ELSS PHARMACOVIGILANCE SOLUTION SUMMARY
Online
literature
databases
Conference
Documents
Journal RSS
Feeds
QUOSA Software and Services
Receive alerts
to rapidly
identify adverse
events in
literature
Review and
annotate
articles from
a scalable
central
library
Use preformatted
output to
easily create
reports
PSURs
ICSRs
Other Safety
and
Compliance
Reports
ELSS SERVICES: Set up advice, consultancy on potential for text mining
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Text Mining & Data Integration