KEY CHALLENGES IN PHARMACOVIGILANCE

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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 post-market). 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.

‘Cost savings of 30–40% can be achieved through outsourced pharmacovigilance activity’

http://www.pmlive.com/pharma_news/outsourcing_pharmacovigilance_352870

Embase, October 2014

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ADDRESSING THE CHALLENGES IN PHARMACOVIGILANCE

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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

2) Save time with better article

pipeline management

1) Avoid missing critical information

4) Manage risk of late-stage failure

3) Connect literature to

broader ecosystem•Automated Literature Triage

•Integration with case reporting systems and audit trails

•Automated Literature Monitoring

•Regulatory Data for Risk Mitigation Strategies

Output Analysis

Case Input

Case Processi

ng

Case Output

Reliable and authoritative content to help the drug and drug-related research community advance new biomedical and pharmaceutical discoveries.

EMBASE

THE WORLD’S MOST COMPREHENSIVE BIOMEDICAL RESEARCH TOOL

Percentage of relevant articles retrieved

0 % 50 % 100 %

Eff

ort

/ t

ools

req

uir

ed

GOOGLE

EMBASE

PUBMED

SOURCE

SCOPUS

TEXT MINING

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

Precise Retrieval

• Deep and focused research using the most powerful retrieval tools

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EMBASE VS. MEDLINE (CONTENT)

INCLUDES ALL MEDLINE CONTENT PLUS MUCH MORE

EMBASE A&G 101 SALES TRAINING, MARCH 2014

• 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)

EmbaseUnique

Medlineon

EmbaseEmbase &

Medline

5.9m

2600

11.8m

3000

8.3m

2500

11EMBASE A&G 101 SALES TRAINING, MARCH 2014

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

IMPROVING BIOMEDICAL LITERATURE SEARCH AND RISK MONITORINGQUOSA

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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 post-market 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

IMPROVING BIOMEDICAL LITERATURE SEARCH AND RISK MONITORINGEMBASE & PHARMAPENDIUM

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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

1

An information specialist develops a comprehensive search strategy for a drugin Embase

Alert results are automatically loaded into QUOSA, deduplicated, full-text retrieved and stored in specified folders

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2

The search strategy is tested, validated and regularly maintained (at least 3 times a year)

Quosa enables further annotation and indexing, ‘internal alerts’ and text analytics

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3

6

The information manager sets up a daily or weekly alert containing the search strategy

PV / regulatory specialistsreceive only relevant full text, annotated and deduplicated, pre-analyzed full text records to review

+

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ELSS PHARMACOVIGILANCE SOLUTION SUMMARY

QUOSA Software and Services

Online literature databases

Conference Documents

PSURs

ICSRs

Journal RSS Feeds

Other Safety and Compliance

Reports

Receive alerts to rapidly identify adverse events in literature

Review and annotate articles from a scalable central library

Use pre-formatted output to easily create reports

ELSS SERVICES: Set up advice, consultancy on potential for text mining

Text Mining & Data Integration