Welcome to our PharmaPendium Webinar!

PharmaPendium, for informed drug development decisions – An introduction

Your host: Chris Flemming Your presenter: Phil MacLaughlin

About us

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Need to know

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What is PharmaPendium?Key product points: Unique content

First product to offer both searchable FDA approval packages and EMA EPARs

• 1.9M newly-searchable pages covering all of FDA history, over 70 years (from 1938),• Searchable EMA EPAR content (from 1995)

Used primarily for Preclinical assessment (Safety, PK, Efficacy) and Regulatory Affairs

Other key sources: •EMA, •AERS (post-marketing events)

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What is PharmaPendium?Extracted Data

First product to bring together preclinical, clinical & post marketing data

•Normalized terminology on searches, extracted data•Which experimental data translates, why or why not?

Over 1,100,000 extracted drug safety observations•Normalized AE/Tox terminology mapped to Class, Target, Structural Chemistry

Over 1,300,000 extracted PK parameter data, preclinical and clinical. Normalized and related the same way (structure, class, target)

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FDA Approval Packages:Examples of original documents

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OCR Example

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FDA Approval PackageSearch result

Pharmacokinetic Module

Project Title

Unprecedented access to Preclinical and Clinical exposure data extracted from FDA packages (current & historic) and EMEA documents.

• preclinical and clinical exposure data at multiple parameters and usually under various experimental conditions:

• Concomitant drugs, disease states, demographic differences, etc.

• The level of PK data to be contained in this database is almost never published (competitive reasons) at this level of detail.

Pharmacokinetics, preclinical and clinical, & Drug Safety databases browsable within the same platform.

PK Module content sources

Project Title

Over 1,000,00 Extracted parameter values from (Every 2 mos.):• FDA Reviews from 1938-Present (FDA Approval Packages)• EMEA EPARs from ~ 1995 – Present

• With filterable fields and special designations for:• Drug name, Species, Study Group (population), Dose,

Route, Parameter, Value (normalized in searching), SD• Enantiomers, Metabolites, Tissue-specific studies,

Concomitants (Food Effects)

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Let’s take a look at PharmaPendium

….by going to www.pharmapendium.com

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