Welcome to our PharmaPendium Webinar!

PharmaPendium, for informed drug development decisions

Your host: Dianne Baunbaek Your presenter: Pooja Jain

An introduction

About us

Webinar control panel:

‘chat’ or ‘ask a question’ for questions

and comments

Option for full screen view

Q&A after presentation

Need to know

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Today’s Agenda

What is PharmaPendium?

How do the documents appear in PharmaPendium?

What is the Pharmacokinetic Module?

Poll

Live Demo

Q&A

What is PharmaPendium?

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What is PharmaPendium?

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)

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What is PharmaPendium?

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

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What is PharmaPendium?

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

AERS (post-marketing events)

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What is PharmaPendium?

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

AERS (post-marketing events)

Unique Content

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What is PharmaPendium?

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

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

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What is PharmaPendium?

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

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What is PharmaPendium?

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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What is PharmaPendium?

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)

Extracted Data

How do the documents appear in PharmaPendium?

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FDA Approval Packages:Examples of original documents

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FDA Approval PackageSearch result

What is the Pharmacokinetic Module?

Pharmacokinetic Module

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

Pharmacokinetic Module

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:

Pharmacokinetic Module

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.

Pharmacokinetic Module

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.

Pharmacokinetic Module

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.

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POLL

The poll should appear on your screen shortly….

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Let’s take a look at PharmaPendium

….by going to www.pharmapendium.com

Questions & Answers

Q&A will be sent to you by e-mail.

For more information and questions please contact bdtraining@elsevier.com

The next PharmaPendium webinar will on the 29th of May and will focus on Pharmacokinetics.

Go to www.trainingdesk.elsevier.com/pharmapendium for all training related materials.

Please fill out the survey that appears on your screen after

leaving the webinar.

Please fill out the survey that appears on your screen after

leaving the webinar.