Safety and efficacy continue to be the two major reasons why drugs fail in clinical trials. Join our free 45-minute webinar, where our PharmaPendium expert, Pooja Jain will: - Demonstrate how PharmaPendium can provide the critical safety and efficacy information you need to mitigate risk and optimize clinical trial success. - Show you how PharmaPendium is uniquely positioned to provide value when using the 505(b)(2) regulatory pathway; from selecting candidates to building clinical bridges. - Reveal how PharmaPendium can provide the comparative translational data that can speed-up decision making and save you critical time and money during the drug discovery phase.

1. Welcome to our PharmaPendium Webinar!
Regulatory Pathways,
strategies and PharmaPendium examples
Your host: Chris Flemming Your presenter: Pooja Jain

2. Need to know
Webinar control panel:
‘chat’ or ‘ask a question’ for questions
and comments
Option for full screen view
Q&A after presentation

3. PP – Regulatory Pathways
Strategies and PP examples

4. 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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5. 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.
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6. Main Regulatory Pathways
$1-1.4 billion NDA
dollars 505(b)(1)
Cost
“The Hybrid” $3-30 million
505(b)(2) dollars
ANDA
505(j)
Degree of Innovation
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7. Development Times
Reason for cost difference?
Source: http://www.camargopharma.com/Userfiles/PageIcons/WhitePaperChartDrgDvlpmtTime.jpg
This can be shortened to as little as
3 years
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8. What can we use it for?
New Indication Labeling
New Active Moiety New Formulation
New Molecular Rx/OTC Switch
(Chemical) Entity
New Dosage Form or New Route of
Strength Administration
New Ester, Salt or Other
Non-covalent Derivative
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9. LIVE DEMO

10. POLL
The poll should appear on your screen shortly….
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11. Questions & Answers

12. Q&A will be sent to you by email.
Our next PharmaPendium webinar will be on the 25th of
April..
For more information and questions please contact
bdtraining@elsevier.com
Go to www.trainingdesk.elsevier.com/pharmapendium for
all webinars and training related materials.
Please fill out the survey that
appears on your screen after
leaving the webinar.