Pharmapendium - Regulatory pathways - 04April2012
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Welcome to our PharmaPendium Webinar! Your host: Chris Flemming Your presenter: Pooja Jain Regulatory Pathways, strategies and PharmaPendium examples
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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.
Transcript of Pharmapendium - Regulatory pathways - 04April2012
Welcome to our PharmaPendium Webinar!
Your host: Chris Flemming Your presenter: Pooja Jain
Regulatory Pathways, strategies and PharmaPendium examples
Webinar control panel:
‘chat’ or ‘ask a question’ for questions
and comments
Option for full screen view
Q&A after presentation
Need to know
PP – Regulatory Pathways
Strategies and PP examples
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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.
Main Regulatory Pathways
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Co
st
Degree of Innovation
NDA 505(b)(1)
ANDA 505(j)
$1-1.4 billion dollars
$3-30 million dollars
“The Hybrid” 505(b)(2)
Development Times
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Source: http://www.camargopharma.com/Userfiles/PageIcons/WhitePaperChartDrgDvlpmtTime.jpg
This can be shortened to as little as 3 years
Reason for cost difference?
What can we use it for?
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New Molecular (Chemical) Entity
New Active Moiety
New Indication
New Ester, Salt or Other Non-covalent Derivative
New Dosage Form or Strength
Rx/OTC Switch
New Route of Administration
Labeling
New Formulation
LIVE DEMO
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POLL
The poll should appear on your screen shortly….
Questions & Answers
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 [email protected]
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.
Please fill out the survey that appears on your screen after
leaving the webinar.
