Welcome to our PharmaPendium Webinar!   Regulatory Pathways,               strategies and PharmaPendium examples       You...
Need to knowWebinar control panel:  ‘chat’ or ‘ask a question’ for questions  and comments  Option for full screen viewQ&A...
PP – Regulatory PathwaysStrategies and PP examples
What is PharmaPendium?Key product points: Unique content    First product to offer both searchable FDA approval packages  ...
What is PharmaPendium?Extracted Data    First product to bring together preclinical, clinical & post marketing    data    ...
Main Regulatory Pathways                                 $1-1.4 billion       NDA                                       do...
Development Times                              Reason for cost difference?Source: http://www.camargopharma.com/Userfiles/P...
What can we use it for?                          New Indication                Labeling      New Active Moiety            ...
LIVE DEMO
POLL    The poll should appear on your screen shortly….10
Questions & Answers
Q&A will be sent to you by email.      Our next PharmaPendium webinar will be on the 25th of      April..      For more in...
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Pharmapendium - Regulatory pathways - 04April2012

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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.

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Pharmapendium - Regulatory pathways - 04April2012

  1. 1. Welcome to our PharmaPendium Webinar! Regulatory Pathways, strategies and PharmaPendium examples Your host: Chris Flemming Your presenter: Pooja Jain
  2. 2. Need to knowWebinar control panel: ‘chat’ or ‘ask a question’ for questions and comments Option for full screen viewQ&A after presentation
  3. 3. PP – Regulatory PathwaysStrategies and PP examples
  4. 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)4
  5. 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.5
  6. 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 6
  7. 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 7
  8. 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 8
  9. 9. LIVE DEMO
  10. 10. POLL The poll should appear on your screen shortly….10
  11. 11. Questions & Answers
  12. 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 thatappears on your screen after leaving the webinar.

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