Pharmapendium an introduction 29 feb2012


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Pharmapendium is the only online resource for searching all drug approval review and correspondence documentation since 1938 (FDA/CDER/FOI archived FDA/ EMA EPAR approval document database), giving you unrivalled insights into the entire history of drug development and comparative data in preclinical, clinical and post-marketing phases.In this webinar we:
- Showed you how your peers are using Pharmapendium to successfully move drugs along the pipeline.
- Demonstrated how you can be “Better informed” and what this really means to you and your colleagues.

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  • Reaxys is developed and maintained by Elsevier and to briefly put it into context, Elsevier is serving 3 main areas of interest to you, Biology, Chemistry and Medicine. [first click] Reaxys is one of the products serving your needs in these areas, we also have Embase, for biomedical answers, Pharmapendium, giving searchable access to all FDA and EMA approval documentation and our new target finding and validation tool, Target Insights. And Pathway Studio’s unique collection of biological relationships allows you to mine for experimental design and hypothesis generation. [second click] Sciverse ScienceDirect provides full text access to over 10 million journal articles and is continuously looking for new and novel ways to enable further understanding of the scientific literature through applications and new article formats. Sciverse Scopus is our all science database, illumin8 enables product and partnering decisions for R&D and innovation professionals working at the front-end of innovation and Sciverse is a lens on the worlds research activity. And so to todays Reaxys session…
  • What can attendees expect from todays’ session?
  • Pharmapendium an introduction 29 feb2012

    1. 1. Welcome to our PharmaPendium Webinar! PharmaPendium, for informed drug development decisions – An introduction Your host: Chris Flemming Your presenter: Phil MacLaughlin
    2. 2. About us
    3. 3. <ul><li>Webinar control panel: </li></ul><ul><li>‘ chat’ or ‘ask a question’ for questions </li></ul><ul><li>and comments </li></ul><ul><li>Option for full screen view </li></ul><ul><li>Q&A after presentation </li></ul>Need to know
    4. 4. What is PharmaPendium? Key product points: Unique content <ul><li>First product to offer both searchable FDA approval packages and EMA EPARs </li></ul><ul><ul><li>1.9M newly-searchable pages covering all of FDA history, over 70 years (from 1938), </li></ul></ul><ul><ul><li>Searchable EMA EPAR content (from 1995) </li></ul></ul><ul><li>Used primarily for Preclinical assessment (Safety, PK, Efficacy) and Regulatory Affairs </li></ul><ul><li>Other key sources: </li></ul><ul><ul><li>EMA, </li></ul></ul><ul><ul><li>AERS (post-marketing events) </li></ul></ul>
    5. 5. What is PharmaPendium? Extracted Data <ul><li>First product to bring together preclinical, clinical & post marketing data </li></ul><ul><ul><li>Normalized terminology on searches, extracted data </li></ul></ul><ul><ul><li>Which experimental data translates , why or why not? </li></ul></ul><ul><li>Over 1,100,000 extracted drug safety observations </li></ul><ul><ul><li>Normalized AE/Tox terminology mapped to Class, Target, Structural Chemistry </li></ul></ul><ul><li>Over 1,300,000 extracted PK parameter data, preclinical and clinical. Normalized and related the same way (structure, class, target) </li></ul>
    6. 6. FDA Approval Packages: Examples of original documents
    7. 7. OCR Example
    8. 8. FDA Approval Package Search result
    9. 9. Pharmacokinetic Module <ul><li>Unprecedented access to Preclinical and Clinical exposure data extracted from FDA packages (current & historic) and EMEA documents. </li></ul><ul><ul><li>preclinical and clinical exposure data at multiple parameters and usually under various experimental conditions: </li></ul></ul><ul><ul><li>Concomitant drugs, disease states, demographic differences, etc. </li></ul></ul><ul><ul><li>The level of PK data to be contained in this database is almost never published (competitive reasons) at this level of detail. </li></ul></ul><ul><li>Pharmacokinetics, preclinical and clinical, & Drug Safety databases browsable within the same platform. </li></ul>Project Title
    10. 10. PK Module content sources <ul><li>Over 1,000,00 Extracted parameter values from (Every 2 mos.): </li></ul><ul><ul><li>FDA Reviews from 1938-Present (FDA Approval Packages) </li></ul></ul><ul><ul><li>EMEA EPARs from ~ 1995 – Present </li></ul></ul><ul><ul><ul><li>With filterable fields and special designations for: </li></ul></ul></ul><ul><ul><ul><ul><li>Drug name, Species, Study Group (population), Dose, Route, Parameter, Value (normalized in searching), SD </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Enantiomers, Metabolites, Tissue-specific studies, Concomitants (Food Effects) </li></ul></ul></ul></ul>Project Title
    11. 11. Let’s take a look at PharmaPendium … .by going to
    12. 12. POLL The poll should appear on your screen shortly….
    13. 13. Questions & Answers
    14. 14. <ul><li>Q&A will be sent to you by email. </li></ul><ul><li>For more information and questions please contact [email_address] </li></ul><ul><li>Go to for all training related materials. </li></ul>Please fill out the survey that appears on your screen after leaving the webinar.