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Finding a drug safety solution for you - Embase and PharmaPendium - Webinar 25 Oct 2012inar. 25 oct2012

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In this webinar, Pooja Jain, our solution expert, showed us how you may first use Embase to track and identify adverse events and move into PharmaPendium to drill down to important information such as looking for evidence of this adverse event in approval stage to mitigate risk moving forward.

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Finding a drug safety solution for you - Embase and PharmaPendium - Webinar 25 Oct 2012inar. 25 oct2012

  1. 1. Welcome to our drug safety webinar! Featuring the Embase and PharmaPendium combined drug safety solution Your host: Ann-Marie Roche Your presenter: Pooja Jain
  2. 2. About us
  3. 3. Need to know• Your control panel: – Questions for asking the presenter a question or making a comment. – Option for full screen view• Questions during the webinar and time for Q&A at the end.
  4. 4. Finding A Drug Safety Solution: Finding A Drug Safety Solution: Embase + PharmaPendium Embase + PharmaPendiumPresented By: Pooja Jain, M.Sc., MBA Date: Oct 25 2012
  5. 5. ••Embase is an online information Embase is an online information PharmaPendium is the only online PharmaPendium is the only online source of biomedical literature that source of biomedical literature that resource to allow drug development resource to allow drug development serves pharmacovigilance reporting serves pharmacovigilance reporting teams to efficiently extract: teams to efficiently extract: needs by broadly tracking adverse needs by broadly tracking adverse events from comprehensive high- events from comprehensive high- ••Best-in-class drug development Best-in-class drug development quality sources. quality sources. information information••Embase records are deeply indexed Embase records are deeply indexed ••Allavailable FDA approvals since 1938 All available FDA approvals since 1938 using our Emtree thesaurus to make using our Emtree thesaurus to make ++EMA since 1995 ++more EMA since 1995 more searching faster, more accurate and searching faster, more accurate and more specific. Emtree lists more than more specific. Emtree lists more than ••More than 1.5 million pages of drug More than 1.5 million pages of drug 60,000 preferred terms and over 60,000 preferred terms and over reviews reviews 260,000 synonyms, including generic 260,000 synonyms, including generic and trade names of drugs. and trade names of drugs. ••More than 4,000 drugs covered More than 4,000 drugs covered••Compared to MEDLINE, Embase has Compared to MEDLINE, Embase has ••Comparative exposure data Comparative exposure data over 2,000 more journals in addition to over 2,000 more journals in addition to conference reports. In total Embase conference reports. In total Embase ••Regulatory precedents Regulatory precedents indexes over 7,000 journals. indexes over 7,000 journals.
  6. 6. Acarbose example “Acarbose” search in Embase Filter by “adverse event” Filter by “liver toxicity” Identification of relevant articlesIdentify any warning Reports of post- Adverse eventssigns that there may Adverse event not marketing adverse reported to affect be drug induced reported in labeling events patient compliance liver toxicity Can we find Did we actually find evidence of these Could we have Was there any evidence of this in adverse events at known about these evidence of this the approval the preclinical and adverse eventsbefore the drug was package? How do clinical stages before the label approved? we mitigate risk before drug was updated? moving forward? approval?
  7. 7. Indexing allows for easyto find information that would otherwise be missed
  8. 8. PubMed returns less than one third of results.
  9. 9. Acarbose example “Acarbose” search in Embase Filter by “adverse event” Filter by “liver toxicity”Identification of relevant articles
  10. 10. What information would you have missed that would pertain to critical post- marketing events?
  11. 11. Search of “acarbose” in Embase
  12. 12. Search of “acarbose” in Embase, filtered based on adverse drug reaction
  13. 13. Filter further on “liver toxicity”
  14. 14. Acarbose example “Acarbose” search in Embase Filter by “adverse event” Filter by “liver toxicity” Identification of relevant articlesIdentify any warningsigns that there may be drug induced liver toxicity Was there any evidence of thisbefore the drug was approved?
  15. 15. Summary• Link critical post marketing findings to the drug and validate its relevance in the context of the studies that were performed as part of the drug approval process• Look at post marketing findings and understand how they could be relevant across different drugs and drug classes• Get directly to the study that was done and now find ways in which study designs could be optimized to reduce the chance of seeing those same events take place with a drug that you are currently developing
  16. 16. Acarbose example “Acarbose” search in Embase Filter by “adverse event” Filter by “liver toxicity” Identification of relevant articlesIdentify any warning Reports of post-signs that there may marketing adverse be drug induced events liver toxicity Can we find evidence of these Was there any adverse events at evidence of this the preclinical andbefore the drug was clinical stages approved? before drug approval?
  17. 17. Filter further on “liver toxicity”
  18. 18. Summary• Found postmarketing adverse event reporting in the Japanese demographic• Found drugs within the antidiabetic drug class which demonstrated similar adverse events in the Japanese demographic and were then able to do comparative adverse event analysis on those drugs• Found extracted drug safety data in both preclinical and clinical studies across different drug classes
  19. 19. Acarbose example “Acarbose” search in Embase Filter by “adverse event” Filter by “liver toxicity” Identification of relevant articlesIdentify any warning Reports of post-signs that there may Adverse event not marketing adverse be drug induced reported in labeling events liver toxicity Can we find evidence of these Could we have Was there any adverse events at known about these evidence of this the preclinical and adverse eventsbefore the drug was clinical stages before the label approved? before drug was updated? approval?
  20. 20. Article: “Medical Management ofMetabolic Dysfunction in PCOS”
  21. 21. 2008 label
  22. 22. 2011 label
  23. 23. Summary• Found postmarketing adverse event reporting in the Japanese demographic• Found drugs within the antidiabetic drug class which demonstrated similar adverse events in the Japanese demographic and were then able to do comparative adverse event analysis on those drugs• Found extracted drug safety data in both preclinical and clinical studies across different drug classes• Found adverse events not yet reported on the label
  24. 24. Acarbose example “Acarbose” search in Embase Filter by “adverse event” Filter by “liver toxicity” Identification of relevant articlesIdentify any warning Reports of post- Adverse eventssigns that there may Adverse event not marketing adverse reported to affect be drug induced reported in labeling events patient compliance liver toxicity Can we find Did we actually find evidence of these Could we have Was there any evidence of this in adverse events at known about these evidence of this the approval the preclinical and adverse eventsbefore the drug was package? How do clinical stages before the label approved? we mitigate risk before drug was updated? moving forward? approval?
  25. 25. Was there anyevidence of lack ofpatient compliancepre drug approval?
  26. 26. Summary• Found evidence that patient compliance was an issue with acarbose due to its adverse events• These concerns were clearly expressed in the approval package and should have been further considered before launching the drug on the market• Now if you are facing similar adverse events in your clinical trials, what information can you find that can help you mediate that risk of patients withdrawing from your drug?
  27. 27. Acarbose example “Acarbose” search in Embase Filter by “adverse event” Filter by “liver toxicity” Identification of relevant articlesIdentify any warning Reports of post- Adverse eventssigns that there may Adverse event not marketing adverse reported to affect be drug induced reported in labeling events patient compliance liver toxicity Can we find Did we actually find evidence of these Could we have Was there any evidence of this in adverse events at known about these evidence of this the approval the preclinical and adverse eventsbefore the drug was package? How do clinical stages before the label approved? we mitigate risk before drug was updated? moving forward? approval?
  28. 28. However a combinatorial drug therapy of acarbose andmetformin is not approved yetby the FDA or EMEA. Was this ever tested before?
  29. 29. Where dowe go from here?
  30. 30. Summary• Found evidence of acarbose plus metformin combination therapy in recent clinical studies• However the same combination has been considered by the FDA before• Gained insight into the risk factors of combining therapies where both drugs have similar adverse events• Found a possible way of mitigating that risk of patient withdrawal if that type of combination therapy were to be explored again
  31. 31. Acarbose example “Acarbose” search in Embase Filter by “adverse event” Filter by “liver toxicity” Identification of relevant articlesIdentify any warning Reports of post- Adverse eventssigns that there may Adverse event not marketing adverse reported to affect be drug induced reported in labeling events patient compliance liver toxicity Can we find Did we actually find evidence of these Could we have Was there any evidence of this in adverse events at known about these evidence of this the approval the preclinical and adverse eventsbefore the drug was package? How do clinical stages before the label approved? we mitigate risk before drug was updated? moving forward? approval?
  32. 32. • The Q&A will be sent to you by email. • For more information and questions please contact bdtraining@elsevier.com • Check out upcoming and previous Embase and PharmPendium webinars at http://www.embase.com/info/embase-webinars and http://www.pharmapendium.com/info/pharmape ndium-webinars.Please fill out the survey Please fill out the surveythat appears on your that appears on yourscreen after leaving the screen after leaving thewebinar. webinar.

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