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Featuring the Embase and PharmaPendium combined drug safety solution Your host: Ann-Marie Roche Your presenter: Pooja Jain Welcome to our drug safety webinar!
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Finding a drug safety solution for you - Embase and PharmaPendium - Webinar 25 Oct 2012inar. 25 oct2012

Jun 11, 2015

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Ann-Marie Roche

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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Page 1: Finding a drug safety solution for you  - Embase and PharmaPendium - Webinar 25 Oct 2012inar. 25 oct2012

Featuring the Embase and PharmaPendium combined drug

safety solution

Your host: Ann-Marie Roche Your presenter: Pooja Jain

Welcome to our drug safety webinar!

Page 3: Finding a drug safety solution for you  - Embase and PharmaPendium - Webinar 25 Oct 2012inar. 25 oct2012

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.

Page 4: Finding a drug safety solution for you  - Embase and PharmaPendium - Webinar 25 Oct 2012inar. 25 oct2012

Finding A Drug Safety Solution: Embase + PharmaPendium

Finding A Drug Safety Solution: Embase + PharmaPendium

Presented By: Pooja Jain, M.Sc., MBA

Date: Oct 25 2012

Page 5: Finding a drug safety solution for you  - Embase and PharmaPendium - Webinar 25 Oct 2012inar. 25 oct2012

•Embase is an online information source of biomedical literature that serves pharmacovigilance reporting needs by broadly tracking adverse events from comprehensive high-quality sources.

•Embase records are deeply indexed using our Emtree thesaurus to make searching faster, more accurate and more specific. Emtree lists more than 60,000 preferred terms and over 260,000 synonyms, including generic and trade names of drugs.

•Compared to MEDLINE, Embase has over 2,000 more journals in addition to conference reports. In total Embase indexes over 7,000 journals.

•Embase is an online information source of biomedical literature that serves pharmacovigilance reporting needs by broadly tracking adverse events from comprehensive high-quality sources.

•Embase records are deeply indexed using our Emtree thesaurus to make searching faster, more accurate and more specific. Emtree lists more than 60,000 preferred terms and over 260,000 synonyms, including generic and trade names of drugs.

•Compared to MEDLINE, Embase has over 2,000 more journals in addition to conference reports. In total Embase indexes over 7,000 journals.

PharmaPendium is the only online resource to allow drug development teams to efficiently extract:

• Best-in-class drug development information

•All available FDA approvals since 1938 + EMA since 1995 + more

• More than 1.5 million pages of drug reviews

• More than 4,000 drugs covered

• Comparative exposure data

• Regulatory precedents

PharmaPendium is the only online resource to allow drug development teams to efficiently extract:

• Best-in-class drug development information

•All available FDA approvals since 1938 + EMA since 1995 + more

• More than 1.5 million pages of drug reviews

• More than 4,000 drugs covered

• Comparative exposure data

• Regulatory precedents

Page 6: Finding a drug safety solution for you  - Embase and PharmaPendium - Webinar 25 Oct 2012inar. 25 oct2012

Acarbose example“Acarbose” search in Embase

Filter by “adverse event”

Filter by “liver toxicity”

Identification of relevant articles

Identify any warning signs that there may

be drug induced liver toxicity

Reports of post-marketing adverse

events

Adverse event not reported in labeling

Adverse events reported to affect

patient compliance

Was there any evidence of this

before the drug was approved?

Can we find evidence of these adverse events at the preclinical and

clinical stages before drug approval?

Could we have known about these

adverse events before the label was updated?

Did we actually find evidence of this in

the approval package? How do we mitigate risk

moving forward?

Page 7: Finding a drug safety solution for you  - Embase and PharmaPendium - Webinar 25 Oct 2012inar. 25 oct2012

Indexing allows for easy to find information that

would otherwise be missed

Page 8: Finding a drug safety solution for you  - Embase and PharmaPendium - Webinar 25 Oct 2012inar. 25 oct2012

PubMed returns less than one third of

results.

Page 9: Finding a drug safety solution for you  - Embase and PharmaPendium - Webinar 25 Oct 2012inar. 25 oct2012

Acarbose example“Acarbose” search in Embase

Filter by “adverse event”

Filter by “liver toxicity”

Identification of relevant articles

Page 10: Finding a drug safety solution for you  - Embase and PharmaPendium - Webinar 25 Oct 2012inar. 25 oct2012

What information would you have missed that would pertain to critical post-

marketing events?

Page 11: Finding a drug safety solution for you  - Embase and PharmaPendium - Webinar 25 Oct 2012inar. 25 oct2012

Search of “acarbose” in Embase

Page 12: Finding a drug safety solution for you  - Embase and PharmaPendium - Webinar 25 Oct 2012inar. 25 oct2012

Search of “acarbose” in Embase, filtered based on adverse drug reaction

Page 13: Finding a drug safety solution for you  - Embase and PharmaPendium - Webinar 25 Oct 2012inar. 25 oct2012

Filter further on “liver toxicity”

Page 14: Finding a drug safety solution for you  - Embase and PharmaPendium - Webinar 25 Oct 2012inar. 25 oct2012

Acarbose example“Acarbose” search in Embase

Filter by “adverse event”

Filter by “liver toxicity”

Identification of relevant articles

Identify any warning signs that there may

be drug induced liver toxicity

Was there any evidence of this

before the drug was approved?

Page 15: Finding a drug safety solution for you  - Embase and PharmaPendium - Webinar 25 Oct 2012inar. 25 oct2012
Page 16: Finding a drug safety solution for you  - Embase and PharmaPendium - Webinar 25 Oct 2012inar. 25 oct2012
Page 17: Finding a drug safety solution for you  - Embase and PharmaPendium - Webinar 25 Oct 2012inar. 25 oct2012
Page 18: Finding a drug safety solution for you  - Embase and PharmaPendium - Webinar 25 Oct 2012inar. 25 oct2012
Page 19: Finding a drug safety solution for you  - Embase and PharmaPendium - Webinar 25 Oct 2012inar. 25 oct2012
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Page 21: Finding a drug safety solution for you  - Embase and PharmaPendium - Webinar 25 Oct 2012inar. 25 oct2012

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

Page 22: Finding a drug safety solution for you  - Embase and PharmaPendium - Webinar 25 Oct 2012inar. 25 oct2012

Acarbose example“Acarbose” search in Embase

Filter by “adverse event”

Filter by “liver toxicity”

Identification of relevant articles

Identify any warning signs that there may

be drug induced liver toxicity

Reports of post-marketing adverse

events

Was there any evidence of this

before the drug was approved?

Can we find evidence of these adverse events at the preclinical and

clinical stages before drug approval?

Page 23: Finding a drug safety solution for you  - Embase and PharmaPendium - Webinar 25 Oct 2012inar. 25 oct2012

Filter further on “liver toxicity”

Page 24: Finding a drug safety solution for you  - Embase and PharmaPendium - Webinar 25 Oct 2012inar. 25 oct2012
Page 25: Finding a drug safety solution for you  - Embase and PharmaPendium - Webinar 25 Oct 2012inar. 25 oct2012
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Page 28: Finding a drug safety solution for you  - Embase and PharmaPendium - Webinar 25 Oct 2012inar. 25 oct2012
Page 29: Finding a drug safety solution for you  - Embase and PharmaPendium - Webinar 25 Oct 2012inar. 25 oct2012
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Page 34: Finding a drug safety solution for you  - Embase and PharmaPendium - Webinar 25 Oct 2012inar. 25 oct2012
Page 35: Finding a drug safety solution for you  - Embase and PharmaPendium - Webinar 25 Oct 2012inar. 25 oct2012
Page 36: Finding a drug safety solution for you  - Embase and PharmaPendium - Webinar 25 Oct 2012inar. 25 oct2012
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Page 38: Finding a drug safety solution for you  - Embase and PharmaPendium - Webinar 25 Oct 2012inar. 25 oct2012
Page 39: Finding a drug safety solution for you  - Embase and PharmaPendium - Webinar 25 Oct 2012inar. 25 oct2012
Page 40: Finding a drug safety solution for you  - Embase and PharmaPendium - Webinar 25 Oct 2012inar. 25 oct2012

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

Page 41: Finding a drug safety solution for you  - Embase and PharmaPendium - Webinar 25 Oct 2012inar. 25 oct2012

Acarbose example“Acarbose” search in Embase

Filter by “adverse event”

Filter by “liver toxicity”

Identification of relevant articles

Identify any warning signs that there may

be drug induced liver toxicity

Reports of post-marketing adverse

events

Adverse event not reported in labeling

Was there any evidence of this

before the drug was approved?

Can we find evidence of these adverse events at the preclinical and

clinical stages before drug approval?

Could we have known about these

adverse events before the label was updated?

Page 42: Finding a drug safety solution for you  - Embase and PharmaPendium - Webinar 25 Oct 2012inar. 25 oct2012
Page 43: Finding a drug safety solution for you  - Embase and PharmaPendium - Webinar 25 Oct 2012inar. 25 oct2012

Article: “Medical Management of Metabolic Dysfunction in PCOS”

Page 44: Finding a drug safety solution for you  - Embase and PharmaPendium - Webinar 25 Oct 2012inar. 25 oct2012
Page 45: Finding a drug safety solution for you  - Embase and PharmaPendium - Webinar 25 Oct 2012inar. 25 oct2012
Page 46: Finding a drug safety solution for you  - Embase and PharmaPendium - Webinar 25 Oct 2012inar. 25 oct2012
Page 47: Finding a drug safety solution for you  - Embase and PharmaPendium - Webinar 25 Oct 2012inar. 25 oct2012
Page 48: Finding a drug safety solution for you  - Embase and PharmaPendium - Webinar 25 Oct 2012inar. 25 oct2012
Page 49: Finding a drug safety solution for you  - Embase and PharmaPendium - Webinar 25 Oct 2012inar. 25 oct2012

2008 label

Page 50: Finding a drug safety solution for you  - Embase and PharmaPendium - Webinar 25 Oct 2012inar. 25 oct2012

2011 label

Page 51: Finding a drug safety solution for you  - Embase and PharmaPendium - Webinar 25 Oct 2012inar. 25 oct2012

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

Page 52: Finding a drug safety solution for you  - Embase and PharmaPendium - Webinar 25 Oct 2012inar. 25 oct2012

Acarbose example“Acarbose” search in Embase

Filter by “adverse event”

Filter by “liver toxicity”

Identification of relevant articles

Identify any warning signs that there may

be drug induced liver toxicity

Reports of post-marketing adverse

events

Adverse event not reported in labeling

Adverse events reported to affect

patient compliance

Was there any evidence of this

before the drug was approved?

Can we find evidence of these adverse events at the preclinical and

clinical stages before drug approval?

Could we have known about these

adverse events before the label was updated?

Did we actually find evidence of this in

the approval package? How do we mitigate risk

moving forward?

Page 53: Finding a drug safety solution for you  - Embase and PharmaPendium - Webinar 25 Oct 2012inar. 25 oct2012

Was there any evidence of lack of patient compliance pre drug approval?

Page 54: Finding a drug safety solution for you  - Embase and PharmaPendium - Webinar 25 Oct 2012inar. 25 oct2012
Page 55: Finding a drug safety solution for you  - Embase and PharmaPendium - Webinar 25 Oct 2012inar. 25 oct2012

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?

Page 56: Finding a drug safety solution for you  - Embase and PharmaPendium - Webinar 25 Oct 2012inar. 25 oct2012

Acarbose example“Acarbose” search in Embase

Filter by “adverse event”

Filter by “liver toxicity”

Identification of relevant articles

Identify any warning signs that there may

be drug induced liver toxicity

Reports of post-marketing adverse

events

Adverse event not reported in labeling

Adverse events reported to affect

patient compliance

Was there any evidence of this

before the drug was approved?

Can we find evidence of these adverse events at the preclinical and

clinical stages before drug approval?

Could we have known about these

adverse events before the label was updated?

Did we actually find evidence of this in

the approval package? How do we mitigate risk

moving forward?

Page 57: Finding a drug safety solution for you  - Embase and PharmaPendium - Webinar 25 Oct 2012inar. 25 oct2012
Page 58: Finding a drug safety solution for you  - Embase and PharmaPendium - Webinar 25 Oct 2012inar. 25 oct2012
Page 59: Finding a drug safety solution for you  - Embase and PharmaPendium - Webinar 25 Oct 2012inar. 25 oct2012

However a combinatorial drug therapy of acarbose and

metformin is not approved yet by the FDA or EMEA. Was this

ever tested before?

Page 60: Finding a drug safety solution for you  - Embase and PharmaPendium - Webinar 25 Oct 2012inar. 25 oct2012
Page 61: Finding a drug safety solution for you  - Embase and PharmaPendium - Webinar 25 Oct 2012inar. 25 oct2012
Page 62: Finding a drug safety solution for you  - Embase and PharmaPendium - Webinar 25 Oct 2012inar. 25 oct2012

Where do we go from

here?

Page 63: Finding a drug safety solution for you  - Embase and PharmaPendium - Webinar 25 Oct 2012inar. 25 oct2012
Page 64: Finding a drug safety solution for you  - Embase and PharmaPendium - Webinar 25 Oct 2012inar. 25 oct2012

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

Page 65: Finding a drug safety solution for you  - Embase and PharmaPendium - Webinar 25 Oct 2012inar. 25 oct2012

Acarbose example“Acarbose” search in Embase

Filter by “adverse event”

Filter by “liver toxicity”

Identification of relevant articles

Identify any warning signs that there may

be drug induced liver toxicity

Reports of post-marketing adverse

events

Adverse event not reported in labeling

Adverse events reported to affect

patient compliance

Was there any evidence of this

before the drug was approved?

Can we find evidence of these adverse events at the preclinical and

clinical stages before drug approval?

Could we have known about these

adverse events before the label was updated?

Did we actually find evidence of this in

the approval package? How do we mitigate risk

moving forward?

Page 66: Finding a drug safety solution for you  - Embase and PharmaPendium - Webinar 25 Oct 2012inar. 25 oct2012
Page 67: Finding a drug safety solution for you  - Embase and PharmaPendium - Webinar 25 Oct 2012inar. 25 oct2012

• The Q&A will be sent to you by email.• For more information and questions please

contact [email protected]• Check out upcoming and previous Embase and

PharmPendium webinars at http://www.embase.com/info/embase-webinars and http://www.pharmapendium.com/info/pharmapendium-webinars.

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.