Successfully reported this slideshow.
We use your LinkedIn profile and activity data to personalize ads and to show you more relevant ads. You can change your ad preferences anytime.
Identifying Safety Signals By Data Mining the
FDA Adverse Event Reporting System with
Empirica Signal
Chris Wocosky, Lead ...
Perficient is a leading information technology consulting firm serving clients throughout
North America and Europe.
We hel...
• Founded in 1997
• Public, NASDAQ: PRFT
• 2013 revenue ~$373 million
• Major market locations throughout North America
At...
Oracle Products
• Argus Safety Suite
• Argus Safety Japan
• Affiliate
• Interchange
• Reconciliation
• Dossier
• Insight
•...
Introduction
Industry Experience: 17 years
• Medical Device Manufacturing
– Edwards Lifesciences (formerly Edwards
Laborat...
Agenda
• Background of Empirica Signal
• Why Empirica Signal?
• Product Overview
• Q&A
Background
• Developed 2003-2005 as a (CRADA) Cooperative Research and
Development Agreement between FDA and Lincoln Techn...
Regulatory Landscape
• Increased focus on technology to save time and money
• Companies are expected to do more with tight...
Drugs Withdrawn Last 5 years*
Withdrawn Drug name Remarks Country(s)
2013 Tetrazepam Serious cutaneous reactions. EU
2011 ...
Why These Drugs Were Withdrawn
• Risks to the patients, serious side effects
• Unexpected AE’s that were not detected duri...
Empirica Signal Solution Area
• Growing government and public concern about drug safety has
increased the importance of ph...
Process Proposed by CIOMS VIII
Signal
Prioritization
Signal
Detection
Signal
Evaluation
GVP Module IX
The signal management process shall cover all steps
from detecting signals (signal detection), through their...
The GVP Module IX Process
Signal Detection
Signal Validation
Exchange of Information
Empirica Signal
Empirica Topics
Signa...
Why Empirica Signal/Topics?
• The same tool developed and in use by FDA, as well as
the MHRA
• Early detection of new pote...
Signal Detection and Management
Signal Detection
• Monitoring of “Drug Profiles”
with visualization tools
• Quick and easy...
Empirica Signal Benefits
• Early detection of potential safety signals for marketed drugs
• Multiple disproportionality sc...
Empirica Signal Drug Profiles
• Drug profiles support easy and consistent drug reviews
– Presentations of statistical and ...
Comprehensive Drug Profile Layout
Empirica Signal
• Proactively identify and
expeditiously manage safety
risks
• Detect and quantify safety
signals by using...
Sector Map (Heatmap, Treemap)
• Overall Safety Profile of a Drug
• Large tiles are the MedDRA System Organ
Class (SOC)
• S...
Visual Presentation of Safety Signals
In this map, you
can clearly see
the large
number of AE’s
in the Cardiac
SOC as
repr...
Sector Map
• The size of PT tiles is based on
the public health impact of PTs,
which is computed as:
(number of times the ...
Side by Side Comparison
Zoom In on A Sector Map
Drug Profile: Desktop View
Drug Profile: Slide Show View
Drug Profiles: Slide Show View
Drug Profile: Slide Show View
Drug Profile: Slide Show View
Access to Safety Report Data
All of the blue underlined
items are hyperlinks to the
underlying data
The sub-menus are the ...
Access to Safety Report Data
Download Safety Report Data
Analytical Graphics for Safety Review
Data Mining, Statistics and Data Visualization
Query & Reporting
Creating a Case Series with the Query Wizard
Use selection options and/or
saved lists
After selecting va...
Flexible Reporting and Tabulation
Empirica Signal Management “Dashboard”
• Supports “strategic pharmacovigilance,” helping drug safety
groups prioritize wor...
Integrated single-table overview
 Drug & event details
 Signal statistics for multiple time points
 Number of new cases...
Annotation
• Annotations at the drug, drug-event combination and case levels
• Permits both free-text and controlled vocab...
Empirica Signal Capabilities
• Data mining and statistics
– Disproportionality statistics including empirical Bayes estima...
Empirica Signal Capabilities
• Query & Reporting
– Aggregate as well as line listing reports
– Library of standard reports...
Empirica Signal Management Capabilities
(Optional)
• Extends Empirica Signal functionality for routine ongoing review by
s...
Empirica Signal Topics Capabilities (Optional)
• Provides workflow, auditing and tracking capabilities for potential
signa...
Key Features
• Customizable, easy-to-use Drug Profile Portal
• Enhanced, configurable workflow
• Support for a full range ...
Key Benefits
• Identify and monitor safety trends using the same tools used by
regulators
• Prioritize and execute critica...
• Hosting
• Training
• Integration: Argus Argus Mart Empirica Signal Topics
Perficient Offerings
Empirica Signal Data Provisioning Services
Subscriptions to periodic updates of prepared data for Empirica Signal
• FDA FO...
Questions?
References
1. Tetrazepam:http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Tetrazepam_containing...
Thank You!
For more information, please contact:
chris.wocosky@perficient.com
LifeSciencesInfo@perficient.com (Sales)
+44 ...
Upcoming SlideShare
Loading in …5
×

Identifying Safety Signals by Data Mining the FDA Adverse Event Reporting System with Empirica Signal

5,987 views

Published on

Ever since the European Union (EU) introduced new legislation that requires life sciences companies to proactively detect, prioritize, and evaluate safety signals, there has been an increased interest, not only from sponsors and CROs in the EU, but globally, in pharmacovigilance systems that can assist with the signal management process.

Perficient's Chris Wocosky, an expert in signal detection and management, shows how your organization can use Empirica Signal, Oracle's state-of-the-art signal detection system to data mine the existing FDA Adverse Event Reporting System (FAERS) to determine safety signals. This presentation and demonstration willhelp you bettter understand how this solution can be used in daily pharmacovigilance activities.

Published in: Technology, Business
  • ⇒ www.WritePaper.info ⇐ This service will write as best as they can. So you do not need to waste the time on rewritings.
       Reply 
    Are you sure you want to  Yes  No
    Your message goes here
  • Hi there! I just wanted to share a list of sites that helped me a lot during my studies: .................................................................................................................................... www.EssayWrite.best - Write an essay .................................................................................................................................... www.LitReview.xyz - Summary of books .................................................................................................................................... www.Coursework.best - Online coursework .................................................................................................................................... www.Dissertations.me - proquest dissertations .................................................................................................................................... www.ReMovie.club - Movies reviews .................................................................................................................................... www.WebSlides.vip - Best powerpoint presentations .................................................................................................................................... www.WritePaper.info - Write a research paper .................................................................................................................................... www.EddyHelp.com - Homework help online .................................................................................................................................... www.MyResumeHelp.net - Professional resume writing service .................................................................................................................................. www.HelpWriting.net - Help with writing any papers ......................................................................................................................................... Save so as not to lose
       Reply 
    Are you sure you want to  Yes  No
    Your message goes here
  • DOWNLOAD THE BOOK INTO AVAILABLE FORMAT (New Update) ......................................................................................................................... ......................................................................................................................... Download Full PDF EBOOK here { https://urlzs.com/UABbn } ......................................................................................................................... Download Full EPUB Ebook here { https://urlzs.com/UABbn } ......................................................................................................................... Download Full doc Ebook here { https://urlzs.com/UABbn } ......................................................................................................................... Download PDF EBOOK here { https://urlzs.com/UABbn } ......................................................................................................................... Download EPUB Ebook here { https://urlzs.com/UABbn } ......................................................................................................................... Download doc Ebook here { https://urlzs.com/UABbn } ......................................................................................................................... ......................................................................................................................... ................................................................................................................................... eBook is an electronic version of a traditional print book THE can be read by using a personal computer or by using an eBook reader. (An eBook reader can be a software application for use on a computer such as Microsoft's free Reader application, or a book-sized computer THE is used solely as a reading device such as Nuvomedia's Rocket eBook.) Users can purchase an eBook on diskette or CD, but the most popular method of getting an eBook is to purchase a downloadable file of the eBook (or other reading material) from a Web site (such as Barnes and Noble) to be read from the user's computer or reading device. Generally, an eBook can be downloaded in five minutes or less ......................................................................................................................... .............. Browse by Genre Available eBOOK .............................................................................................................................. Art, Biography, Business, Chick Lit, Children's, Christian, Classics, Comics, Contemporary, CookBOOK, Manga, Memoir, Music, Mystery, Non Fiction, Paranormal, Philosophy, Poetry, Psychology, Religion, Romance, Science, Science Fiction, Self Help, Suspense, Spirituality, Sports, Thriller, Travel, Young Adult, Crime, EBOOK, Fantasy, Fiction, Graphic Novels, Historical Fiction, History, Horror, Humor And Comedy, ......................................................................................................................... ......................................................................................................................... .....BEST SELLER FOR EBOOK RECOMMEND............................................................. ......................................................................................................................... Blowout: Corrupted Democracy, Rogue State Russia, and the Richest, Most Destructive Industry on Earth,-- The Ride of a Lifetime: Lessons Learned from 15 Years as CEO of the Walt Disney Company,-- Call Sign Chaos: Learning to Lead,-- StrengthsFinder 2.0,-- Stillness Is the Key,-- She Said: Breaking the Sexual Harassment Story THE Helped Ignite a Movement,-- Atomic Habits: An Easy & Proven Way to Build Good Habits & Break Bad Ones,-- Everything Is Figureoutable,-- What It Takes: Lessons in the Pursuit of Excellence,-- Rich Dad Poor Dad: What the Rich Teach Their Kids About Money THE the Poor and Middle Class Do Not!,-- The Total Money Makeover: Classic Edition: A Proven Plan for Financial Fitness,-- Shut Up and Listen!: Hard Business Truths THE Will Help You Succeed, ......................................................................................................................... .........................................................................................................................
       Reply 
    Are you sure you want to  Yes  No
    Your message goes here
  • My personal experience with research paper writing services was highly positive. I sent a request to ⇒ www.HelpWriting.net ⇐ and found a writer within a few minutes. Because I had to move house and I literally didn’t have any time to sit on a computer for many hours every evening. Thankfully, the writer I chose followed my instructions to the letter. I know we can all write essays ourselves. For those in the same situation I was in, I recommend ⇒ www.HelpWriting.net ⇐.
       Reply 
    Are you sure you want to  Yes  No
    Your message goes here
  • DOWNLOAD THIS BOOKS INTO AVAILABLE FORMAT (2019 Update) ......................................................................................................................... ......................................................................................................................... Download Full PDF EBOOK here { https://soo.gd/irt2 } ......................................................................................................................... Download Full EPUB Ebook here { https://soo.gd/irt2 } ......................................................................................................................... Download Full doc Ebook here { https://soo.gd/irt2 } ......................................................................................................................... Download PDF EBOOK here { https://soo.gd/irt2 } ......................................................................................................................... Download EPUB Ebook here { https://soo.gd/irt2 } ......................................................................................................................... Download doc Ebook here { https://soo.gd/irt2 } ......................................................................................................................... ......................................................................................................................... ................................................................................................................................... eBook is an electronic version of a traditional print book THIS can be read by using a personal computer or by using an eBook reader. (An eBook reader can be a software application for use on a computer such as Microsoft's free Reader application, or a book-sized computer THIS is used solely as a reading device such as Nuvomedia's Rocket eBook.) Users can purchase an eBook on diskette or CD, but the most popular method of getting an eBook is to purchase a downloadable file of the eBook (or other reading material) from a Web site (such as Barnes and Noble) to be read from the user's computer or reading device. Generally, an eBook can be downloaded in five minutes or less ......................................................................................................................... .............. Browse by Genre Available eBooks .............................................................................................................................. Art, Biography, Business, Chick Lit, Children's, Christian, Classics, Comics, Contemporary, Cookbooks, Manga, Memoir, Music, Mystery, Non Fiction, Paranormal, Philosophy, Poetry, Psychology, Religion, Romance, Science, Science Fiction, Self Help, Suspense, Spirituality, Sports, Thriller, Travel, Young Adult, Crime, Ebooks, Fantasy, Fiction, Graphic Novels, Historical Fiction, History, Horror, Humor And Comedy, ......................................................................................................................... ......................................................................................................................... .....BEST SELLER FOR EBOOK RECOMMEND............................................................. ......................................................................................................................... Blowout: Corrupted Democracy, Rogue State Russia, and the Richest, Most Destructive Industry on Earth,-- The Ride of a Lifetime: Lessons Learned from 15 Years as CEO of the Walt Disney Company,-- Call Sign Chaos: Learning to Lead,-- StrengthsFinder 2.0,-- Stillness Is the Key,-- She Said: Breaking the Sexual Harassment Story THIS Helped Ignite a Movement,-- Atomic Habits: An Easy & Proven Way to Build Good Habits & Break Bad Ones,-- Everything Is Figureoutable,-- What It Takes: Lessons in the Pursuit of Excellence,-- Rich Dad Poor Dad: What the Rich Teach Their Kids About Money THIS the Poor and Middle Class Do Not!,-- The Total Money Makeover: Classic Edition: A Proven Plan for Financial Fitness,-- Shut Up and Listen!: Hard Business Truths THIS Will Help You Succeed, ......................................................................................................................... .........................................................................................................................
       Reply 
    Are you sure you want to  Yes  No
    Your message goes here

Identifying Safety Signals by Data Mining the FDA Adverse Event Reporting System with Empirica Signal

  1. 1. Identifying Safety Signals By Data Mining the FDA Adverse Event Reporting System with Empirica Signal Chris Wocosky, Lead Business Consultant Life Sciences Business Unit facebook.com/perficient twitter.com/Perficientlinkedin.com/company/perficient
  2. 2. Perficient is a leading information technology consulting firm serving clients throughout North America and Europe. We help clients implement business-driven technology solutions that integrate business processes, improve worker productivity, increase customer loyalty and create a more agile enterprise to better respond to new business opportunities. About Perficient
  3. 3. • Founded in 1997 • Public, NASDAQ: PRFT • 2013 revenue ~$373 million • Major market locations throughout North America Atlanta, Boston, Charlotte, Chicago, Cincinnati, Columbus, Dallas, Denver, Detroit, Fairfax, Houston, Indianapolis, Los Angeles, Minneapolis, New Orleans, New York City, Northern California, Philadelphia, Southern California, St. Louis, Toronto and Washington, D.C. • Global delivery centers in China, Europe and India • >2,100 colleagues • Dedicated solution practices • ~90% repeat business rate • Alliance partnerships with major technology vendors • Multiple vendor/industry technology and growth awards Perficient Profile
  4. 4. Oracle Products • Argus Safety Suite • Argus Safety Japan • Affiliate • Interchange • Reconciliation • Dossier • Insight • AERS • TMS • Empirica Signal • Empirica Topics Our Solutions Expertise Life Sciences Business Unit Safety & Pharmacovigilance Provides Consulting, Implementation, Integration, Upgrade, Migration and Hosting Services for the most widely used and highly sought after drug safety, pharmacovigilance, risk, and signal management systems in the world.
  5. 5. Introduction Industry Experience: 17 years • Medical Device Manufacturing – Edwards Lifesciences (formerly Edwards Laboratories) Abbott Vascular (formerly Guidant), J&J Biosense Webster • Cardiovascular and Electrophysiology – Tissue & Mechanical Heart Valves, Coronary Stents and Ablation Catheters • Quality/Reliability Engineering, Quality Assurance, Regulatory Compliance and Complaint Management Software Experience: 8 years • Software Application Sales – ArisGlobal, Phase Forward, Oracle, BioPharm Systems (now Perficient) • Safety & Pharmacovigilance Products – Register, inforMed, ARISg; – ClinTrace, Empirica Signal, Study and Topics – Siebel AECM, Argus Safety Suite • Pre-Sales Consulting, Implementation Consulting, Training Christina Wocosky Lead Business Consultant Safety and Pharmacovigilance Life Sciences Business Unit o: 951-676-9501 m: 951-505-7011 chris.wocosky@perficient.com
  6. 6. Agenda • Background of Empirica Signal • Why Empirica Signal? • Product Overview • Q&A
  7. 7. Background • Developed 2003-2005 as a (CRADA) Cooperative Research and Development Agreement between FDA and Lincoln Technologies, Inc. lead by Bill DuMouchel and Ana Szarfman. • Objective: User friendly / web based tool for FDA • WebVDME – Web Visual Data Mining Environment • Conclusion: Tool assists in identifying unusual patterns – BUT – the patterns need interpretation! • 2005 - Phase Forward acquired LT – rebranded as Empirica Signal • 2010 - Oracle acquired Phase Forward • In use at FDA today
  8. 8. Regulatory Landscape • Increased focus on technology to save time and money • Companies are expected to do more with tighter budgets • Global requirements growing – still not harmonized • An increased focus on safety related issues
  9. 9. Drugs Withdrawn Last 5 years* Withdrawn Drug name Remarks Country(s) 2013 Tetrazepam Serious cutaneous reactions. EU 2011 Drotrecogin alfa (Xigris) Lack of efficacy as shown by PROWESS-SHOCK study WorldWide 2010 Propoxyphene (Darvocet/Darvon) Increased risk of heart attacks and stroke. WorldWide 2010 Gemtuzumab ozogamicin (Mylotargz) No improvement in clinical benefit; risk for death. US 2010 Rosiglitazone (Avandia) Risk of heart attacks and death. This drug continues to be available in the U.S. EU 2010 Sibutramine (Reductil/Meridia) Increased risk of heart attack and stroke. Australia, Canada, China, the EU, Hong Kong, India, Mexico, New Zealand,the Philippines, Thailand,the UK, and the US 2010 Sitaxentan Hepatotoxicity Germany 2009 Efalizumab (Raptiva) Increased risk of progressive multifocal leukoencephalopathy Germany *See References
  10. 10. Why These Drugs Were Withdrawn • Risks to the patients, serious side effects • Unexpected AE’s that were not detected during Phase III Clinical Trials • Only became apparent from post-market surveillance data from the wider patient community • Not limited to drugs that were ever approved by the FDA • Some were approved in markets other than the US
  11. 11. Empirica Signal Solution Area • Growing government and public concern about drug safety has increased the importance of pharmacovigilance – Traditional methods such as individual case review no longer suffice due to increased data volume and complexity – New strategies to proactively identify and expeditiously manage emerging safety risks are needed • In this highly competitive and risk-averse environment, it is essential for regulatory authorities as well as pharmaceutical companies to establish pharmacovigilance programs – Need to capitalize on multiple data sources using advanced tools for developing a thorough and well understood safety profile
  12. 12. Process Proposed by CIOMS VIII Signal Prioritization Signal Detection Signal Evaluation
  13. 13. GVP Module IX The signal management process shall cover all steps from detecting signals (signal detection), through their validation and confirmation, analysis, prioritization and assessment to recommending action, as well as the tracking of the steps taken and of any recommendations made.
  14. 14. The GVP Module IX Process Signal Detection Signal Validation Exchange of Information Empirica Signal Empirica Topics Signal Analysis and Prioritization Signal Assessment Recommendation for Action
  15. 15. Why Empirica Signal/Topics? • The same tool developed and in use by FDA, as well as the MHRA • Early detection of new potential signals, or changes in signal profiles over time • Track and document every step you take from the first moment a potential signal is identified, monitoring, verification, decisions and all actions taken • Provide regulators with a .pdf with all the necessary information to back up decisions If you didn’t document it, it didn’t happen!
  16. 16. Signal Detection and Management Signal Detection • Monitoring of “Drug Profiles” with visualization tools • Quick and easy drill down to the data under the charts and graphs • Create your own data mining runs to further refine your analysis • Compare “like” products side by side with the same charts and graphs Signal Management • Integrate quantitative signal detection techniques into routine safety reviews • Assess the latest information on all marketed products and how “signals” evolve as data accumulates over time • Store public and private comments and blanket comments for multiple drug-event combinations • Store findings with all other data sources
  17. 17. Empirica Signal Benefits • Early detection of potential safety signals for marketed drugs • Multiple disproportionality scores available • Powerful graphical visualizations to facilitate medical interpretation • Intuitive user interface including drill-down capabilities without requiring any programming • Built-in functionality to address confounding and assist in signal assessment such as stratification, logistic regression and extended logistic regression • Extensive built-in signal management, tracking and documentation functionality
  18. 18. Empirica Signal Drug Profiles • Drug profiles support easy and consistent drug reviews – Presentations of statistical and other information about one or more drugs (generic, trade or ingredient) – Users don’t need to navigate Empirica Signal; instead they can review their drug using a pre-defined set of charts/graphs • Display can be in slide show mode or desktop review • Full power of data mining results, including drilldown, without having to navigate Empirica Signal • This graphical, easy to use review tool is directly accessible upon login without the need to issue any commands – Layouts define the charts (graphs or report outputs), options and positioning to be included – All graphs and tables can be printed directly according to the user-defined layouts – Access to publicly available labeling information (FDA, NIH)
  19. 19. Comprehensive Drug Profile Layout
  20. 20. Empirica Signal • Proactively identify and expeditiously manage safety risks • Detect and quantify safety signals by using advanced data mining techniques that can be applied to any spontaneous reporting database • Use the most advanced set of tools to develop a thorough and well understood safety profile
  21. 21. Sector Map (Heatmap, Treemap) • Overall Safety Profile of a Drug • Large tiles are the MedDRA System Organ Class (SOC) • Smaller tiles are the Preferred Terms (PT) • Colors represent the strength of the signal – bright red indicates the AE’s occurring significantly higher than expected with the drug – bright green indicates significantly less occurrences than expected, or potential indications. • The chart below, is the ranking in descending order by the user selected disproportionality score – the algorythm in this example is the (EBGM – Empirical Bayes Geometric Mean) – also available are EB05,Chi or PRR. • The focus is on a particular drug, with the background being the 5M+ cases in the FDA AERS database
  22. 22. Visual Presentation of Safety Signals In this map, you can clearly see the large number of AE’s in the Cardiac SOC as represented by the bright red color. This led to the 1998 market withdrawal of Seldane
  23. 23. Sector Map • The size of PT tiles is based on the public health impact of PTs, which is computed as: (number of times the PT occurs in serious-or-fatal cases) * (proportion of cases with that PT that are serious-or-fatal). • PTs with values over a minimum threshold are included in the sector map. • A higher Public Health Impact score corresponds to a larger tile in the sector map. • Since size is based on the number of cases of the PT alone (not the number of cases that have the PT and a particular drug), the tile size is stable over sector maps for different drugs.
  24. 24. Side by Side Comparison
  25. 25. Zoom In on A Sector Map
  26. 26. Drug Profile: Desktop View
  27. 27. Drug Profile: Slide Show View
  28. 28. Drug Profiles: Slide Show View
  29. 29. Drug Profile: Slide Show View
  30. 30. Drug Profile: Slide Show View
  31. 31. Access to Safety Report Data All of the blue underlined items are hyperlinks to the underlying data The sub-menus are the same on the charts and graphs
  32. 32. Access to Safety Report Data
  33. 33. Download Safety Report Data
  34. 34. Analytical Graphics for Safety Review
  35. 35. Data Mining, Statistics and Data Visualization
  36. 36. Query & Reporting Creating a Case Series with the Query Wizard Use selection options and/or saved lists After selecting variable values, edit the query logic to combine query elements
  37. 37. Flexible Reporting and Tabulation
  38. 38. Empirica Signal Management “Dashboard” • Supports “strategic pharmacovigilance,” helping drug safety groups prioritize work and focus resources on areas of greatest impact • Combines signal scores with metrics based on case counts and changes over time • Easy-to-use table and graphs interface with workflow and annotation tools
  39. 39. Integrated single-table overview  Drug & event details  Signal statistics for multiple time points  Number of new cases in current period  Trending  50% increase in EBGM from last period  Current EB05 > EB95 measured previously  Indication of labeled event (“expectedness”)  Indication of FDA “sentinel event”  Percent of database cases with event that were fatal  Percent of database cases with event that were serious  Quadrant – A, B, C, D quadrant (Patrick Waller - MHRA)  Additional columns are easy to add
  40. 40. Annotation • Annotations at the drug, drug-event combination and case levels • Permits both free-text and controlled vocabulary comments • Convenient way to build and share knowledge base
  41. 41. Empirica Signal Capabilities • Data mining and statistics – Disproportionality statistics including empirical Bayes estimates of relative reporting rate (EBGM) and non-Bayesian statistics such as PRR and ROR – Logistic regression using adverse event as a response variable – Graphical and tabular presentation of results • Access to safety report data – Convenient drilldown to case data from graphs and tables – Download of signal scores and case data – Available for both public and private safety databases
  42. 42. Empirica Signal Capabilities • Query & Reporting – Aggregate as well as line listing reports – Library of standard reports – Drilldown, download and publishing capabilities • Fully web-based application environment – All processing on the server – can be provided as hosted service – Simple web browser client – operates through firewalls
  43. 43. Empirica Signal Management Capabilities (Optional) • Extends Empirica Signal functionality for routine ongoing review by safety evaluators • Combines disproportionality measures with other relevant information such as listedness, fatal outcomes, etc. to enhance the review process • Purpose: Timely detection of signals for marketed products while minimizing the overall monitoring effort • Capabilities include: – Easy detection of changes in signal scores – Structured on-line assessments – Prioritize, track and document signals – ‘Drill down’ to AE reports in underlying data
  44. 44. Empirica Signal Topics Capabilities (Optional) • Provides workflow, auditing and tracking capabilities for potential signals • Supports topic attachments from multiple sources, either from inside the Empirica Signal application or from files or web site references • Provides topics workflow assignment and deadline capabilities • Topics can encompass multiple individual Topic Actions, each with their own description, attachments, assignees and deadlines • Topic visibility can be controlled in great detail • At any point in time a Topic can be represented in the form of a PDF or ZIP file for communication and archiving purposes
  45. 45. Key Features • Customizable, easy-to-use Drug Profile Portal • Enhanced, configurable workflow • Support for a full range of statistical techniques • Enhanced, higher performance logistic regression • Bayesian Multi-item Gamma Poisson Shrinker interaction calculations for runs with three or more dimensions • Direct access to safety data through drilldown and case series features • Streamlined interface • Interactive reporting with parameter driven case selection • Options to download data and case details in native Microsoft Excel (.xls), .pdf, or rich text (.rtf) format • Robust, comprehensive online help
  46. 46. Key Benefits • Identify and monitor safety trends using the same tools used by regulators • Prioritize and execute critical pharmacovigilance activities • Employ a variety of classical and Bayesian data mining techniques • Analyze both drug/event combinations and drug/drug interactions • Filter out false positives to focus on the most important risks • Detect problems that may have been overlooked during clinical development • Gather intelligence on competing drugs’ safety profiles • Maintain a comprehensive history of safety related topics • Track signals and manage actions in a regulatory complaint environment
  47. 47. • Hosting • Training • Integration: Argus Argus Mart Empirica Signal Topics Perficient Offerings
  48. 48. Empirica Signal Data Provisioning Services Subscriptions to periodic updates of prepared data for Empirica Signal • FDA FOI AERS data (1968 – present) Substantial data cleaning is conducted to prepare a proprietary version of FOI AERS safety data; these same cleaning techniques are also used to prepare the FDA-internal version of the AERS data for the FDA’s use with Empirica Signal: • Integrate incremental information at database and case level • Harmonize MedDRA coding of adverse events throughout the cumulative database across dictionary updates • Map verbatim drug descriptions to a controlled hierarchical vocabulary of trade and generic names (WHO-DD and WHO-ATC) • Identify and flag duplicate cases • FDA VAERS data (1990 – present) • Offered as a monthly or quarterly subscription • WHO-UMC Vigibase database of reports (1968 – present) • In-house corporate adverse event databases • Occasional spiking of in-house data into public sources
  49. 49. Questions?
  50. 50. References 1. Tetrazepam:http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Tetrazepam_containing_medicinal_products/human_re ferral_prac_000015.jsp&mid=WC0b01ac05805c516f.htm 2. Xigris: https://investor.lilly.com/releasedetail.cfm?ReleaseID=617602.htm 3. PropoxypheneDarvocet/Darvon):http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm234389.htm 4. Gemtuzumab ozogamicin (Mylotargz):http://www.fda.gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm216458.htm 5. Rosiglitazone (Avandia): http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2010/09/news_detail_001122.jsp&mid=WC0b01ac058004d5c1 6. Sibutramine (Reductil/Meridia): http://www.fda.gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm228830.htm 7. Sitaxentan: http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON105752 8. Efalizumab (Raptiva): http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm133337.htm 9. CIOMS VIII: http://www.cioms.ch/index.php/publications/available-publications?task=view&id=27&catid=54
  51. 51. Thank You! For more information, please contact: chris.wocosky@perficient.com LifeSciencesInfo@perficient.com (Sales) +44 (0) 1865 910200 (U.K. Sales) +1 877 654 0033 (U.S. Sales) www.facebook.com/perficient www.perficient.com www.twitter.com/perficient http://www.oracle.com/us/products/applications/health-sciences/safety/empirica-signal/index.html

×