Challenges In Pharmacovigilance Dr Vishwas, by Dr. Vishwas Sovani MD ,VP Pharma Delivery TCS


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  • TCS Safety and Pharmacovigilance KPO Services is a modular stack which can be customized as per the needs of the Pharma companies existing drug safety environment. TCS provides a proven onsite-offshore model built on a secure platform and breadth of services addressing complete Safety and Pharmacovigilance processes.
  • Challenges In Pharmacovigilance Dr Vishwas, by Dr. Vishwas Sovani MD ,VP Pharma Delivery TCS

    1. 1. Challenges in Pharmacovigilance - Different sponsors, same drug Dr. Vishwas Sovani MD , VP Pharma Delivery TCS
    2. 2. Different Sponsors same drug <ul><li>Possibilities </li></ul><ul><ul><li>Drug used as comparator in trial </li></ul></ul><ul><ul><li>Drug sold under license by another company </li></ul></ul><ul><ul><li>Generics marketed by various companies </li></ul></ul><ul><ul><li>Orphan drugs marketed by more than one company </li></ul></ul><ul><ul><li>Biosimilars marketed by more than one company </li></ul></ul><ul><ul><li>Same drug, different indications, different companies </li></ul></ul><ul><ul><li>Same drug different formulations different companies </li></ul></ul>
    3. 3. Australian Guidelines for PV responsibilities of sponsors <ul><li>When 2 or more separately registered medicinal products which are identical in all respects except their name are marketed in Australia by separate sponsors, each sponsor is obliged to meet the usual PV obligations. </li></ul><ul><ul><li>Where co marketing arrangements exist, the sponsors may enter into practical arrangements for joint data collation & analysis but each is individually responsible for the legal responsibility. </li></ul></ul><ul><ul><li>One more such arrangement that is allowed, is appointment of a common Qualified PV person for that product </li></ul></ul>
    4. 4. Different Sponsors: Best practices <ul><li>Licensee partner agreements </li></ul><ul><li>Timely reporting becomes a challenge </li></ul><ul><li>Different safety reporting software - Repeat work </li></ul><ul><li>Data shared between sponsors (electronic via E2B) </li></ul><ul><li>Limitations of gateway capacity </li></ul><ul><li>Standardizing Terminology using MedDRA </li></ul><ul><li>Integrating Electronic Document Management repositories to manage workflow & correspondence </li></ul>
    5. 5. PV operations for generic manufacturers <ul><li>Case processing </li></ul><ul><li>Data entry and reporting for own products </li></ul><ul><li>Reporting of same molecule of other manufacturer whenever the information is received on call?? </li></ul><ul><li>Data submission to country authorities where company markets the product </li></ul><ul><li>Aggregate safety reporting / Signal detection </li></ul><ul><li>Assessment of safety across all cases reported for the active moiety from all manufacturers </li></ul><ul><li>Difficult to obtain data from other manufacturers </li></ul><ul><li>Alternative is to do data mining from the official regulatory databases: </li></ul><ul><li>FDA </li></ul><ul><li>EMEA </li></ul><ul><li>Netherlands Pharmacovigilance Foundation </li></ul><ul><li>UK Yellow Card database </li></ul><ul><li>WHO Uppsala Monitoring Centre </li></ul><ul><li>PEM database </li></ul><ul><li>Literature case processing </li></ul><ul><li>Products from all manufacturers for an active moiety </li></ul><ul><li>Great value in signal detection in the generic scenario </li></ul><ul><li>Need appropriate time cut-offs during searches </li></ul>Finally… Companies can enter into Safety Data Exchange Agreements
    6. 6. Biosimilars <ul><li>Bioequivalence difficult to prove </li></ul><ul><li>If manufacturing method is different, it may lead to a little different </li></ul><ul><li>effect & also side effects </li></ul><ul><li>EMEA stipulates that biosimilars manufacturers must have a plan </li></ul><ul><li>for continuous post-marketing monitoring and pharmacovigilance </li></ul><ul><li>The current systems for naming of generic synthetic pharmaceutical products cannot be applied to biosimilars, as they are not identical to the originator product. </li></ul><ul><li>Distinct International Non-proprietary Names (INNs) and trade names should be given to each biosimilar product, to optimise adverse events recording and product tractability. </li></ul>
    7. 7. <ul><li>Reactive evolution of Pharmacovigilance </li></ul><ul><li>Lack of standardization of processes and data within organization </li></ul><ul><ul><li>- Across product lines </li></ul></ul><ul><ul><li>- Across geographic locations </li></ul></ul><ul><li>Lack of harmonization </li></ul><ul><li>Delay in making better decisions </li></ul><ul><ul><li>- Multiple applications </li></ul></ul><ul><ul><li>- Multiple guidelines </li></ul></ul>Industry Challenges What do we need? Paradigm shift
    8. 8. The Future
    9. 9. Ideal safety monitoring system <ul><li>PV in the 21st century could also be considered a systems approach to PV, with IT systems enabling. </li></ul><ul><li>Pioneers in the drug safety field developed many of those best practices over the past three decades. </li></ul><ul><li>Modern computer technology has allowed these individual best practices to be joined in a supportable process </li></ul><ul><li>The technical tools now available can identify alerts from random data. </li></ul><ul><li>These computer systems can make the human more productive and less likely to miss important public health information hidden in ‘haystacks’ of data. </li></ul><ul><li>They also provide the needed tools and work environments to analyze the data so that a full assessment can be conducted in an efficient and effective manner. </li></ul><ul><li>One such is “Safety in a Capsule” </li></ul>
    10. 10. Safety in a Capsule <ul><li>Safety in a Capsule from Tata Consultancy Services (TCS) is a pre-packaged comprehensive solution for the safety requirement of pharmaceutical companies. </li></ul><ul><li>It combines TCS’ Drug Development Services with industry‘s leading products to provide cost effective Drug Safety services for pro-active pharmacovigilance. </li></ul><ul><li>The products include: </li></ul><ul><li>Adverse Events Reporting System </li></ul><ul><ul><li>Powerful set of case management features ,a comprehensive suite of data consistency checks online, discrepancy management system & allows users to create and save queries and case lists </li></ul></ul><ul><li>Call Center Application - Comprehensive data receipt system </li></ul><ul><li>Signal detection solution </li></ul><ul><ul><li>It is a workflow-based analytical tool, works seamlessly with the AE Reporting System data as well as data from external sources, such as the U.S. Food & Drug Administration and the WHO. Drug safety teams can monitor and analyze – in a single instance, legacy, clinical, and pre- and post-market adverse event data. </li></ul></ul>
    11. 11. Unified Architecture for Drug Safety & Pharmacovigilance ADR submitted through Safety Manager ADR collected by the Call Centre Call Centre creates new ADR record which is pulled in by AE Rep System Unified Drug Safety and Pharmacovigilance environment AE Rep System and external DB for Signal detection, assessment & management AE Rep System generated reports for regulatory submission
    12. 12. Benefits Safety in a Capsule <ul><li>Risk mitigation - The solution leverages safety analytics for early insight into the drug’s safety profile; rapidly detect and analyze patterns in adverse events that may indicate emerging drug safety risks pre and post-market. </li></ul><ul><li>Flexible analytics - It helps perform analytics and reports in a flexible and timely manner, which would help assure regulators and consumers that the approved drugs are safe and effective. </li></ul><ul><li>Modular services - Solution design is modular which work in your existing environment </li></ul>
    13. 13. Conclusion <ul><li>PV issues could arise if same product marketed by different companies </li></ul><ul><li>They are in the areas of aggregate reporting & signal detection, literature searches </li></ul><ul><li>Biosimilars are different cup of tea </li></ul><ul><li>If companies have to risk manage the molecule optimally, they will need to analyse data from international databases,literature & realtime cases </li></ul><ul><li>A platform based IT led approach should enable them to achieve this </li></ul>
    14. 14. Questions ????????
    15. 15. <ul><li>Back up slides </li></ul>
    16. 16. Industry Challenges in Pharmacovigilance <ul><li>Clinical development & Pharmacovigilance work in silos with different objectives </li></ul><ul><li>Clinical database & safety database are held by different groups </li></ul><ul><li>CR&D is ultimately responsible for finding blockbusters of tomorrow while the safety department is compliance driven & mainly a keeper of timelines & metrics. </li></ul><ul><li>What is needed is seamless continuous safety monitoring </li></ul>
    17. 17. Continuous Safety Monitoring <ul><li>Data input from all sources on realtime basis </li></ul><ul><li>Review & analysis of cases on a regular & automatic basis </li></ul><ul><li>Signal detection </li></ul><ul><li>Not possible for individual companies unless out licenced </li></ul><ul><li>Done by regulatory agencies </li></ul><ul><li>Better Risk management if companies could do it themselves </li></ul>
    18. 18. Determinants of signal selection <ul><li>Detection of new adverse drug reactions (Signals) after marketing is often based on a manual review of reports sent to a Spontaneous Reporting System (SRS). </li></ul><ul><li>Several factors may help to determine whether or not a particular signal is worth further investigation. </li></ul><ul><li>In general, four categories may be identified, which are for instance represented by the acronym `SNIP', used by the Medicines Control Agency. </li></ul><ul><li>S trength of a signal, </li></ul><ul><li>whether or not the issue is N ew, </li></ul><ul><li>the clinical I mportance as judged by the seriousness of the reaction and severity of the cases </li></ul><ul><li>potential for P reventive measures by the regulatory authorities </li></ul>
    19. 19. Signal Detection Current Data Mining databases <ul><li>Spontaneous reporting is a passive system, </li></ul><ul><ul><li>inconsistent reporting is a limitation with more frequent reporting for unusual reactions, reactions for new drugs and serious reactions </li></ul></ul><ul><ul><li>. Data could be inaccurate. </li></ul></ul><ul><ul><li>FDA database has >2mln reports over 35 years </li></ul></ul><ul><li>Prescription event monitoring (PEM) </li></ul><ul><ul><li>Used to detect ADEs by collecting high-quality data from family doctors, on a select group of patients exposed to a specific (new) drug, for a limited period of time. </li></ul></ul><ul><ul><li>Lacks adequate control group as it has clusters of patients. Eg Tolterodine & hallucinations </li></ul></ul><ul><li>Large linked health administrative databases , </li></ul><ul><ul><li>Medicaid in the USA and the Ontario provincial databases, contain data on millions of subjects. </li></ul></ul><ul><ul><li>May apply to elderly or low income & not whole population </li></ul></ul><ul><li>Electronic medical records (EMRs) </li></ul><ul><ul><li>Contain a large number of data fields, including details such smoking , laboratory data and social circumstances, on a smaller number of patients and may also be used for data mining </li></ul></ul><ul><li>Other databases Clinical trials databases and specialist databases such as overdose or toxicology databases may also contain valuable information </li></ul>
    20. 20. Data Mining - statistical techniques <ul><li>Predictive modeling </li></ul><ul><li>Clustering or database segmentation eg: Fenfluramine Phentermine & heart disease </li></ul><ul><li>Link analysis refers to methods that identify associations or links between records or sets of data </li></ul><ul><li>Deviation detection looks for outliers or values that deviate from the norm and can be seen either graphically or statistically. </li></ul><ul><li>Measures of disproportionality are the only techniques which have been used to identify ADEs. They have been used by the Netherlands Pharmacovigilance Foundation , the UK Yellow Card database , WHO Uppsala Monitoring Centre and PEM database. </li></ul><ul><li>e.g. Withdrawal bleeding with OCs while on Itraconazole </li></ul><ul><li>However </li></ul><ul><li>It is currently not possible to link all available datasets together and run one of the data mining techniques to identify all possible adverse events </li></ul>
    21. 21. Safety-in-a-Capsule TM - Solution Stack Services Processes Qualification & Validation Safety & Pharmacovogilance Implementation Configuration Administration Customization Production Support Technology Physical Security Data Security Data Privacy Business Continuity Information Security Monitoring Early warning Threshold triggers E-mail Alerts Signal detection Statistical Analysis Informed judgment Analysis Clinical Review, PA, Comparisons, Correlations, Drug-Drug Interaction Reporting SAE reporting PSUR, SUSAR, Periodic Oracle – AERS Oracle – TMS Oracle – Portal Siebel – Call Center DrugLogic – QSCAN Oracle – Business Intelligence Collection & Processing Maintain Database Data Collection (Call Center, Internet, e-Mail, Fax, etc.) Data Entry Medical coding Cleansing & Scrubbing Validation