Building a Foundation for Proactive and Predictive Pharmacovigilance
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Learn how PV teams can easily keep up with evolving compliance requirements with modern safety applications that provide better data control and drive greater efficiencies. View on-demand session: https://bit.ly/3vIzQG9
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Building a Foundation for Proactive and Predictive Pharmacovigilance
- 1. 1 Copyright © Veeva Systems 2021 Building a Foundation for Proactive and Predictive Safety Saba Darvesh, Senior Director Vault Safety Strategy
- 2. • Almost 20 years of consulting experience supporting biotech and pharmaceutical companies • Extensive experience and knowledge implementing and managing PV systems, including safety signal solutions • Driven complex global technology implementations, designed future state business processes, and defined governance across PV and broader R&D Saba Darvesh Senior Director, Vault Safety Strategy
- 3. 3 Copyright © Veeva Systems 2021 Building a Foundation for Proactive Surveillance Leading to Predictive Drug Safety • Approaches to centralizing key pharmacovigilance data and content • Seamless cross-functional safety processes enabled by modern solutions • How technology is supporting the shift to predictive and proactive safety • Impact from gaining a more complete view of pharmacovigilance data and content
- 4. 4 Copyright © Veeva Systems 2021 Industry Challenges and Pressures Safety Organization Focus on Patient Centricity • Patients are more aware and actively involved • Customized medication and therapies • Enhanced quality of life Streamline Pharmacovigilance • More efficient and faster processes driven by technology innovations • Reduce operational costs • Use skilled resources for high value activities • More accurate benefit-risk assessments of medicinal products Growing Disease Complexity • Leading into complex clinical trials and innovation of medicinal products More Regulatory Demand • Evolving global regulatory landscape adding complexity • Enforcement of regulatory ethics Increasing Publicly Available AE data • Processing of more cases • Potentially more noise
- 5. 5 Copyright © Veeva Systems 2021 Basic Research Drug Discovery Pre-Clinical IND Submitted NDA/BLA Submitted Agency Approval Clinical Trials Phase I Phase II Phase III Agency Review Post-Approval Research & Monitoring Phase IV Product Lifecycle Insight More accurate benefit- risk evaluation Proactive surveillance leading to predictive models Faster time-to-market with no compromise on patient safety Direct patient participation and enhanced patient experience Data Data Across the End-to-end Product Lifecycle Data and Content Sales Data Claims Safety Biomarkers, Clinical Trial Data PV Data – SAEs, ICSRs, Aggregate/ Periodic listings Regulatory Data – FAERS, VAERS, VigiBase, EudraVigilance, JADER, MedDRA, WHO Drug Medical Literature Animal Testing, Safety Biomarkers API Information Patient Registries, EMR/ EHR Social Media
- 6. 6 Copyright © Veeva Systems 2021 Harnessing the Value of Information Proactively • Better evidence of efficacy and safety with serious and non- serious AE data • Earlier benefit-risk assessment from pre-market-controlled trials Clinical Data • Patient exposure information • Assessing impact on sub- groups of patient population based on gender, race, ethnicity Sales Data • Identify medication errors, novel reactions • Improve patient care EMR / EHR/ Claims • Augment formal data sources • Track how products are used or misused in real life • Insight into patient’s quality of life Social Media Improved Predictive Pharmacovigilance Anticipate what may potentially happen and prepare to mitigate the risks …
- 7. 7 Copyright © Veeva Systems 2021 Analysis Reporting & Metrics Processing Intake Oversight & Management Submissions Gateway What Does a PV System Architecture Look Like Today? Signal Tracking Local Reporting Business Objects – Case Management Cognos, Qlik – Metrics & user reporting Signal Detection Case Analysis Signal Management – Real Time Analysis of Clinical Cases Compliance Tracking & Remediation PV Agreements Tracking Receipt & Triage Reconciliation Log & Track Safety Support Issues Japanese Safety Database Safety Database Dictionary & Coding Mgt Safety Database Copy Data Mart PSMF, Local Trackers, Safety Letters, Investigator Communications Document Management ROW Document Management EU Literature Assessment Follow-up Letters, Clinical Queries & Tracking Aggregate Reporting Massive Replication and Duplication of Data Many Different Ways of Managing Content Bolt-on Automation and Analytics
- 8. 8 Copyright © Veeva Systems 2021 Challenges Bringing Information Together Enablers • Technology • Cloud technology • Secure and easy data access • Maintaining data privacy • Translation engines • Analytics and Visualization of multi- dimensional data • Standardization • Data format - E2B R2/R3 • Coding of medical products and events - MedDRA (EMA, FDA), WHO DRUG, ATC • Many data sources • Data sources are siloed • Unstructured data • Inconsistent coding • Different languages • Separate data and content systems • Difficult to access or get the data
- 9. 9 Copyright © Veeva Systems 2021 Unified and Connected Pharmacovigilance Solution Aggregate or Periodic Reporting Case Intake Partner Management Content Management Case Processing and Management Submissions and Distribution Signal & Risk Management Artificial Intelligence, Reporting, Analytics, Dashboards Other Data Sources Partners Other Functional Areas • Cloud Platform Unified Safety System
- 10. 10 Copyright © Veeva Systems 2021 The Power of a Unified Solution AI and AUTOMATION DATA ANALYSIS CONTENT Data and AI • Determine case trends • Automate intake with machine learning Data and Content • PSMF and tracking of content • PV agreements link to compliance metrics Data and Analysis • Retrieve data to conduct Signal analysis and assessment Analysis and Content • RMP/REMS • Signal assessment documentation AI and Content • Population of document sections in aggregate reports, risk management plans, etc. • Identification and tracking of PSMF content
- 11. 11 Copyright © Veeva Systems 2021 Clinical Operations Clinical Data Management Regulatory Quality Clinical Sites MedComms Seamless Flow of Data and Content Periodic Report Submission Quality Complaints Safety Letters Adverse Events and Queries Adverse Events, Queries and Reconciliation Adverse Events Product Dictionary Controlled Docs, CAPAs Clinical Info Safety Labelling Updates • Cloud Platform
- 12. 12 Copyright © Veeva Systems 2021 Moving to Proactive and Predictive Safety People Technology Process Executive alignment and sponsorship Embracing modern technology Shift in mindset - part of the journey, focus on longer term gains Bring in or access external data Directly incorporate partners into processes Replace repetitive and manual processes with seamless cross-functional processes Unified data standards Advanced analytics and business intelligence Cloud technologies and applications Continuous innovation Break down application and data silos
- 13. 13 Copyright © Veeva Systems 2021 Business Value to the Industry Insights Tangible cost reduction • Reduce financial cost of a product label update or product recall • Reduce overall cost of drug development Speed to Market • Support faster decision making • Reduced end-to-end drug development cycle • No compromise on patient safety Enhanced Patient Experience • Minimize risk and cost to patients >> loyalty and confidence • Accuracy of precision medicine >> better quality of life • Empowering patients >> active participation Increased Brand Awareness • Focus on data driven value of drug to patients • Accelerate patients moving from product awareness to product purchase Driving Observational Studies • Enable Identification of high- risk patient population through prospective and retrospective cohort studies
- 14. Thank you Hear a biopharmaceutical company's approach to unifying pharmacovigilance data: https://bit.ly/3cIqmlm
Editor's Notes
- Building a Foundation for Proactive and Predictive Safety There is rising pressure to move from reactive to proactive and predictive pharmacovigilance. With a comprehensive view into relevant information from intake to post-market surveillance, companies can better mitigate risks and make benefit-risk safety decisions. Assessing safety information is challenging with regulatory demand to incorporate new data types and sources, increasing amount of pharmacovigilance data and content, and growing complexity of information. Modern pharmacovigilance solutions easily bring together internal and external sources of safety data and content while broadening access and ensuring traceability. Making it easier to keep up with evolving compliance requirements and technology innovation, new safety applications provide better data control and drive greater efficiencies. Join us as we discuss: Impact from gaining a more complete view of pharmacovigilance data and content How technology is supporting the shift to proactive and predictive safety Approaches to centralizing key pharmacovigilance data / content Seamless cross-functional safety processes enabled by modern solutions
- There is rising pressure to move from reactive to proactive and predictive pharmacovigilance. With a comprehensive view into relevant information from intake to post-market surveillance, companies can better mitigate risks and make benefit-risk safety decisions. Assessing safety information is challenging with regulatory demand to incorporate new data types and sources, increasing amount of pharmacovigilance data and content, and growing complexity of information. Modern pharmacovigilance solutions easily bring together internal and external sources of safety data and content while broadening access and ensuring traceability. Making it easier to keep up with evolving compliance requirements and technology innovation, new safety applications provide better data control and drive greater efficiencies.
- Traditionally, the processes around pharmacovigilance are fragmented, siloed, and rife with manual tasks and workflows. By introducing modern, unified cloud technologies, pharmacovigilance can begin to break down application and data silos, moving toward simplification of workflows through automation and AI.
- There are many instances of data duplication in the pharmacovigilance landscape. The legacy applications used are often siloed, bulky, and difficult to update and keep up with a changing landscape. By adopting modern cloud applications that can provide a single view to all pharmacovigilance data and content, organizations can streamline and remove repetitive and manual processes. Cloud technologies also offer solutions that are continually improving and delivered through multiple updates a year.
- Case Intake Case Processing Submissions and Distribution Managing Partners Aggregate Management Signal Detection through Risk Management