Pharmacovigilance in the next 5 years The Industry Vision Vicki - PowerPoint PPT Presentation

Looking forward. Pharmacovigilance in the next 5 years  The Industry Vision Vicki Edwards 24 September, 2018 1

Intentional 2

Precision Pharmacovigilance Technology Harmonization Process and Innovation Partnerships Adaptability of PV Resource Legislation Efficiency Constantly Creating Incorporating changing to effective cutting-edge learn new partnerships, patient Precision skills and both internal outreach PV capabilities, and external strategies and Sources of leveraging Benefit-Risk Safety digital Information technologies Patient Insights 3

Precision Pharmacovigilance Technology NLP Harmonization AI Process and of PV Resource Legislation Efficiency Bots Precision Wearables PV Sources of Digital Health Benefit-Risk Safety Information ePIL Patient Insights eRisk Minimization 4

Opportunity for PV Technology O P O P P O P ORT U N I T Y  Simplified Compliance  Better quality of data and analysis  Reduced cost/increased efficiency E X P E R I ME NT NTAT I ON  Case Assignment  Email Management  MeDRA Adverse Event T ECH CH N OLOG I ES Coding  Machine Learning  Non-Qualifiable Case  Natural Language Identification and Processing Handling  Robotic Process Automation  API 5 5

Artificial Intelligence (AI) Machine Learning Larger and more interconnected data enable analyses previously not thought possible AI systems require thorough preparation of data, intensive monitoring of algorithms, and customization to be useful The same system that recommends a shirt you may like on Amazon may be used to identify ADRs from text 6 6

Wearables 7 7

AE Reporting & Digital Portals Regulators are developing and adopting new technology to optimise reporting of Adverse Events 8

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Precision Pharmacovigilance Outsourcing – strategic partnerships Technology More efficient processes Harmonization Process and of PV Resource Legislation Efficiency Different ways of working Stronger internal partnerships with stakeholder Precision PV Do more with less Sources of Benefit-Risk Safety Information Challenge status quo Patient Insights Increased cross industry collaboration Global databases 10

Realize a disruptive and dramatic industry-wide optimization by establishing a multi-tenant pharmacovigilance database platform with O B JEC T I V E true cost-sharing. I ndus ndustr y C Cha hall enges Meeti ng t the he C Cha hal leng nges Stop Utilit ility Oppo portun unit ity Signif nific icant Expen pensiv ive Mo Mode del Direct Cost sts Upgrade des Cost sts Scala labilit bility Low Low C Cost Solut lutio ion Inef effic icien ient Redu dund ndanc ncy Spen ending ing Disti tinct t Mult Mu lti- and d tena enanc ncy Flex exible ible 11 11

Precision Pharmacovigilance Real World Data Technology Patient Support Programs Process and Harmonization of Resource PV Legislation Efficiency ICH E19 Registries Precision PV PASS Sources of Benefit-Risk Safety Information Sentinel Patient Insights Risk minimization effectiveness studies 12

Epidemiologists can effectively use Real World Data across the product life-cycle EARLY LY S STAGE LATE P E PHASE E EXEC ECUTION PLANN NNING NG R&D &D Prio iorit itiz izatio ion Opt ptim imiz ize Iden entif ify U Unmet Portfolio lio Target et P Patien ent Need eed Ex Expansi sion Popula pulatio ion Clinic inical T l Tria ial l Po Post-Marketing ing Explo lore C Caus use e Desig ign Safet ety S Studies es of Di of Disease DRUG D G DEVELOPM PMENT P PROGR GRESSION 13 13

Precision Pharmacovigilance Technology Preference Studies CIOMS XI Process and Harmonization of Resource PV Legislation Efficiency Health Literacy Precision PV Patient-Centricity Sources of Risk Minimization Tools Benefit-Risk Safety Information Patient Organizations Patient Insights Effective Risk Communication 14

Precision Pharmacovigilance Technology Structured B-R Assessment Process and Thoughtful Risk Management Harmonization Resource Planning of PV Legislation Efficiency Prioritizing Public Health Precision PV Targeted Education (Med, Sources of Nursing, Pharm Schools) Benefit-Risk Safety Information Risk Minimization Tools Patient Insights Public-Private Partnerships 15

Structured B/R Assessment – The New Normal Having a robust, structured approach for B/R assessment is a new and high priority for industry Evolving ‘best’ practice Past decade of B/R initiatives established new approaches to perform assessments Regulatory Requirements Recent ICH guideline introduced structured B/R into Clinical Overview (CTD) Lifecycle approach Flexibility to address development and on-market products (i.e. use in PBRER, PSUR) 16

Precision Pharmacovigilance ICH Technology Harmonization Process and Right Sized PV of PV Resource Legislation Efficiency WHO partnerships Precision PV Gates Foundation Sources of Benefit-Risk Safety Information Proliferation of nat’l QPPVs Patient Insights Frenetic pace of regulatory change 17

The Global PV landscape is rapidly changing in emerging markets Drugs Regulatory Unit Ministry of Health 18

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