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

1

Looking forward.

Pharmacovigilance in the next 5 years  The Industry Vision

Vicki Edwards

24 September, 2018

2

Intentional

3 Technology Process and Resource Efficiency Sources of Safety Information Patient Insights Benefit-Risk Harmonization

• f PV

Legislation

Precision PV

Precision Pharmacovigilance

Incorporating cutting-edge patient

• utreach

strategies and leveraging digital technologies

Innovation

Creating effective partnerships, both internal and external

Partnerships

Constantly changing to learn new skills and capabilities,

Adaptability

4

Precision Pharmacovigilance

NLP AI Bots Wearables Digital Health ePIL eRisk Minimization

Technology Process and Resource Efficiency Sources of Safety Information Patient Insights Benefit-Risk Harmonization

• f PV

Legislation

Precision PV

5

Opportunity for PV Technology

5

E X P E R I ME NT NTAT I ON

• Case Assignment
• Email Management
• MeDRA Adverse Event

Coding

• Non-Qualifiable Case

Identification and Handling

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

T ECH CH N OLOG I ES

• Machine Learning
• Natural Language

Processing

• Robotic Process Automation
• API

6

Artificial Intelligence (AI)

6

Larger and more interconnected data enable analyses previously not thought possible

The same system that recommends a shirt you may like on Amazon may be used to identify ADRs from text

AI systems require thorough preparation of data, intensive monitoring of algorithms, and customization to be useful

Machine Learning

7

Wearables

7

8

AE Reporting & Digital Portals

Regulators are developing and adopting new technology to optimise reporting of Adverse Events

9

10

Precision Pharmacovigilance

Outsourcing – strategic partnerships More efficient processes Different ways of working Stronger internal partnerships with stakeholder Do more with less Challenge status quo Increased cross industry collaboration Global databases

Technology Process and Resource Efficiency Sources of Safety Information Patient Insights Benefit-Risk Harmonization

• f PV

Legislation

Precision PV

11

Redu dund ndanc ncy Signif nific icant Direct Cost sts Oppo portun unit ity Cost sts Inef effic icien ient Spen ending ing Utilit ility Mo Mode del Stop Expen pensiv ive Upgrade des Scala labilit bility Mu Mult lti- tena enanc ncy

I ndus ndustr y C Cha hall enges Meeti ng t the he C Cha hal leng nges Realize a disruptive and dramatic industry-wide optimization by establishing a multi-tenant pharmacovigilance database platform with true cost-sharing.

Disti tinct t and d Flex exible ible Low Low C Cost Solut lutio ion

11

O B JEC T I V E

12 Technology Process and Resource Efficiency Sources of Safety Information Patient Insights Benefit-Risk Harmonization of PV Legislation

Precision PV

Precision Pharmacovigilance

Real World Data Patient Support Programs ICH E19 Registries PASS Sentinel Risk minimization effectiveness studies

13

Epidemiologists can effectively use Real World Data across the product life-cycle

Iden entif ify U Unmet Need eed Portfolio lio Ex Expansi sion Explo lore C Caus use e

• f Di
• f Disease

Po Post-Marketing ing Safet ety S Studies es Opt ptim imiz ize Target et P Patien ent Popula pulatio ion R&D &D Prio iorit itiz izatio ion Clinic inical T l Tria ial l Desig ign

EARLY LY S STAGE PLANN NNING NG

DRUG D G DEVELOPM PMENT P PROGR GRESSION

LATE P E PHASE E EXEC ECUTION

13

14 Technology Process and Resource Efficiency Sources of Safety Information Patient Insights Benefit-Risk Harmonization of PV Legislation

Precision PV

Precision Pharmacovigilance

Preference Studies CIOMS XI Health Literacy Patient-Centricity Risk Minimization Tools Patient Organizations Effective Risk Communication

15 Technology Process and Resource Efficiency Sources of Safety Information Patient Insights Benefit-Risk Harmonization

• f PV Legislation

Precision PV

Precision Pharmacovigilance

Structured B-R Assessment Thoughtful Risk Management Planning Prioritizing Public Health Targeted Education (Med, Nursing, Pharm Schools) Risk Minimization Tools Public-Private Partnerships

16

Structured B/R Assessment – The New Normal

Having a robust, structured approach for B/R assessment is a new and high priority for industry

Regulatory Requirements

Recent ICH guideline introduced structured B/R into Clinical Overview (CTD)

Evolving ‘best’ practice

Past decade of B/R initiatives established new approaches to perform assessments

Lifecycle approach

Flexibility to address development and

• n-market products (i.e. use in PBRER,

PSUR)

17 Technology Process and Resource Efficiency Sources of Safety Information Patient Insights Benefit-Risk Harmonization

• f PV

Legislation

Precision PV

Precision Pharmacovigilance

ICH Right Sized PV WHO partnerships Gates Foundation Proliferation of nat’l QPPVs Frenetic pace of regulatory change

18

The Global PV landscape is rapidly changing in emerging markets

Drugs Regulatory Unit Ministry of Health

19