CONFIDENCEAT EVERY TURNCONFIDENCEAT EVERY TURN

Prakriteswar Santikary, PhDVice President and Global Chief Data Officer

ERT’S MODERN DATA AND AI PLATFORM AT SCALE IN THE CLOUD – A PERSPECTIVE FROM DATA SECURITY, PRIVACY AND PROTECTION

ABOUT ERT

│ © Copyright ERT 20182

Founded in 1977; privately held

Supporting Pharmacos, Biotechs & CROs around the world

Operations in 12 countries

2500+ employeesMINIMIZING RISK &

UNCERTAINTY, SO

YOU CAN MOVE

AHEAD QUICKLY

WITH CONFIDENCE

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GLOBAL REACH & EXPERIENCE

│ © Copyright ERT 20183

Boston, MA

Boulder, CO

Bridgewater, NJ

Cleveland, OH

Philadelphia, PA

Raleigh, NC

Rochester, NY

Scotts Valley, CA

St. Louis, MO

Brussels, BE

Estenfeld, GER

Geneva

Nottingham, UK

Peterborough, UK

Tokyo, JP

>50%

new drug

approvals

trials

sites spanning 114

languages & 106

countries

of all FDA

approvals over

the past 4 years

550+

13K+

230K+

patients3M+

SUPPORT FOR…

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CLINICAL TRIAL INDUSTRY CHALLENGES

│ © Copyright ERT 20184

Complexity In clinical

trials

§ Multiple data sources§ Multiple devices§ Multiple data types§ Multiple vendors§ Patient recruitment§ Site qualification

§ real time data ingestion at scale§ Real time data processing§ Data siloes – lack of governance§ Difficult to identify issues and

resolve them in real time§ Lack of visibility into actions

being taken to address issues

§ Patient compliance§ Site compliance§ Query resolution§ Visit compliance§ Regulatory compliance

§ Oversight of trials and sites§ Oversight of vendors§ Oversight of systems§ Monitoring of trial risks§ Data security and privacy

Data Collection

Oversight and Monitoring

Data Processing and Access01 02

0304 Data Quality

SYSTEM DISPARITY IS GROWING WITH SPECIALIZATION

│ © Copyright ERT 20185

MORE SYSTEMS ARE INTRODUCED IN CLINICAL RESEARCH EACH YEAR

EDC

CTMS

IVR

mHealth

Labs

Images

Esta

blis

hed

eClin

ical

Sys

tem

s

eCOA

mHEALTH

PATIENT IDENTIFICATION

HOME MONITORING EMR

PATIENT ENGAGEMENT

TRIALS GETTING MORE COMPLEX

│ © Copyright ERT 20186

Increasing interest in building protocols based on real-time

outcomes; mitigating risk of protocol change

mid trial

Increase in Complex Trials

Continued move to a single Cloud-

based platform as trial methodology of choice powered by

data. Allows for agility and speed to

market.

Key

Insi

ght

Impl

icat

ions

Technology advancements driving highly individualized

patient therapeutics administration.

Advancement of Precision Medicine

Ability to do smaller targeted trials

improving outcomes based on

lifestyle, environment and genetic makeup.

Shift in more active patient engagement - improving access

to trials via mHealth, virtual

trials and focusing on outcomes.

Patient Centricity

Further investment in clinical trials that meet patient needs – less burdensome, increased diversity

and better outcomes.

An explosion of data from

wearables, genomics, social,

imaging, etc. –driving advances in data interaction and

visualization.

More Big Data & AI Modeling

Need to standardize data

sets - mine previous data sets, and better ingest,

analyze and manager larger, more complex

data.

The promise of Blockchain to help

concerns over privacy, data sharing and

reproducibility.

Blockchain

Increased investment in

blockchain technology to improve data

security –competitive

differentiation.

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VOLUME

VELOCITY

VARIETY

VERACITY

EXPONENTIAL DATA GROWTH IN LIFE SCIENCES

│ © Copyright ERT 20187

Clinical, compliance, medical, RWE/commercial and actimetry

Ability to gain insight from aligned data sets

Digitization has increased the speed of information

More types along with more endpoints

Organizations must implement scalable infrastructures to deal with increased data volumes

Leading customer experiences require contemporary insights that can be acted on

Flexible data models are required to integrate customer information

Need to enable multiple user groups with consumable insights

Implications

RECENT SECURITY TRENDS / EVENTS**Pharma expanding security / cyber-security organizations:

● Amgen - 88 open security roles● Eli Lily - 11 open security roles● Pfizer - 35 open security roles● Merck - 22 open security roles● Sanofi - 11 open security roles

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Pharma & Other cyber security incidents:

● Charles River Labs - data breach - April 2019● Merck / NHS (UK) - zero-day virus attack - June

2017● Qwest Diagnostics – Data Breach – 11.9 M patient

data compromised ( PII, Financial Data) - June 2019● *The average cost of a security attack on a company

is $2.4 M● *The average cost in time of a security attack is 50

days● *From 2016 to 2017 there was an 22.7 percentage

increase in cybersecurity costs● *Malware and web-based attacks are the two most

costly attack types — companies spent an average of US $2.4M in defense.

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CONDUCTING CLINICAL TRIALS COMES WITH UNCERTAINTY AND RISK

│ © Copyright ERT 20189

TRIALSTART

TRIALEND

<10%OF

TRIALS END ON TIME

48%OF SITES

UNDER-ENROLL SUBJECTS

5-12SYSTEMS

PER GLOBALSTUDY

58%INCREASEIN SITES

PER TRIAL

71%INCREASE IN

AVERAGE ENDPOINTS

30%AVG PATIENT

DROPOUT RATE

GROWING TRIAL COMPLEXITY ADDS TO DECLINING PERFORMANCE

High administrative burden to extract and re-enter data Into other systems Difficult to filter out noise to identify real issues that require attentionMore effort is spent confirming the accuracy of data than interpreting it for decision-makingCost overrun and delay to time-to-market

Our customers are crying out for help –“Please simplify the complex!”

CLINICAL TRIAL TEAMS ARE DROWNING IN DATA

WAVES OF INFORMATION THAT AREN’T ACTIONABLE

│ © Copyright ERT 201810

TRANSFORMING DATA INTO STRATEGIC BUSINESS ASSETS USING MODERN, SECURE, CLOUD-BASED DATA PLATFORM

SCALEMODERN TECH STACK GOVERNED

REAL TIME REPORTING ANALYTICS AND DATA SCIENCE

│ © Copyright ERT 201811

Data platform architecture at a glance• Lambda architecture (batch and speed layers)• Modular microservices architecture• Serverless Computing• Master data management/data governance• Data ingestion at scale• Adapters and connectors for third party data

integration• Modern data visualization architecture

Customer benefits at a glance• Enables real time decision making• Enables self-service reporting and analytics• Enables data monetization;• Reduces complexity and improves quality• Enables Data-driven decision making• Enable Speed to market of life-saving drugs• Centralizes risk and performance management of trials• Enables cost savings & operational efficiencies• Enables AI and ML capabilities – anticipatory oversight

CLOUD BASED

ERT’ AI and ML Approach

ERT’S DATA SECURITY APPROACH

│ © Copyright ERT 2017 13

Assure data security & compliance as required by regulatory

Build security in requirements (PLC) and development (DLC) of ERT products & services.

Improve ERT’s security awareness

Unify ERT’s security posture across all LOBs

Achieve industry-recognized security

management certification

Establish standard security controls and audit evidence

SecureERT

▪ Establish Sponsor confidence in ERT security controls to protect clincial data

▪ Reduce applications security vulnerabilities

▪ Standardize ERT security posture across all applications and hosting facilities

▪ Reduce ERT internal security vulnerabilities

ERT PLATFORM SECURITY OPERATION

DEFENSE (SECURITY) IN DEPTH

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Security Enhancement Program to address ERT Security Posture Gaps and associate Security Risks.

Security in Depth is an information assurance (IA) methodology that implements security controls in layers.

KEY TAKEAWAYS FROM TODAY’S DISCUSSION

│ © Copyri

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Data Governance

To unleash the potential of data - Master data management, data quality, data profiling, data policies and standards – fosters cross-organizational collaboration

Modern Data Foundation

Ingest any data of any type of any velocityData processing at scale, easy data access, provides self service, provides advanced analytics capabilities including AI and ML

Data security and access Governed data store, transparency, regulatory compliance,

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QUESTIONS?

?…Prakriteswar Santikary, PhDprakriteswar.santi@ert.com