Medidata - Using AI & Advanced Analytics on Clinical Trial ...

Medidata Using AI & Analytics on Clinical Trial DataLife Science Forum Basel7th June 2018

2© 2018 Medidata Solutions, Inc. – Proprietary and Confidential

Principal, Data & [email protected]

Sean McDonnell


RAVEEDC

MEDS: Clinical Trials Data Repository

Expertise Advance Clinical Development

Medidata Solutions


*Optional footnote goes here.

“…computer systems able to perform tasks normally requiring human intelligence, such as visual perception, speech recognition, decision-making…”

English Oxford Living Dictionary

Artificial Intelligence

5© 2018 Medidata Solutions, Inc. – Proprietary and Confidential © 2018 Medidata Solutions, Inc. – Proprietary and Confidential 5

Streamlining genomic biomarker discoveryRave Omicsw/ Biomarker Discovery

Outlier detection to ensure data quality

Edge Central Monitoringw/ Machine Learning &Edge Trial Assurance

Mitigate go/no-go decision risks

MEDS Synthetic Control Arms & Synthetic Control Data

Medical coding faster & more accurate via NLP

Rave Coder

AI already transforming clinical research


63.2%

30.7%

58.1%

85.3%

9.6%

0%

20%

40%

60%

80%

100%

Phase I to II Phase II to III

Phase III to NDA/BLA

NDA/BLA to Approval

Phase I to Approval

Success Rates 2006-2015(N = 9,985)2

© 2018 Medidata Solutions, Inc. – Proprietary and Confidential

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~10 YearsLong timelines1

~$2.6 BillionHigh development cost3

Industry performance will improve through AI

FDA ApprovedLow success rate

Source: 1. Biopharmaceutical Research & Development:, The Process Behind New

Medicines, PhRMA, 20152. Clinical Development Success Rates 2006-2015, BIO, Biomedtracker, Amplion3. Tufts Center for the Study of Drug Development, November 2014


76.7%

46.7%

76.5%

94.5%

25.9%

63.0%

28.8%

55.0%

83.9%

8.4%

0%

20%

40%

60%

80%

100%

Phase I to II Phase II to III Phase III to NDA/BLA NDA/BLA to Approval Phase I to Approval

With Selection Biomarkers

Without Biomarkers

Source: 1. Biotechnology Innovation Organization (BIO), Biomedtracker, AMPLION (2016, May 25). Clinical Development Success Rates 2006-2015. Retrieved January 20, 2018, from

https://www.bio.org/sites/default/files/Clinical%20Development%20Success%20Rates%202006-2015%20-%20BIO,%20Biomedtracker,%20Amplion%202016.pdf

Clinical trials with molecular biomarkers are better — 3X success rates


Only a small number of genomic biomarkers have reached clinical application, many more to be found!


Upload Link MachineLearning

BiomarkerDiscovery

Rave Omics



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Rave Omics has already found evidence of new genomic biomarkersSponsor 1: Found gene associated with treatment response in oncology trial

Sponsor 2: Pharmacovigilance: Found strong evidence that mutations impact AEsData quality, scientific discovery, AE correlations on oncology trial

High specific gene levels in patient, relevant for drug in trial and response

Possible new disease sub-type

• Two specific genes reported as top signatures for metastatic melanoma

Sample biopsy issue where liver cells included with tumor


Monthscleaned and QC’ed data

3

Rave Omics discovered 6 patient subsets, with 3x differential response rate

Yearscollect data

8 MinutesIntegrated data

30 MinutesNovel patient clusters

15


improve data quality machine learning



13

Edge Central Monitoring w/ Machine Learning

Analyzes Millions of Data Points and Finds Thousands of Patterns



14

Using machine learning to find errors, some that humans missed

• Highly correlated measurements

• Anomalous data identified

One site looks different


Automating Medical Coding with Rave Coder & NLP

96.6%For Adverse Events

97.8%For Con Meds

Coverage 100% Coverage 100%


“Headache” going from verbatim to preferred


ThePromiseofPrecisionMedicine

Efficacy and Safety studyModerate asthma• No effect on FEV1 and

only a small numerical trend on exacerbations

Investigator-sponsored trials• Severe asthma with eosinophilic

inflammation

1997

IND opened

1999

Three pivotal Efficacy and Safety studiesSevere asthma with eosinophilic inflammation• Two studies – dramatic

reduction in exacerbations• One study – reduction in

corticosteroid use possible

2009 - 2012 2015

FDA ApprovalIn asthma patients with eosinophilic inflammation

KeytoProgramSuccessIdentificationofhigh-respondingsubgroup

No Go Go!

© 2018 Medidata Solutions, Inc. – Proprietary and Confidential 5


Synthetic Controls streamlines clinical development and mitigates Go/No-go decision risk



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MEDS Synthetic Control Products

Product Details: • An aggregated dataset of hundreds (or

thousands) of patients in an oncology indication

• Selected from multiple recent trials chosen to match key customer inclusion/exclusion criteria

• Delivered via a visualization application allowing customer interaction with pre-built biostatanalyses and dynamic population subsetting

Product Options:

• MEDS Synthetic Control Arm (SCA)• MEDS Synthetic Control Data (SCD)

Synthetic Control Visualization Tool Familiar statistical views tailored to research question

Subgroup drill-down in every view

Comparison between experimental treatment arm and synthetic control group

© 2018 Medidata Solutions, Inc. – Proprietary and Confidential 120


Data Capture & Management

Trial Planning & Management

Study Design & Feasibility

Mobile Health

Images Genomics

RWE

Site &Lab Data

Random-ization & Supply

Biostats& Safety

Site Payments & Grants

Strategic Monitoring

CTMS

eTMF

RAVE


Thank you.Visit us during the break to learn more!

Principal, Data & [email protected]

Sean McDonnell

Medidata - Using AI & Advanced Analytics on Clinical Trial ...

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