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Copyright © 2015 Covance. All Rights Reserved

PRAGMATIC SOLUTIONS FOR

IMMUNO-ONCOLOGY PROGRAMS

Frank Makosiej, Jr., PharmDExecutive Director, Operational Strategy & Planning,Oncology

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Objectives

Exponential increase in the number of trials evaluating immuno-oncology treatment options

Immuno-oncology trials are different and require an enhanced skill set from all parties involved in a clinical trial

Choosing the right country and site for successful trial execution is a critical step in the entire drug development program

Leveraging historical data to better predict more efficient and scalable ways to recruit patients for clinical trials has been the focal point for the biopharmaceutical industry

How to utilize a historical data-driven methodology to pin-point specific investigators who are consistently excellent performers to ensure trial success. The importance of a quality knowledgebase and data breadth will also be discussed.

Boston Oncology Leader's Forum2

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Key Messages

Model:

Agile,

Scalable

Method:

Site-Centric

Quality-Focused

Value Add:

Support a Changing Immuno-Oncology

Portfolio

Success:

Productivity and Efficiency Gains

Boston Oncology Leader's Forum3

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Immune-related toxicities (irAE)

Response criteria (irRC)

Duration of treatment

(maintenance?, retreatment upon

progression)

Biomarkers (predictors of

response)

Combination treatment

Tumor types

Characteristics of Immunotherapy

Boston Oncology Leader's Forum4

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Characteristics of Immunotherapy

Mandate Informed Insights

Increasing

Combination

Treatments

Immuno-

Oncology

Immune-

Related

Response

Criteria

irRC

Duration of

Treatment

Biomarkers

Predictors of

Response

Broadening

Tumor Types

Immune-

Related

Toxicities

irAEs

Boston Oncology Leader's Forum5

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Xcellerate® Informatics Technology Platform

Solutions Provide Informed Insights

Interactive Demonstration

Boston Oncology Leader's Forum6

Covance Inc., headquartered in Princeton, NJ, is the drug development business of Laboratory Corporation of America® Holdings

(LabCorp®). Covance is the marketing name for Covance Inc. and its subsidiaries around the world. © Copyright 2015. Covance Inc.