Overcome unmet needs in IBD clinical development with an experienced and trusted partner There have been seven approved drugs for inflammatory bowel disease (IBD), comprising of ulcerative colitis and Crohn's disease, in the past decade. However, there remains a significant unmet need: current drugs typically induce remission in less than half of patients. Due to this need there is an increased interest in developing new IBD therapies and a concomitant increase in competition for trial sites and eligible patients.

1. 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Adalimumab approved
for Crohn’s disease
Adalimumab approved
for ulcerative colitis
Ustekinumab approved
for Crohn’s disease
Vedolizumab approved
for UC/Crohn’s
Natalizumab and Certolizumab
approved for Crohn’s disease
Golimumab approved
for ulcerative colitis
Year
Numberofstudies
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
100
17
29
38
34
38
32
56
44
52
38
58 59 56 53
73
69
80
8690
80
70
60
50
40
30
20
10
0
► The focus on patients with moderate to severe IBD reduces the eligible patient population by almost half,
resulting in challenges meeting recruitment timelines and locating optimal trial sites
► Many investigators are involved in multiple studies, sometimes up to nine, which significantly limits the
number of patients they can enroll per study
► Use of endpoints incorporating endoscopy assessments and patient-reported outcomes (PROs) increases
the chance of excessive data variability and inconclusive results
► Complex regulatory approval and commercial reimbursement processes require expert advice and support
INFLAMMATORY BOWEL DISEASE DRUG DEVELOPMENT PAIN POINTS
Source: TrialTrove/PharmaProjects (November 2017)
INFLAMMATORY BOWEL
DISEASE DRUG
DEVELOPMENT SOLUTIONS
Overcome Unmet Needs in IBD
Clinical Development with an
Experienced and Trusted Partner
There have been seven approved drugs for inflammatory bowel disease (IBD), comprising of ulcerative colitis
and Crohn’s disease, in the past decade. However, there remains a significant unmet need: current drugs
typically induce remission in less than half of patients. Due to this need there is an increased interest in
developing new IBD therapies and a concomitant increase in competition for trial sites and eligible patients.
INFLAMMATORY BOWEL DISEASE TREATMENT LANDSCAPE
NUMBER OF INDUSTRY-SPONSORED IBD STUDIES PER YEAR
(ALL PHASES AND LOCATIONS)

2. LOCATING THE OPTIMAL TRIAL SITES
► Xcellerate®
Trial Design leverages data in the Covance clinical trial knowledgebase,
which houses >40% global trial data at any one time – this real-world data can be
used to match areas of high patient density with the location of high-performing
investigators to find optimal trial sites, and includes:
–– Global data on >2,000 experienced IBD sites
–– LabCorp network of approximately 55,000 physicians with IBD patients
REACHING RECRUITMENT TARGETS AND MAXIMIZING
PATIENT RETENTION
► Covance leverages established relationships with IBD patient advocacy
groups worldwide
► LabCorp database of approximately 237,000 IBD patients in the U.S., 1,380 of
whom have opted to be contacted directly for clinical trial participation
► Use voice of patient insights to support participating patients and reduce study burden
MAINTAINING HIGH-QUALITY DATA
► Centralized assessment of endoscopy data ensures consistency of interpretation
across trial sites
► We provide PRO training to site staff and patients to ensure PROs are collected
and interpreted correctly
► We implement measures to control placebo response, such as ensuring patients
are assessed by the same independent assessor throughout the trial and proactively
discussing the potential for placebo response with investigators
► Xcellerate Monitoring, part of our proprietary informatics suite, enables rapid
identification of potential issues so that immediate preventative action can be taken
NAVIGATING REGULATORY PATHWAYS
► Dedicated regulatory team have nearly 30 years’ experience each with local and
global regulatory bodies
► Generate real-world evidence to communicate product value via Covance Market Access
Learn more about our drug development solutions at www.covance.com
Covance Inc., headquartered in Princeton, NJ, USA is the drug development business of Laboratory
Corporation of America Holdings (LabCorp). COVANCE is registered trademark and themarketing
name for Covance Inc. and its subsidiaries around the world.
The Americas +1.888.COVANCE (+1.888.268.2623) +1.609.452.4440
Europe / Africa +00.800.2682.2682 +44.1423.500888
Asia Pacific +800.6568.3000 +65.6.5686588
© Copyright 2018 Covance Inc. INFCDS012-0118
INFLAMMATORY BOWEL
DISEASE DRUG
DEVELOPMENT SOLUTIONS
Avoid Common Clinical
Development Challenges with
Covance IBD Solutions