This document summarizes Covance's expertise in respiratory clinical trials and their solutions for overcoming common challenges. There remains substantial unmet medical need in respiratory conditions like asthma, COPD, cystic fibrosis, and idiopathic pulmonary fibrosis. Covance has extensive experience conducting respiratory trials, including over 720 immune-mediated inflammatory disease trials in the last five years and helping develop 14 of the top 15 respiratory drugs. They offer specialized testing and analyses. Covance also provides solutions to address common pain points like patient recruitment and retention, trial design, access to experts, and ensuring consistent high-quality data.

1. OVERCOMING UNMET NEEDS
IN RESPIRATORY CLINICAL
DEVELOPMENT
Succeed in Respiratory Trials With an
Experienced and Trusted Partner
Covance has deep experience in respiratory clinical development, with global expertise in asthma, COPD,
upper and lower respiratory infections, cystic fibrosis, idiopathic pulmonary fibrosis, interstitial lung disease,
acute respiratory distress syndrome, and many more.
THERE REMAINS SUBSTANTIAL UNMET MEDICAL NEED AND CHALLENGES
IN THE TREATMENT OF RESPIRATORY CONDITIONS, INCLUDING:
Asthma COPD CF IPF
► Proportion of patients
with uncontrolled
asthma remains high
(45% – REALISE
survey), despite
treatment innovations
► Economic costs of
asthma are among
the highest for non-
communicable diseases
(~$55 bn per year
in U.S.)
► Existing COPD
treatments do not
modify the long-term
decline in lung
function
► By 2030 it is predicted
that COPD will be the
third leading cause of
death globally
► CF remains one of
the most common
life-shortening inherited
diseases, despite
breakthroughs in
targeted therapies
► Management of
pulmonary
exacerbations
is suboptimal
► Median survival is only
three to five years from
diagnosis, despite
decades of clinical
research
► Lung transplant is the
most effective treatment,
but only a small number
of patients qualify
WE HAVE EXTENSIVE GLOBAL EXPERIENCE IN RESPIRATORY TRIALS …
► Supported over 720 immune-mediated inflammatory disease (IMID) clinical trials in the past five years, including
at least 113 asthma, 79 COPD, 34 CF and 26 IPF trials
► Helped develop 14 of the 15 top IMID drugs, of which a number are indicated in respiratory conditions
… AND EXPERTISE IN SPECIALIZED RESPIRATORY TESTS AND ANALYSIS
Covance has the operational expertise, infrastructure and experience to ensure collection of the high-quality data
needed to meet clinical trial endpoints
► Pulmonary function testing, centralized spirometry and fractional exhaled nitric oxide (FeNO)
► High-resolution computed tomography (HRCT)
► Measures of exercise capacity, including six-minute walk test (6MWT) and cardiopulmonary exercise testing (CPET)
► Sputum sampling and processing for biomarker assays, microbiology and cytology
► Bronchoscopy with bronchoalveolar lavage (BAL)
► Patient-reported outcomes (ePROs/diaries) and questionnaires

2. COVANCE RESPIRATORY DRUG
DEVELOPMENT SOLUTIONS
Addressing the Pain Points of Respiratory
Clinical Development
Development challenges Covance solutions
Suboptimal patient
recruitment due
to competitive trial
environment
► Partnership sites giving access to 150,000 asthma/COPD patients
► Strong relationship with network of specialized CF sites that have worked with
CF patients since early childhood
► Targeting experienced sites with high recruitment rates using
Xcellerate®
Trial Design
► Specialist inflammatory biomarker analysis, e.g. eosinophil cationic protein
and periostin
Access to experienced
investigators
► Access to >3,100 asthma and >2,600 COPD investigators worldwide
► Identifying highest-ranking investigators using our historical investigator
performance database
Poor patient retention over
long trial periods
► Incorporating an active site management strategy
► Pre-existing patient relationships and established patient support systems
► Patient-centric trial designs incorporating voice of patient and/or parent insights
Ineffective trial design
leading to inappropriate
enrollment and eligibility
creep
► Pressure testing protocol decisions before finalizing entry criteria
► High-quality training of site staff and careful selection of patients to minimize
rising placebo response rates
Data inconsistencies within
and across sites
► Centralized objective endpoint analysis to reduce variability
► Ensuring availability of appropriate instrumentation, and providing study-specific
training on instrumentation use, and data collection, handling and interpretation
Insufficient support with
regulatory approval and
commercial reimbursement
► Dedicated team of global regulatory experts with up to 30 years’ experience
each in engagement with both global and local agencies
► Generating real-world evidence to demonstrate molecule efficacy and
communicating product value to key stakeholders via Covance Market Access
OVERCOMING RESPIRATORY TRIAL CHALLENGES:
A FOCUS ON PEDIATRIC PATIENTS
Development challenges Covance solutions
Identifying and enrolling
appropriate patients
► Expertise in pediatric protocol design and implementation
► Identifying and supporting high-performing pediatric investigators
Conforming to current
pediatric regulations
► Formulation of a pediatric development plan and engagement of regulatory
agency early in development process
Maintaining pediatric
patient compliance
► Understanding patient challenges using voice of patient and/or parent
insights, and incorporating into trial design
► Site infrastructure to support patient and family needs
Covance has participated in 295 studies involving pediatric patients, equating to approximately
35% of all U.S. pediatric trials
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 the
marketing name for Covance Inc. and its subsidiaries around the world.
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