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.
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Overcome Respiratory Trial Challenges
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