rare disease drug development solutions...rare disease drug development solutions combining...
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RARE DISEASE DRUG DEVELOPMENT SOLUTIONS Combining extensive rare disease clinical trial experience with actionable, patient-centric approaches to address high unmet medical needs
At Covance, we recognize the importance of developing therapies to address indications with high unmet medical needs. About 200 approved therapies exist for just a few of the 7,000+ rare diseases affecting more than 350 million people who live with a rare disease.
A promising outlook
▶ Accelerated time to market. Orphan drugs in development average 3.9 years from Phase II to market versus 5.4 years for drugs without orphan status.
▶ Higher approval rates. Orphan drugs have been approved by the FDA at a much higher rate – 82% versus 35% – than traditional medicines.
▶ Increasing scientific understanding and technological capabilities. 80% of rare diseases are genetically defined.
Ongoing challenges
▶ Proving significant benefit and clinical superiority of a drug candidate.
▶ Finding eligible patients among a small population.
▶ Obtaining sufficient support with healthcare sites to recruit and retain participants.
▶ Designing a robust rare disease clinical trial that also aligns with patient-centered outcomes.
TherapeuticAreas
EarlyDevelopment
PatientRelations
CovanceLab
Services
Regulatory
MedicalAffairs
Chiltern
LabCorp
RARE AND
ORPHANTEAM
RegulatoryStrategy
PatientEngagement
Genomics
GeneticCounseling
ClinicalOperations
Medical
The Rare Disease Drug Development Solution Delivering a comprehensive approach to rare disease drug development
Achieve success with integrated, patient-centric solutions
Address the inherent complexities of rare disease drug development with combined capabilities and comprehensive solutions across Covance, LabCorp and Chiltern.
From early stage development to the clinic, from award to completion, you can trust in our established and dedicated Rare Disease Drug Development Team every step of the way. We’ll apply best practices, provide therapeutic area expertise and ongoing consultation and pull in other experts as needed. The end result is a truly patient-centric approach to rare disease clinical trials that eases the burden on sites and patients.
RARE DISEASE DRUG DEVELOPMENT SOLUTIONS Driving development to help address unmet medical needs
Identify & mitigate risks early with proven clinical trial experience
Therapeutic Area# of Full Service
Studies# of Sites # of Subjects
Bone & Joint Disease 2 45 162
Cardiovascular 14 795 4,109
Dermatology 2 109 304
Endocrinology and Metabolism
19 525 23,780
Gastroenterology and Hepatology
3 169 410
Hematology 6 42 235
Immunology 5 112 702
Infectious Disease 5 128 650
Nephrology 4 187 1,345
Neuroscience 18 354 1,324
Oncology 108 4,187 17,131
Ophthalmology 11 117 892
Pulmonary/Respiratory 31 1,374 4,994
Women's Health 1 20 55
Grand Total 229 8,164 56,093
Align with the evolving paradigm of patient centricity
Forge stronger partnerships with patient groups through:▶ Use of patient input to help inform study design▶ Education and dissemination of clinical study information ▶ Enhanced patient identification and participation ▶ Capture and incorporation of “voice of the patient” input to strengthen participant compliance
and retention
Receive world-class clinical development services
Access integrated solutions and proven operational capabilities to:▶ Leverage genetic counselor networks and LabCorp “opt-in” patient care data, informing patient-centric
approaches to trial designs▶ Obtain regulatory insights to guide in study designs and paths to regulatory approval▶ Recognize the value of service and quality results by employing a single-source provider▶ Access expert genomic and diagnostic solutions across LabCorp and Covance
Covance Inc., headquartered in Princeton, NJ, USA, is the drug development business of Laboratory Corporation of America Holdings (LabCorp). COVANCE is a registered trademark and the marketing name for Covance Inc. and its subsidiaries around the world.
The Americas +1.888.COVANCE (+1.888.268.2623) +1.609.452.4440Europe / Africa +00.800.2682.2682 +44.1423.500888 Asia Pacific +800.6568.3000 +65.6.5686588
© Copyright 2018 Covance Inc. SSCDS089-0918