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. Therapeutic Areas Early Development Patient Relations Covance Lab Services Regulatory Medical Affairs Chiltern LabCorp RARE AND ORPHAN TEAM Regulatory Strategy Patient Engagement Genomics Genetic Counseling Clinical Operations Medical The Rare Disease Drug Development Solution Delivering a comprehensive approach to rare disease drug development

Transcript of Rare Disease Drug Development Solutions...RARE DISEASE DRUG DEVELOPMENT SOLUTIONS Combining...

Page 1: Rare Disease Drug Development Solutions...RARE DISEASE DRUG DEVELOPMENT SOLUTIONS Combining extensive rare disease clinical trial experience with actionable, patient-centric approaches

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

Page 2: Rare Disease Drug Development Solutions...RARE DISEASE DRUG DEVELOPMENT SOLUTIONS Combining extensive rare disease clinical trial experience with actionable, patient-centric approaches

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


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