This document describes the cell and gene therapy development services offered by Covance, including expertise across preclinical, clinical, and post-approval phases to help reduce time and risks. Services include in vitro and in vivo studies, biomarkers, clinical trials, regulatory consulting, and commercialization support. Covance has experience helping develop the first two FDA-approved gene replacement therapies and both approved CAR-T therapies.

1. CELL & GENE THERAPY
Preclinical, Clinical & Post-Approval Solutions
With specialized expertise, coordinated capabilities and focused
investments across preclinical, clinical and post-approval phases, we’ll
help you to reduce the time and risk in your product’s development.
Reduce scientific, regulatory and commercial risks
and accelerate development wherever you are in the
process with expertise in each phase and across the continuum
Preclinical, clinical, laboratory, post-approval solutions
Gene therapies, gene-modified cell therapies, etc.
Rare diseases, pediatrics, oncology and immuno-oncology
Adoptive T-cell therapies
Reduce development timeline whitespace, complexity
and risks with coordinated capabilities from one partner
Science
Program consultation and management
Regulatory
Commercialization
Biomarkers and companion diagnostics
Supported
development of
BOTH
FDA approved CAR-T
therapies
Helped advance the
first 2 FDA-approved
GENE REPLACEMENT
THERAPIES
Delivering
development
solutions for cell
and gene therapy
products
20+
YEARS
Access impactful innovation to advance your precision and regenerative medicines through
our focused investments in and commitment to cell and gene therapy development
Corporate strategic area of focus and resource alignment
Ongoing investments in people, process and technologies
Partnerships and acquisitions – MI Bioresearch, OmniSeq®
, MissionBio™, Envigo and more

2. CELL & GENE THERAPY
Preclinical, Clinical & Post-Approval Solutions
Preclinical Solutions:
In vitro and in vivo
pharmacology and toxicology
Bioanalysis: distribution,
persistence and shedding
Biomarkers
Regulatory and strategic product
development consulting
CMC analytical testing
Clinical development preparation
Commercialization strategy
Clinical Phase Solutions:
Clinical studies, with focused expertise in
oncology, rare diseases and pediatrics
Regulatory and strategic product development
consulting
Biomarkers, including companion diagnostics
Central Labs
Bioanalysis: distribution, persistence and shedding
CMC analytical testing
Commercialization strategy
Post-Approval Solutions:
Long-term follow-up monitoring and studies
Real-world evidence
Pharmacovigilance
Post-marketing commitments
Regulatory consulting
Specialized clinical testing
Commercialization
CMC analytical testing
Precision Medicine Solutions Designed Around You®
Visit us at www.covance.com/CGT
Covance is the drug, medical device and diagnostics business segment of LabCorp, a leading
global life sciences company. 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) +1.609.452.4440
Europe / Africa +00.800.2682.2682 +44.1423.500888
Asia Pacific +800.6568.3000 +65.6.5686588
© Copyright 2019 Covance Inc. SSCGT001-0819
Conducted for cell
and gene products
in the last 4 years
(pharmacology and
toxicology; mostly
in vivo studies)
Conducted in the
last 4 years for cell
and gene products
across the U.S.,
Europe and Asia
Pacific
In the U.S., Europe and
Asia Pacific supporting
RWE studies and post-
marketing commitments
(all product types
therapeutic areas)
Experience in post-approval
studies, globally (all product
types therapeutic areas)
Published in peer-
reviewed journals
for cell and gene
products
Submissions in the
last 5 years, and 67
in prior positions
for strategists and
PMs (all product
types therapeutic
areas)
300+
STUDIES
42+
CLINICAL
STUDIES
60+
LOCATIONS
30+
YEARS
10RD
PAPERS
11NDA/MAA