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1. 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) +1.609.452.4440
Europe/Africa +00.800.2682.2682 +44.1423.500888
Asia Pacific +800.6568.3000 +65.6.5686588
© Copyright 2019 Covance Inc.BROBPH005-0219
Learn more at covance.com/thebioexperience
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YEAR 6Q2 / YEAR 1 Q1 / YEAR 1Q4Q3Q2Q1 Q2 / YEAR 1 Q3 / YEAR 1 Q4 / YEAR 1
-12 -11 -10 -9 -8 -7 -6 -5 -4 -3 -2 -1 0 1 2 3 4 5 6 7 8 9 10 11 12
Define Commercial Strategy Develop Commercial Evidence Develop Commercial Evidence Develop Commercial Evidence
Target Binding
Assays
Pharmacology
In Vitro In Vivo
Preliminary Toxicology Study
(Dose Tolerance)
Tox Dose Stability
Analysis
Final Species
Selection
Reagent Development
for Bioanalytical
Method Development
Reagent Development
for Bioanalytical Method
Development
General Tox Studies
Protocol
Development
Safety Pharmacology
(Can Be Run as Part of
Toxicology)
FIH Study Design
(Clinical Specialists generate
as part of IND
submission package.)
Immunotoxicology Studies
(Can Be Run as Part of
Toxicology)
Reagent Development/
Clinical
Sample Analysis
Preliminary Development
Integrated Structural Characterization Support & In-process Testing
Preliminary Process Development Non-GMP Manufacture
GMP
Manufacture
(1)
Process Refinement
Batch Record
Preparation
Pre-Formulation Development with Accelerated Stability Studies Prepare Report
Drug Product Optimization &
Final Image Selection
Method Development Qualification (GMP)
Write
Reports General Support/Consultation/Assay Robustness Assessment (GMP)
Preliminary Formulation Development
Bioanalytical Method
Development
IND/CTA
Preparation
GLPNON — GLP
Chemistry, Manufacturing & Controls — Analytics
Species
Selection
for
Pharmacology/
Toxicology
Immunotoxicology Studies
Biomarker
Analysis
Regulatory/
Analytical
Strategy
Reagent
Development
for CMC Assays
Reference Standard
Preparation
and Qualification
PK/PD Study
Metabolism Metabolism
Bioanalytical PK Bioanalytical PK
Multiple Ascending Dose Trials
(May include cohort(s) of patients seen in a
research clinic – a “hybrid design.”)
*Exploratory Clinical Trials
(*Requires Exploratory IND)
Process Optimization and Scale-up
Drug Product Optimization and Final Image Selection Drug Product Optimization and Final Image Selection
Phase I — First in Human (FIH)
Phase IIa — Proof of Principle (PoP)/
Proof of Concept (PoC)
Proof of Principle (PoP) /Proof of Concept (PoC) Study
(Average study length approx. 12 months.)
Clinical
Development
Design and
Recruitment
for PoP/PoC
TOX (Chronic Tox Studies)
TOX (DART — Developmental & Reproductive Tox)
FIH Study
Design
MABEL
/NOAEL
Process Optimization and Scale-up
Drug Product Optimization and Final Image Selection Drug Product Optimization and Final Image Selection
Phase IIb — Dose Confirmatory
Clinical Drug Interaction
*Metabolism DDI studies can be done anytime in Phase I, II or
IIb as long as they are completed before Phase III.
Pre-Validation Activities/Perform Support
Dose Confirmatory Study
(Average study length approx. 12-18 months.)
Toxicology
Design and
Recruitment
for Phase III
Phase III — Registrational Studies
Integrated Structural Characterization Support & In-process Testing
Process Validation Analytical Testing for Key Intermediates,
Drug Substance & Drug Product
Assay Validation Activities and Reports BLA Preparation and Support/Reports
Registrational Studies
(Usually requires two. Average study length approx. 12-18 months.)
Peri-approval Studies
(Timing is highly variable. Health authority and sponsor
will negotiate scope, size and timing of any needed
Phase IIIb studies. Sponsor-initiated health
economics studies to support commercialization.)
*Not all programs will require peri-approval studies.
Strategy, Design and
Recruitment for Phase IV
and/or Peri-approval
TOX (DART — Developmental & Reproductive Tox)
TOX (Carcinogenicity)TOX (Carcinogenicity)
Design and
Recruitment
for Phase IIb
Pharmacokinetic Data Analysis Pharmacokinetic Data Analysis Pharmacokinetic Data Analysis
PK/PD Analysis of Samples PK/PD Analysis of Samples PK/PD Analysis of Samples
Biomarkers/ Companion Diagnostics Biomarkers/ Companion Diagnostics Biomarkers/ Companion Diagnostics
Reagent Development/Clinical Sample Analysis Reagent Development/Clinical Sample Analysis Reagent Development/Clinical Sample Analysis
Chemistry, Manufacturing & Controls — AnalyticsChemistry, Manufacturing & Controls — Analytics
Regulatory Milestones & Commercialization
Integrated Structural Characterization Support & In-process Testing
GMP Release and ICH Stability for Key Intermediates, Drug Substance & Drug Product GMP Release and ICH Stability for Key Intermediates, Drug Substance & Drug Product GMP Release and ICH Stability for Key Intermediates, Drug Substance & Drug Product
General Support/Consultation/Assay Robustness Assessment
Go/
No
Go
Single Ascending
Dose Trials
Go/
No
Go
First-in-Human Study
(Average study length approx. 8-9 months.)Tox Dose Analysis
Bioanalytical PK Bioanalytical PK
ADA Method Development
(Biologics Only)
ADA Method Validation
(Biologics Only) Immunogenicity (ADA & NAb) Assessment (Biologics Only) Immunogenicity (ADA & NAb) Assessment (Biologics Only) Immunogenicity (ADA & NAb) Assessment (Biologics Only)
REPORT GENERATION
Endo
f PII Me
eting
BLA/NDA/MAA REPORT PREPARATION BLA/NDA/MAAREPORTFINALIZATION
Regulatory Milestones & Commercialization Regulatory Milestones & Commercialization
ADA and
NAb Method
Development
(Biologics Only)
ADA and
NAb Method
Development
(Biologics Only)
Exploratory Tissue
Cross Reactivity
(Biologics Only)
Definitive Tissue
Cross Reactivity
(Biologics Only)
G
o/No G
o
Pre-I
ND Me
eting
IND/C
TA SUBM
ITTED
*Phase IIIb — Peri-Approval Studies Post Market
BLA/ND
A/MAA Su
bmission
Communicate Commercial Value
Mar
ket Lau
nch
Central Laboratory Services Central Laboratory Services
Go/
No
Go
Central Laboratory Services
Go/
No
Go Central Laboratory Services
Go/
No
Go
Patient Safety &
Pharmacovigilance
Patient Support
Field Services
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