More than 1,000 biotech firms choose to develop their novel drugwith Covance each year.

Design your journey.Your way. With the hub.Regardless of where you are and how far you aspire to

go, you can advance your program – comprehensively,

economically and with unprecedented continuity.

With the hub, you have exclusive access to innovative

solutions designed specifically for nimble biotech firms.

Advance your journey at your pace, study by study – or

consider an integrated approach with a combination of

complementary solutions to fit your goals.

Whichever journey you are on – the hub offers packages that make sense for your endeavor.

A distinct drug development experience for your progressive venture

Begin Your Personalized Drug Development Experience. Covance.com/TheHub

You are tenacious.Determined to navigate the uncertainty and complexity of today’s drug development requirements.

You pursue the impossible.Believing new answers are waiting to be unlocked.

You will break through.With a partner who’s nimble, committed to your pursuit and has a history of helping biotech firms succeed.

For the Bold. Relentless. You.

Welcome to a Tailored Experience Where you get a personalized engagement from start to finish – to accelerate your endeavor.

Embrace a Unique Approach.

Begin an intimate CRO

partnership with a devoted team

that also offers exclusive access

to the hub of comprehensive

drug development resources.

Personalized Attention Want personalized attention? You got it. Collaborate with a team devoted to nimble biopharma programs, who are passionate about your goals. Plus, gain direct access to executive advocates to

champion your success and advance your program.

Collaborative Engagement Looking to stay connected and intimately involved with the daily operations and progress of your program? Agile processes, ongoing communications and innovative technology make it possible. A devoted team flexibly adapts to the way you work.

Specialized Expertise Is stakeholder confidence the ticket to your success? Don’t compromise. Tap into specialized expertise – scientific, operational, regulatory and therapeutic – that puts your venture on the fast track. Sound advice and a prospective plan has you navigating potential pitfalls, insightfully.

Envision Your Success.

Gain line of sight to your

entire venture, so you can

easily meet stakeholder

goals and milestones.

MOVE FROM CANDIDATE THROUGH COMMERCIALIZATION

COMPLETE EARLY DEVELOPMENTAND LICENSE OR SELL ASSET

CONDUCT A COMPREHENSIVECLINICAL TRIAL

Save up to

30% o� your timelines with a programmatic approach

Improve your return

> $600keach day by streamlining data delivery for submission

Save

~1 yearof patent life on a full development program – by reducing time of ramp-up, data consolidation and gaps between phases

It’s a program of passion. Patients are waiting for a breakthrough. And, our stakeholders may only give us one shot.

- biotech client

“

“

MarketPlaceCapitalize on the value of your asset by gaining critical visibility and establishing the right connections early with investors and development partners. Finding your partner may only be a click away via this unique, online networking solution.

Early Phase Development SolutionsMove swiftly through IND/CTA and into the clinic 30% faster with a prospective plan and unprecedented continuity. Your asset is surrounded with a cross-functional team of experts and proven efficient processes that save you time and money.

Integrated Clinical PharmacologyGain critical data to make earlier and more confident decisions, by leveraging a global network of clinical pharmacology units and an integrated approach to e�ciently manage complex trials in healthy volunteers, patients and special populations.

Clinical-BiotechExperience a collaborative, flexible approach to your clinical trial. Engage with an executive lead for the duration of your program. Gain insights from a devoted team with scientific, regulatory and therapeutic expertise in a variety of indications, including oncology and rare and orphan diseases.

Central Laboratory ServicesEnjoy streamlined safety and esoteric testing with a biotech-dedicated study management team. Get trial-specific specimen collection kits, unmatched logistics support and access to scientific expertise.

Biomarkers and Companion DiagnosticsReach patients who will benefit most from your novel drug through the power of precision medicine. Go from pathway selection, biomarker development and validation to an informed regulatory and commercial strategy for your companion diagnostic.

Actionable Data and AnalyticsReduce study costs, speed time to market and increase patient recruitment with visibility into optimal sites and clusters of eligible participants. Enable improved enrollment and retention with proprietary patient diagnostic data, unrivaled site performance data and unique patient insights.

Regulatory and Commercial ConsultingAdvance your nonclinical and clinical strategies, navigate regulatory requirements and identify the right approach with a Target Product Profile. Then, pave the way to commercial success with insights from early-stakeholder and market research.

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 2019 Covance Inc.

BROBPH006-0119

More than 1,000biotech firms choose to develop their novel drugwith Covance each year.

Design your journey.Your way. With the hub.Regardless of where you are and how far you aspire to

go, you can advance your program – comprehensively,

economically and with unprecedented continuity.

With the hub, you have exclusive access to innovative

solutions designed specifically for nimble biotech firms.

Advance your journey at your pace, study by study – or

consider an integrated approach with a combination of

complementary solutions to fit your goals.

Whichever journey you are on – the hub offers packages that make sense for your endeavor.

A distinct drug development experience for your progressive venture

Begin Your Personalized

Drug Development Experience.

Covance.com/TheHub

You are tenacious.

Determined to navigate the uncertainty and complexity of today’s drug development requirements.

You pursue the impossible.

Believing new answers are waiting to be unlocked.

You will break through.

With a partner who’s nimble, committed to your pursuit and has a history of helping biotech firms succeed.

For the Bold. Relentless. You.

Welcome to a tailored experience, Designed Around You.®Where you get a personalized engagement from start to finish – to accelerate your endeavor.

Embrace a Unique Approach.

Begin an intimate CRO

partnership with a devoted team

that also offers exclusive access

to the hub of comprehensive

drug development resources.

Personalized Attention Want personalized attention? You got it. Collaborate with a team devoted to nimble biopharma programs, who are passionate about your goals. Plus, gain direct access to executive advocates to

champion your success and advance your program.

Collaborative Engagement Looking to stay connected and intimately involved with the daily operations and progress of your program? Agile processes, ongoing communications and innovative technology make it possible. A devoted team flexibly adapts to the way you work.

Specialized Expertise Is stakeholder confidence the ticket to your success? Don’t compromise. Tap into specialized expertise – scientific, operational, regulatory and therapeutic – that puts your venture on the fast track. Sound advice and a prospective plan has you navigating potential pitfalls, insightfully.

Envision Your Success.

Gain line of sight to your

entire venture, so you can

easily meet stakeholder

goals and milestones.

MOVE FROM CANDIDATE THROUGH COMMERCIALIZATION

COMPLETE EARLY DEVELOPMENT

AND LICENSE OR SELL ASSET

CONDUCT A COMPREHENSIVECLINICAL TRIAL

Save up to

30% off your timelines with a programmatic approach

Improve your return

> $600keach day by streamlining data delivery for submission

Save

~1 yearof patent life on a full development program – by reducing time of ramp-up, data consolidation and gaps between phases

It’s a program of passion. Patients are waiting for a breakthrough. And, our stakeholders may only give us one shot.

- biotech client

“

“

MarketPlaceCapitalize on the value of your asset by gaining critical visibility and establishing the right connections early with investors and development partners. Finding your partner may only be a click away via this unique, online networking solution.

Early Phase Development SolutionsMove swiftly through IND/CTA and into the clinic 30% faster with a prospective plan and unprecedented continuity. Your asset is surrounded with a cross-functional team of experts and proven efficient processes that save you time and money.

Integrated Clinical PharmacologyGain critical data to make earlier and more confident decisions, by leveraging a global network of clinical pharmacology units and an integrated approach to efficiently manage complex trials in healthy volunteers, patients and special populations.

Clinical-BiotechExperience a collaborative, flexible approach to your clinical trial. Engage with an executive lead for the duration of your program. Gain insights from a devoted team with scientific, regulatory and therapeutic expertise in a variety of indications, including oncology and rare and orphan diseases.

Central Laboratory ServicesEnjoy streamlined safety and esoteric testing with a biotech-dedicated study management team. Get trial-specific specimen collection kits, unmatched logistics support and access to scientific expertise.

Biomarkers and Companion DiagnosticsReach patients who will benefit most from your novel drug through the power of precision medicine. Go from pathway selection, biomarker development and validation to an informed regulatory and commercial strategy for your companion diagnostic.

Actionable Data and AnalyticsReduce study costs, speed time to market and increase patient recruitment with visibility into optimal sites and clusters of eligible participants. Enable improved enrollment and retention with proprietary patient diagnostic data, unrivaled site performance data and unique patient insights.

Regulatory and Commercial ConsultingAdvance your nonclinical and clinical strategies, navigate regulatory requirements and identify the right approach with a Target Product Profile. Then, pave the way to commercial success with insights from early-stakeholder and market research.

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.

BROBPH006-0119

Welcome to a Tailored Experience

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) +1.609.452.4440Europe/Africa +00.800.2682.2682 +44.1423.500888 Asia Pacific +800.6568.3000 +65.6.5686588

© Copyright 2020 Covance Inc.

BROBPH006-0120

QUARTER 1YEAR 1

QUARTER 2YEAR 1

QUARTER 3YEAR 1

QUARTER 4YEAR 1

QUARTER 1YEAR 2

QUARTER 2YEAR 2

QUARTER 3YEAR 2

QUARTER 4YEAR 2

QUARTER 1YEAR 3

QUARTER 2YEAR 3

QUARTER 3YEAR 3

QUARTER 4YEAR 3

QUARTER 1YEAR 4

QUARTER 2YEAR 4

QUARTER 3YEAR 4

QUARTER 4YEAR 4

QUARTER 1YEAR 5

QUARTER 2YEAR 5

QUARTER 3YEAR 5

QUARTER 4YEAR 5

QUARTER 1YEAR 6

QUARTER 2YEAR 6

QUARTER 3YEAR 6

QUARTER 4YEAR 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

TargetBindingAssays

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

ProtocolDevelopment

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

PreliminaryDevelopment

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 ReportDrug Product Optimization &

Final Image Selection

Method DevelopmentQualification

(GMP)Write

Reports

Preliminary Formulation Development

Bioanalytical Method Development

GLPNON — GLP

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

*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

General Support/Consultation/Assay Robustness Assessment (GMP)

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)

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

forPhase 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

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

Single Ascending Dose Trials

First-in-Human Study (Average study length approx. 8-9 months.)

Central Laboratory Services Central Laboratory Services

Central Laboratory Services Central Laboratory Services

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 BLA/NDA/MAA REPORT PREPARATION BLA/NDA/MAA REPORT FINALIZATION

Regulatory Milestones & Commercialization Regulatory Milestones & Commercialization

ADA andNAb Method Development

(Biologics Only)

ADA andNAb Method Development

(Biologics Only)

Exploratory Tissue Cross Reactivity(Biologics Only)

Definitive Tissue Cross Reactivity(Biologics Only)

*Phase IIIb — Peri-Approval Studies Post Market

Communicate Commercial Value

Multiple Ascending Dose Trials(May include cohort(s) of patients seen in a research clinic – a “hybrid design.”)

Expedite Your Drug Development JourneyRegardless of where you are in your molecule’s journey, you can propel your path forward efficiently with one partner. Gain exclusive access to a comprehensive hub of drug development solutions distinctly designed for the progressive biotech venture.

Learn more at Covance.com/thehub

FIH Study Design

Clinical Development

FIH StudyDesignMABEL/NOAEL

IND/CTA

Preparation

Go/NoGo

Go/NoGo

Go/NoGo

Go/NoGo

Go/NoGo

Preliminary Process DevelopmentPreliminary Process Development Non-GMP Manufacture Process Refinement

BLA/NDA/MAA REPORT FINALIZATIONBLA/NDA/MAA REPORT FINALIZATIONBLA/NDA/MAA REPORT FINALIZATION

BLA

/NDA

/MAA Submissio

n

QUARTER 4

Communicate Commercial Value

A SSubmmissio

n

Communicate Commercial Value

Mar

ket Launch

Final Image Selection Drug Product Optimization and Final Image Selection

IND

/C

TA SUBMITTE

DD/

D/

DC/C/

B

/C

T T

Go/No Go

o

GGo/ o

End

o

f PII Meeting

M

doof e

Chemistry, Manufacturing & Controls — Analytics Chemistry, Manufacturing & Controls — AnalyticsChemistry, Manufacturing & Controls — Analytics

Final Image Selection

Regulatory Milestones & Commercialization Pre

-IND Meeting

M

eIN et

Patient Safety &

Pharmacovigilance

Patient Support

Field Services