REALIZING LATE PHASE VALUE THROUGH STRATEGIC PARTNERSHIPS WITH CROSJoshua SchultzCorporate Vice President, PAREXEL Peri and Post Approval Services

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WHY IS THERE A NEED FOR LATE PHASE-SPECIFIC PARTNERSHIPS?

• More scope for study and portfolio optimization due to heterogeneity of late phase study designs and stakeholders

• Lack of well developed approach to non-interventional, HEOR and other types of late phase study types in many pharmaceutical companies

• Continuing cost pressures require new solutions to evidence generation

• Use of emerging late phase technologies requires longer time frames, expertise and intimate collaboration

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WHAT IS A LATE PHASE PARTNERSHIP?

Financial LeverageRate Discounts, Programmatic

Efficiencies,Innovation

Rate Discounts

Protocol Optimization

Start with research/business questionStart with final protocol

Portfolio Optimization

Linking insights from global payers and regulators with operational implications

None

Late Phase Strategic Partnerships

Incentive Alignment Risk/reward to incentivize shared goalsNone

Joint Innovation Explicit focus None

Transactional Approaches

Expertise Sharing NIS, HEOR, Epi experts available ‘on demand’None

Time Frame Multi-year relationshipShort term

Focus Late Phase portfolio-focusedStudy-by-study

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PORTFOLIO of OUTSOURCED

INDIVIDUAL TRANSAC-

TIONAL STUD-IES

Program Synergy

Volume Discount

Oversight Ratio Efficiency

Innovations Pass-through Management

PORTFOLIO of STRATEGIC

PARTNERSHIP STUDIES

PORTFOLIO of STRATEGIC

PARTNERSHIP STUDIES

0

20

40

60

80

100

$M

Service Fees

Sponsor Internal

Pass-throughs

Service FeesPass-throughs

Protocol and Operational Plan

Optimization

Strategic Partnership

Value

Sponsor Internal

Scope R

eduction

Strategic Partnership Focus

Late Phase Strategic Partnership Focus

PARTNERSHIPS OFFER OPPORTUNITIES FOR SAVINGS ACROSS A BROAD SPECTRUM

5

Dedicated OR Experts (Portfolio Director, Epi, SME, Operations Lead) plus additional expertise

(Medical, HERON, MedCom, etc.)

Best way to generate the data (Study? Survey? EHR? Hybrid)

Fit-for-purpose study design andoperational model

Optimise study budget and timeline and ensure meaningful

data

What type of Information

will be collected?

Why are we conducting this study?

Who should participate –

sites and patients?

• Regulatory mandate?• Information for payors?• Assess standard of care?• Publications?• Achieve a leadership position?

• Effectiveness?• Safety?• Adherence?• QoL?• Healthcare utilization?• Prospective, retrospective or a combination?

PRXL Optimization ApproachObjectives

• “Real world” practitioners?• KOLs?• Major institutions, clinical,

managed care, etc?

STUDY OPTIMIZATION REQUIRES EARLY ENGAGEMENT FOR MAXIMUM VALUE

+

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EARLY ENGAGEMENT ENABLES USE OF SPECIALIZED TOOLS TO SUPPORT STUDY OPTIMIZATION

Pragmatic Score 28 – Protocol adjusted to ensure patient management reflects clinical practice

Pragmatic Score 19 – Representative patient population but trial conducted under rigorous trial conditions

Size of patient pool

ExplanatoryApproach

PragmaticApproach

Optimizing trial design to generate the right evidence

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CASE STUDY: ALTERNATIVES TO ORIGINAL DESIGNProtocol

Much more data than mandated by the agency

Revision with focus on need to have data

Decreases the amount of data entry, data review, site burden and visits

Operational Model

Many visits per site, regular visit schedule, heavy SDV

Pool of for cause visits, online data review, remote ‘visits’, and focused data collection

On-site visits not the first approach – remote site management supported by in person when necessary.

Site Burden

Heavy data collection that stays constant over multiple years

Titrate collection down after year 1 as value of incremental longitudinal data drops in the relevant population

Minimal site requirements and “ just in time” management- leads to improved compliance, positive experience

Site Relationship

Nothing explicit

Regular engagement with affiliate and development of an affiliate platform to support site relationship building

Allows for explicit role for MSL and affiliate in study

Orig

inal

Alte

rnat

ive

Ope

ratio

nal I

mpa

ct

Impact on study costs: 30% decrease

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OPPORTUNITIES FOR OPTIMIZATION INCREASE WITH THE DEPTH OF PARTNERSHIP

Final Protocol FPI

CRO Engagement RFP-based

Final Protocol FPI

CRO EngagementAlternative scenarios, modeling, innovative

technology options and operational expertise

Study Design and

Planning

Final Protocol FPI

CRO EngagementAlternative scenarios, modeling, innovative technology options,

operational and other expertise, shared data assets,

Study Design and

Planning

Portfolio Planning

Transactional Approach

Partnership Approach

Partnership Approach

(2nd Generation)

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OPERATIONAL AND COMMERCIALIZATION OPTIMIZATION

Purpose of Trial

Practitioner Expertise

Nature of Trials Outcomes

Participant Eligibility Criteria

Comparators

Flexibility in Administering Treatments (what medications)

Participant Compliance (how medication)

Study Protocol Procedural Requirements (how patient managed)

Participant Burden

Data Collection

01234

“PRAGMATIC Platform”

$M

Standar

d Inte

rventi

onal

PRAGMATIC To

ol Sco

ping

'Low In

terventio

nal' S

copin

g

Observa

tiona

l Sco

ping

$0$4$8

$12$16

+Commercialization OptimizationOperational Plan Optimization

00.10.20.30.40.50.60.70.80.9

1

EarlyMidLate

Price

Pro

babi

lity

cost

effe

ctiv

e

Value of Evidence by Lifecycle StageStudy Cost by Type

SUMMARY

• Taking a broader view of late phase outsourcing enables new sources of value to be unlocked

• Special late phase needs for expertise and flexibility in approach are well suited to partnership relationship structures

• Deeper partnerships enable more opportunities for optimization

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THANK YOU

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