Realizing Late Phase Value Through Strategic Partnerships with CROs by Joshua SchultzCorporate Vice President, PAREXEL Peri and Post Approval Services

1. REALIZING LATE
PHASE VALUE
THROUGH
STRATEGIC
PARTNERSHIPS
WITH CROS
Joshua Schultz
Corporate Vice President,
PAREXEL Peri and Post Approval Services

2. 2
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

3. 3
WHAT IS A LATE PHASE PARTNERSHIP?
Financial Leverage
Rate Discounts, Programmatic
Efficiencies,
Innovation
Rate Discounts
Protocol
Optimization
Start with research/business
question
Start 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 goals
None
Joint Innovation Explicit focusNone
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

4. 4
0
20
40
60
80
100
$M ServiceFees
Sponsor
Internal
Pass-throughs
ServiceFeesPass-throughs
Protocol and
Operational
Strategic
Partnership
Value
Sponsor
Internal
Scope
Reduction
Strategic Partnership
Focus
Late Phase Strategic
Partnership Focus
PARTNERSHIPS OFFER OPPORTUNITIES FOR
SAVINGS ACROSS A BROAD SPECTRUM

5. 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 and
operational 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
+

6. 6
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
Explanatory
Approach
Pragmatic
Approach
Optimizing trial design to
generate the right evidence

7. 7
CASE STUDY: ALTERNATIVES TO ORIGINAL DESIGN
Protocol
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
OriginalAlternativeOperationalImpact
Impact on study costs: 30% decrease

8. 8
OPPORTUNITIES FOR OPTIMIZATION INCREASE WITH
THE DEPTH OF PARTNERSHIP
Final
Protocol
FPI
CRO Engagement
RFP-based
Final
Protocol
FPI
CRO Engagement
Alternative scenarios, modeling, innovative
technology options and operational expertise
Study
Design and
Planning
Final
Protocol
FPI
CRO Engagement
Alternative 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)

9. 9
OPERATIONAL AND COMMERCIALIZATION OPTIMIZATION
0
1
2
3
4
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
“PRAGMATIC Platform”
$M
$0
$2
$4
$6
$8
$10
$12
$14
$16
$18
Standard
Interventional
PRAGMATIC
Tool Scoping
'Low
Interventional'
Scoping
Observational
Scoping
+
Commercialization OptimizationOperational Plan Optimization
0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0.9
1
Probabilitycosteffective
Price
Early
Mid
Late
Value of Evidence by Lifecycle StageStudy Cost by Type

10. 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

11. 11
THANK YOU
11