realizing late phase value through strategic partnerships with cros by joshua schultzcorporate vice...
TRANSCRIPT
REALIZING LATE PHASE VALUE THROUGH STRATEGIC PARTNERSHIPS WITH CROSJoshua SchultzCorporate Vice President, PAREXEL Peri and Post Approval Services
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
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
4
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
+
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
ExplanatoryApproach
PragmaticApproach
Optimizing trial design to generate the right evidence
7
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
8
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)
9
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
11
THANK YOU
11