Strategic Alliance Partnership between small to mid-size ... · PDF fileStrategic Alliance Partnership between small to mid-size (Bio)Pharma companies and CRO industry Axel Mescheder,

Strategic Alliance
Partnership between
small to mid-size
(Bio)Pharma companies
and CRO industry
Axel Mescheder, M.D.
VP Medical & Regulatory Affairs
Europe

FOCUSED. TRUSTED. GLOBAL.
Key Topics
o What is a partnership?
o The current business landscape
o Key factors for success in strategic partnerships
o Typical obstacles and how to overcome them
o Measures for success
o Case study presentation

What is a Partnership?
o A shared goal
o An agreement on the methods or
standards
o A plan to measure success and
correct actions
o A forum

Why Develop a Partnership?
o Increase the visibility of the Sponsor and
program within the CRO
o Streamline communication and escalation pathways
o Benefit from senior level medical, scientific and
operational oversight

Mid-size vs Large Pharma
o Mid-size - Greater openness to true partnering
Volume + partnering = True savings
Willingness to follow CROs SOPs and best practices
Achieve short and long term benefits
o Large Pharma rarely partner:
Contract for volume
Require CRO to model their processes
Generate short term savings
Results in costly changes to procurement practices

Current Business Landscape

The Situation
o Pharmaceutical and biotech industry under
increasing pressure
Patent expiry, generic competition, declining
revenues
Strong demand for increased efficiency
Concerns about pipeline/lack of blockbuster targets
Increased regulatory oversight
International competition
Increased frequency and value of strategic
partnerships

Biotech Challenges
o Strategic considerations in drug development
and outsourcing considerations
Program planning
Regulatory strategy (global)
End game for company
Competition

Market Trends
Z. Brennan, Outsourcing Pharma, 07Apr2014; Frost & Sullivan, PR newswire, 27Mar2014
o Smaller biotech, pharma and medical device companies expand R&D business
o Trend to cooperate with mid-size CROs
o Increased emphasize on expertise and quality management
o EU CRO market expected to reach $13.52 billion (2015) up from $7.10 billion (2008) with biomarkers as future growth driver
o Opportunity for full service CROs with scale, global capabilities and expertise

Hurdles to Overcome
o Getting companies to understand
outsourcing models
o Smaller companies assume they
cannot enter into strategic
outsourcing
o Internal disputes over what to
outsource
o Complexity of CRO selection is
increasing
o RFPs are becoming longer and
more complex
o 2/3 of companies do not use
preferred vendors or negotiate
master service agreements
(MSAs) with CROs

Overall Market Size and Growth

Outsourced Phase I-IV Development Spending

Service-line Distribution
2014 Service-line distribution (%) of the CRO market size 2014
Clinical Monitoring 22.1%
Investigator Payments 13.5%
Data Management 11.4%
Laboratory 10.9%
Project Management 10.0%
Patient and site Recruitment 8.5%
Biostatistics 6.6%
Technology 6.6%
Medical Writing 3.5%
Regulatory 3.0%
Quality Assurance 2.6%
Other 1.3%
Total 100%

Development Ph I-IV Distribution
2014 Development phase (%) of the CRO market size 2014
Phase I 23.0%
Phase II 26.9%
Phase III 38.8%
Phase IV 11.6%
Total 100%
2014 Development phase ($B) of the CRO market size 2014
Phase I $5.4
Phase II $6.3
Phase III $9.1
Phase IV $2.7
Total $23.6B

Top 10 Attributes Sponsors use when Choosing a
Service Provider
o Low cost
o Therapeutic expertise
o Patient recruitment strategy
o Prior positive experience with service provider
o Project manager quality
o Network of sites / investigators
o Responsiveness
o Metrics for meeting overall project timelines
o CRA quality
o Up-front contingency planning, risk management
www.ISRreports.com 2014 | CRO Quality Benchmarking Phase II/III Service Providers (2014)

Structuring a Partnership
o Multi-tiered governance and oversight Executive Committee
Operations Committee
Program Management Team
o Operating charter - governance details of the partnership Partnership principles
Escalation pathway
Objectives of each committee
KPIs and metrics to be measured and evaluated
Meeting documentation and follow-up, includes lessons-learned and process improvements

Measure Success
o Quality Process Audits
Regulatory Authority Audits
Protocol Deviations
o Clinical Milestones Actual versus contracted
Final protocol to all sites activated
Final protocol to last patient last visit (LPLV)
LPLV to database lock (DL)
DL to final study report
o Contract and Cost Management Actual versus contracted
Change in scope management

Case Study: The Situation
o Small biotech (limited internal resources)
o Autologous immunotherapy (increased
complexity)
o 12 months = 29 newly qualified / 0 active sites
o No dedicated CRO team
o The integrated system CTMS, DM, IVRS had to be built
o First global Ph3 oncology trial for incumbent
CRO

The Solution
o Experienced in global oncology Phase III studies
o Centralized model for startup, project management, data management
o Proven, highly customizable technology -CTMS/IVRS/EDC
o Dedicated CTMs, CRAs, regulatory, and start-up team including project management, regulatory, and legal
o Single-minded dedication to activate 50 sites to ensure accrual began within four months of transition
o Flexible approach

Communication and Take Away
o True partnership extension of Sponsor company
o Process not impeding progress
o Mutual respect
o Common goal
o Timing not waiting until its too late
o Dont be afraid to fail
o Have a map not a plan
o Communication and flexibility

Conclusion
o Developing a partnership requires time,
commitment and expertise
o The long-term benefits of a partnership exceed the investment needed to create and sustain it
o A well thought out strategic partnership
between a Sponsor and a CRO results in the optimization of quality, time, and money

Documents

Strategic Alliance Partnership between small to mid-size ... · PDF fileStrategic Alliance Partnership between small to mid-size (Bio)Pharma companies and CRO industry Axel Mescheder,