Strategic Alliance Partnership between small to mid-size (Bio)Pharma companies and CRO industry

Transcription

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

2 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

3 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

4 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

5 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

6 Current Business Landscape

7 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

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

9 Market Trends 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 Z. Brennan, Outsourcing Pharma, 07Apr2014; Frost & Sullivan, PR newswire, 27Mar2014

10 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

11 Overall Market Size and Growth

12 Outsourced Phase I-IV Development Spending

13 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%

14 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

15 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 CRO Quality Benchmarking Phase II/III Service Providers (2014)

16 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

17 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

18 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

19 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

20 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 it s too late o Don t be afraid to fail o Have a map not a plan o Communication and flexibility

21 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