- The future of Sponsor-CRO partnerships
- Developing an ideal CRO relationship
- Building quality and safety into CRO relationships
- The role and outcome of multi-vendored studies
- Offshore outsourcing opportunities
- Minimising risk in CRO relationships
- Choosing the right CRO partner
- CRO trial negotiations
- Metrics to build stronger partnerships
Mitchell Katz
Executive Director, Medical Research Operations
Purdue Pharma
Yariv Hefez
Director Global Business Development & Alliance Management
Merck Serono&n
Conference agenda
Anne-Maria Ylisaari's experience and qualifications
Purpose and scope of the workshop
How to start: Aligning the requirements to the business Defining the risks and designing the interface to handle conflicts How to utilise the relationship in practice: "The skills understanding gap" Managing the learning and adjustment over time Chairman's Opening Remarks Mitchell Katz, Executive Director, Medical Research Operations, Purdue Pharma L P The future of Sponsor-CRO partnerships
Demand drivers, trends and expectations
Role of strategic partnerships
Planning for partnerships of the future
Illustrative examples
Mitchell Katz, Executive Director, Medical Research Operations, Purdue Pharma L P Outsourcing to a central laboratory Hermann Schulz, CEO, INTERLAB
Selection criteria: RFI versus lab visits
How to inspect global laboratories without being a lab expert
Logistical challenges: planning vs. Reality
Role of pre-analytical factors e.g. Blood collection, transportation, storage
Contractual aspects
Outsourcing medical governance Jonathan Stewart, Disease Area Head, Neuroscience, Immunology and Pain, Bristol-Myers Squibb Pharmaceuticals Ltd
Selecting the CRO
Setting up the process
Ongoing oversight and review
Lessons learned
What makes a good partner? Richard Beesley, Director of European Strategic Business Relations , 3M Health Care
The importance of combining cultures
What key lessons have been learnt
Programme governance & operational protocols
Key challenges faced
How Biotech interacts with CROs Kristof Vercruysse, Director Clinical Operations, Ablynx
Ablynx History: Selection of CRO's
Maintaining flexibility during Clinical Development
How to deal with a diverse pipeline
Resulting into Strategic Partnership: win-win situation
Choosing the right CRO partner Roger Joby , Managing Director, 1to1to1, R & NR Consulting
How do you measure the value of a CRO
Traditional KPIs related to cost time and quality are 2 guesses and a phenomenon
Successful projects rely on high levels of collaboration and medium levels of structure
What should you look for in a CRO
Quality of information and communication
Quality of planning
Flexibility
Developing metrics for successful R&D laboratory outsourcing relationships Roderick Cameron, Deputy Director of Global Clinical Immunology Outsourcing, Sanofi Pasteur
Developing metrics at the beginning of an outsourced partnership/relationship
Optimising metrics based on past performances
Implementing Penalties and Bonuses "the carrot and stick approach"
Driving performance for continuous improvement
Offshore outsourcing opportunities Jacquie Mardell, Partner, Anhvita BioPharma Consulting
Staying abreast of a changing regulatory landscape
Standards in the emerging regions
Consent and vulnerability
Matching trials to the right country
Making the most of CRO partnerships
Partnerships with Academic Research Organisations Rick Grobbee, Chief Scientific Officer, Julius Clinical Research
Advantages and shortcomings
COIs arising out of academic-industry relationships
Integrating academic expertise and industry clinical objectives
Unique considerations
Perceived differences
Chairman’s Closing Remarks and Close of Day One Chairman's Opening Remarks Albert Agro, President, HNZ Strategy The role and outcome of multi-vendored studies Albert Agro, President, HNZ Strategy
The pros of single vendor studies (from the CRO and sponsor side)
The pros of the multi-vendor study
Case studies looking at cost, timelines, data integrity, outcome, investigator enthusiasm
Two multi-vendor trials
Running two identical trials: one with multi-vendor the other with single vendor
Managing long term Central Laboratory partnerships Gary White, Global Operational Client Lead, Quintiles
Aligning sponsor and provider interests
Developing clear expectations and avoiding miscommunication
Managing cultural dynamics
Focus on delivery and dealing with delays
Governance structure; dedicated sponsor-provider staffing
Case study: proactive Central Laboratory risk and performance monitoring
The business relationship as a driver of partnership success
Partner selection and reciprocal validation measures.
Fit-gap analysis - what actions are required to identify the business needs of the partnership.
Identification and implementation of fundamental requirements - how to build a core foundation for success.
Setting metrics/measures for partnership success - determining what those metrics are and the appropriate benchmarks.
Measures for continuous partnership and process improvements.
Building and expanding a strong organizational culture (within and outside of the direct governance body).
Breakthrough ideas - driving operational and relationship value while minimizing waste.
James Chennells, Head of Global Strategic Sourcing Pharma Development Services, Bayer Healthcare Thomas Marchisello, Global Executive Director, Commercial Finance and Business Development Operations, Covance Inc Case study: Rolling out an innovative operational risk sharing CRO partnership model Yariv Hefez, Director Global Business Development & Alliance Management, Merck Serono
Why a new model was required
The benefits of switching to a delivery based model
True operational risk sharing with a few strategic partners
The organisational resistance to change and measures taken to mitigate
Interactive Panel Discussion Topics including:
Challenges being faced by sponsors and CROs
Differing business models and costing strategies
Opportunities for enhancement
Taking what we have learned over the past 2 days and making immediate improvements
Albert Agro, President, HNZ Strategy Sanjiv Kanwar, Managing Director, Polaris BioPharma Consulting Ltd Thomas Marchisello, Global Executive Director, Commercial Finance and Business Development Operations, Covance Inc James Chennells, Head of Global Strategic Sourcing Pharma Development Services, Bayer Healthcare Yariv Hefez, Director Global Business Development & Alliance Management, Merck Serono Is outsourcing paediatric activities different to what we always do? Philippe Auby, Director, International Clinical Research, Paediatric Neuro-Psychiatry, Lundbeck
What is the Regulatory paediatric background?
Is paediatric clinical development different?
What are the practical aspects of paediatric studies?
What could be an example of efficient governance?
Smart collaboration: The importance of having IT at the table
Creating the mindset and behaviours for a successful partnership
Are you ready for the key IT interventions, considerations and impacts on your organisation
Optimising processes, systems and tools with a common shared goal
Managing communication and assumptions
Potential pitfalls
Elvira Martin, European Medical IT Program Manager, Lilly Research Centre Ltd Ian Hamilton, Medical IT Manager, Lilly Research Centre Ltd SMEs and CROs: How to get the best Mike Wood, Research Director, Vernalis Plc
Partnerships with CROs - how far to go
Understanding each other
Building a relationship
Measuring success
Chairman’s Closing Remarks and Close of Day Two
Workshops
Hilton London Kensington 6 October 2010 London, United Kingdom
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