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Day one Wednesday 22 October 2008 plenary
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8.50am | Chairman's opening remarks
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9am | Clinical outsourcing state of play: industry trends and developments driving drug development partnerships
• Industry overview, challenges, business models, drive for productivity improvements, evolving marketplace, budget management & delivering value
• How do you determine the scope of outsourced studies?
• Evolution of relationships
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9.30am | Industry trends in clinical outsourcing
• What are the economic and regulatory drivers of change for drug developers today?
• What are current drug development metrics on times, costs, and risks?
• How can clinical outsourcing and offshoring improve R&D efficiency and performance?
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10am | Review of the CRO industry: a financial analyst’s perspective
• Key trends of the pharmaceutical and CRO industry: past and future
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| | Dr David Windley, Managing Director - Healthcare Equity Research, Jefferies & Company, Inc.
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10.30am | Morning tea
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11am | How can strategic outsourcing address the current and future challenges in drug development? An industry perspective
- What are the key challenges for the industry?
- Strategic vs. tactical
- Program outsourcing versus study outsourcing
- Is functional outsourcing a thing of the past?
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| | Fred Naids, Senior Strategic Sourcing Director, Shire Pharmaceuticals
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11.30am | How can strategic outsourcing address the current and future challenges in drug development? A CRO perspective
• How has the service provider community responded to industry challenges?
• What is the true value of a strategic partnership for a CRO?
• What the industry has in store for vendors as global studies increase
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| | Adrian McKemey, Practical Leader, Product Development and Commercialization, Quintiles Consulting
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12pm | Clinical outsourcing considerations for the biotechnology industry
• Additional considerations stemming from the increased complexity of biological products R&D partnerships
• Moving from a service only to a strategic partnership: advantages for biotechs
• How to identify your key needs from a partnership and ensuring your vendor can provide solutions to these
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| | Dr Adam Ruskin, Director, Clinical Research and Operations, Maxygen, Inc.
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12.30pm | Panel discussion: strategic outsourcing in drug development. Are we there yet?
Have your say and hear from a selection of the keynote speakers in this interactive discussion session as they view their thoughts on the hot topics of the morning.
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1pm | Lunch
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| STRATEGIC OUTSOURCING / CLINICAL OUTSOURCING PERFORMANCE MANAGEMENT |
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2pm | Chairman's opening remarks
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| | David S Zuckerman, President and Author of Pharmaceutical Metrics, Customized Improvement Strategies
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2.05pm | Case Study: Successful Relationship Management
Establishing the partnership: resources, communication, SOPs, challenges
• Relationship progression: changes to workload assignment, co-management of territories, interaction/ communication changes
• Current relationship: communication changes, region overlay, external sourcing, increasing governance |
| | Dr Mark Evans, Executive Director Clinical Research Operations US, Merck
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2.50pm | Financial Considerations for Clinical Outsourcing
• Standard processes and considerations when submitting the RFP
• Budgetary considerations when entering into a partnership
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| | Ross Pettit, Vice President, Clinical Operations, ARIAD Pharmaceuticals, Inc.
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3.20pm | Performance Metrics in Outsourced Clinical Trials
• Determining what is important to measure in a pharma-CRO relationship
• Using metrics to decrease risk and increase the probability of success
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| | David S Zuckerman, President and Author of Pharmaceutical Metrics, Customized Improvement Strategies
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3.50pm | Afternoon Tea
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4.20pm | Outsourcing Considerations for Small and Mid-Sized Pharma
• Operational models, vendor selection, contracts, management and infrastructure
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4.50pm | Vendor Selection in Outsourced Trials
• Clinical outsourcing considerations
• Outsourcing vendor requirement
• Establishing worthwhile partnerships
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5.20pm | Sourcing Models for Clinical Trials
• Pros and cons of global CROs vs. networks
• Financial incentives and risk sharing
• Relationships management for each model
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5.50pm | Contractual Considerations
• Available contract model insight: choosing the right contract model for you
• Contract management: eliminating mismatched partnership expectations at project launch to ensure the smooth running of a project
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6.20pm | Closing remarks from the chair
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6.30pm | Networking Drinks Reception
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Day two Thursday 23 October 2008
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8am | Registrations & coffee
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8.55am | Chairman's opening remarks
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| | Dr Dianne Kikta, Vice President Global Clinical Strategic Resourcing, Wyeth
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9am | Implementing off-shoring strategies in your business model
• Case study: new pharmaceutical sourcing models in pharmacovigilance
• Major considerations during the development of the new sourcing model
• Resulting impact on business performance & lessons learnt
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| | Dr Amrit Ray, Vice President, Medical Safety - Global Medical Affairs & Pharmacovigilance, Bristol-Myers Squibb
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9.30am | Biosimilars: considerations for outsourcing
• A number of exciting biological products are coming off patent over the next few years. What does this mean for biogeneric manufacturers?
• Clinical outsourcing; speed, efficiency and other considerations specific for this niche market
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10am | Relationship management in clinical outsourcing
• Good relationship: why is it so important and how can they boost your business operations?
• Common industry issues: opening communication routes and build trust for a structured, productive and mutually beneficial partnership
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| | Dr Dianne Kikta, Vice President Global Clinical Strategic Resourcing, Wyeth
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10.30am | Speed networking
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11am | Morning tea
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11.30am | Globalization of clinical trials
• Key considerations for running overseas trials in the emerging markets
• Patient enrolment benefits and pitfalls in emerging markets: why does it work and what can go wrong?
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| | Dr Vinod Mattoo, Director, Cardiovascular & Metabolics Global Development & Medical Affairs, Bristol Myers Squibb, Asia-Pacific Region
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12pm | Clinical outsourcing: what can we learn from other industries?
• How has outsourcing been integrated into other industries and improved business operations
• What lessons can be utilized in the pharmaceutical industry?
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| | Audra nichols, Global Strategic Sourcing Leader, Pricewaterhouse Cooper
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12.30pm | The Art and Science of Selecting the Most Productive Countries and Sites for Your Protocol
Have your say and hear from a selection of the keynote speakers in this interactive discussion session as they view their thoughts on the hot topics of the morning
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| | Linda Wolf, Leader, Emerging Markets and Services, BBK Worldwide
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1pm | Lunch
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2pm | Chairman's opening remarks
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2.05pm | Contingency planning
• Risk management and planning: what can be done to control the potential for risk?
• Moving contingency planning to the forefront of your operations in the early stages of the partnership
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2.35pm | Strategic Outsourcing in Virtual Pharmaceutical Organizations
• Structural and logistical considerations
• Differences and communalities between clinical outsourcing in virtual & traditional organizations
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| | Solomon Babani, Director Outsourcing & Vendor Management, Celtic Pharma
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3.05pm | Ensuring Quality in Outsourced Trials
• How to ensure quality standards in an outsourced trial?
• Obstacles & solutions
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3.35pm | Afternoon Tea
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4.05pm | Strategies to Reach the General Public and Heighten Awareness of Clinical Trials
• Strategies to provide public outreach and education to improve patient recruitment and retention
• Public perception of clinical research and opportunities for raising awareness and trust
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| | Jill McNair, National Director, AWARE for All, Center for Information & Study on Clinical Research Participation (CISCRP)
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4.35pm | Closing remarks and end of conference
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