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Pre-conference workshop - Tuesday 27 January 2009
Increasing pharma-CRO partnership’s success using value analysis and deliverable budgets
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09.00 | Registration & coffee
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| MORNING SESSION |
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09.30 | Contracting issues
• Tactical
• Strategic
• Principal agent theory
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10.30 | Morning tea
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11.00 | Current contract types
• Fixed
• Fixed unit priced
• Variable
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12.00 | Lunch
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| AFTERNOON SESSION |
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13.00 | Planning
• Key performance indicators
• Deliverables (exercise in defining deliverables)
• Metrics
• Identifying risk
• Defining project success
• Identifying stakeholders
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13.45 | Earned Value Analysis (EVA) using deliverable budgets
• History of EVA
• Mapping task related budgets to deliverables
• Measuring project performance using EVA.
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14.30 | Afternoon tea
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15.00 | Other uses of deliverable budgets
• Comparing CRO prices
• Accruals
• Income recognition
• Forecasting
• Payment schedules
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Day one - Wednesday 28 January 2009
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08.45 | Registration & coffee
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09.15 | Opening remarks from the chair
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09.30 | How can strategic outsourcing address the current and future challenges in drug development? An industry perspective;
• In the last 30 years clinical outsourcing has grown to a multi billion dollar industry yet there is still an uneasy relationship with the pharma industry
• The challenges facing the pharma industry have never been higher and the need for effective outsourcing strategies is critical
• How can we partner better to lower the cost of drug development and increase speed?
• A ‘one size fits all’ is unlikely to work and there are new partnerships forming that break the traditional cycle of short term tactical arrangements to supplement internal capacity |
| | Dr Adrian Otte, VP Global Development Operations, Amgen, United States
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10.00 | Clinical outsourcing state of play: industry trends and developments driving drug development partnerships
• Challenges in the pharma industry
• Building effective partnerships in a challenging environment
• Learning in strategic outsourcing from other business sectors |
| | Doug Price, Global Procurement Lead, AstraZeneca, United Kingdom
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10.30 | Morning coffee
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11.00 | Outsourcing models: is there room for innovation?
• Where are we today
• Is your outsourcing approach aligned with your development strategy?
• Can innovation change how the industry is working? |
| | Dr Pasi Piitulainen, Director, Global Clinical Development Affairs, Actelion Pharmaceuticals Ltd
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11.30 | Options available for pharma in progressing clinical development programs and the development of parallel clinical development portfolios
• Advancing R&D portfolios using a variety of partnering options and business structures
• Sharing risk and reward in partnering R&D portfolios
• Assessing and prioritizing the portfolio to identify and execute on partnering opportunities |
| | Dr David Rosen, Head of Development and Commercial Strategic Alliances, Pfizer, United States
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12.00 | Panel discussion: Strategic outsourcing in drug development; are we there yet?
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12.30 | Lunch
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Day one - Stream 1 STRATEGIC OUTSOURCING
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13.30 | Opening remarks from Quintiles
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13.40 | How can strategic outsourcing address the current and
future challenges in drug development? A CRO perspective;
• How has the pharmaceutical services community responded to industry challenges?
• What is the true value of a strategic partnership with a CRO?
• How will the industry-CRO relationship change as global studies increase? |
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14.10 | India case study 1: Early Development Clinical Trials in India: Strategic and Operational Considerations
In this presentation, the factors considered for conducting early phase clinical trials in India will be reviewed with a special emphasis on small molecule drug development. In addition, a small case study will be presented to describe the operational management aspects in conducting a early development clinical trial in India. |
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14.40 | Ensuring Quality with Service Providers - Inspections and Case Study Examples
• You can delegate everything except your responsibilities
• Establish realistic contracts to avoid misinterpretations and issues
• Selection processes, documentation and communication and the essential elements for success |
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15.10 | Speed networking
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16.00 | A dedicated team approach to medical writing: pushing limits to maximize quality
- Improved continuity for clients means better client-provider relations
- A new system to vastly decrease time needed to write documents
- Dedicated teams can make medical writing more cost effective
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| | Dr Barry Drees, Managing Director, Trilogy Writing & Consulting, Germany
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16.30 | Quality risk management of outsourced trials
• Integrated quality risk management processes vs. traditional auditing
• Increasing efficiences in quality management of CRO's
• Can sponsors & service providers collaborate to minimise duplication of effort in quality management? |
| | Dr Brian O'Neill, Global Head CQA External Alliances, F-Hoffmann-La Roche Ltd., Switzerland
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17.00 | Key legal issues and trends in global clinical outsourcing
• The indemnity issue
• When should powers of attorney be given?
• Warranties and undertakings – does your CRO really have the expertise/experience and how to cover your company legally? |
| | Leigh Hanif, Senior Legal Counsel , Sanofi-Aventis UK, United Kingdom
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Day one - Stream 2: CLINICAL OUTSOURCING PERFORMANCE MANAGEMENT
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13.30 | Opening remarks from the chair
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13.40 | Relationship management: conditions for building a strong
partnership
• Good relationships; how can they boost your business?
• Common industry issues: opening communication routes and trust building
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| | Dr Dianne Kikta, Vice President Global Clinical Strategic Resourcing, Wyeth, United States
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14.10 | Clinical outsourcing relationship management
• Aligned objectives between sponsor and CRO/vendor
• Creating interactive relationships
• Shared responsibility
• Transparent communication |
| | Dr Gaby Anthonijs, Associate Director Clinical Pharmacology Exploratory Development Department, Astellas Pharma Europe R&D, The Netherlands
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14.40 | Outsourcing considerations for virtual and small companies
• Outsourcing trials by small or virtual pharma: special factors and considerations
• How do small pharma / CRO relationships & cooperation vary from those of big pharma?
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15.10 | Speed networking
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16.00 | Pharma / CRO relationships
• Key elements of success...and failure
• Setting the scene, expectations and teamwork
• Preferred providers - create the value!
• Tips for building outsourcing strategies |
| | Dr Rikke Winther, Head of Outsourcing Management Corporate Project Management R&D, H. Lundbeck A/S, Denmark
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16.30 | Case study: experience of mid-sized pharma in the
cooperation with CROs
• Grünenthal’s latest clinical outsourcing experiences and the operational considerations for a mid sized organisation |
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17.00 | Ensuring the project runs smoothly: project management and SMOs
• Skills & challenges
• Learning to manage the CRO’s managers
• Managing the project timelines |
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Day two - Thursday 29 January 2009
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08.00 | ERT Breakfast Briefing
ePRO has been proven to increase accuracy and integrity of data collected, improve the compliance of the patient and reduce investigator bias….but can it reduce your costs?
Many sponsors are currently utilizing ePRO in a variety therapeutic areas and applying the service in several critical functions within clinical trials without a clear understanding of what ePRO approach is best suited to their study needs.
ERT will discuss how ePRO can reduce clinical trial budgets and prove the value advantage over paper and other modalities. ePRO and other technologies provide an effective, cost-beneficial solution to a number clinical study “pain points” including subject recruitment, compliance and data capture speed and accuracy. The data shows that ePRO is the only way to go for many difficult and expensive indications when looking at patient compliance in paper versus electronic diaries. ERT will also walk attendees through the ePRO landscape covering regulatory, operational impact and benefits, modalities and keys to implementation.
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08.30 | Registration and coffee
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09.15 | Opening remarks from the chair
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09.30 | Clinical outsourcing considerations for the biotechnology
industry
What additional considerations are required during clinical outsourcing partnerships with biotechs?
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10.00 | Implementing off-shoring strategies into your business
model off shoring data management in India
• Review of Eisai's move to offshore data management to India
• The major considerations for assessing the sourcing options available, the model used, how this was finally implemented and lessons learnt. |
| | Dr Lan Bandara, Associate Director, Contracts Eisai Global Clinical Development, Eisai, United Kingdom
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10.30 | Creating a clear and transparent process for costing industry contract research
• The UKCRN Industry Costing Template: calculates
the prices associated with commercial contract research
• Using the template to speed up the initiation of commercial contract trials by reducing the time required for site-by-site negotiations |
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11.00 | Morning tea
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11.30 | 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 utilised in the pharmaceutical industry? |
| | Audra Nichols, Global Strategic Sourcing Leader, PWC, United States
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Day two - Stream 1: STRATEGIC OUTSOURCING
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12.00 | Opening remarks from the chair
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12.10 | India case study 2: early development clinical trials in
India
• Strategic and operational factors for conducting and
managing early phase clinical trials in India will be reviewed |
| | Dr Gangadhar Sunkara, Associate Director, Translational Sciences Lead Coordinator, TS India Business Strategy, Novartis Pharmaceuticals, United States
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12.40 | Vendor selection in outsourced trials
navigating clinical trial outsourcing from within a
biotech start-up
• Cost effective and timely clinical proof of concept through clinical outsourcing within a venture capital-backed biotech start-up
• Solace case study; a “virtual” yet multinational structure and mission command operating principles aid in clinical trial outsourcing
• Get it right the first time and build lasting partnerships with CRO's - RFP's and contracts |
| | Dr Kevin Pojasek, Senior Director Development Programs Leader, , Solace Pharmaceuticals, United States
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Day two - Stream 2: CLINICAL OUTSOURCING PERFORMANCE MANAGEMENT
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12.00 | Opening remarks from the chair
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12.10 | Outsourcing Phase I healthy volunteer studies: the
good, the bad and the ugly
• Protocol design impact on CRO selection
• Factors to consider in selecting a Phase I Unit and
support services
• Organising your service and provider team for success
• How to optimise your team’s performance |
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12.40 | Ensuring quality in clinical trials already in the
contracting phase
• What to take into account when contracting
• Different contract types and their quality aspects
• Practical considerations regarding each contract type |
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Day two - Afteroon plenary session
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13.10 | Lunch
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14.10 | Opening remarks from the chair
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14.20 | U-TURN
This is your opportunity to create your own
conference agenda to be discussed at the second day of the conference.
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14.50 | Optimising time and money in clinical trials - patient recruitment in Russia, Ukraine and Belarus
- What are the benefits of running outsourced trials in this region?
- What is the current environment for receruiting patients in this region?
- Key criteria for a successful partnership
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15.20 | Case study: the road to the use of CRO preferred provider
solutions
• Move from the use of full-service CROs to niche providers for many services such as labs, clinical services, data
management and statistics, ECGs
• Resulting need to review bids, assess and manage many CROs with the associated resource burden
• Shire’s move to preferred providers for biometrics and pharmacovigilance activities identified allowing work to be allocated
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| | Dr Paul Quinn, Senior Clinical Program Director, Shire, United Kingdom
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16.20 | Closing remarks
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16.30 | Afternoon tea and end of conference
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Post-conference workshop - Friday 30 January 2009
Project management for outsourced clinical trials
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09.00 | Registration & coffee
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| MORNING SESSION - Effective Project Management |
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10.30 | Morning tea
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11.00 | Contracts for success
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12.00 | Lunch
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| AFTERNOON SESSION - Project Team dynamics and Project Progress Monitoring |
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14.30 | Afternoon tea
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15.00 | Project Management Risk in a clinical context
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