Conference Documentation: Outsourcing Clinical Trials

Published by: SMI Publishing, Ltd

Published: Nov. 29, 2006

Table of Contents

Day 1

8.30 Registration & Coffee

9.00 Chairman's Opening Remarks

Mrs Julianne Hull, Senior Director, Operations Planning & Vendor Management, Wyeth Research.

9.10 CURRENT TRENDS IN CLINICAL OUTSOURCING

A cure for clinical trial failure - reshaping the drug development services industry

What are the current trends affecting growth in the contract drug development industry?

How much is being spent on CRO services globally?

The size and growth of R&D spending, in- and out-of-house

Factors driving contract research strategy

Who is competing for what?

Smaller, regional CROs vs global players - who wins?

Is clinical outsourcing more strategic than in previous years?

Are we now focussing on development planning and protocols above all else?

What are the new service models?

Will the current trend to outsource clinical trials to Asia be successful?

Mr Mark Lipscombe, Consultant, PA Consulting Group.

9.50 SOURCING AN INTERNAL OR OUTSOURCED TRIAL?

What factors should a sponsor consider when deciding whether to do a project in- or out-of-house?

When to rely on in-house capabilities

When to take advantage of an outsourced provider

Outsourcing some functions with a provider, while keeping other activities in-house - the possibilities

Deciding which aspects of the clinical trial process to outsource - depending on core competencies of both the vendor and sponsor

Full service providers vs niche providers

Challenges and limitations of having both in house and outsourced components of a trial

Ms Anne Maria Ylisaari, Head, In- & Outsourcing, Orion Pharma.

10.30 Morning Coffee

11.00 SUCCESSFUL PATIENT RECRUITMENT OUTSOURCING

Best practice advice

What do you need to look for when outsourcing such a critical component of your company’s clinical studies?

Possibilities and pitfalls

Key considerations that exist in the patient and site recruitment arena

What should your providers expect from you?

Trends in patient recruitment

Future competition - will traditional pharma reduce the number of providers and carry out less transactional outsourcing, while forging closer relationships to increase efficiencies and quality delivery?

Ms Michelle Jones, Senior Director , Covance Clinical And Periapproval Services Ltd.

11.40 OUTSOURCING YOUR CLINICAL TRIALS-SELECTING THE RIGHT PROVIDER

Selecting a central laboratory partner, can the use of reverse e-Auction to support the price negotiation element add value?

· Key considerations for selecting an outsourcing partner

· Central laboratory analysis, commodity or service?

· Core competencies of the outsourcing partner (quality of service, flexibility, responsiveness, project management capabilities and price)

· Identifying service providers for evaluation

· Can e-Auction support successful price negotiations within the laboratory arena?

· History, advantages, pitfalls and impact on business relationships/vendor psychology

· Processes critical to e-Auction success:

· Defining specifications, conducting RFIs

· Cost model development to support "Apples to Apples" comparison

· e-Auction design

· Vendor training

· Post e-Auction learning

· Evaluating vendor capabilities and cost competitiveness

· The role of the service user/stakeholder

Ms Sindy Denyer, Outsourcing Manager, Pfizer.

12.20 Networking Lunch

1.50 PANEL DISCUSSION: THE PROS AND CONS OF OUTSOURCING CLINICAL TRIALS TO DEVELOPING ECONOMIES

Ms Maureen Hynes, Senior Clinical Contracts Manager, Genzyme Corporation.

Ms Maria Makarovskaya, Associate Director, Clinical Outsourcing, Sepracor Inc..

Mr Rene Sluijter, Global Head, Alliance Management, Solvay Pharmaceuticals.

2.30 BRINGING A RADICAL NEW MODEL FOR OUTSOURCING TO A BREAKTHROUGH LEVEL

Case Study- Solvay Pharmaceuticals

· Lessons learned from 5 years partnership

· Levels of collaboration

· Outlook of the next breakthrough level

· The roadmap

Mr Rene Sluijter, Global Head, Alliance Management, Solvay Pharmaceuticals.

3.10 Afternoon Tea

3.40 MANAGING LEGAL AND REGULATORY CONSIDERATIONS IN CLINICAL OUTSOURCING

Key issues to consider when strengthening the outsourcing relationship and aiding the start-up of clinical development projects

Mr Paul Ranson, Partner, Stringer Saul.

5.00 Chairman’s Closing Remarks and Close of Day One

Day 2

8.30 Registration & Coffee

9.00 Chairman's Opening Remarks

Mr Michael Massaro, Director, Clinical Planning, Medimmune Inc.

9.10 INTERCOMPANY AUDITING AGREEMENT AS PART OF STRATEGIC RISK MANAGEMENT OF SERVICE PROVIDERS

Strategic risk management of service providers- resources required by both the sponsor and service provider

Where and how can greater efficiencies be achieved in the quality risk management of our service providers?

· Advantages available to both sponsor and service provider as a result of strategic co-operation among pharma companies in quality risk management of service providers routinely used

· Results from an ongoing initiative set up as proof of concept for auditing co-operation between sponsor companies using the same service providers

Dr Brian O'Neill, Global Head, CQA External Alliances, F.Hoffmann-La Roche.

Miss Alison Holland, Black Belt, Six Sigma, Business Development, Covance Clinical And Periapproval Services Ltd.

9.50 IMPLEMENTING A GLOBAL CLINICAL OUTSOURCING STRATEGY

Case study - Genzyme

Practical considerations - assessing the level of difficulty to implement

International clinical trials - what are the regional advantages?

Standardising clinical outsourcing on a global scale

What are the regulatory, ethical, and cultural issues impacting studies conducted abroad?

How are sponsors, providers and study sites dealing with them?

Effective processes for multinational clinical trials

Best practice advice

Ms Maureen Hynes, Senior Clinical Contracts Manager, Genzyme Corporation.

10.30 Morning Coffee

11.40 ESTABLISHING AND MAINTAINING THE SPONSOR AND PROVIDER RELATIONSHIP

Best practice advice for building an effective and successful relationship between sponsors and the CRO

Developing a relationship that is clearly structured, productive and mutually beneficial

What are the sponsor’s and CROs expectations and how can they be delivered?

Negotiating and implementing a successful sponsor-provider relationship

What is the objective of the work to be outsourced? Who takes responsibility for what?

Increasing the value added from the CRO to the drug development process

Do risk sharing opportunities help or hinder the relationship?

Mr Michael Massaro, Director, Clinical Planning, Medimmune Inc.

12.20 Networking Lunch

1.50 PROJECT GOVERNANCE - MANAGING OUTSOURCED CLINICAL TRIALS

Best practice advice on the strategic management of outsourcing

Perfecting your project governance plan - defining the sponsor- provider relationship to reduce fatal misunderstandings

Roles and responsibilities of project teams

Succession planning

Communication and decision-making

Expectations and performance metrics

Issue resolution

Budget planning and management

Improving trust and transparency to ensure more effective working relationships

Ms Maria Makarovskaya, Associate Director, Clinical Outsourcing, Sepracor Inc..

2.30 WHAT ARE THE STRATEGIC RISKS WITH CLINICAL OUTSOURCING?

Learning how to mitigate risk

Defining risk - making sure both parties are made aware of the threats to the successful completion of your outsourced clinical trials

How are sponsors minimising relationship risks with contractors?

Controlling the potential for risk

Key risks and mitigation actions

Confidentiality and intellectual property risks

Personnel risks

Company volatility risks

Production risks

Do the benefits far out weigh the risks?

Dr Peter Schuler, Vice President, Medical Affairs, PRA International.

3.10 Afternoon Tea

3.40 WHAT HAPPENS WHEN IT ALL GOES WRONG?

How to prevent it - a case study

How challenging and unpredictable are clinical trials?

When vendors are involved how do the challenges increase?

Contingency plans - doesn’t every clinical vendor manager have one?

Case study - presenting real life scenarios to cover contingency lessons learned and how a potentially disastrous situation may be turned around

Mrs Julianne Hull, Senior Director, Operations Planning & Vendor Management, Wyeth Research.

4.20 MEASURING THE PERFORMANCE OF YOUR OUTSOURCING PARTNERS

Making sure that sponsors and outsourcing providers are using the same metrics

Defining agreed targets for clinical studies

What strategies are companies adopting to improve time and success?

Setting a standardised approach for study reports

Using good metrics to improve trust and maximise clinical trial success

Using metric predictors to insure the site and study fit, if intervention is necessary and when it may be appropriate?

Mr Ravin Warnakulasuriya, Director, Operations, Averion Inc.

5.00 Chairman’s Closing Remarks and Close of Day One

Abstract

• Dr Brian O’Neill, Global Head, CQA External Alliances, F-Hoffmann-La Roche
• René Sluijter, Global Head, Alliance Management, Solvay Pharmaceuticals
• Dr Fidela Moreno, Senior Director, Global Development Operations, Asia & Latin America, Amgen
• Julianne Hull, Senior Director, Operations Planning & Vendor Management, Wyeth Research
• Anne Maria Ylisaari, Head, In- & Outsourcing, Orion Pharma
• Maureen Hynes, Senior Clinical Contracts Manager, Genzyme Corporation
• Sindy Denyer, Outsourcing Manager, Pfizer
• Dr Michael Massaro, Director, Clinical Planning, MedImmune
• Patricia Williams, Vice President, Global Contracts, Quintiles
• Dr Peter Schüler, Vice President, Medical Affairs, PRA International

• MAKING THE DECISION TO OUTSOURCE: Learn how to define and evaluate your company’s core competencies whilst making the decision to outsource. What are the strategic, financial and operational considerations?
• SELECTING THE RIGHT PROVIDER: What factors should a sponsor consider when deciding whether to do a project in- or-out-of-house?
• LEGAL & REGULATORY CONSIDERATIONS: Listen to the experts as they discuss the key legal and regulatory issues to consider when strengthening an outsourcing relationship or aiding in the start-up of clinical development projects
• PLANNING AND IMPLEMENTING AN OUTSOURCING STRATEGY: Understand every step of the outsourcing process to deliver successful and cost effective clinical trials. How can you avoid design hurdles in clinical trial outsourcing?
• PROJECT GOVERNANCE: Hear best practice advice on the strategic management of outsourcing and learn how to perfect your project governance plan by defining the sponsor-provider relationship and reducing fatal misunderstandings
• MITIGATING RISK: Learn how to develop and create strategic solutions to mitigate risk factors when using outsourcing services
• Outsourcing Clinical Trials will provide an excellent opportunity to network, enhance your company’s profile and keep you up-to-date on the latest trends in outsourcing for clinical development.

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