Programme

Day One
Tuesday 30 June 2009

Registration

Keynote Presentation:
Unlocking the value of your trial processes: maintaining profitability and recession-proofing in uncertain times

• The critical role of clinical trials in the current environment
• Maximising your resources: doing more with less
• Speeding time to market and enhancing efficiency: best practice approaches to designing, running and measuring your processes
• Identifying the profit-critical factors
• Balancing financial viability and innovation
• Tools and strategies for maximising and demonstrating ROI

Dr. Christoph Schnorr
Senior Vice President, Global Clinical Operations
Merck Serono

Networking break

Exclusive interview with
Robert Smith
Director of Clinical Pharmacy Research Services, Quality Assurance and Qualified Person
Genzyme

Networking break

Clinical Trial Supply

Outsourcing Clinical Trials

e-Clinical Trials

Leveraging software technology to improve the management of clinical supplies during clinical trials

• Study planning and setup considerations
• Study tracking and alignment of supplies with site/patient status
• Adapting to changing trial conditions and supply requirements
• Embedding processes within technology to enforce standards
• Utilizing software tools to track supply forecasts vs. site actuals

Dick Winokur
Vice President, Clinical Investigational Products, Clinical Supply Chain
SANOFI-AVENTIS

Tactical vs. strategic outsourcing: deciding which strategy works for you

• Defining tactical (best provider for the job) and strategic approaches (leveraging the vendor expertise)
• Developing an outsourcing strategy
• Managing the relationship: simpler vs. more complex management models

Graeme Currie
Vice   President, Clinical Operations
Sepracor

CASE STUDY- Are we gaining the full benefit of ‘e’ business for clinical research?

• What did we plan to achieve by going electronic?
• What was the value proposition?
• How effective were we?
• Did we reach our targets?
• What were the enabling factors and how sustainable are they?
• Where are we going next?

Jane Clarke
Assistant Vice President - EDC System Owner, Global Development Support
Wyeth Research

Networking break

Exclusive interview with
Graeme Currie
Vice President, Clinical Operations
Sepracor

Networking break

Exclusive interview with
Mark Elsley
Acting Head of Clinical Research
Novo Nordisk Scandinavia

Lunch and networking break

Networking break

Evaluating the performance of the CTS processes using KPIs

• Establishing accurate KPIs
• Calculating the success of the supply chain as a whole
• Ensuring successful supply chain management

Mike Dey
Vice President,
Pharmaceutical Development
IPSEN

Choosing an effective strategy: outsourcing projects or in-sourcing people

• Understanding the rationale for choosing an in-sourcing model
• Finding the balance between outsourcing and in-sourcing
• Effectively managing relationships with vendors
• Developing contracted talent

Automatic loading of laboratory data into eCRF - practical experiences

• Why use automatic lab data loading?
• What are the requirements?
• Discussing the features of different systems in use
• Understanding the necessary pre-settings
• Role of CDISC
• Day to day challenges and how to solve them
• Lessons learned

Ingeborg Cil, Dipl.–Ing.
Clinical Data Manager
Clinical Data Management
Global Clinical and Medical Affairs
BAXTER INNOVATIONS GMBH

Networking break

Exclusive interview with
Mike Dey
Vice President, Pharmaceutical Development
Ipsen 

Networking break

Case study - international distribution strategies

• Managing carriers and monitoring the progress
• Dealing with cold chain distribution
• Depots versus direct to site
• Implementing effective returns processing strategies

Douglas Hawley
IM Operations, Senior Specialist,
Global Logistics
CELGENE CORP.

Managing the sponsor/service provider relationship

• Setting realistic and achievable goals
• Providing detailed information about services to be provided and relevant timelines
• Ensuring that there is transparency throughout the process and that updates are provided
• Effective communication techniques

Bernice Kuca
Contractor in Clinical Operations
Idenix

The added value of Electronic Health Record (EHRs): linking patient care, clinical research and public health

• Setting the scene: definitions, legal, technical, collaboration and penetration of EHR
• Examples of opportunities and challenges for pharma industry
• Status of EU initiatives, pilots and examples of EHR re-use in EU and USA
• The high level recommendations for moving forward and discussion about the opportunities for pharma and health care

Mats Sundgren
Principal Scientist
Astrazeneca

Networking break

Exclusive interview with
David Bernstein
Vice President, Pharmaceutical Sciences and Regulatory Compliance
Bernstein CMC Regulatory Consulting

Close of day one

Day Two
Wednesday 1 July 2009

Registration

Keynote Presentation:
Leveraging out-licensing and partnering trends in clinical trials: where are the opportunities?

• Examining how clinical trial models have changed in the last years
• Balancing risks and benefits in clinical partnering models
• Assessing approaches to internal development using out-licensing
• Considering emerging markets: which countries will play a leading role and to what extent?
• Overcoming cross-border challenges: identifying a common strategic ground
• Optimizing the clinical development portfolio while executing partnering and out-licensing opportunities successfully

David K. Rosen
D.V.M., Executive Director, Head of Out Licensing, World Wide Business Development
Pfizer

Networking break

Exclusive interview with
Ashok Katdare
Vice President of Pharmaceutical Development
Adamas Pharmaceuticals

Networking break

Clinical Trial Supply

Outsourcing Clinical Trials

e-Clinical Trials

Successfully modifying the clinical supply chain to accommodate adaptive trials

• Understanding how adaptive trials will impact on CTS
• Adjusting current procedures to facilitate adaptive trials
• Ensuring flexibility in the supply chain to support an adaptive design

Henk Mollee
Director, Clinical Supply and Operations
Astellas Pharma

Considering the ethics of conducting trials in developing countries

• Understanding the challenges of conducting ethical clinical trials
• Ensuring adherence to informed consent principles
• Ethics committees: their involvement and continuing checks
• CROs and ethical issues in developing countries
• Ensuring good ethical practice and a high standard of care throughout the trial
• Beyond international guidelines: addressing ethical dilemmas

François Bompart
Vice-President, Medical, Access to Medicines
Sanofi Aventis      

Monitoring the progress of clinical trials using EDC

• Introducing prerequisites for suitable progress monitoring
• Discussing elements of progress monitoring
• Outlining alerts and communication

Hermann Huss
Head Global Clinpharm and NIS Data Management
Bayer Vital Gmbh

Networking break

Enhancing CTS throughout the chain: an end user’s perspective

• Taking the needs of the end user into account when setting up the supply chain
• Pitfalls at the end of the supply chain
• Maximising IVRS efficiency and compliance at the user’s level

Angelique Keijzer
Clinical Support Manager
Sanofi Aventis

Managing international drug development expansion successfully by choosing the right model

• Evaluating the size of opportunity available
• Picking the right location
• Centralised vs decentralised trial management models
• Choosing service providers
• Validating the concept

Jacek Nowak
Executive Medical Director, Eastern Europe
Amgen

Debating data integration and the e-clinical landscape

• Integrating clinical data: purpose, process and technical implications
• Critical drivers for a solution design
• Conclusions on concepts for e-clinical landscapes

Norbert Fritz
Head Clinical Architecture and Infrastructure, Pharma Development Operation
F. Hoffmann La Roche

Networking break

Tackling packaging challenges for clinical trials

• The need for compliant packaging with maximum flexibility for modification
• Assessing the benefits of outsourcing to contract manufacturers
• Producing cost-effective clinical trial kits

Robert Smith
Director of Clinical Pharmacy Research Services, Quality Assurance and Qualified Person
Genzyme

Packaging, labelling and distribution vendor selection: finding the right vendor for the right job

• Defining vendor selection criteria: capacity, capability, technology, experience
• Qualifying your vendor selections
• Audit scope: facilities, SOPs, systems, quote process
• Establishing agreements: Quality/Technical, Master Service
• What is the "right number" of vendors you should have for your company

CASE STUDY
Taking CDISC standards to the next level

• The limitations of GSK’s current approach to defining standards
• Aspirations and how these translate into requirements
• Describing what CDISC is doing to meet these requirements: the development of a populated CDISC Metadata Repository
• Describing how a populated CDISC Metadata Repository will deliver the benefits we all need

Simon Bishop
Director and Head of Data Standards
GLAXOSMITHKLINE

Lunch and Networking break

Networking break

Effectively managing limited drug supply

• Working with your clinical team to minimise drug loss
• Developing flexible randomization and labelling schemes
• Using an IVRS/IWRS to keep tight control of your clinical supplies

Panel discussion: the pros and cons of outsourcing clinical trials

• Working effectively with CROs in developed and emerging markets
• Outlining the challenges
• Dealing with regulatory issues and requirements
• Ensuring effective communication between sites, sponsors and CROs
• Sharing success stories

CASE STUDY – Implementing digital pen technology to enhance on-site data capture

• Converting paper into an easy and smart EDC interface
• Introducing digital pen technology
• Putting ourselves into the investigator's shoes: looking at EDC from another point of view
• Different implementation scenarios

Networking break

Close of conference