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CONFERENCE

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3rd Annual Clinical Trials Conference 2009

Improving clinical trials efficacy while ensuring regulatory compliance

29th - 30th June 2009, BSG Conference Centre, London, UK

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Background Info
Day 1
Day 2
Partners
Past Papers

Media Partners

Background Info

Key Speakers
• John Luthman, Global Head, Experimental Medicine, Merck Serono
• Gareth Lewis, Director of Clinical Research, Pfizer
• Bruno Thédenat, Technology Project Manager, Wyeth Research
• Valdo Arnera, General Manager, PHT Corporation Europe
• Peter MacLennan, Director of Project Development, Orion Clinical Services
• Trudy Madden, VP, IRT Marketing Communications, Phase Forward
• Ewan J Campbell, Director, The Clinical Trial Company
• Sally Shorthose, Partner, Bird & Bird
• Dr. Robin Pope, Center for European Integration Studies and Experimental Economics Laboratory, Bonn University
• Dr Bill Byrom, Senior Director, Product Strategy, Perceptive Informatics, a PAREXEL Company
• Karen Roy, Global Business Development Director, Phlexglobal

In recent years the nature of clinical trials has changed considerably. An increased emphasis has been put on pharmaceutical research cost-effectiveness. The pharmaceutical industry has been witnessing a rapid expansion of outsourced services from developing countries. Outsourcing is not limited to the fact that clinical trials are being conducted in economically beneficial developing countries, but pharmaceutical companies are increasingly delegating the responsibility of clinical trials to contract research organisations (CROs).

The major challenge for the pharmaceutical companies in the next five years is to maintain high growth rates. Existing generic competition, the impending loss of major patents and a relatively thin pipeline will all apply substantial pressure to the branded pharmaceutical industries, because of the nature of the clinical trials industry, it will, in turn be under increasing pressure. The market is clearly shifting away from the traditional “one-fits all” model of drug discovery as patients and healthcare professionals increase the demand for targeted therapies. The idea of personalised medicine is to use insights into differences at
the molecular level to develop tests and treatments tailored to the needs of specific patient population.

Reviewing the current trends within the pharmaceutical industry, as well outsourcing clinical research organisations (CROs), clinical research is a multi-billion dollar business.

You will be presented with the latest background information for clinical trials and how the pharmaceutical industry is altering its approach to drug development, as well as introducing recent developments in regulatory affairs for clinical trials

Key Themes:
• Current trends of clinical trials environment
• Discovering technologies and techniques for successful clinical trial management
• Techniques for applying risk management principles to clinical trials
• Next generation of clinical trials – How big will the market be?
• Case studies: Analysing the successes and challenges of Phase I & II clinical trials
• Project management of patient clinical trials
• Leveraging interactive response systems to manage cost and risk around drug reconciliation
• Knowledge, attitude and clinical research practices in India
• Setting up clinical trial research hub
• Exploring the efficacy and safety of new interventions in clinical trials
• Clinical trials of gene therapy for inherited blindness

Who Should Attend:
VPs, Directors, Heads and Managers of:
• Clinical Research and Development
• Clinical Research Services
• Clinical Data Management
• Medical Affairs
• Clinical Study Design
• Safety Surveillance
• Subject Recruitment
• Product Development
• Marketing/Sales
• Regulatory Affairs
• Clinical Pharmacology
• Projected Management
• Scientific Affairs
• Healthcare Professionals
• Licensing and Partnering

Target Audience - Industry:
Pharmaceutical Organisations, Generic pharmaceutical companies, Contract Research Organisations, Patient Recruitment Companies, Government- Department of Health, Non-profit Organisations/Association, Academics. Consultants

Day 1

Day 1, Monday 29th June 2009

09:00 Registration and refreshments

09:30 Chair’s opening remarks

Ewan Campbell
Director
The Clinical Trial Company

09:40 Insight into the evolution of clinical trials
• Analysing the aims of the global clinical trial business
• Evaluating how the pharmaceutical industry is altering its approach to drug development
• Introducing recent developments in regulatory affairs for clinical trials
• What are the challenges for the pharmaceutical companies in the next five years is to maintain high growth rates?

Peter MacLennan
Director, Project Development
Orion Clinical Services

10:20 Drivers of a changing clinical trials environment
• How the pharmaceutical industry is altering its approach to drug development?
• Introducing recent developments in regulatory affairs for clinical trials
• How vigilant are pharmaceutical manufacturers to political threats?
• Overcoming global obstacle of the current recession

John Luthman
Global Head, Experimental Medicine
Merck Serono

11:00 Morning refreshments & networking session

11.20 Using integrated technologies in today's clinical trials
• Models and benefits of effective technology integration
• Case studies
• The future: applications convergence - process-focused integration

Dr Bill Byrom
Senior Director, Product Strategy
Perceptive Informatics, a PAREXEL Company

12:00 Lunch

13:00 Electonic Trial Master Files
• How does it support excellence in clinical research
• Challenges and limitations in implemeting eMTS?
• How does it meet standards by the pharmaceutical industry?
• Case Studies: Insight into live mass market adoption

Karen Roy
Global Business Development Director
Phlexglobal

13:40 Afternoon refreshments & networking session

14:00 Panel Discussion: Global outsourcing of clinical trials
Panelists will analyse the safety and ethics of clinical trials? Focus will be on the benefits and risks of global outsourcing

14:40 Electronic patient diaries in clinical trials
• How technology revolutionising an entire industry?
• Why Paper Diaries Should Be Banned in Clinical Trials?
• Enabling more reliable, smaller, faster, safer trials
• Electronic diaries are the future, today

Valdo Arnera
General Manager
PHT Corporation Europe

15:20 The role of cognitive testing within clinical trials
• Reasons & advantages of automation
• Advantages of automated cognitive testing in clinical pharmacology
• Early indications of efficacy
• Patient Trials & Therapeutic Area’s of benefit
• What you should seek from a vendor

Mark Cusack
Head of Business Development (Europe/Asia)
Cognitive Drug Research

16:00 Chairperson’s closing remarks

16:10 Networking Drinks Reception
Take your discussions further and build new relationships in a relaxed and informal setting

Day 2

Day 2, Tuesday 30th June 2009

09:00 Registration and refreshments

09:30 Chair’s opening remarks

Ewan Campbell
Director
The Clinical Trial Company

09:40 Leveraging interactive response systems to manage cost and risk around drug reconciliation
• Streamlining the drug reconciliation process by eliminating multiple data entry and data discrepancies
• Eliminating lag of data visibility with access to real time information - speeding up database finalisation
• Mitigating risks and improved compliance through electronic signatures and edit/logic checks

Trudy Madden
VP, IRT Marketing Communications
Phase Forward

10:20 Functional Outsourcing of Data Management to India
• High Level Benefits
• Key Challenges to Offshore Operations
• Strategic Oversight
• Business Case Benefits

Robert King
Assc. VP - Global head of Clinical Data Operation and management
Eisai

11:00 Morning refreshment & networking session

11:20 eBusiness for Clinical Trials

Bruno Thedenat
Technology Project Manager
Wyeth Research

12:00 The impact of growing study placement in emerging markets
• Case studies
• Summary and recommendations

Gareth Lewis
Director of Clinical Trials
Pfizer

12:40 Lunch

13:40 Optimising phase II clinical trials
• What we should know by end of phase II - by indication
• Logistic and practicalities of phase II clinical research
• Combining phase II and III: some business cases
• Summary and recommendations

Chris Hannigan
EVP Business Development
Synexus

14:20 Clinical Trial Outcomes for Mental Illnesses: Combine Drugs with Whiffs of Danger
• Situation - little long term (5+ years) success from drugs alone for depressions
• Why - risk starvation also in dementias, strokes, epileptic fits, anxiety attacks, substance abuse
• Solution - in clinical trials inject "whiffs of danger"
• Procedure - frequently inject a different whiff
• Result - brain improved/restored from right sorts of risk exercise

Dr. Robin Pope
Center for European Integration Studies and Experimental Economics Laboratory
Bonn University

15:00 Afternoon refreshments & networking session

15:20 Regulatory policy and implications in clinical trials
• Perspectives on clinical trials legal challenges
• Responding to the rapid changes in the regulatory environment
• Quality standards in clinical trials
• Improving the clinical trial framework design and implementation

Sally Shorthose
Partner
Bird & Bird

16:00 Chairperson’s closing remarks

16:10 End of conference

Partners

Media Partners:

PharmiWeb.com
PharmiWeb.com is the leading industry-sponsored portal for the pharmaceutical sector. Supported by most of the leading pharmaceutical corporations, PharmiWeb.com provides dynamic real-time news, features, events listings and international jobs to industry professionals across Europe and the US. For further information please email: corporate@pharmiweb.com

BIOTECHNOLOGY EUROPE
BIOTECHNOLOGY EUROPE is owned by BIOTECHNOLOGY WORLD. It is based and located in Warsaw, Poland. Biotechnology World was founded in 2007 to provide the world’s biotech and pharma information and market to make it universally accessible and useful for scientific and business processes. Its first step to fulfilling that mission was building the BIOTECHNOLOGY EUROPE platform that will allow a quick spread of information in different channels. BIOTECHNOLOGY EUROPE offers companies completed internet public relations, publication and marketing solutions. One of the main goals of BIOTECHNOLOGY EUROPE is to integrate the Biotech and Pharma Sector in Europe to global biotechnology, pharmaceutical and life science activities. For further information please visit www.biotechnology-europe.com

Future Pharmaceuticals
Future Pharmaceuticals has forged powerful relationships with key industry leaders to provide a platform for successful brand recognition, and for senior decision-makers to have the means to procure and plan implementation strategies based on the topics covered. Positioned to be an authoritative resource within top pharma companies as well as small, specialty, and biotech, Future Pharmaceuticals magazine is geared to create a deep penetration into a highly targeted and responsive audience, bridging the gap between the industries' top issues and the solutions top-tier vendors can provide. For further information, please visit www.futurepharmaus.com

InPharm
InPharm is the online platform for exclusive pharmaceutical news, comment, contracts, services, jobs and events and is home to InPharmjobs.com, Pharmafile and Pharmafocus. For further information please visit: www.In-Pharm.com

Enquiries

If you would like more information on the range of sponsorship or exhibition possibilities for visiongain's 3rd Annual Clinical Trials Conference, please contact:
Ronald Magali, +44 (0)20 7549 9934
ronald.magali@visiongainglobal.com

Past Papers

Speaker presentations are free to delegates. If you are unable to attend the event, the presentations are published two weeks after the event and are available to purchase.

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