Optimizing the clinical trial process to increase the chance of clinical and commercial success is a hot topic across the pharmaceutical industry, as witnessed by the number and range of attendees at Pharmaceutical Business Review’s recent webinar ‘Perspective on the future of drug development’.

Nick Bennett, Research & Analysis Director, Healthcare, at Datamonitor, said: “Pharma is experiencing tough times, facing both economic and regulatory pressures, with increasing demands for improved safety data and comparative efficacy studies. A number of strategies can be implemented – either in isolation, but more effectively in combination – to optimize the clinical trial process and increase the chance of clinical, and ultimately, commercial success”.

Webinar attendees came from top global pharmaceutical companies, biotech companies, and leading clinical research organizations, confirming the growing interest in new approaches to drug development, including Adaptive Clinical Trials. The webinar panels’ experiences of scaling up to move adaptive trials into the mainstream provides key insight into the challenges of achieving organizational change, both internal and external, and what change means from a technology perspective.

Professor Don Berry, of Berry Consultants, stressed the importance of facing changes in strategies used in drug development. Berry said: “I have been encouraged by the FDA’s Critical Path Initiative which seeks to achieve better outcomes more cost effectively, such as the use of Adaptive Clinical Trials, the development of biomarkers, and a growing focus on translational medicine”.

Tessella’s Head of Clinical Trials Solutions, Tom Parke, commented: “As more information needs to be assimilated and more options opened up in how drug development can be carried out, the operational processes that support drug development will become increasingly complex. This poses a major challenge to pharmaceutical companies to prepare for this new world, as it requires new operating procedures that traverse existing departmental structures, changes in the skills base, integrated information management, better information flow and IT infrastructure to support these new processes”. Parke added: “organizations need to act now to prepare for these changes.”

To listen to a recorded version of the webinar please visit:
www.tessella.com/clinicaltechnologies

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Notes to editors:

• For press enquiries or to arrange an interview with Tessella please email Christina Tealdi, Marketing & Communications PR Executive, at christina.tealdi@tessella.com
• Tessella’s life sciences expertise and experience spans: Adaptive Clinical Trials management & simulation, Drug Supply Forecasting, Informatics & Knowledge Exploitation, ‘Omics Data Management & Analysis, and Laboratory Automation
• For decades, Tessella has been successfully delivering technology and consulting services to world leaders in research and development, science and engineering. Through the application of scientific methodology and information technology, Tessella has enabled clients such as Pfizer, Shell, Unilever and Lockheed Martin to achieve a vast range of objectives, including, increasing drug discovery and development efficiency, developing fusion technology, enhancing military sensor capability, and reducing risk to health and the environment in the extraction and production of energy. Tessella’s 250 problem solvers are based at offices in North America, the UK, and our European base in the Netherlands
• Berry Consultants is a statistical consulting company specializing in adaptive clinical trial design in pharmaceutical and medical device research and development. They are leaders in the Bayesian approach to statistics – which is radically changing the way research is done throughout the medical industry. They employ world-renowned experts in Bayesian statistics and strive to set the standard for Bayesian design and analysis in the statistical and medical communities. & Workflows, Biomarkers & Systems Biology, PK/PD Modelling, Toxicity Modelling, Drug Formulation & Delivery Modelling
• The webinar ‘Perspective on the future of drug development’ was co-hosted by Pharmaceutical Business Review and Tessella, and broadcast on October 16 2008

 
Tessella contact details:
www.tessella.com
info@tessella.com

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