• What are the major conclusions of the guidance?
• How does the guidance affect the future of clinical design?
• Is it positive or negative for adaptive designs?
• What role does Bayesian play in the guidance…if any?
• What role, if any, does simulation play in the guidance?
• Why has Phase III been so clearly differentiated from earlier phases in the guidance?

Play the webinar

08:00 (PDT) 11:00 (EDT) 16:00 (BST)  17:00 (CEST)

Join Tom Parke as he quizzes adaptive trial gurus Prof. Don Berry and Dr. Scott Berry on the implications of the recent FDA Guidance on Adaptive Design for Clinical Trials. Tom will be getting answers to the key questions the guidance raises, namely:

• What are the major conclusions of the guidance?
• How does the guidance affect the future of clinical design?
• Is it positive or negative for adaptive designs?
• What role does Bayesian play in the guidance…if any?
• What role, if any does simulation play in the guidance?
• Why has Phase III been so clearly differentiated from earlier phases in the guidance?

Over 2 days, the comprehensive and scientific conference programme will feature key note addresses, case study presentations, panel and roundtable discussions of over 45 senior level industry speakers from leading pharmaceutical, biotechnology organisations as well as academia covering the following hot topics:

• R&D strategies and business models and pharma/biotech alliances collabroations
• Medicinal chemistry/drug design
• Screening techniques and assay development
• Biomarkers and personalised / translational medicine
• Bioinformatics
• Biologics

Dr Andrew Chadwick, Consultant (Life Sciences and Healthcare)  at Tessella will be giving a solution provider presentation on the Rational Approach to Risk Reduction: What can discovery screening planners learn from volcanos and dust detection, on Wednesday 6th June 2010, covering the following topics:

• The purpose of screening and the principles of value-adding screening plans
• The importance of finding the right, tailored screening plan for each project
• Risk perception and the pitfalls of cognitive biases for decision-making
• Metrics that should guide the choice, sequence, combinations and cutoffs for tests
• Ways of balancing the important factor (downstream consequences of error, cost and time for screening, and predictive performance)
• The need to overcome the challenge of uncertain inputs
• What is the right balance between exploitation and exploration of product options and technology performance?
• Effective approaches to supporting learning and continuous improvement

To find out more about this event or to register online, visit http://www.drugdiscovery-summit.com

For further information about this event, please email info@tessella.com.

For information about FACTS and clinical trial solutions, visit www.smarterclinicaltrials.com

Tom Parke, head of clinical trial solutions at Tessella is a speaker at the event and will be giving a talk on Adpative Clinical Trials and Biomarkers and Scott Berry, President and Senior Statistical Scientist at  Berry Consultants will be giving a talk on Designing Clinical Trials for Personalised Medicine at the event.

To find out more or to register online, visit www.adaptcongress.com

Oxford, UK | 27 April 2010. Today, Tessella, the information technology and consulting services company selected by R&D, science and engineering leaders for business-critical assignments previewed clinical trial design software that addresses the challenge of designing Phase 1 trials for combination therapies. Tom Parke, head of clinical technologies at Tessella, is presenting Smarter Clinical Trials at the Optimising Clinical Development in Oncology 2010 conference on the 27th April 2010 at Le Meridien Piccadilly, London, UK.

The development of combination therapies is becoming increasingly common in oncology, but currently development teams are limited to traditional Phase I clinical trial designs that only allow them to evaluate changing the dose of one of the agents, keeping the dose of the other agent fixed. This is incredibly limiting, significantly reducing the combination options that are explored, quite possibly missing combinations that offer greater therapeutic value for no increase in the level of toxicity. For a combination of two drugs there will be a series of combined doses which generate the same level of toxicity. What the “Combination Finder” trial design allows the drug developer to do is find the full range of combinations that could be taken forward to further trials.

“A clinical trial seeking to determine the Maximum Tolerated Dose must use as few patients as possible, avoiding either wasting subjects on too-low combinations or too-high toxicity combinations – these would not only be poor for the patients in the trial, but also not as informative from the drug development program as placing subjects on combinations just below the limit of tolerability.” said Parke. “Designing these kinds of trials is particularly challenging, and basing our tool on some published work at MD Anderson, University of Texas and the University of North Carolina we believe our prototype will allow the industry to assess how close we are to having a practical solution.”

Tessella plan to work with existing users of Tessella & Berry Consultants FACTS™ clinical trial design software, as well other leading pharmaceutical companies to refine the functionality of the prototype. If successful the capability could be integrated into the next release of FACTS scheduled for September.

-Ends-

Notes to the editor

About Tessella
For decades, Tessella has been successfully delivering IT and consulting services to world leaders in R&D, science and engineering. We enable our clients in life sciences, energy, the public sector, and consumer industries to achieve a wide range of objectives, including, forecasting floods, developing fusion power, enhancing military sensor capability, improving drug discovery and development efficiency, and reducing risk to health and the environment in the extraction and production of oil and gas. With offices in Europe and North America, global companies rely on Tessella for business critical assignments.

Further information available at www.tessella.com

Media Contact

Tessella
Christina Tealdi | PR/AR Executive
Phone: +44 (0) 1235 555511 | Mobile: + 44 (0) 779 9346453

christina.tealdi@tessella.com

The cost and time associated with bringing a new blockbuster drug to market is reaching astronomical heights – an average of $1 billion over 12 years…read more