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Oxford, UK | 15th December 2011. Tessella, the international provider of science powered technology and consulting services, is proud to be hosting a free online webinar for all life sciences professionals interested in deepening their understanding of Adaptive Clinical Trials.

Clinical trials that employ frequent adaptation offer great opportunity but pose specific challenges. In this free webinar adaptive trial veterans; Tom Parke (Head of Clinical Trial Solutions, Tessella ) and Martin Kimber (Project Manager, Adaptive Clinical Trials, Tessella) will share their experience gained on over 30 adaptive trials. The webinar will discuss: what these trials are, why people run them, how they are designed, how the logistics to run them are put together, what it’s like to run one as well as observed benefits both expected and unexpected.

The “Running Adaptive Clinical Trials; Myth and Reality webinar” will take place on Thursday December 15th 2011, 3:00 PM (GMT) Greenwich Mean Time: Dublin, Edinburgh, Lisbon, and London. To register online for the event visit: https://tessella.adobeconnect.com/_a970567468/runningadaptivetrialsevent/event/event_info.html

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Notes to the Editor

About Tessella
Founded in 1980, Tessella is the international provider of science powered technology and consulting services. World leading organizations choose our unique blend of science, engineering and sector expertise to deliver innovative and cost-effective solutions to complex real-world commercial and technical challenges. Our people are high achievers from leading universities and are passionate about delivering value to clients.

For further information visit our dedicated microsite on http://www.smarterclinicaltrials.com

Media Contact

Tessella
Christina Tealdi | Public and Analyst Relations Executive
Phone: +44 (0) 1235 555511 | Mobile: + 44 (0) 779 9346453 | christina.tealdi@tessella.com

Kevin Vogelsang, Clinical Technologies Business Development at Tessella Inc. will be talking about Designing Smarter Trials to Support Personalized Medicine on Wednesday, September 7th 2011 from 11.45am to 12.15pm.

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

You would like an prearranged meeting with Tessella, please email info@tessella.com

Tom Parke, Head of Clinical Technologies, Tessella

I was lucky enough to join a focus group at the recent 8th Annual SAS Health Care & Life Sciences Executive Conference (http://www.sas.com/news/preleases/hlsconf-clinicaltrials.html). The group comprising of selected pharmaceutical industry executives, SAS, Berry Consultants and Tessella discussed clinical research best practices.

So what did the group observe? Two points struck me:

1. The growth of personalised medicines, increased use of biomarkers and intensification of comparative effectiveness studies are making drug development more complex than ever. Smarter clinical trials are seen as a key method to respond to this complexity.
2. Concern that companies will need to break down silos and increase inter-operability between groups and IT systems in order to execute trials in an agile and flexible fashion.

The second point could be seen as pessimistic, yet the recent Perceptive Informatics global survey (http://www.perceptive.com/news/press-releases/2011/perceptive-informatics-global-survey-results-show-growing-indust/) is encouraging. It shows that despite these concerns the industry’s willingness to use innovative approaches in clinical trials, such as adaptive trials, is growing. During a recent webinar presented by Perceptive and Tessella, more than 300 industry professionals answered questions about implementing adaptive trials. The survey showed that 80% of respondents were considering implementing adaptive trials within the next year.

Tom’s topics are:

• Incorporating biomarker data in clinical trials for developing personalised medicine
• Commercial Software Solutions for Exploratory Studies
• Using simulations to communicate the expected consequences of planned statistical analyses

To find out more about Tom’s sessions or about this event and how to register online, visit http://www.diahome.org

To find out more about the webinar and to register online, visit http://www.perceptive.com

Tom Parke be giving a talk on:

• What adaptive clinical trials promise

• What it takes to run an adaptive trial

• What can go wrong and how to prevent it, dodge it or cope with it.

To find out more about this event or to register online, visit www.perceptive.com/news/2010-user-group-meeting/

The first upgrade to a one-of-a-kind simulation tool co-developed by Tessella and Berry Consultants significantly enlarges the proportion of clinical studies that can benefit from simulation of the design…read more

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 | Texas, US | September 14, 2010. Tessella, the information technology and consulting services company selected by R&D, science and engineering leaders for business-critical assignments and Berry Consultants, leaders in the Bayesian approach to medical statistics announce the availability of their trial design simulation tool: Tessella and Berry Consultants FACTS™ 2. FACTS™ 2 significantly increases the scope of trial designs that can be easily modelled and simulated by drug development teams.

Scott Berry President and Senior Statistical Scientist at Berry Consultants commented: “The new functionality and features in FACTS provide an amazing platform for trial design optimization. FACTS has the ability to simulate continuous, dichotomous, or time-to-event trials, as well as trials with multiple endpoints. The interface is very easy to use and extremely powerful. It is an amazing tool for trial design–the absolute state-of-the-art.”

Tom Parke, Head of Clinical Trial Design at Tessella said: “The new trial designs available significantly increases the scope of studies that the tool can be used for. We believe that this will be particularly useful for those working in oncology and CNS. The tool can now be used for Time-to-Event studies such as Oncology trials and dual endpoint studies where the degree of efficacy has to be balanced with having acceptable levels of drug tolerability. The dual endpoint facility in particular allows trial designers to easily explore types of trial design that have never been used before.”

Parke continued: “In oncology it can be difficult to recruit trial subjects and it is important that drug developers are able to optimize their oncology trial designs, but it is important to cancer sufferers too. Optimized trials should get good drugs to market quicker and have fewer people tested using poor ones”.

Tessella began its work in Clinical Trial Optimization over 10 years ago, and currently provides trial optimization services to 5 of the top 20 pharma companies. The goal of trial optimization is to explore design options by simulating the planned trial using the different designs over a range of scenarios. Studying the observed operating characteristics of the simulated trials gives much greater insight into the planned trial than conventional trial planning techniques.

FACTS™2 will be launched at ADAPT 2010, taking place on September 13th – 16th September 2010, Hyatt Regency Crystal City, Arlington, VA, USA.

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Notes to the editor:

New features of FACTS™2

Does finding with multiple endpoints
Often the best measure of how useful therapies are in clinical development involves a trade-off between efficacy and toxicity. FACTS™ 2 supports using a “utility function” in the trial which combines two separately estimated responses dose by dose. For instance, the efficacy value can be scaled by a safety factor which reduces the utility of a dose if side-effects are above a chosen threshold. Decisions as to how to optimise the trial can be explored using a range of potential scenarios, allowing the choice of the utility function to be understood, discussed and agreed on. Like the existing FACTS™ 1 dose-finding simulators, longitudinal modelling of the independent responses can be included in order to maximise the information from subjects that have dropped-out or are not yet complete.

Time-to-event trials

This class of trial design makes decisions based on a time duration measurement, such as time to death, or time to progression in oncology. This includes accounting for censored data, which handles the statistics for analysis during the trial recruitment when some subjects have only been in the trial for a comparatively short time. Using adaptation in the design can be easily explored via simulation, allowing the potential benefits of early stopping, dropping ineffective arms, and adaptive randomization to be assessed. For example adaptive randomization can be incorporated so that subsequent randomization favours doses that have performed well so far, leading to a greater exposure on the most promising dose than a corresponding non-adaptive design may achieve. This effectively gives later stages of the development program a head start.

For more information visit our dedicated site on www.smarterclinicaltrials.com

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.

About Berry Consultants

Don Berry is a key opinion leader in Bayesian biostatistics, cancer research and policy, and adaptive trial design. Professor Berry has long championed adaptive trials in clinical research. His vision became reality and adaptive designs earned favor by U.S. and international regulating agencies, and more and more companies looked to collaborate with Prof. Berry. To meet this demand, he started Berry Consultants with Scott Berry in 2000. Since then Berry Consultants has designed over 100 unique adaptive trials for medical device, biotech, and pharmaceutical companies.

In addition to Don Berry, along with Scott Berry as President and principal modeler/programmer, Berry Consultants includes full-time statistical scientists and a variety of other collaborators to precisely tailor adaptive designs for each unique company, breakthrough technology, and regulatory situation.

Further information is available at www.berryconsultants.com

Media Contact

Tessella

Christina Tealdi | PR/AR Executive

Phone: +44 (0) 1235 555511 | Mobile: + 44 (0) 779 9346453

christina.tealdi@tessella.com