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.

By Courtney Andersen

In an age of increasing financial and logistical pressures facing biotech and pharmaceutical companies, optimizing R&D success is a critical task. But in a commentary published last year in Drug Discovery Today, Andrew Chadwick of Tessella and Matthew Segall of Optibrium argued that psychology could be hindering the productivity of drug discovery teams, even suggesting that the traditional approach to discovery is actually blocking progress…read more

Join Dr Andrew Chadwick, Principal Consultant at Tessella, as he discusses with Prof Orest Hurko, Senior Clinical Consultant, Biologics Consulting Group, Inc, how to get more value from decisions on predictive technology provision and planning.

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

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.

-Ends -

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

To find out more or to register online visit http://www.bio-itworldexpo.com/

The paper identifies that while company rules, processes and systems seek to foster objectivity, common biases in decision making may hinder achievement of best possible performance. Psychological research proves again and again that people are bad at making complex decisions where there is risk involved. The paper demonstrates how better individual and team decision-making within drug discovery would enhance R&D performance. Feedback on problem solving performance could be one of the simplest measures to improve selection of compounds and effective screening sequences. The study also highlights that computational tools provide a more scientific approach that encourages objective consideration of all of the available information, helping scientists make decisions that are both balanced and rational, in the domains of library design, compound selection, screening, profiling and experimental design.

Drug discovery leaders receive much conflicting advice on possible ways to improve productivity and restore the rate of successful drug launches. Continuing technology investment, outsourcing of shared services and formation of smaller, disease-specific units, which bring researchers closer to clinicians are all current trends. However, senior management cannot afford to ignore the human dimension – are their teams making the best possible decisions given the information available to them, or that could be available given the right experiments?

Dr. Andrew Chadwick, Principal Consultant, Tessella, explains, “Past experience shows that many practical researchers remain baffled or confused by probabilistic models and so shy away from formal decision analysis. Yet reliance on gut instinct tends to lead to consistent patterns of mistakes. Discovery groups need to define and encourage ‘best practice’ to conduct projects in a way that captures wider company and industry experience. There is a need to make this as simple and accessible as possible via a more scientific approach.”

Good decision-making is central to drug discovery success and the new paper demonstrates that the interactive software platform, StarDrop from Optibrium, can help drug discovery scientists to guide their scientific judgment to make decisions with greater success. Dr. Matthew Segall, CEO of Optibrium, explains, “StarDrop can help drug discovery scientists to guide their decisions while designing and prioritising molecules with the aim of achieving an optimal balance of properties. The probabilistic scoring approach, employed by the StarDrop software platform to guide compound selection decisions in drug discovery, indicates the likelihood of success of a compound against a set of property criteria, given the available property data for that compound and taking into account the underlying uncertainty in the data.”

The intuitive software provides a decision-making framework, offering advantages over traditional predictive modelling platforms as it specifically helps users to identify chemistries with a high chance of success and focus expensive in-house resources. Used by pharmaceutical and biotech companies and research establishments globally, StarDrop guides compound selection and design decisions in all stages of drug discovery. The software provides a comprehensive range of features to support design and prioritization of high quality compounds including: probabilistic scoring; chemical space and glowing molecule visualisation; ADME QSAR models; P450 metabolism models and automatic model building.

To learn more about how StarDrop can aid good decision-making in drug discovery please call Optibrium on +44 (0) 1223 815 900, email info@optibrium.com or visit www.optibrium.com.

About Optibrium Ltd

Optibrium (www.optibrium.com) is dedicated to providing software to guide decisions involving complex, uncertain data in an intuitive way. Optibrium’s primary product, StarDrop, is focused on the drug discovery industry, helping scientists to guide decisions in the design and selection of high quality drug candidates. Optibrium was founded in 2009 as a spin-out of one of Galapagos service divisions: BioFocus. The founding group was responsible for the development of StarDrop from 2003 and, prior to this, research and development of related technologies since 1994. Based in Cambridge, UK, Optibrium has a global customer base ranging from top-ten pharmaceutical companies to small biotechs and academic groups.

For further press information please contact: Sarah Evans, The Scott Partnership, 1 Whiteside, Station Road, Holmes Chapel, Cheshire CW4 8AA, UK Tel: + 44 1477 539539 Fax: +44 1477 539 540 E-mail: optibrium@scottpr.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.

Media contact

Christina Tealdi
PR/AR Executive | Tessella

D: +44 (0) 1235 546 638
M: +44 (0) 779 934 6453

E: christina.tealdi@tessella.com

Better individual and team decision-making should enhance R&D performance. Reproducible biases affecting human decision-making, known as cognitive biases, are well understood by psychologists.  These threaten objectivity and balance and so are credible causes for continuing unpleasant surprises in Development and high operating costs…read more