In this free webinar Tom Parke discusses key questions about the use of quantitative decision making in drug development through simulation. Model based drug development produces estimates of the likely response to a drug, how should this be used to design a trial? The environment for drug development is becoming more complex, with issues such as sub-population analysis, safety, comparative effectiveness and using drugs in combination is more and more commonplace. How can development teams decide what to explore in the next trial and how can they decide whether to continue or abandon development?  Simulating all the remaining phases of development up to registration and comparing the performance of different strategies is one approach. But is it too complex? Is there too much uncertainty? Will it take too long to run? Could the results be trusted?

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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.

If you would like to have a prearranged meeting with Tessella at the event then please email info@tessella.com.

To find out more about Bio-IT World Conference 2012, visit http://www.bio-itworldexpo.com/

Growing implementation of adaptive clinical trials following the publication of draft guidance on adaptive designs by the US Food and Drug Administration in February 2010 is helping to ease regulatory concerns within industry about the approach, says eClinical solutions specialist Perceptive Informatics…read more

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

When human biases distort drug discovery decision-making, software tools can guide thinking towards objective answers…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.

Tom Parke, Head of Clinical Technologies at Tessella will be speaking at the event.  His talk will be on Incorporating Biomarkers into Trial Designs.

To find out more or to register on-line visit http://www.biomarkers-congress.com