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Conference 2009 - Keynote Presentation

Dr. Diane Jorkasky gave a highly relevant, provocative and out-of-the-box-thinking keynote speech at this year’s conference which has been cited and mentioned in many subsequent presentations throughout the whole event.

Here is a short list of bullet points to summarise her points:

  • The key asset of any pharmaceutical company is the data. Without clinical data, no compound will make it to the market, no matter how good it is.

  • Currently the industry is not using the data to its full potential

  • Well organized, structured and easily accessible data-depositories built on a compound level are rare

  • Consequently retrieving any kind of information over a whole compound (i.e. al patients who ever took the drug during a study) is extremely time consuming and costly, if not impossible. This because of non-standard data models, legacy servers residing on legacy servers, etc...

  • Usage of placebo data within a therapeutic area across compounds is hardly possible. Companies have to buy expensive placebo data to circumvent this incapability of using the already available data

  • Using pre-clinical data for better prediction of an optimal dose for Early Development studies could save a lot of time and effort.

Dr. Jorkasky proposes three strategies to improve this situation:

  • Drive standards

  • Drive technologies

  • Drive new ways of doing the business process

The video shows examples and success stories for each one of these points:

 Conference 2009 Keynote - Diana Jarkorsky

PhUSE US Computational Science Symposium 2017

The PhUSE Computational Science Symposium (CSS) will be celebrating its 6th annual event in 2017, having established itself as the premier collaboration within the clinical trial environment. The collaboration has continued to grow, hosting its inaugural event in Europe during 2016 and engaging other regulatory agencies including the EMA and PMDA.

This year's event will once again be co-sponsored by the FDA and PhUSE and will bring together academia, regulators, industry and technology providers to address computational science needs in support of regulatory review.

Find Out More