Annual Conference 2016
Fast Track to Approval: Speed and Efficiency
9th - 12th October 2016
Over the past years we have talked about data standards, patient centricity, data transparency and turning data into knowledge, which is very much focusing on science and changes in the pharmaceutical industry. This has been, and continues to be, very important to us. But, the biggest challenge we face today in the pharmaceutical industry is time. It takes too long and costs too much money to get our drugs to the market.
Therefore, the theme of the 2016 Conference will be how to achieve a “fast track to approval”. The focus will be on time and efficiency. How can we standardise, automatise, design trials and utilise data more effectively to reduce the time to approval? We have to find new ways to optimise the time and ensure quality, having all the required high quality deliverables in place at the right time. If we can achieve this we have the opportunity to transform the entire business and help our companies survive. We as data scientists are key in this process and we must take responsibility for driving the development in the right direction.
In order to become more effective and be able to reduce the time to approval we have to discuss pooling strategies, data standards, supporting softwares, programming techniques, statistics and regulatory requirements early on in our projects. For example, we can look at performance in our code to reduce the execution time, we can look at providing regulatory agencies with analysis results metadata which may speed up their review process there are so many things we can do if we focus on time and efficiency. We have an obligation to do whatever we can in our area of expertise to ensure we are on the fast track to approval.
We also have to work closely together with the regulatory agencies to ensure that we deliver the critical elements at the right time to facilitate their review and understanding of our clinical trial results. PhUSE has a very important role in bridging the gap between the pharma companies and the regulatory agencies. This gives the Conference a unique possibility to add value and a forum to discuss how we best support our submissions for market approvals.
Everything that has made PhUSE so successful over the years will continue in 2016 (with some new influences). The streams will remain the backbone of the Conference; inspiring keynote speakers will start each day of the Conference; interactive sessions will open the floor for debate on relevant subjects; new topics will be identified for our popular Hands-on Workshops; and, of course, the Conference will remain a unique opportunity to network and share knowledge with colleagues and friends. In 2016 we will introduce a new stream dedicated to Real-world Evidence, focusing on handling of all kinds of observational data, including but not limited to, registries, health claims and medical records databases, and non-interventional prospective and retrospective studies.
The 2016 Conference is going to bring time and efficiency to the table, as an important focus area for data scientists in drug development. It will put us on the fast track to approval.
We look forward to meeting you in Barcelona in 2016!
Åsa Carlsheimer Jules van der Zalm
Trialbee OCS Consulting
Conference Chair Conference Co-Chair