We’ve just returned from the third leg of our now annual Phoenix roadshow. In this leg, I helped deliver workshops in Beijing, Osaka and Tokyo. In total, our product development team has visited eight cities in the US, Europe and Asia. We gave both technical and scientific PK/PD modeling presentations to more than 250 clients.
Certara’s commitment to our customers
To meet the needs of drug development scientists, we continually enhance our products and services. We accomplish this goal through new Phoenix releases and creating a software ecosystem that streamlines drug development. Our Phoenix development team includes scientists that have worked in industry and academia, pharmacometric consultants, software architects and developers, and QA professionals.
We leveraged these roadshow events to assess customer feedback via 1:1 discussions and surveys. To discuss the future development of Phoenix, we played Monopoly, Certara Edition. During the game, each attendee had the opportunity to vote for the features and enhancements that were most important to them. The results of that voting will guide our software development. This valuable feedback will help us to fulfill the needs of our customers.
Phoenix roadmap highlights
In 2016, Phoenix development will center around several themes:
- Migration to the Cloud: Cloud computing provides key advantages that have driven our decision to invest in this new delivery method. First, users will be able to access the most current, validated version of Phoenix. From a regulatory perspective, computer system validation has become an increasingly important requirement for all software used in drug development. Accessing Phoenix-in-the-Cloud eliminates the need for users to install, configure and validate Phoenix, while providing flexible licensing options and increased computing power for large modeling projects.
- Phoenix 2.0 – Regulatory Submittal-Ready Graphics, Increased Speed: A picture is worth a thousand words. As voted by the roadshow attendees, the mid-year 2016 release of Phoenix will include a package of rich, advanced graphics capabilities to visually enhance your pharmacokinetic/pharmacodynamic (PK/PD) results. Key to successful communication of your work, these new graphics will improve visualization of results to better inform key drug development decisions. Most important, these new graphic packages are designed for regulatory submittals, allowing you to best articulate to regulators the drug development decisions informed by PK/PD modeling.
- Phoenix 2.0 – Grid Computing: Another key addition in Phoenix 2.0 will be increased speed via parallelized grid computing using either Windows, Linux or Unix. The increased speed will be especially valuable for large modeling projects. Phoenix 2.0 provides additional enhancements for NLME. Phoenix NLME 2.0 will also use enhanced algorithms to increase speed and accuracy of model convergence.
- New Services that Expand the Power of Phoenix: Maximizing the time that scientists spend analyzing data versus preparing or manipulating that data was the driving force behind these next advances for Phoenix. In 2016, we will introduce a series of template toolkits. These toolkits will contain pre-defined, commonly used scientific workflows for specific analyses to standardize and expedite analysis as well as minimize costly reruns and quality control steps. Example toolkits, provided as a service offering, include toxicology analysis, SEND submittal, and First-in-Human. On average, scientists spent 30% of their time formatting data before performing population PK/PD analysis. A new GUI-driven tool will identify potential data problems and create needed variables. By reducing data cleanup and preparation, this tool will help scientists spend more of their time performing higher value work.
Aligning with pharmacometrics leaders in Asia
- During our roadshow in Beijing China, we were joined by Dr. Pei Hu, the Director of the Clinical Pharmacology Research Center, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences. Dr. Hu spoke about her institution’s pharmacometrics leadership position in China. A longtime advocate for both Phoenix and Simcyp, Peking University Hospital has performed almost 21% of all clinical trials in China. They have provided early stage modeling and simulation services for 15 new molecular entities. Their services used biosimulation to advise on first-in-human and proof of concept trials. The group has published more than 50 papers, all using Phoenix WinNonlin.
- In Tokyo, we were honored to have Yusake Tanigawara, Ph.D. join our workshop. He delivered a presentation around the future of pharmacometrics in Japan. Dr. Tanigawara is on the faculty of the Department of Clinical Pharmacokinetics and Pharmacodynamics at the Keio University School of Medicine and serves as the Chair of the 15th Annual Congress of Therapeutic Drug Monitoring and Clinical Toxicology conference. Dr. Tanigawara also sits on the committee responsible for drafting the PMDA’s first PK/PD guidance, due out at the end of this year.
Stay posted for more exciting developments coming to the Phoenix platform! I hope to see you at our next Phoenix Roadshow!
Phoenix makes it easy to perform population PK modeling
We’ve written a whitepaper that illustrates how integration of the NLME module within the Phoenix platform provides users with a single, easy-to-use tool for pharmacokinetic and pharmacodynamic analysis from early nonclinical work through Phase 3 clinical trials. I hope that you’ll read it and let me know what you think in the comments section!