Last year during our inaugural Phoenix Roadshow workshop program across the US, Europe and Asia, we gained valuable feedback and ideas from our customers on “All Things Phoenix.”Based on the success of that program, and with new updates and case studies to share with our users, we commenced our 2nd Annual Phoenix Roadshow in April with stops throughout the US and Europe. To date, our team of experienced scientists and consultants delivered presentations and demos to over 150 clients in Basel, Switzerland; Cambridge, UK; Princeton, NJ; San Diego, CA; Lincolnshire, IL; and Cambridge, MA.
The value of pharmacokinetic/pharmacodynamic (PK/PD) modeling and other biosimulation approaches in drug development continues to gain widespread recognition. Many regulatory guidance documents recommend using predictive modeling in filings. PK/PD models have proven to be effective in supporting critical decisions for dose selection (especially for special populations), predicting potential drug-drug interactions, and trial design. Numerous regulatory guidances advocate using pharmacometrics early and often in the drug development process.
This year’s theme – Leveraging the Power of Phoenix – was developed in response to requests from the community to learn to use Phoenix to its maximum potential. They also wanted to learn more about how Phoenix meets current and future pharmacometric regulatory requirements. As part of our continued commitment to enhancing the platform, we reviewed many of the new features that have been implemented in Phoenix 7.0, which will be launched this summer. Many of these new features are the direct result of customer feedback from last year’s roadshow. A review of the development roadmap provided our users with a glimpse into what to expect in future releases.
Phoenix Roadshow highlights
The program kicked off with a recap of last year’s roadshow and introduced the features voted as top priorities by our customers.
- Phoenix v7.0 will provide many user-requested features, including improved graphics and charting capabilities, NCA performance optimization, NLME enhancements and improvements, creation of a new Data Layer, execution of runs on grids and on UNIX/Linux, and more informative error messages. Stay tuned for future communications on this new release.
- Phoenix Roadmap: A review of the product roadmap gave a glimpse into the 2017 software release. Phoenix 7.5 will focus on numerous non-compartmental analysis (NCA) enhancements, optimizations and Windows 10 support.
- Pharmacometric Case Studies: Three case studies were presented that demonstrated how Certara scientists leveraged Phoenix to inform drug development. The first case study demonstrated how modeling and simulation can help translate drug efficacy from pre-clinical animal models to humans. The second case study focused on dosing recommendations in subpopulations and revealed how Phoenix was used to influence a drug product label. The final case study on liver safety analysis revealed how to reconcile potential contradictions between safety biomarker levels and observed drug exposures.
- Phoenix Workflow Templates and CDISC SEND Compliance: This session showed users how Phoenix workflow templates can improve productivity and streamline results in PK/PD studies that use repeated analyses. The presentation focused on tips & tricks and best practices for successfully developing a workflow template. The session also introduced new Phoenix Workflow Templates designed by our Phoenix Technology Services team for a variety of analyses including pre-clinical toxicokinetic studies and the new regulatory guidance on using CDISC SEND and SDTM data standards in submissions that go into effect later this year. For more information on CDISC SEND, check out our CDISC SEND brochure and Get Ready for CDISC SEND! blog post.
- Certara University On-Demand Training: The final session of the day provided attendees with a look at the newly redesigned Certara University web site and the introduction of On Demand courses. The On Demand content mirrors our classroom courses with the extra flexibility to take the course anywhere, from any laptop, PC, or tablet and at your own pace. The courses feature topics taught by our team of Certara University experts through video lectures and real-time software demonstrations. Once enrolled, participants will have long-term access to the course materials which can be viewed for reference or as a refresher. Currently available On Demand courses include Fundamentals of Pharmacokinetics, Introduction to WinNonlin, and Introduction to Population PK using Phoenix NLME. Additional courses will be released this fall and throughout 2017.
In all, the 2016 Phoenix Roadshow is a venue to meet with our users, gain critical feedback for platform improvements, and serve as an interactive forum to share and communicate various drug development, pharmacometric, and regulatory topics with the model-informed drug development community. We encourage you to join us at future events and share your experiences and feedback with the Phoenix community.
The roadshow will continue later in the fall so register for an upcoming Phoenix Roadshow event near you. I’ll see you there!
To learn about how we’ve improved Phoenix to make performing NCA and PK/PD modeling even easier, please watch this webinar by my colleague, Dr. Nathan Teuscher, on the latest enhancements to Phoenix.