Pharsight Insights
The Newsletter for Model-Based Drug Development
Fall 2010
News
Pharsight Launches Phoenix Pharmacometric Productivity Challenge
Pharsight is pleased to launch the Phoenix Pharmacometric Productivity Challenge, a competition to recognize excellence in the application of pharmacometric software to critical problems in drug development. We are now accepting submissions from industry and academia for the inaugural 2011 Phoenix Challenge. The winning submission will be announced at the American Conference on Pharmacometrics (ACoP) to be held April 4-7, 2011 in San Diego, California.
Learn More and Submit Your Phoenix Challenge Entry
Pharsight Strengthens European Team, Appoints Henri Merdjan to Head Regulatory Analysis and Reporting Services
Pharsight has expanded its presence in the European market by appointing Henri Merdjan as Senior Director of Consulting Services. Henri, a 25 year industry veteran who most recently served as Vice President, Drug Metabolism and Pharmacokinetics at Novexel, will lead European business development for Pharsight's regulatory-compliant PK/PD analysis and reporting services.
Read Press Release on Henri Merdjan Appointment
Events
Pharsight Gears Up For AAPS 2010
Please allow us to be your host at AAPS 2010 in New Orleans. Start AAPS with Pharsight at Booth #2601: meet and greet scientists and staff, sign-up for Phoenix® product demonstrations; register to win a 32GB Apple iPad. Then hear Rene Bruno, PhD, Managing Director, deliver a symposium talk on modeling tumor growth. Join a poster session to discuss fixed-dose combination modeling for a recently approved blood pressure-lowering agent. Finally, attend a CPTR Open Forum supported by Pharsight on open source development of mechanistic/systems biology models.
Want Dates and Times? Download Your Guide to Pharsight at AAPS 2010
Pharsight Presents on Model-Based Competitive Positioning at Drug Development 'Boot Camp'
Farkad Ezzet, PhD, Senior Scientist, recently gave an invited presentation to biotech and pharma company executives attending an intensive two-day drug development course sponsored by the Cornell University Center for Technology Enterprise and Commercialization. Dr. Ezzet presented a case study on the use and value of model-based approaches that integrate animal biomarker data and public literature on approved competitor treatments to project safety/efficacy profiles and first-in-human dosing regimens for a Factor Xa inhibitor.
View Case Study: "Do We Really Need Another Anti-Platelet?"
Success Stories
Powerful Business Case for Pharmacometrics Published in CPT
In the August issue of Clinical Pharmacology and Therapeutics, the newly formed ASCPT Task Force for Advancing Phamacometrics summarized the advantages and benefits of pharmacometric analysis for improved drug development and regulatory decision-making. The Task Force's assertions on the economic and public health benefits of applying pharmacometrics are supported by a series of more than 20 detailed case studies compiled from industry, FDA and academic practitioners.
Download Business Case for Pharmacometrics Published Online in CPT
Customer Feedback on Phoenix
Pharsight is committed to making Phoenix an even more powerful and integrated software environment for model-based drug development. To that end, Pharsight continues to collaborate with customers and industry stakeholders such as FDA (through Pharsight's CRADA with CDER) to identify and implement improvements and new tools for the Phoenix platform. Here are several examples of what we've heard so far from customers about Phoenix® WinNonlin® and Phoenix® NLME™. We would love to hear from you as well.
Join Our Phoenix User Community
Scientific Contributions
Journals: Tumor Growth Inhibition-Survival Modeling Framework to Support Early Development Decisions (published in Cancer Chemotherapy and Pharmacology) View Citation
Laurent Claret, PhD, Senior Scientist, has collaborated with industry colleagues on a manuscript describing a modeling framework that simulates clinical endpoints to support development of a thyroid cancer treatment. Results suggest that the modeling framework, which builds on earlier work, can serve as a tool to simulate Phase II trials and support early development decisions for oncology drug candidates.
View Related Pharsight Oncology M&S Case Examples
Books: Contributed Chapter on Clinical Utility Modeling
TJ Carrothers, ScD, Senior Scientist, and colleagues have contributed a chapter on the application of a Clinical Utility Index(SM) to decision-making in drug development, in the newly published book edited by Holly Kimko and Carl Peck entitled "Clinical Trial Simulations: Applications and Trends." (AAPS Press, 2010). View Book Details
View More CUI References and Case Studies