PK/PD Data Analysis Experts to Lead Advanced Model-Based Drug Development Workshop

November 21, 2014

PRINCETON, NJ – Nov. 21, 2014 – Certara®, the leading global technology-enabled drug development and drug safety consultancy, today announced that industry-renowned pharmacokinetic (PK) and pharmacodynamic (PD) modeling experts Drs. Daniel Weiner and Johan Gabrielsson will be leading an Advanced Level PK-PD Data Analysis Workshop in San Diego, CA from Feb. 17-20, 2015.

The FDA Critical Path Initiative is calling for more and more use of PK/PD modeling in drug development. As a result, the industry cannot satisfy its demand for Advanced PK/PD scientists and that gap will continue to widen in the coming years. Our training course provides you with the opportunity to advance your skills as a highly-trained pharmacometrician who can support the discipline of pharmacometrics and move it to the next level within your organization.

Course participants will learn how to design, implement, and analyze in vivo experiments and to build PK/PD models to support optimization of drug doses and regimens used in preclinical trials and then extrapolate those data across preclinical species and into man.

Topics to be covered include:

  • Population PK
  • Translational aspects of PK and PD
  • Experimental design
  • Target-mediated drug disposition
  • Instantaneous and delayed drug responses
  • Effect-compartment, turnover and binding models
  • Functional adaptation
  • Transduction
  • Mixture dynamics
  • Drug-combination PD
  • Pattern recognition

This course will contain a mixture of lectures, group exercises, and hands-on PK/PD data analysis sessions using real-life case studies.

Participants will gain experience working with the industry gold standard PK/PD modeling and non-compartmental analysis software – Certara’s Phoenix® WinNonlin® – and the company’s Phoenix Nonlinear Mixed Effects Modeling (NLME™) product for population PK/PD analysis.

Dr. Daniel Weiner has more than 30 years’ drug development experience and was chief architect of Phoenix WinNonlin. Dr. Weiner has served as an expert consultant to the U.S. Food and Drug Administration (FDA) on PK modeling and bioequivalence assessment. He is also co-author of the seminal textbook entitled, “Pharmacokinetic and Pharmacodynamic Data Analysis: Concepts and Applications,” 4th ed. (2006).

Dr. Johan Gabrielsson is a professor of integrative pharmacology at the Swedish Agricultural University in Uppsala, Sweden. He has been published extensively in the field of PK-PD modeling and reasoning, and led numerous graduate and undergraduate courses on those topics in Europe, the US and Asia.

About Certara
Certara is the leading global technology-enabled drug development and drug safety consultancy. Its customers include hundreds of biopharmaceutical companies around the globe, together with several regulatory agencies. Certara’s solutions, which span the discovery, preclinical and clinical stages of drug development, enable data-driven decisions, leading to more precisely designed trials with a reduced risk of failure and improved subject safety.

Certara Contact:
Teresa A. Bradford, 919-852-4644
Senior Director, Marketing
teresa.bradford@certara.com

Media Contact:
Lisa Osborne, 206-992-5245
Rana Healthcare Solutions
lisa@ranahealth.com

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