Certara Consultants to Discuss PK/PD Modeling Advances and ISoP Standards at ACoP5

Certara consultants will present a total of five seminars and five posters at ACoP5 being held from Oct. 12-15 in Las Vegas, Nev.

ST. LOUIS, MO – Oct. 8, 2014 – Certara®, the leading global technology-enabled drug development and drug safety consultancy, today announced that its Simcyp and Pharsight consultants will present a total of five seminars and five posters at the fifth American Conference on Pharmacometrics (ACoP5) being held from Oct. 12-15 at the Mirage Resort & Spa in Las Vegas, Nev.

“ACoP is an important conference which highlights the indispensable role that drug (PK/PD), disease, and clinical trial models play in the drug development process,” said Certara’s Managing Director of Pharsight Consulting Services Europe René Bruno, Ph.D. “Once developed, these models can be used to simulate untested new clinical scenarios, inform go/no-go decisions, dose selection, trial design and labeling. We are proud to make such a significant contribution to this year’s meeting.”

Certara’s contributions to ACoP sessions are outlined below:

Oct. 13, 3-5 p.m., Session 2c

Variabilities in Accounting for Variability: Where Does PK Stop and PD Start? – Vice President of R&D Amin Rostami-Hodjegan, PharmD, PhD
The Added Value of Combining “Bottom-up” and “Top-down” Approaches in PK/PD Modeling – Senior Scientific Adviser and Head of Modeling and Simulation Masoud Jamei, PhD

Oct. 14, 7-9:30 p.m., ACoP5 Open Forum

When Children are Just Small Adults: Examining Current Approaches in Extrapolation of Adult Efficacy Data for Pediatric Drug Development – Senior Scientist Pharmacometrics Nastya Kassir, PharmD, PhD, FCP

Oct. 15, 9:45-11:45 a.m., Session 5

Introduction to International Society of Pharmacovigilance (ISoP) Standards and Best Practices Committee, to MoEv and to the Symposium – Dr. René Bruno
Guidelines from Industry on Model Evaluation: the ISoP-MoEv wiki – Associate Director PK/PD at Pharsight Dr. Samer Mouksassi, PharmD, PhD, FCP

Oct. 14, 7:30-9:30 a.m.

T-016: Modeling the Binding Kinetics of Antibody, Antigen and FcγRs – Li at al.
T-058: Incorporation of the Time-dependent Post-prandial Increase in Splanchnic Blood Flow into a PBPK Model to Predict the Effect of Food on Oral Propranolol Pharmacokinetics – Rose et al.

Oct. 15, 7:30-9:30 a.m.

W-006: Modeling and Simulations of Equine Botulinum Antitoxin to Support Study Design in Pediatrics – Kassir et al.
W-027: Tutorial: Advanced Phoenix NLME Capabilities – Mouksassi et al.
W-034: Rationale for PML Design – Dunlavey et al.

Certara will also be exhibiting in booth #2, where senior members of its research and development team will be available to take questions, provide demonstrations, and discuss the company’s expert consultancy services.

For more information about ACoP5, please visit http://www.acop5.org.

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. For more information, visit www.certara.com.

Certara Contact:
Teresa A. Bradford, 919-852-4644
Senior Director, Marketing

Media Contact:
Lisa Osborne, 206-992-5245
Rana Healthcare Solutions

Media Contact:

Jieun W. Choe, Chief Strategy and Marketing Officer. jieun.choe@certara.com