Certara Consultants to Discuss Advances in Biosimulation & PK/PD Modeling at ASCPT Annual Meeting

March 5, 2015

Certara is contributing to 11 presentations and poster sessions at this year’s conference

PRINCETON, NJ – Mar. 5, 2015 – Certara®, the global biosimulation technology-enabled drug development and drug safety consulting company, today announced that its Simcyp® and Pharsight® consultants will contribute to 11 seminars and poster sessions at the American Society for Clinical Pharmacology and Therapeutics (ASCPT) 2015 Annual Meeting to be held March 3-7 at the Hyatt Regency in New Orleans, LA.

“Biosimulation and PK/PD modeling are playing an increasingly central role in the drug development and regulatory approval processes. There is thirst for knowledge in this area, whether it be to determine the most appropriate dose for a Phase I trial, learn how the absorption of a particular drug may change as subjects age, or identify possible drug-drug interactions. The ASCPT Annual Meeting provides an excellent venue to share this type of knowledge and our latest thinking and we are delighted to be able to contribute,” said Certara Senior Vice President of R&D and Chief Scientific Officer Amin Rostami, Pharm.D., Ph.D.

Certara’s involvement in the 2015 ASCPT sessions is outlined below:

Pre-conference Workshops
Tuesday, March 3
“Physiologically-based Cardiomyocyte Model: Predicting QT Changes in Humans.” – Sebastian Polak. Session Title: Quantitative Systems Pharmacology: Multiscale Model-based Drug Development through Integrating Systems Biology and Pharmacometrics.

“Application of PBPK and Bayesian Modeling for Prediction of the Likelihood of Individual Patients Experiencing Serious Adverse Reactions to a Standard Dose of Efavirenz.” – Mano Chetty. Poster: QP-03

Thursday, March 5
“Modeling, Simulations and External Validation of an Optimal Dosing Strategy of Testosterone Undecanoate in Hypogonadal Men.” Clinical Pharmacology & Therapeutics, Volume 97 Supplement 1, February 2015 – N. Kassir, S. Mouksassi, J.F. Marier. Poster: PI-070

“Simulating Cardiac Consequences of the Genetic Variability at the Metabolism Level with Use of Middle-out Approach and Flecainide as an Example Compound.” – Sebastian Polak. Poster: PI-105

Friday, March 6
“Application of PBPK Modeling for Prediction of Buprenorphine Exposure in Neonates: Incorporation of CYP3A4 and UGT1A1 Ontogenies.” – Karen Rowland Yeo. Session Title: Practical Approaches for Optimizing Pediatrics Dosage or Delivery: PW-06

“Population Pharmacokinetics of Bevacizumab: Analysis of Individual Data from 1792 Patients with Solid Tumors from 15 Studies.” Clinical Pharmacology & Therapeutics, Volume 97 Supplement 1, February 2015 – T. Peyret, N.H. Gosselin, M. Mouksassi, S. Girish, D.E. Allison, J. Jin. Poster: PII-033

“Population Pharmacokinetic and Pharmacodynamic Analysis of Eculizumab to Support Phase III Dosing Regimen in Patients with Refractory Generalized Myasthenia Gravis.” Clinical Pharmacology & Therapeutics, Volume 97 Supplement 1, February 2015 – N. Kassir, S.M. Mouksassi, B. Jayaraman, J. Marier. Poster: PII 091

“Pharmacokinetic/Pharmacodynamic Modeling of Anti-FGF23 Antibody (KRN23) and Serum Phosphorous in Adults with X-linked Hypophosphatemia.” Clinical Pharmacology & Therapeutics, Volume 97 Supplement 1, February 2015 – N.H. Gosselin, J. Marier, T. Peyret. Posters: PII-097 & QP-06

“Population Pharmacokinetics of KRN23, a Human Anti-FGF23 Antibody Developed for the Treatment of Adults With X-linked Hypophosphatemia.” Clinical Pharmacology & Therapeutics, Volume 97 Supplement 1, February 2015 – T. Peyret, N.H. Gosselin, J. Marier. Poster: PII-078

“A Model Relating Overall Survival Related to Tumor Growth Inhibition in Renal Cell Carcinoma Patients Treated with Sunitinib, Axitinib or Temsirolimus.” – L. Claret, R. Bruno. Poster: PII-032

Saturday, March 7
“Ongoing Challenges in Regulatory Sciences: Emerging Perspectives” – Karen Rowland Yeo.

Senior Certara staff members will also be available to answer questions and discuss the company’s consultancy services in booth #210.

For more information about the ASCPT 2015 Annual Meeting, please visit http://www.ascpt.org.

About Certara
Certara is the global biosimulation technology-enabled drug development and drug safety consulting company. 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
teresa.bradford@certara.com

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

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