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Certara Scientists Showcase PK/PD Modeling Advances at ASCPT Annual Meeting

Certara experts will present 17 posters in addition to leading a workshop and a symposium

PRINCETON, NJ – Mar. 13, 2017 – Certara®, the leading provider of decision support technology and consulting services for optimizing drug development and improving health outcomes, today announced that its scientists will be highlighting pharmacokinetic (PK) and pharmacodynamic (PD) modeling advances during 19 sessions at the American Society for Clinical Pharmacology and Therapeutics (ASCPT) 2017 Annual Meeting. This conference will be held from Mar. 15-18 at the Washington Marriott Wardman Park in Washington, DC.

“As model-informed drug discovery and development (MID3) is increasingly adopted by industry, academia and the global regulatory agencies, and its role in informing new drug labels grows, we are committed to continuing to share our experiences with our peers at ASCPT, and helping to propel the field forward,” said Chief Scientific Officer Amin Rostami, PharmD, PhD. “This year, we will be presenting empirical and mechanistic modeling of several vulnerable populations, including pediatric, oncology and organ-impaired patients.”

Certara’s contributions to this year’s ASCPT Annual Meeting are outlined below. The company will also have experts available to answer questions at booths 10 and 11.

Wednesday, Mar. 15


4:00-6:30 p.m.

  • LB-011: Development of a PK and PD Model to Quantitate the Effect of BIM23B065 on a Growth Hormone Stimulation Test – Piet van der Graaf (contributing author)
  • LB-024: On Early Pediatric Study Design: Sample Size Calculation Using PBPK Approach within the Simcyp Simulator – Farzaneh Salem
  • LB-036: Does Birth Change The Gestational Trajectory Of UGT2B7 Activity? Insight from Premature Post-menstrual Age and Different Gestational Age at Birth – Farzaneh Salem
  • LB-042: A PBPK Model for Cobicistat, a Potential Strong CYP3A4 Inhibitor for Clinical DDI Studies with CYP3A4 Victim Drugs – Lisa Almond

Thursday, Mar. 16


4:30-6:30 p.m.

  • PWIII-001: Clinical Application of PBPK Modeling: Mechanistic Insights into Variability in Morphine Clearance Among Pediatric Adult Patients – Trevor Johnson, Sibylle Neuhoff (contributing authors)
  • PWIII-005: Application of PBPK Modeling For Prediction of Buprenorphine Exposure In Subjects With Hepatic Impairment – Karen Rowland Yeo, Trevor Johnson

Friday, March 17


3:00-4:30 p.m.

  • Optimizing Maternal Influenza Immunization Timing to Best Protect Infants – Michael Dodds


7:00-9:00 a.m.

  • PII-017: PK Modeling and Simulations of Human Anti-C1s Antibody (TNT009) in Normal Human Volunteers and Patients with Complement-mediated Disorders – Colin Chang
  • PII-018: PK/PD Analysis of Human Anti-C1s Antibody (TNT009) and Classical Complement Pathway (CP) Activity – Colin Chang
  • PII-062: Evaluation of CYP2B6 Induction and Prediction of Clinical DDI using PBPK Modeling – Alice Ke
  • PII-091: PK/PD Analyses of ARQ 087, a Novel-Class of FGFR Inhibitors, in Subjects with Advanced Solid Tumors, Including Intrahepatic Cholangiocarcinoma – JF Marier
  • PII-122: Delineating the Role of Various Factors in Renal Disposition of Digoxin through Application of Physiologically-based Kidney Model to Renal Impairment Populations – Amin Rostami
  • PII-132: PBPK Modeling Prediction of Effect of Itraconazole on Pharmacokinetics of Olanzapine and Samidorphan Given in Combination as ALKS 3831 – Karen Rowland Yeo (contributing author)
  • PII-139: PK/PD Modeling of Functional Complement 1 Esterase Inhibitor and Complement 4 for the Prevention and Treatment of Hereditary Angioedema Attacks – JF Marier, Grygoriy Vasilinin (contributing authors)
  • PII-140: Population PK Modeling of Teduglutide to Support Dosing in Pediatric Patients with Short Bowel Syndrome – JF Marier, Nastya Kassir (contributing authors)
  • PII-144: Population PK of Rucaparib (CO-338) in Patients with Advanced Ovarian Cancer or Other Solid Tumors – Michelle Green (contributing author)
  • PII-154: Predictive Performance of PBPK Modeling of Sufentanil in Children – Trevor Johnson (contributing author)
  • PII-155: Application of PBPK Modeling to Predict Ondansetron PK in Children – Trevor Johnson (contributing author)

Saturday, Mar. 18


1:15-3:15 p.m.

  • Reflections on the Practice of R&D: Balancing Academic Curiosity Analyzing Observations for a Lifetime with Patient-centricity and Market-driven Necessities to Move Fast – Amin Rostami

Certara について
Certara is a leading decision support technology and consulting organization committed to optimizing drug development and improving health outcomes. Certara’s solutions, which span drug discovery through patient care, use the most scientifically-advanced modeling and simulation technologies and regulatory strategies to increase the probability of regulatory and commercial success. Its clients include hundreds of global biopharmaceutical companies, leading academic institutions, and key regulatory agencies.

Certara Contact:
Ellen Leinfuss, 609-216-9586
Chief Marketing Officer

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

Media Contact:

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