Certara thought leaders are contributing to workshops, presentations, posters, and a tutorial
PRINCETON, NJ – Oct. 13, 2017 – Certara®, the global leader in model-informed drug development and regulatory science, today announced that it is participating in 27 sessions at the eighth American Conference on Pharmacometrics (ACoP8). This annual International Society of Pharmacometrics (ISoP) conference will be held at the Marriott Resort: Harbor Beach Hotel in Fort Lauderdale, Fla. from Oct. 15-18.
“Pharmacometrics has progressed from being a scientific nicety to a regulatory necessity, a discipline that is employed at every step along the drug development path from discovery through to post-marketing requirements. For example, FDA’s Center for Drug Evaluation and Research is currently using modeling and simulation to predict clinical outcomes, inform clinical trial designs, support evidence of effectiveness, optimize dosing, predict product safety, and evaluate potential adverse event mechanisms1,” said Certara Chief Executive Officer Edmundo Muniz, MD, PhD. “As a leader in this field, Certara takes its responsibility to help further pharmacometric science and educate new pharmacometricians very seriously. We are delighted to play such an active role in ACoP8.”
Underscoring Certara’s commitment to pharmacometric education, its Director of Pharmacometrics Samer Mouksassi, PharmD, PhD, FCP, will be appointed Chair of the ISoP Education Committee during ACoP8.
Certara’s contributions to this year’s conference are described below:
Saturday, Oct. 14
Pre-meeting Workshop
8:00 am–5:00 pm
- Physiological Modeling of Therapeutic Proteins and Antibody-drug Conjugates
Sunday, Oct. 15
Pre-meeting Workshop
8:00 am–5:00 pm
- Bridging PBPK with PopPK for Pediatrics
Monday, Oct. 16
Presentations
11:30 am–1:00 pm
- Lunch and Learn—The Application of Pharmacometrics to the Development of Reversal Agents for Direct Oral Anticoagulants—Mark Lovern
2:15–3:45 pm
- Session 2a: How Model-based Meta-analysis Informs Drug Development in Autoimmune Diseases—Mark Lovern
4:00–5:30 pm
- Session 3c: QSP, IVIVE, PBPK, PKPD, MICE, CiPA, AP, QT, EAD, pseudoECG, and CV – Is It Just a Mess or a Real Step Forward in the Drug’s Cardiac Safety Assessment?—Sebastian Polak
Posters
7:00–9:00 am and 11:30 am–1:00 pm
- M-018: R-based VPC for Time-to-event Models with Non-linear Hazard Functions—Benjamin Rich, Samer Mouksassi
- M-063: PK/PD Model for BIIB059, a Monoclonal Antibody for the Treatment of Systemic and Cutaneous Lupus Erythematosus—Sonja Hartmann (contributing author)
Tuesday, Oct. 17
Posters
7:30–9:00 am and 12:15–1:30 pm
- T-002: Meta-analysis of HbA1c and Hypoglycemic Event Rates of Mealtime Insulins in Randomized Clinical Trials in T1DM Subjects: Exploration of POC Trial Design Options—Mark Lovern, Jos Lommerse, Jaap Mandema, Thomas Kerbusch (contributing authors)
- T-006: Simulation Re-estimation and Baysian Optimal Design for PopPK Studies—Kevin Feng, Robert Leary, Michael Dunlavey, Amin Rostami-Hodjegan
- T-012: nlmixr: An Open-source Package for Pharmacometric Modeling in R—Yuan Xiong (contributing author)
- T-032: Differentiation of Basal Insulins in Randomized Clinical Trials in T2DM Subjects: A Model-based Meta-analysis of HbA1c and Hypoglycemic Event Rates—Mark Lovern, Jos Lommerse, Jaap Mandema, Thomas Kerbusch (contributing authors)
- T-054: PharmTeX: A LaTeX-based Open-source Platform for Automated Reporting Workflow—Christian Hove Rasmussen
- T-073: Simulation Approach to Inform Modeling Analysis Plan to Assess Exposure-Response for Cognition Efficacy in an Alzheimer’s Disease Study—Huub J Kleijn (contributing author)
- T-084: Development and Integration of a Dynamic Lactation Model within a Full PBPK Model—Khaled Abduljalil, Trevor Johnson, Masoud Jamei
- T-088: A Regression Approach to Visual Predictive Checks for PopPK and PD Models—Kris Jamsen, Kashyap Patel, Keith Nieforth
Wednesday, Oct. 18
Presentations
9:00–10:30 am
- Session 6a: Update on the Initiative for “Influencing Source—Data Quality for Pharmacometric Dataset Creation”—Vishak Subramoney
10:45 am–12:15 pm
- Session 7a: Impact of Pharmacometrics in Immuno-oncology: The Example of Pembrolizumab—Rik de Greef
Tutorial
2:00–5:30 pm
- Tutorial 2: Modular Design of QSP Models? Examples in Immunogenicity and Immuno-oncology—Andrzej Kierzek
Posters
7:00–9:00 am and 1:00–2:00 pm
- W-001: An R-shiny Web Application to Support Early Assessment and Decision-making of Oncology Studies Using Multivariate Tumor Growth Inhibition and Overall Survival Disease Models —Mathilde Marchand
- W-017: An Integrated PBPK/PD Feedback Model to Predict Drug-drug Interactions Between Gastric Acid Reducing Agents and Drugs with pH-dependent Solubility—Rachel Rose, Shriram Pathak, Masoud Jamei
- W-026: Towards Virtual Exposure Assessment of Dermally-applied Drugs—PBPK Model of Buprenorphine Transdermal Patches—Sebastian Polak, Nikunjkumar Patel, Karen Rowland Yeo, Masoud Jamei
- W-032: An Application of PBPK/PD Model to Identify the Target Site of Prolactin Response Induced by D2 Receptor Antagonists: Which is the Target Site, Brain or Plasma?—Francisco Bellanti (contributing author)
- W-033: Implementation of Distributed Delays for Absorption Delays and Delayed Drug Response—Shuhua Hu, Michael Dunlavey, Serge Guzy, Nathan Teuscher
- W-045: Evaluation of Dosing Strategy for Pembrolizumab for Oncology Indications—Rik de Greef (contributing author)
- W-070: PBPK Modeling Prediction of CYP3A4 and CYP1A2 Inhibition or Induction on Exposure of Olanzapine and Samidorphan Given in Combination as ALKS 3831—Karen Rowland Yeo (contributing author)
- W-085: Characterization of Body Temperature, Heart Rate, and Sleeping Patterns in Preterm Neonates—Marc Pfister (contributing author)
- W-090: Application of PBPK Modeling to Predict Desloratadine Pharmacokinetics in Children—Trevor Johnson (contributing author)
Additional information about this conference is available at http://www.acop8.org.
Reference
- Dr. Gottlieb blog post: “How FDA Plans to Help Consumers Capitalize on Advances in Science.” FDA Voice. July 7, 2017.
About Certara
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.
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