Conference Presentations, Posters & Abstracts
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2012
March
Bruno R. Invited presentation on Oncology Drug-Disease Modeling Framework to Predict Clinical Endpoints, as part of workshop on "Should We Tolerate the Maximally Tolerated Dose for Targeted Anti-Cancer Agents?" To be presented at: American Society for Clinical Pharmacology and Therapeutics (ASCPT) Annual Meeting; March 12-17, 2012; National Harbor, Maryland.
Marier JF, Gosselin NH, Mouksassi MS, Kassir N, Yee S, Petersen C, Day W. POPULATION PK/PD MODELING OF VI-0521, A FIXED-DOSE COMBINATION PRODUCT OF IMMEDIATE-RELEASE PHENTERMINE AND CONTROLLED-RELEASE TOPIRAMATE FOR THE TREATMENT OF OBESITY. [poster presentation]. To be presented at: American Society for Clinical Pharmacology and Therapeutics (ASCPT) Annual Meeting; March 12-17, 2012; National Harbor, Maryland.
Marier JF, Kassir N, Mouksassi MS, Gosselin NH, Yee S, Petersen C, Day W. POPULATION PK MODELING OF IMMEDIATE-RELEASE PHENTERMINE AND MODIFIED-RELEASE TOPIRAMATE ADMINISTERED AS A FIXED-DOSE COMBINATION PRODUCT (VI-0521). [poster presentation]. To be presented at: American Society for Clinical Pharmacology and Therapeutics (ASCPT) Annual Meeting; March 12-17, 2012; National Harbor, Maryland.
Graham RA, Chang I, Jin JY, Wang B, Dufek MB, Ayache J, Ezzet F, Zerivitz K, Low J, Dresser MJ. DAILY DOSING OF VISOMODEGIB TO STEADY-STATE DOES NOT PROLONG THE QTc INTERVAL IN HEALTHY VOLUNTEERS. [poster presentation]. To be presented at: American Society for Clinical Pharmacology and Therapeutics (ASCPT) Annual Meeting; March 12-17, 2012; National Harbor, Maryland.
Marier JF, Jomphe C, McCauley TJ, Beliveau M. Pharmacokinetic and Pharmacodynamic (PK/PD) Correlation of Idursulfase in Cerebro Spinal Fluid (CSF) of Cynomolgus Monkeys after Intrathecal (IT) and Intravenous (IV) Administration. [poster presentation]. To be presented at Society of Toxicology (SOT) Annual Meeting; March 11-15, 2012; San Francisco, California.
Jomphe C, McCauley TG, Marier JF, Beliveau M. Pharmacokinetics (PK) of Arylsufatase A and Idursulfase in Cynomolgus Monkeys Cerobro-Spinal Fluid (CSF) after Intrathecal (IT) Administration. [poster presentation]. To be presented at Society of Toxicology (SOT) Annual Meeting; March 11-15, 2012; San Francisco, California.
McCauley TG, Jomphe C, Marier JF, Beliveau M. Pharmacokinetics (PK) of Arylsufatase A and Idursulfase in Cynomolgus Monkeys Serum after Intravenous (IV) Administration. [poster presentation]. To be presented at Society of Toxicology (SOT) Annual Meeting; March 11-15, 2012; San Francisco, California.
Beliveau M, McCauley TG, Jomphe C, Marier JF. Sytemic and Central Nervous System (CNS) Distribution of Arylsufatase A and Idursulfase in Cynomolgus Monkeys after Intrathecal (IT) and Intravenous (IV) Administration. [poster presentation]. To be presented at Society of Toxicology (SOT) Annual Meeting; March 11-15, 2012; San Francisco, California.
Poulin P, Tolomeo T, Lemire I, Leonard P, Marier JF, Beliveau M. Role of the Asialoglycoprotein Receptors in Predicting the Systemic Clearance of ENB-0040, a Human Recombinant Tissue Non-Specific Alkaline Phosphatase Currently Being Developed for the Treatment of Hypophosphatasia. [poster presentation]. To be presented at Society of Toxicology (SOT) Annual Meeting; March 11-15, 2012; San Francisco, California.
2011
December
Bruno R, Jonsson F, Zaki M, Jacques C, Richardson P, Rajkumar SV, Claret L. [poster presentation]. Simulation of Clinical Outcome for Pomalidomide plus Low-Dose Dexamethasone in Patients With Refractory Multiple Myeloma Based on Week 8 M-Protein Response. [poster presentation]. Presented at: American Society of Hematology (ASH) Annual Meeting and Exposition; December 10-13, 2011; San Diego, California.
November
Reyderman L, Darpo B, Carrothers TJ, Kristensen A. Analysis of the concentration-QTc relationship for eribulin mesylate. [poster presentation]. Presented at: AACR-NCI-EORTC International Conference on
Molecular Targets and Cancer Therapeutics; November 12-16, 2011; San Francisco, California.
Liang E, Wagg J, Jonsson F, Cedarbaum J, Abushakra S. Correlations of Pharmacokinetic (PK) Measures to Pharmacodynamic (PD) Effects of ELND005 (Scyllo-inositol) from a Phase 2 Dose-Ranging Study in Mild to Moderate Alzheimer's Disease. [poster presentation]. Presented at: Clinical Trials on Alzheimer's Disease 4th Annual Conference; November 3-5, 2011; San Diego, California.
October
Miller B, Hershberger E, Chandorkar G, Friedland I, Umeh O, Mouksassi S, Fenneteau F, Marier JF. Probability of Target Attainment (PTA) of CXA-201 in Patients with Renal Hyperclearance. [poster presentation]. Presented at: 49th Annual Meeting of the Infectious Diseases Society of America (IDSA); October 20-23, 2011; Boston, Massachusetts.
September
Wagg J. Bridging Ethnic Factors in Pharmacometric Modeling and Simulation of Clinical Trials. [invited presentation]. Presented at: Kitasato-Harvard Symposium on Advanced and Global Drug Development; September 27-28; 2011; Tokyo, Japan.
Claret L, Jonsson F, Zaki M, Jacques C, Richardson P, Rajkumar VS, Bruno R. Simulation of clinical endpoints (survival, PFS) in patients with refractory multiple myeloma treated with pomalidomide based on interim week 8 M-protein response. [poster presentation]. Presented at: The European Multidisciplinary Cancer Congress; September 23-27, 2011; Stockholm, Sweden.
Claret L, Chanu P, Lindbom L, Stark FS, Gilberg F, Frey N, Bruno R. Clinical trial simulations to assess capecitabine dose reduction in combination with docetaxel in second line treatment of metastatic breast cancer. [poster presentation]. Presented at: The European Multidisciplinary Cancer Congress; September 23-27, 2011; Stockholm, Sweden
Miller B, Hershberger E, Mouksassi MS, Benziger DP, Steenbergen J, Fenneteau F, Marier JF, Friedland I. CXA-201 (CXA/TAZ) Dose Selection Based on Probability of Target Attainment (PTA) and Drug Exposure in Subjects with Varying Degrees of Renal Impairment (RI). [presentation]. Presented at: Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC); September 17-20, 2011; Chicago, Illinois.
Marier JF. Target-Based Dosing Strategies of Monoclonal Antibodies: Applications to Special Populations. [invited presentation]. Presented at: American College of Clinical Pharmacology (ACCP) Annual Meeting; September 11-13, 2011; Chicago, Illinois.
Carrothers TJ. Modeling and simulation of the exposure-QTc relationship: from preclinical to early clinical to the TQT study. [invited presentation]. Presented at: 2nd DIA Cardiac Safety Workshop in Japan; September 5-6, 2011; Tokyo, Japan.
Bax L. Contemporary Topics In Meta-analysis For Drug Development And Evaluation. [invited presentation]. Presented at: Japanese Conference on Pharmacometrics (JCoP); September 2-3, 2011; Tokyo, Japan.
July
Cedarbaum JM, Wagg JK. Predicting Initial Changes in Brain Volume with Effective Anti-Amyloid Agents: Just Ask Alice. [poster presentation]. Presented at: International Conference on Alzheimer's Disease (ICAD); July 16-21, 2011; Paris, France.
Liang E, Cedarbaum JM, Abushakra S, Green M, Yan L, Wagg JK. Population Pharmacokinetic Analysis of Plasma, Cerebrospinal Fluid, and Brain ELND005 in Patients with Mild to Moderate Alzheimer’s Disease. [poster presentation]. Presented at: International Conference on Alzheimer's Disease (ICAD); July 16-21, 2011; Paris, France.
June
Poland B, Kastrissios H, Gupta S, Stone J. Population Pharmacokinetic Analysis Finds No Clinically Important Effects of Demographic and Health Covariates on Boceprevir Exposure. [abstract driven presentation]. Presented at: 6th International Workshop on Clinical Pharmacology of Hepatitis Therapy; June 22-23, 2011; Boston, MA.
The following posters were presented at the Annual Meeting of the Population Approach Group in Europe (PAGE); June 7-10, 2011; Athens, Greece.
Pediatrics
Chanu P, Gao X, Smith M, Bruno R, Harnisch L. A dose selection rationale based on hemodynamics for sildenafil in pediatric patients with pulmonary arterial hypertension (PAH).
Methodology and Applications: Cardiovascular
Facius A, Claret L, Bruno R, Lahu G, Bredenbröcker D. Modelling and Simulation based Techniques to support Trial Design and Submission of Daxas.
Ezzet F, Correa I. Meta-Analysis of Antiplatelets in Patients with Atrial Fibrillation: A Survival Model.
Estimation Methods
Leary RH, Chittenden J, Dunlavey M, Matzuka B. Exact Reproducibility of Population PK/PD NLME Numerical Results across Different Computational Environments.
Chitenden J, Leary RH, Matzuka B, Dunlavey M. Evaluation of the Lindstrom-Bates FOCE Algorithm with Simulated Pharmacokinetic Datasets.
May
Harnisch LO, Chanu P, Gao X, Smith M, Bruno R. Hemodynamics As An Additional Measure To Prove Efficacy And To Provide A Dose Rationale For Sildenafil In Pediatric Patients With Pulmonary Arterial Hypertension (PAH). [poster presentation]. Presented at: American Thoracic Society (ATS) International Conference; May 13-18; Denver, Colorado.
Hershberger E, Mouksassi M, Steenbergen J, Benziger D, Fenneteau F, Marier JF. CXA-101/tazobactam probability of target attainment using population pharma-cokinetic analysis. [poster presentation]. Presented at: 21st European Congress of Clinical Microbiology and Infectious Diseases (ECCMID)/27th Intl. Congress of Chemotherapy (ICC); May 7-10, 2011; Milan, Italy.
Hershberger E, Benziger D, Pheng L, Trinh M, Marier JF. Pharmacokinetics of CXA-101/tazobactam in subjects with mild or moderate renal impairment. [poster presentation]. Presented at: 21st European Congress of Clinical Microbiology and Infectious Diseases (ECCMID)/27th Intl. Congress of Chemotherapy (ICC); May 7-10, 2011; Milan, Italy.
April
The following posters were presented at the American Conference on Pharmacometrics (ACoP); April 3-6, 2011; San Diego, CA.
PK/PD and Mechanistic Modeling
Fenneteau F, Kassir N, Mouksassi MS, Merdjan H, Marier JF, Hershberger E, Benziger D. Population PK/PD Modeling and Simulations of a Fixed-Dose Combination of CXA 101 and Tazobactam to Optimize Dosing Strategies in Renal Impaired Patients With Complicated Urinary Tract Infection.
Prins NH, Green M, Haughie S, Johnson P, Martin SW. Use of Model Based Meta-Analysis Combining Patient-Level with Summary-Level Data Using Multilevel Random Effects to Provide a Quantitative Assessment of the Clinical Efficacy (IPSS) Profile and Competitive Positioning of a PDE5 Inhibitor (UK369,003).
Gupta M, Wang B, Carrothers TJ, Joshi A, LoRusso P, Chu W, Shih T, Loecke D, Girish S. Exposure-Response Analysis in Patients with HER2-positive (HER2+) Metastatic Breast Cancer (MBC) to Assess the Effect of T-DM1 on QTc Prolongation.
Gohore DG, Fenneteau F, Barrire O, Li J, Nekka F. Rational Drug Delineation: A Global Sensitivity Approach based on Therapeutic Tolerability to Deviations in Execution.
Special Populations - Pediatrics
Marier JF, Mouksassi MS, Gosselin NH, Breitmeyer J, Royal M. Application of Trial Simulations to Support Optimal Dosing of Intravenous Acetaminophen in Pediatric Patients: Regulatory Approval of the Product Based on a Minimum Number of Patients.
Mouksassi MS, Gosselin NH, Fenneteau F, Kassir N, Rich B, Marier JF. A Novel GAMLSS Model to Facilitate Simulations of Demographic Covariates in Special Populations: Selection of Realistic Covariates in Pediatric and Geriatric Patients in Clinical Trial Simulations to Optimize Dosing.
Smith MK, Harnisch L, Chanu P, Gao X, Bruno R. Hemodynamics as an Additional Measure to Prove Efficacy and to Provide a Dose Rationale for Sildenafil in Pediatric Patients With Pulmonary Arterial Hypertension (PAH).
Kassir N, Delaloye JR, Mouksassi MS, Lapeyraque AL, Labbe L, Alvarez F, Lallier M, Beaunoyer M, Theoret Y, Litalien C. An Optimal Sampling Strategy for Tacrolimus in Pediatric Liver Transplant Recipients Based on a Population Pharmacokinetic Model.
Clinical Applications - Antiviral
Poland B, Caro L, Green M, Nachbar B, Wenning L, Khan A, Wright H, Saltzman J, Stone J. Viral Dynamics Modeling and Simulation of the HCV Protease Inhibitor MK-7009 (Vaniprevir) with Peg-Interferon and Ribavirin.
Levi M, Frey N, Lemenuel A, Chanu P.Mechanistic Viral Kinetic (VK) modeling of a triple therapy for Hepatitis C: a protease inhibitor (Danoprevir) in combination with Pegasys® (PEG-IFN alpha-2a ) and Copegus® (Ribavirin).
Tools and Techniques
Mouksassi MS, Gosselin NH, Kassir N, Fenneteau F, Rich B, Marier JF. Cluster Analyses, Logistic Regressions, and Receiver Operator Characteristics (ROC) to Complement PK/PD Modeling: Case Studies for Immunomodulator, Anti-Depressive, and Anti-Diabetes Products.
Mouksassi MS, Beliveau M, Guinan E, Moore H, Gomeni R, Li X, Della Pasqua O, Weiner D, Hoke. Streamlining Pharmacometric Analyses Utilizing Multiple Data Management and Modeling Tools.
Bax L, Moons K, Satoh T, Carrothers TJ, Poland B. Graphical Assessments in Aggregate Level Meta-analysis; an Illustration with Clozapine Data.
Poland B. Extending Clinical Utility Analyses to Economic Decision Analyses.
Chittenden J. Estimating a Time-Variant Pharmacokinetic Parameter as a Random Process.
Leary RL, Dunlavey M. QRPEM, A Quasi-random Parametric EM Method for PK/PD NLME Estimation.
March
Royal MA, Marier JF, Ang R, Pan C, Breitmeyer JB. IV Acetaminophen Dosing Simulations in Neonates and Infants. [poster presentation]. Presented at American Society of Pediatric Anesthesiology Meeting; March 31 - April 3, 2011; San Diego, California.
Poland B. When Pharmacometrics is Not Enough: Incorporating Utility and Economic Modeling. Invited oral presentation, as part of panel on 'Extending Pharmacometrics to Strategic Decisions.' Presented at: American Society for Clinical Pharmacology and Therapeutics (ASCPT) Annual Meeting; March 2-5, 2011; Dallas, Texas.
Kassir N, Savant I, Mouksassi MS, Marier JF, Zhu W, Lau H. POPULATION PK AND EXPOSURE-RESPONSE ANALYSES OF APREMILAST IN SUBJECTS WITH ACTIVE PSORIATIC ARTHRITIS. [poster presentation]. Presented at: American Society for Clinical Pharmacology and Therapeutics (ASCPT) Annual Meeting; March 2-5, 2011; Dallas, Texas.
Gosselin NH, Hsu CP, Mouksassi MS, Lu JF. POPULATION PHARMACOKINETIC (PK) MODELING OF CONATUMUMAB (CON) IN CANCER PATIENTS (PTS). [poster presentation]. Presented at: American Society for Clinical Pharmacology and Therapeutics (ASCPT) Annual Meeting; March 2-5, 2011; Dallas, Texas.
Marier JF, Beliveau M, Stewart A, Jhee S, Ereshefsky L, Yen M, Moran S, Kim E, Fox A, Morimoto B. DAVUNETIDE PHARMACOKINETICS IN PLASMA AND CSF OF ALZHEIMER’S PATIENTS AND HEALTHY VOLUNTEERS. [poster presentation]. Presented at: American Society for Clinical Pharmacology and Therapeutics (ASCPT) Annual Meeting; March 2-5, 2011; Dallas, Texas.
Marier JF, Trinh MM, Pheng LH, Mouksassi MS, Benziger D. POPULATION PK ANALYSIS OF INTRAVENOUS CXA-101 IN SUBJECTS WITH COMPLICATED URINARY TRACT INFECTION, INCLUDING PYELONEPHRITIS. [poster presentation]. Presented at: American Society for Clinical Pharmacology and Therapeutics (ASCPT) Annual Meeting; March 2-5, 2011; Dallas, Texas.
Gupta M, Wang B, Carrothers T, Joshi A, LoRusso PM, Chu W, Shih T, Loecke D, Girish S. EXPOSURE-RESPONSE ANALYSIS IN PATIENTS WITH HER2-POSITIVE (HER2+) METASTATIC BREAST CANCER (MBC) TO ASSESS THE EFFECT OF T-DM1 ON QTC PROLONGATION. [poster presentation]. Presented at: American Society for Clinical Pharmacology and Therapeutics (ASCPT) Annual Meeting; March 2-5, 2011; Dallas, Texas.
Hammer G, Yaster M, Royal MA, Marier JF, Gosselin NH, Mouksassi S, Ang R, Hardalo C, Pan C, Breitmeyer JB. IV Acetaminophen Dosing Simulations in Neonates and Infants. [poster presentation]. Presented at: American Society for Clinical Pharmacology and Therapeutics (ASCPT) Annual Meeting; March 2-5, 2011; Dallas, Texas.
Dart R, Cantrell L, Offerman SR, Heard K, Krenzelok EP, Rumack B, Gosselin NH, Mouksassi S, Marier JF, Hardalo C, Breitmayer JB, Royal MA. IV Acetaminophen Overdose Simulations: Guidance for Making Decisions on Early Treatment of IV Overdoses. [poster presentation]. Presented at: American Society for Clinical Pharmacology and Therapeutics (ASCPT) Annual Meeting; March 2-5, 2011; Dallas, Texas.
Jomphe C, Lemire I, Leonard P, Reimer MJ, Beliveau M. Species-Specific Factors when Predicting Systemic Clearance in Rabbits via an Allometic Scaling Approach. [poster presentation]. Presented at: Society of Toxicology (SOT) Annual Meeting; March 6-10, 2011; Washington, DC.
February
Wagg J. Population Pharmacokinetics and PK-PD Correlation. [invited presentation]. Presented at: Applied Pharmaceutical Analysis - India 2011; February 6-9, 2011; Hyderabad, India.
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