ACoP15 2024
We are excited to be presenting at this conference
Workshop: Simcyp Designer PBPK-QSP Focused Workshop, Certara
Feliz Stader, PhD and Adriana Zyla, PhD
Workshop: Modeling Delays in Pharmacokinetics and Pharmacodynamics using Phoenix, ISoP MCS SIG
발표자 Shuhua Hu, PhD, Principal Research Scientist
Preconference: A brief history of model-informed discovery and development of advanced therapies
Piet van der Graaf, PharmD, PhD
ACoP CODEX Customer Council – Monday, November 11
Join us at ACOP for the first ever CODEX Customer Council. We’re bringing together your peers and Certara experts to share how organizations are using the industry’s leading clinical outcomes database to inform critical drug development decisions.
Complimentary breakfast and plenty of coffee will be available.
Featured Speakers
- Monica Simeoni, Director, Clinical Pharmacology Modeling & Simulation, GSK
- Garrett Nieddu, Associate Director, Quantitative Pharmacology and Pharmacometrics, Merck
- Matt Zierhut, VP, Integrated Drug Development, Certara
- Nick Brown, Director, Global Portfolio Lead for Certara.AI
Event Details
Date: Monday, November 11
시간:7 – 9 a.m. MST
Where: Palm 3AB, Arizona Grand Resort
C1A – Quantitative Systems Pharmacology in Late Stage Oncology Drug Development– New Horizons to Dose Optimization
Chair: Piet van der Graaf, PharmD, PhD – Certara
Chair and Speaker: Amitava Mitra, PhD – Clinical Pharmacology
발표자 Tommy Li, PhD – Genmab
발표자 Atiqur Rahman, PhD – FDA
C1C – Modeling approaches in pregnancy and lactation for drug development: operational, ethical and regulatory perspectives
Chair: Karen Rowland Yeo, PhD – Certara UK Ltd
Chair: Priya Jayachandran, PharmD, MSE – Regeneron Pharmaceuticals, Inc.
발표자 Walter K. Kraft, MD (he/him/his) – Thomas Jefferson University
발표자 Catriona Waitt, PhD – University of Liverpool, UK and Infectious Diseases Institute, Makerere University, Uganda
발표자 Elimika Pfuma Fletcher, PharmD, PhD – U.S. Food and Drug Administration
발표자 Lang Li
발표자 Sara Quinney
C2B – Mind the gap – successful bridging of QSP and PMX in drug development
Chair: Georgi Kapitanov, PhD – Certara / Applied BioMath
Chair: Amita Joshi, PhD – Genentech, South San Francisco, CA
발표자 Mirjam Trame, Ph.D – Certara
발표자 Kapil Gadkar
발표자 Blerta Shtylla, PhD – Pharmacometrics & Systems Pharmacology, Pfizer Research and Development, La Jolla, CA
Panelist: CJ Musante
Panelist: Jin Jin
Joined PMX and QSP modeling to guide step-up dosing of a bispecific antibody for prostate cancer
Mirjam Trame, Ph.D
Panel Discussion
Panelist: Amita Joshi, PhD – Genentech, South San Francisco, CA
Panelist: Mirjam Trame, Ph.D – Certara
Panelist: Blerta Shtylla, PhD – Pharmacometrics & Systems Pharmacology, Pfizer Research and Development, La Jolla, CA
Panelist: Kapil Gadkar
Panelist: CJ Musante
Panelist: Jin Jin
Panel Discussion
Panelist: Stephen Duffull, PhD, Sr. Scientific Advisor
Tutorial: Using Past Models to Bridge to Open Models and Open Science using nlmixr2
Chair: Matthew L. Fidler, M.Stat., PhD (he/him/his) – Novartis
Speaker and Panelist: William S Denney, PhD (he/him/his) – Human Predictions
Speaker and Panelist: Mirjam Trame, Ph.D – Certara
Speaker and Panelist: Justin J. Wilkins, PhD (he/him/his) – Occams
Tutorial: Model-Based Meta-Analysis: towards more precisely predicted clinical scenarios
Chair and Speaker: Monica Simeoni, PhD – Clinical Pharmacology Modelling and Simulation, Precision Medicine, GSK
Chair: Phyllis Chan, PhD – Modeling & Simulation, Clinical Pharmacology, Genentech
발표자 Matthew L. Zierhut, PhD, VP Consulting, Certara
발표자 Rana JREICH, PhD – Clinical Modeling, Clinical Modeling & Evidence Integration, Sanofi
발표자 Abhinav Kurumaddali, PhD – Advanced Pharmacometrics, QCP, Daiichi Sankyo
발표자 Elyes Dahmane, PhD – FDA
Certara Posters and Abstracts
Mechanistic modeling in AD
A quantitative systems pharmacology (QSP) model to enable prediction of ARIA-E incidence with anti-Aβ monoclonal antibody therapies for Alzheimer’s disease
Sarah DiBartolo, Senior Scientist, Certara
Development and application of a mechanistic model for Alzheimer’s Disease
Stephen Duffull, Senior Scientific Advisor, Certara
Novel approaches
A Pharmacokinetic Analysis of Drug Concentration Using a Novel Deep Learning Model
Ayman Akil, Director, Pharmacometrics & Machine Learning, Certara
A Scalable Cloud-Based QSP Modeling System for Virtual Patient Generation
Andrew Matteson, Director of Product, Certara
Automatic differentiation, a possible solution to numerical instability in Population PK parameter estimation
Mark Sale, Vice President, Certara
Building Automated Pharmacometrics Analysis Workflows in R with NMsim
Boris Grinshpun, Associate Director, Pharmacometrics, Certara
Optimizing oncology drug development
Augmented Definitive Screening Design Provides Efficient Phase 1 Selection of CAR T-cell and Lymphodepletion Regimen
Michael Dodds, Executive Director, Certara
Population Pharmacokinetic Modeling of Niraparib to Assess Different Absorption Models
Anna Gaffney, Scientist, Pharmacometrics, Certara
Preclinical data exposures underpredict clinical physiologically active doses for bispecific TCEs in solid tumors indications; are there better metrics? – insights from a small mechanistic MBMA
Georgi Kapitanov, Senior Director, QSP, Certara
A Model-Informed Drug Development Framework for the Development and Dose Optimization of Targeted Radiation Therapies
Hunter Stephens, Associate Scientist, Pharmacometrics, Certara
Oncology MIDD Simulator, A User-Friendly Application for Overall Survival Forecasting in Early Oncology Trials
Mourad HAMIMED, Scientist, Clinical Pharmacometrics, Certara
Impact of PD-L2 on Relative Efficacy of Anti-PD-1 and Anti-PD-L1 Antibodies: Insights From QSP-Based Meta-Analysis
Carter Johnson, Senior Scientist, Certara
Simultaneous Population PKPD Analysis of Belantamab Mafodotin, Soluble BCMA, and Serum M-Protein in Subjects With Relapsed/Refractory Multiple Myeloma (RRMM)
Inmaculada C. Sorribes, Associate Director, QSP, Certara
Population pharmacokinetics of revumenib in patients with relapsed/refractory acute leukemias
YU-WEI LIN, Pharmacometrician, Certara
PBPK
Revumenib physiologically based pharmacokinetic model for evaluation of age effect and CYP3A4-mediated drug-drug interaction in relapsed/refractory acute leukemias
Alenka Chapron, PBPK Consultant, Certara
Real world examples of PBPK impact on CYP3A4 victim DDI drug label content
Ian Templeton, Senior Director, PBPK Consultancy, Certara
Pharmacometrics in the development of oligonucleotides
K-PD model of Plozasiran in Patients with Severe Hypertriglyceridemia
Nathalie Gosselin, Senior Director, Certara
K-PD Modeling of Plozasiran – Mixed Hyperlipidemia
Nathalie Gosselin, Senior Director, Certara
Population PK
Population pharmacokinetic modeling of TBA-7371 in healthy participants describes apparent auto-induction of clearance and predicts PK of participants with Mycobacterium tuberculosis
David Salinger, Senior Director, Certara
Integrated Population Pharmacokinetic Model of Bemnifosbuvir and Metabolites
Christine Neumar, PhD, Associate Director, Pharmacometrics, Certara
Acoramidis (ALXN2060) Population Pharmacokinetic Modeling and the Importance of Exploring Categorization of Covariate Values
Bill Poland, Vice President, Lead Scientist, Certara
Understanding exposure-response
Direct and Indirect Exposure-Response Modeling for Transthyretin Amyloid Cardiomyopathy Treated with Acoramidis
Co-authors:
Bill Polland, PhD, Vice President, Lead Scientist, Certara
Brian Adam, PhD, Scientist, Certara
Impacts of dose titration on logistic exposure-response in simulated flexible-dose clinical trials
Bill Poland, Vice President, Lead Scientist, Certara
Simulations to Inform Dose Selection for a Phase 2b Trial Investigating TOUR006, a Fully Human Anti-IL6 Antibody, for Treatment of Thyroid Eye Disease
Swati Debroy, Associate Director of Pharmacometrics, Certara
Join us at Booth #4 & 5 for a Demo!
2024년 11월 11일 월요일
7:00 AM – 9:00 AM – Booth Hours
12:45 PM – 2:15 PM – Booth Hours
12:15pm-12:45pm
Phoenix – PK/PD Analysis and Pharmacometrics
Keith Nieforth, Shuhua Hu
1:00pm-2:15pm
Simcyp (PBPK Platform, Simcyp Discovery, Simcyp Biopharmaceutics) – Mechanistic Modeling – PBPK
Himanshu Mishra
3:30 PM-5:00 PM – Booth Hours
3:30pm – 4:00pm
CODEX Analytics App- Software to enable intuitive exploration and analyses of clinical outcomes databases
Matt Zierhut
2024년 11월 12일 화요일
7:00 AM – 9:00 AM – Booth Hours
12:30 PM – 2:00 PM – Booth Hours
12:30pm-1:00pm
Simcyp (PBPK Platform, Simcyp Discovery, Simcyp Biopharmaceutics) – Mechanistic Modeling – PBPK
Himanshu Mishra
1:15pm-1:45pm
Phoenix – PK/PD Analysis and Pharmacometrics
Keith Nieforth, Shuhua Hu
3:30 PM – 5:00 PM – Booth Hours
3:30pm – 4:00pm
MIDD Oncology Simulator
Adekemi Taylor
4:15pm – 4:45pm
Assess– Mechanistic Modeling – Web based early-stage drug discovery and development applications
Andrew Matteson
2024년 11월 13일 수요일
7:00 AM – 9:00 AM – Booth Hours
12:00 PM – 1:45 PM – Booth Hours
12:00pm – 12:30pm
CODEX Analytics App- Software to enable intuitive exploration and analyses of clinical outcomes databases
Matt Zierhut
12:45pm-1:15pm
Assess – Web based early-stage drug discovery and development applications
Andrew Matteson
Additional Resources
Before or after your visit to our booth, explore our “molecule to market” solution ecosystem through the resources below.
Certara MIDD
Translational and Preclinical
Mechanistic Modeling – PBPK
- Simcyp™ PBPK Simulator Brochure
- What’s New in the Simcyp™ Simulator – from Regulatory Advances to New Modalities [On-Demand Webinar]
- Simcyp™ PBPK Simulator Software
- Simcyp™ PBPK 기술 기반 서비스
Mechanistic Modeling – QSP
- [Webinar] QSP Modeling for FIH Starting Dose in Oncology
- [Webinar] Bridging the Gap: Integrating Pharmacometrics with QSP for Smoother Clinical Phase Transitions
- [Blog] Four Ways that Mechanistic Modeling Accelerates Bispecific (and Multispecific) Antibody Drug Development
- [Publication with Ichnos Glenmark Innovation] ISB 2011 trispecific T cell engager shows strong tumor cytotoxicity and overcomes immune escape mechanisms of multiple myeloma cells
- [Customer Success Story with CDR-Life] Systems Modeling Delivers Efficiencies and Savings in Clinical Development
PK/PD Analysis and Pharmacometrics
- Phoenix™ PK/PD Platform Overview
- Phoenix Hosted 개요
- Phoenix NLME for popPK
- Phoenix WinNonlin for non-compartmental analysis and PK, PD, and TK modeling
- Pirana 모델링 워크벤치
Certara.AI – GPTs specialized for the life sciences
Clinical and Pre-clinical Data
규제 제출물 작성
CODEX
Certara for Academia