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ACoP15 2024

ACoP15 2024

We are excited to be presenting at this conference

2024년 11월 10일 일요일​ | 8:00 AM – 5:00 PM MST​

Workshop: Simcyp Designer PBPK-QSP Focused Workshop, Certara​

Feliz Stader, PhD and Adriana Zyla, PhD

2024년 11월 10일 일요일​ | 8:00 AM – 5:00 PM MST​

Workshop: Modeling Delays in Pharmacokinetics and Pharmacodynamics using Phoenix, ISoP MCS SIG

발표자 Shuhua Hu, PhD, Principal Research Scientist

2024년 11월 10일 일요일​ | 8:15 AM – 9:00 AM MST​

Preconference: A brief history of model-informed discovery and development of advanced therapies​

Piet van der Graaf, PharmD, PhD

2024년 11월 11일 월요일 ​| 7:00 AM – 9:00 AM MST​

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

2024년 11월 11일 월요일 ​| 11:00 AM – 12:30 PM MST​

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​

2024년 11월 11일 월요일 ​| 11:00 AM – 12:30 PM MST​

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​

2024년 11월 11일 월요일 ​| 3:15 PM – 4:45 PM MST​

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

Mechanistic Modeling – QSP

PK/PD Analysis and Pharmacometrics

Certara.AI – GPTs specialized for the life sciences

Clinical and Pre-clinical Data

규제 제출물 작성

CODEX

Certara for Academia

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