Feliz Stader, PhD and Adriana Zyla, PhD

Piet van der Graaf, PharmD, PhD

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

日期：Monday, November 11
时间：7 – 9 a.m. MST
地点：Palm 3AB, Arizona Grand Resort

Chair: Piet van der Graaf, PharmD, PhD – Certara​
Chair and Speaker: Amitava Mitra, PhD – Clinical Pharmacology​
主讲人：Tommy Li, PhD – Genmab​
主讲人：Atiqur Rahman, PhD – FDA​

Chair: Karen Rowland Yeo, PhD – Certara UK Ltd​
Chair: Priya Jayachandran, PharmD, MSE – Regeneron Pharmaceuticals, Inc.​
主讲人：Walter K. Kraft, MD (he/him/his) – Thomas Jefferson University​
主讲人：Catriona Waitt, PhD – University of Liverpool, UK and Infectious Diseases Institute, Makerere University, Uganda​
主讲人：Elimika Pfuma Fletcher, PharmD, PhD – U.S. Food and Drug Administration​
主讲人：Lang Li​
主讲人：Sara Quinney​

Chair: Georgi Kapitanov, PhD – Certara / Applied BioMath​
Chair: Amita Joshi, PhD – Genentech, South San Francisco, CA​
主讲人：Mirjam Trame, Ph.D – Certara​
主讲人：Kapil Gadkar​
主讲人：Blerta Shtylla, PhD – Pharmacometrics & Systems Pharmacology, Pfizer Research and Development, La Jolla, CA​
Panelist: CJ Musante​
Panelist: Jin Jin​

Mirjam Trame, Ph.D

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​

Panelist: Stephen Duffull, PhD, Sr. Scientific Advisor

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​

Chair and Speaker: Monica Simeoni, PhD – Clinical Pharmacology Modelling and Simulation, Precision Medicine, GSK​
Chair: Phyllis Chan, PhD – Modeling & Simulation, Clinical Pharmacology, Genentech​
主讲人：Matthew L. Zierhut, PhD, VP Consulting, Certara
主讲人：Rana JREICH, PhD – Clinical Modeling, Clinical Modeling & Evidence Integration, Sanofi​
主讲人：Abhinav Kurumaddali, PhD – Advanced Pharmacometrics, QCP, Daiichi Sankyo​
主讲人：Elyes Dahmane, PhD – FDA​

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

利用新型深度学习模型进行药物浓度的药代动力学分析
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

使用 NMsim 在 R 中构建自动化药代动力学-药效学分析工作流程
Boris Grinshpun, Associate Director, Pharmacometrics, Certara

Optimizing oncology drug development

增强型确定性筛选设计为 CAR-T 细胞和淋巴清除疗法的 1 期筛选提供了高效率
Michael Dodds, Executive Director, Certara

尼拉帕利（Niraparib）群体药代动力学建模以评估不同吸收模型
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 — 用于早期肿瘤学试验总生存期预测的用户友好型应用程序
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

群体 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

贝米福斯布韦（Bemnifosbuvir）及其代谢物的综合群体药代动力学模型
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

剂量滴定对模拟灵活剂量临床试验中逻辑暴露-反应关系的影响
Bill Poland, Vice President, Lead Scientist, Certara

利用模拟结果为探索全人源抗 IL-6 抗体 TOUR006 治疗甲状腺眼病的 IIb 期试验确定剂量
Swati Debroy, Associate Director of Pharmacometrics, Certara

2024 年 11 月 11 日, 星期一
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

2024 年 11 月 12 日, 星期二
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

2024 年 11 月 13 日, 星期三
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

Before or after your visit to our booth, explore our “molecule to market” solution ecosystem through the resources below.

Certara MIDD

• 生物模拟和加速审批的智能解决方案

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 技术服务

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 平台简介
• Phoenix Hosted 概述
• Phoenix NLME for popPK
• Phoenix WinNonlin for non-compartmental analysis and PK, PD, and TK modeling
• Pirana 建模工作平台

Certara.AI – GPTs specialized for the life sciences

• Certara.AI

Clinical and Pre-clinical Data

• Certara Integral 数据存储库

监管写作

• 人工智能驱动的法规撰写

CODEX

• 减重（GLP-1）临床结果数据库
• CODEX Clinical Outcomes Database

Certara for Academia

• Certara 大学：成长为一名 PK/PD 科学家
• 利用行业领先的软件增强学生的能力
• 模型引导的药物开发（MIDD）学术卓越中心