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Sessions: ​

Suzhou​
Thursday, September 3, 1pm – 5pm, Adocklab​

Beijing​
Tuesday, September 8, 1pm – 5pm, Yizhuang Biomedical Park​

Summary

Join this interactive workshop to explore how Model-Informed Drug Development (MIDD) approaches can accelerate decision-making across the drug development lifecycle — from early discovery to market access.​

​Through expert-led sessions and real-world case studies, participants will learn how modeling and simulation approaches, including QSP, PBPK, and Pharmacometrics, can support data-driven decision-making, optimize development strategies, and generate quantitative insights throughout the drug development process.

Benefits of the event

  • Understand the role of MIDD in accelerating drug development and improving decision-making​
  • Explore real-world applications of QSP, PBPK, and Pharmacometrics across different therapeutic modalities​
  • Learn how modeling approaches support complex modalities, special populations, DDIs, and dose optimization​
  • Gain insights into quantitative strategies for regulatory submissions and market access in global markets​
  • Discover software solutions that enable scalable modeling and simulation workflows

Register now


Who should attend

This workshop is designed for professionals involved in drug development, including:​

  • Clinical Pharmacologists and Pharmacometrics scientists​
  • QSP and PBPK modelers​
  • Translational Medicine and DMPK researchers​
  • Discovery and development scientists​
  • R&D strategy and project leaders seeking to leverage MIDD approaches for faster, smarter drug development

Location

Agenda

13:00
Reception opens
13:30
Opening & MIDD Overview
13:40
QSP as a Bridge: Translating Complex Biologic Mechanisms to Decisions
14:20
Leveraging PBPK for Small Molecule Therapeutics: Case Studies in Special Populations and DDI Prediction
14:50
Tea Break
15:10
MIDD in Action: How Modeling Shapes What's on the Label
15:40
Navigating US & EU Market Access: How MIDD Accelerates Approval and Optimizes Market Entry
16:10
From Data to Decisions: Integrating QSP-PBPK-Pharmacometrics Software in Drug Development
16:40
Closing

Speakers:

Caroline Mello

Portfolio Account Manager, Certara

Caroline is a Portfolio Account Manager at Certara specializing in modeling and simulation, including QSP, PBPK, and Pharmacometrics. She joined Certara via the acquisition of Applied BioMath, which focused on QSP for complex biologics. With a background in biochemistry and medicine, she is passionate about accelerating better therapeutics to patients through modeling and simulation.

Jia Ning, PhD

Senior PBPK Consultant

Jia Ning, PhD joined Certara’s Simcyp group in 2019. She is primarily responsible for establishing PBPK models for drugs, predicting drug-drug interactions (DDI), and predicting pharmacokinetics (PK) in special populations.

She conducted research at Wageningen University in the Netherlands from 2015 to 2019. She excels in using PBPK models to predict hepatotoxicity of drugs and comparing differences between species and ethnic groups.

Yu-Wei(Wayne) Lin, PhD

Senior Director, Drug Development Solutions, Certara​

Dr Yu-Wei Lin is Senior Director of Pharmacometrics and APAC Quantitative Sciences Solutions Team Lead at Certara. He is an experienced pharmacometrician with expertise across population PK/PD, exposure–response, translational modelling, and model-informed drug development. His work spans oncology, monoclonal antibodies, antibody–drug conjugates, infectious diseases, and complex biologics, supporting dose optimization, regulatory strategy, and clinical development decision-making.​

​Dr Lin has led and contributed to global modelling and simulation programs across early- and late-stage development, including ADC-related quantitative pharmacology strategies. In addition to his role at Certara, he holds academic appointments and maintains an active research portfolio in antimicrobial PK/PD, AI-enabled pharmacometrics, and translational drug development.​

Alex Gee

Senior Director, Certara

Alex has over 30 years’ experience in the pharma industry, having worked in both biotechs and large pharma including Novartis, UCB and GSK. For the last 15 years he has been working in market access consultancy helping global clients achieve their access and commercial goals.

Ruijuan Zhu

APAC Solutions Consultant, Certara​

Ruijuan Zhu graduated from East China Normal University and worked as a visiting scholar at the University of Houston, US. As a specialist in bioinformatics, she has accumulated extensive experience in disease detection and pharmaceutical R&D. Now serving as a solutions consultant at Certara, she masters the application of D360 for expediting drug discovery, proficiently analyzes and reviews nonclinical data via SEND Explorer, and fully understands how P21E enables CDISC-aligned data organization and streamlines project regulatory submissions.​