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Conference: ISSX 2025 International Meeting

Date: September 12 - 14, 2025

Location: Chicago, Illinois

Booth: 315

In the spirit of the 14th International ISSX meeting theme “New Frontiers and Challenges: Novel Therapeutic Modalities, Technologies and Approaches” Certara will showcase technology innovations and expert solutions to help companies operate with greater certainty across the early stages of drug development. Visit us at Booth #315 to learn more about our latest product innovations and strategic early development solutions.

Our scientists are also spearheading several short courses and educational workshops on Sunday, Sept. 21. Complete descriptions and a list of presenters appears further down this page.

Discover the industry’s largest scientist-curated database for assessing drug interactions and safety

Trusted by 200+ pharmaceutical and biotech companies, as well as regulatory agencies, Certara’s Drug Interaction Database (DIDB®) provides unparalleled access to qualitative and quantitative human in vitro and clinical data. By incorporating information on extrinsic and intrinsic factors such as co-medications, excipients, food products, natural products, organ impairment, and genetics, DIDB® enables informed decision-making and supports the development of safer, more effective therapies.

Visit booth #315 for a demo of DIDB’s dynamic research tool’s and applications:

  • Retrieve information using 70+ pre-formulated queries
  • Optimize and validate PBPK models and static predictions
  • Support drug labeling recommendations
  • Calculate clinical DDI risk using static prediction models and generate submission-ready reports
  • Quickly identify relevant concomitant medications
  • Gain insights beyond DDIs

Learn more about Certara’s innovative early development approach

Our cross-funtional approach emphasizes operational efficiency with a dedicated program lead to reduce complexity for biotech and pharma copmanies while ensuring continous, scalable coverage.

  • Target product profile (TPP) and development strategy – develop a product strategy by assessing competition, viability, pricing, market access and regulations.
  • IND-enabling/FIH planning, design and regulatory strategy – develop functional plans, drug development strategies and study designs to ensure TPP alignment.
  • IND/FIH-enabling execution and reporting – oversee drug development, non-clinical studies, vendor management, DMPK analyses and translational modeling
  • IND authoring and submission – prepare and submit regulatory documents, including FIH protocol, Investigator Brochure and IND/CTA filings.
  • FIH execution/reporting – guide CRO selection, manage study execution, analyze data, and prepare for the next development phase.

Get an exclusive preview of DIDB Concomitant Meds Navigator

Built on regulatory agency-recommended classifications and powered by DIDB data, Concomitant Meds Navigator is scheduled to launch in Fall 2025. Sign up for a product demo to learn about how Concomitant Meds Navigator helps scientists to quickly identify concomitant medications.

Complete this form to schedule a DIDB product demo at ISSX 2025

Simulate and predict drug exposure

The Simcyp PBPK Simulator is the industry leader and most widely adopted platform for PBPK modeling in drug development. Developed through the expertise of a 25 year-long consortium involving 37 leading global pharmaceutical companies, the Simcyp PBPK Simulator is recognized and licensed by 11 regulatory agencies worldwide.

Ask our experts about your most complex DDI situations

With unique and multi-disciplinary expertise in DDIs, Certara’s Center of Excellence in Drug Interaction Science paves the way for leading experts across multiple teams to work in concert and solve event the most complex DDI scenarios form early development to regulatory approval.

Where to hear Certara insights and expertise

Sunday, September 21, 9am – 12pm
Short Course 1: Human Mass Balance Study - How When, Why: From Practical Issues to Regulatory Guidance

Co-Chairs: Lei Zhang, Silver Springs, MD; Dennis Heller, Certara

Human radiolabeled mass balance studies are an important component of the clinical pharmacology programs supporting the development of new investigational drugs. These studies allow for understanding of the absorption, distribution, metabolism, and excretion (ADME) of the parent drug and metabolite(s) in the human body. Understanding the drug’s disposition as well as metabolite profiling and abundance via mass balance studies can help inform the overall drug development program. Recently, U.S. FDA published the final guidance on “Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies” (https://www.fda.gov/media/158178/download). This short-course will discuss the purpose and design of human mass balance study, metabolite profiling, data analysis and interpretation. When to conduct mass balance study in drug development and how the data may be used to support various decision making related to drug-drug interactions and supporting PBPK modeling will be discussed. New development and regulatory expectation and perspectives will also be provided.

  • Mass balance study and metabolite profiling: Design, data analysis, and interpretation – Chandra Prakash, Agios Pharmaceuticals, USA
  • Industry application and case examples – Ellen Cannady, Eli Lilly, USA
  • FDA guidance on human radiolabeled mass balance studies and regulatory perspectives – Zhixia Yan Danielsen, US Food and Drug Administration, USA
  • EMA’s perspectives on human mass balance studies – Karin Fawkner, Medical Products Agency, Sweden
Sunday, September 21, 9am – 12pm
Short Course 2 - Implementing biomarkers and clinical probes to assess transporter-mediated drug-drug interactions

Co-Chairs: Bhagwat Prasad, Cincinnati Children’s Hospital and Eva Berglund, Certara

This short course will focus on the role of clinical probes and biomarkers in evaluating transporter-mediated drug-drug interactions (DDIs). Attendees will gain insights into the emerging importance of transporter biomarkers in drug development, with emphasis on how they inform and confirm DDI risk of an investigational drug. The short-course will also include the selection and application of clinical drug probes to assess transporter function, study design considerations, and the interpretation of resulting data. Regulatory perspectives of biomarkers as well as exogenous probes will be discussed to highlight best practices and emerging guidelines for incorporating transporter biomarkers and drug probes into DDI risk assessments during drug development.

  • Strengths and weaknesses of biomarker PBPK models to assess transporter-mediated DDIs – Hiroyuki Kusuhara, The University of Tokyo, Japan
  • Endogenous probes in practice, purpose, when in drug development, study design considerations – Bridget Morse, Lilly, USA
  • Clinical transporter probes: Selectivity and sensitivity​ – Xiaoyan Chu, Merck, USA
  • Endogenous transporter probes from a clinical pharmacology perspective -Xinning Yang, Ellicott City, MD, USA
Sunday, September 21, 1-4pm
Short Course 4: Model-informed drug discovery and development for challenging modalities

Co-chairs: Jaydeep Yadav, Merck; Fei Hua, Certara; Vivaswath Ayyar, GSK

Computational approaches enable in silico investigation of drug concentrations and effects that can support decision making throughout drug discovery and development. The mechanisms that drive the PK/PD, and the level of detail at which these mechanisms are understood and can be modelled quantitatively, vary across modalities, leading some modalities to be more challenging during discovery and development. This short course will introduce attendees to the key considerations and data requirements for PBPK and PK/PD modelling for challenging modalities.

  • FIH dose predictions for protein degraders with PKPD modelling – Jaydeep Yadav, Merck
  • Translational strategies for multi-specific antibodies (t-cell engagers) in oncology/immunology – Fei Hua, Certara
  • Modelling of oligonucleotides and RNAi therapeutics – Vivaswath Ayyar, GSK
Sunday, September 21, 5-5:45pm
Concurrent Focus Group Meeting

Focus Group: Modeling & Simulation

Host: Oliver Hartley, Senior Principal Scientist, Certara Simcyp

Poster presentation

Pharmacokinetic Drug Interactions with Drugs Approved by the US Food and Drug Administration in 2024: A Review of Clinical Data Available in New Drug Application Reviews

Presenting Author: Jingjing Yu, Director, Drug Interaction Solutions
Co-Author(s): Sophie Argon, Katie Owens, Yan Wang, Isabelle Ragueneau-Majlessi

In the present work, drug metabolism, drug transport, and drug interaction in vitro, in silico, and clinical data for small molecular drugs approved by the U.S. Food and Drug Administration in 2024 (N = 34) were analyzed using Certara Drug Interaction Database (DIDB®)

Schedule a demo or request a free trial

Discover how DIDB® can transform your drug development process. Schedule a demo or request a free trial today to explore its advanced features and capabilities.

Access the industry’s largest scientist-curated drug interaction database.
Retrieve and analyze data with over 70 pre-formulated queries.
Explore in-depth drug monographs.