BioTechX US

With over a year having passed since the beginning of the purported “AI Revolution,” a question remains: how can life science companies best utilize this technology to accelerate safer and more efficacious therapeutics to patients? Currently, Andreesen Horowitz estimates that 73% of pharmaceutical companies are struggling to adopt AI effectively. The key lies in defining concrete use cases that maximize the capability of the AI technology to assist scientists at the bench, data scientists in the dry lab, to medical writers working with regulatory agencies. This presentation will cover three examples:

• Utilizing GPTs to support structured content authoring in medical writing and regulatory submissions
• Automating data transformation to support eCTD standardization
• Expanding the scope and improving the validation of the creation of quantitative systems pharmacology (QSP) models to improve target ID, PK/PD, and clinical trial design

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

創薬

Accelerate drug discovery with the D360 Scientific Informatics Platform

• Webpage
• Capabilities brochure
• Recent webinar: Closing the Loop – How to Improve the Management of Your Design-Make-Test-Analyze Cycle

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技術主導サービス

Mechanistic Modeling – QSP

• Drug Development’s New Model: Biosimulation from Discovery to Label Expansion [WEBINAR]
• Quantitative Systems Pharmacology (QSP) in Clinical Development [WEBINAR]
• Applied BioMath Assess Fact Sheet

PK/PD Analysis and Pharmacometrics

• The Phoenix Platform for PK/PD Analysis and PMX Modeling
• Phoenix WinNonlin for non-compartmental analysis and PK, PD, and TK modeling
• Phoenix NLME for popPK
• Integral Data Repository for source data to CDISC report pipelines
• Phoenix Hosted for high performance, low cost operations at scale

Non-Clinical Data Analysis and Toxicology

• SEND Explorer for analyzing and visualizing SEND datasets
• Quantitative Systems Toxicology and Safety Consulting to predict adverse reactions earlier

Clinical Data Management and Biometrics

• Pinnacle 21 for study builds, data standardization, validation, and submission preparation
• Pinnacle 21’s Data Exchange for centralized vendor data specification, validation, and transfer
• Biometrics and Data Sciences Services

Regulatory Sciences

Document creation

• AIをフル活用したレギュラトリーライティング
• Regulatory writing services
• CoAuthor: The Generative AI-Enabled Regulatory Writing Platform
• Transparency and disclosure solutions

Package submission

• GlobalSubmit software for eCTD publication, review, and transfer
• 薬事申請サービス

お客様向けテクニカル・サポート（日本専用）

• Real world evidence and commercialization capabilities
• BaseCase for product value communication

Certara.AI – GPTs specialized for the life sciences

• Certara.AI Fact Sheet