Therapeutic Specialties Archives

Case Study

Systems Modeling Delivers Efficiencies and Savings in Clinical Development

Discover how an IO-focused company developing immunotherapies applied QSP modeling solutions for cost-effective clinical development.…

CertaraJuly 12, 2024

Press Coverage

Accelerating the Progress of Kinase Inhibitors in Oncology

The potential of PBPK modeling in answering key questions around these drugs. Hannah Jones, PhDMasoud…

CertaraMay 20, 2024

Blog

How to Navigate the FDA Landscape for an Orphan Drug

Rare diseases are a public health priority. FDA has launched several programs and a final…

CertaraFebruary 21, 2024

Publication

Incorporating Pragmatic Elements in Study Designs to Enhance Oncology Randomized Clinical Trials

A FRIENDS OF CANCER RESEARCH WHITE PAPER The article explores the complex landscape of determining…

CertaraDecember 19, 2023

Poster

FDA Trends for Accelerated Drug Approvals in Oncology Indications

The FDA has modified and increased expectations around data needed to support accelerated approvals in…

CertaraSeptember 20, 2023

Poster

Adoption of PROs in Early Clinical Trials for Oncology Drugs: Challenges and Opportunities

Despite changes in regulatory expectations, adoption of PROs in early-phase oncology trials remains very low…

CertaraSeptember 20, 2023

Conference

American College of Toxicology 2025 Annual Meeting

– – Booth

CertaraMay 24, 2023

Blog

Artificial Intelligence: What is it & how can it accelerate rare disease drug development?

Large & complex information streams present opportunities for the AI data scientist to aid in…

CertaraFebruary 3, 2023

Case Study

Using Modeling & Simulation to Develop a Dosing Regimen for a Bispecific Antibody for Pediatric Cancer

Bispecific antibodies are an emerging class of antibodies developed in recent years that provide new…

CertaraJanuary 23, 2023

Conference

ACCP Annual Meeting

– – Booth

CertaraJuly 15, 2022

Therapeutic Specialties