Oncology/Hematology Archives

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

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

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

Case Study

PBPK Model Informs Antibody-Drug Conjugate Label for DDIs Without Clinical Trials

Genentech was developing polatuzumab vedotin (Polivy), an anti-CD79b-vc-monomethyl auristatin E (MMAE) antibody-drug conjugate (ADC) to…

CertaraApril 11, 2022

Blog

What is the FDA’s Project Optimus & How Will it Affect Oncology Drug Development?

Project Optimus is an initiative proposed by the U.S. Food and Drug Administration’s Oncology Center…

CertaraFebruary 2, 2022

On-Demand Webinar

What Oncology Drug Developers Should Expect from the FDA’s Project Optimus

Historically, the dosing strategy for oncology drugs has focused on the maximum tolerated dose. This…

CertaraJanuary 13, 2022

On-Demand Webinar

PBPK Modeling of Antibody-Drug Conjugates – Concept and Application

Antibody-Drug Conjugates (ADCs) can be an ideal drug treatment for cancer because they deliver a…

CertaraJanuary 13, 2022

Blog

Developing Targeted Covalent Inhibitor Drugs: 3 Key Considerations

Traditional mechanisms of drug action rely on the reversible, noncovalent interaction of a ligand with…

CertaraNovember 5, 2021

Oncology/Hematology