Drug Target Review

APRIL 7, 2025

The emergence and adoption of clinically relevant biomarkers is gradually presenting alternatives to MTD, particularly around therapies such as cell and gene therapy (CGT) and immunotherapy. Biomarkers can play a crucial role throughout clinical development, especially in early phases. Clinical Pharmacology and Therapeutics.

Clinical Development 69

Clinical Development Clinical Trials Clinical Pharmacology Trials 69

The Premier Consulting Blog

JULY 31, 2024

In this blog, we explain the role of clinical pharmacology in drug development and demonstrate how the right strategy can accelerate development under the US Food and Drug Administration (FDA) 505(b)(1) and 505(b)(2) New Drug Application (NDA) pathways. Listed Drugs [LDs]) and/or published scientific literature.

Clinical Pharmacology 52

Clinical Pharmacology Drug Development Pharmacokinetics Drugs 52

Agency IQ

DECEMBER 11, 2023

In 2015, the FDA, along with the American Association for Cancer Research (AACR), held a workshop on dose optimization for small molecules. Despite challenges in enrolling pediatric patients with rare cancers in trials, KRISTEN WESSEL of the FDA’s Division of Clinical Pharmacology recently argued that it’s not impossible.

FDA 40

FDA Science Clinical Trials Trials 40