Biologics Archives

Publication

Postmarketing Assessment of Antibody–Drug Conjugates: Proof-of-Concept Using Model-Based Meta-Analysis and a Clinical Utility Index Approach

This study explores a model-based meta-analysis (MBMA) and a clinical utility index (CUI) approach to…

Danielle Pillsbury2025年3月4日

Blog

CMS による細胞・遺伝子治療（CGT）アクセスモデルの解説：意外と知られていない、薬価に関する最重要法案

2024年12月13日 The Centers for Medicare & Medicaid Services (CMS) is piloting a program…

Danielle Pillsbury2024年12月13日

Publication

Advancing pharmacometrics in Africa – Transition from capacity development toward job creation

This CPT article showcases, the Applied Pharmacometrics Training (APT) program, launched in 2021 by Pharmacometrics…

Danielle Pillsbury2024年12月9日

Publication

A Sequential Population Pharmacokinetic Model of Zilovertamab Vedotin in Patients with Hematologic Malignancies Extrapolated to the Pediatric Population

Danielle Pillsbury2024年11月7日

Poster

Semi-mechanistic Model of ATG-101, a PD-L1/4-1BB Bispecific Antibody, for Treatment of Solid Tumors

Abstract Trimer formation is key to the pharmacology of the bispecific ATG-101 but is difficult…

Renee Fisher2024年9月16日

Poster

Blinatumomab Trimer Formation

Insights from a Mechanistic PKPD Model on the Implications for Switching from Infusion to Subcutaneous…

Renee Fisher2024年9月16日

Poster

Dose Selection for DuoBody®-PD-L1x4-1BB (GEN1046)

Abstract DuoBody®-PD-L1x4-1BB (GEN1046) is an investigational, first-in-class, bispecific antibody designed to elicit an antitumor immune…

Renee Fisher2024年9月9日

Poster

Optimizing Avidity of Bispecific Drugs

Abstract Bispecific drugs have great potential to improve tissue selectivity through avid binding interactions but…

Renee Fisher2024年9月9日

Poster

Effects of Tissue Targeting Bispecifics on Therapeutic Window

Abstract Objectives: The presence of target receptors in non-target tissues can reduce the therapeutic window…

Renee Fisher2024年9月9日

Case Study

臨床開発の最適化：時間とコストを削減

Strategic mechanistic modeling solutions help an immunoncology biotech accelerate their clinical development of novel therapeutics.

Danielle Pillsbury2024年8月16日

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生物学的製剤

Postmarketing Assessment of Antibody–Drug Conjugates: Proof-of-Concept Using Model-Based Meta-Analysis and a Clinical Utility Index Approach

CMS による細胞・遺伝子治療（CGT）アクセスモデルの解説：意外と知られていない、薬価に関する最重要法案

Advancing pharmacometrics in Africa – Transition from capacity development toward job creation

A Sequential Population Pharmacokinetic Model of Zilovertamab Vedotin in Patients with Hematologic Malignancies Extrapolated to the Pediatric Population

Semi-mechanistic Model of ATG-101, a PD-L1/4-1BB Bispecific Antibody, for Treatment of Solid Tumors

Blinatumomab Trimer Formation

Dose Selection for DuoBody®-PD-L1x4-1BB (GEN1046)

Optimizing Avidity of Bispecific Drugs

Effects of Tissue Targeting Bispecifics on Therapeutic Window

臨床開発の最適化：時間とコストを削減

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