Biologics Archives

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CMS Cell and Gene Therapy (CGT) Access Model Explained: The Most Significant Drug Pricing Legislation You’ve Never Heard Of

December 13, 2024 The Centers for Medicare & Medicaid Services (CMS) is piloting a program…

CertaraDecember 13, 2024

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…

CertaraDecember 9, 2024

Publication

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

CertaraNovember 7, 2024

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…

CertaraSeptember 16, 2024

Poster

Blinatumomab Trimer Formation

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

CertaraSeptember 16, 2024

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…

CertaraSeptember 9, 2024

Poster

Optimizing Avidity of Bispecific Drugs

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

CertaraSeptember 9, 2024

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…

CertaraSeptember 9, 2024

Case Study

Optimizing Clinical Development: Saving Time and Costs

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

CertaraAugust 16, 2024

Publication

Application of Quantitative Systems Pharmacology to guide the optimal dosing of COVID-19 vaccines

Optimal use and distribution of coronavirus disease 2019 (COVID-19) vaccines involves adjustments of dosing. Due…

CertaraJuly 31, 2021

Biologics

CMS Cell and Gene Therapy (CGT) Access Model Explained: The Most Significant Drug Pricing Legislation You’ve Never Heard Of

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

Optimizing Clinical Development: Saving Time and Costs

Application of Quantitative Systems Pharmacology to guide the optimal dosing of COVID-19 vaccines

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