The iBx Network is a global expert network providing integrated services for preclinical and clinical drug development

We offer:

  • Strategic and technical consulting
  • Design of nonclinical and translational drug development programs and studies
  • Regulatory strategies and document preparation
  • Modeling and Simulation

Areas of Expertise

Pharmacology — Toxicology — Immunogenicity
Preclinical and clinical PK/PD — First in human studies — Pediatric drug development
Bio-analytics — Regulatory Strategies — Model based drug development

Product Areas

Therapeutic proteins — Synthetic peptides — Bi-specifics — Novel protein scaffolds
Antibody-drug conjugates — PEGylated proteins — Gene & cell therapies
Xenotransplantation — Vaccines and therapeutic vaccines — Small molecules

Services

Integrated nonclinical and translational drug development strategy and program design

Strategic and technical consulting — Design and implementation of discovery and development programs
Support for global nonclinical development programs — Study design
PK/PD-biomarker strategies — PK/PD-immunogenicity bio-analytical assays
Interpretation of nonclinical PK/PD and safety data — Immunogenicity risk assessments
Risk minimisation strategies

Regulatory interaction and document preparation

Preparation and presentation of internal and external documentation on pharmacology and nonclinical safety:
Investigator’s Brochure, IND, IMPD, CTD, PIP proposals, Health Authority briefing books.
Assist in addressing regulatory questions and responses

Modeling and Simulation

Selection of first dose in human (MABEL) and dose escalation — Pediatric dose selection
Dose adjustments for special patient populations — Animal to human scaling for estimation of therapeutic dose and therapeutic index
Investigation of dose-response and PK/PD relationship
Design and analysis of preclinical and clinical studies — Population PK/PD analysis
Investigation of target mediated drug disposition — Physiological modeling