Preclinical development
Peptide Preclinical Development — IND-Enabling Studies and Beyond
Advancing a peptide development candidate to IND requires a comprehensive preclinical package — pharmacology, PK/PD, toxicology, formulation, and manufacturing feasibility. Building this package efficiently requires integrating computational prediction with targeted experimental studies. We support peptide preclinical development from development candidate selection through IND filing.
The Preclinical Development Challenge
Preclinical development is the most resource-intensive phase of peptide drug development before clinical trials. Building a complete IND-enabling package — covering pharmacology, PK/PD, safety pharmacology, toxicology, formulation, and manufacturing — requires coordinating multiple scientific disciplines and regulatory requirements.
Computational methods can significantly reduce the experimental burden of preclinical development by predicting PK parameters, identifying potential toxicity liabilities, and optimizing formulation approaches before expensive in vivo studies are conducted.
Our Preclinical Development Approach
IND-enabling study planning
Comprehensive planning of the preclinical package required for IND filing, with computational pre-screening to prioritize studies.
PK/PD optimization
Computational PK prediction and experimental PK/PD characterization to define dosing regimen and exposure targets.
Toxicity liability assessment
Computational identification of potential toxicity liabilities before in vivo safety studies.
Formulation development
Computational and experimental formulation optimization for the intended route of administration.
Preclinical Development Workflow
Development candidate assessment
Comprehensive evaluation of the development candidate against IND-enabling criteria.
Preclinical package planning
Definition of the IND-enabling study package and timeline.
In vitro pharmacology
Comprehensive in vitro characterization of pharmacology, selectivity, and mechanism.
PK/PD studies
In vivo PK/PD characterization and exposure-response modeling.
Safety and toxicology
Safety pharmacology and toxicology studies to support IND filing.
IND package preparation
Compilation and review of the complete IND-enabling data package.
What Can Be Evaluated
What You May Receive
IND-enabling data package
Complete preclinical data package supporting IND filing.
PK/PD report
Comprehensive pharmacokinetic and pharmacodynamic characterization.
Safety assessment report
Safety pharmacology and toxicology data with regulatory interpretation.
Regulatory strategy document
Recommended regulatory pathway and IND filing strategy.
Deliverables depend on program scope and development candidate characteristics. Regulatory outcomes cannot be guaranteed.
Who This Is For
Biotech companies
Companies with development candidates requiring IND-enabling studies and regulatory preparation.
Academic spinouts
Spinout companies advancing academic peptide discoveries toward clinical development.
Pharmaceutical teams
Drug development teams requiring preclinical support for peptide candidates in their pipeline.
Frequently Asked Questions
Advance Your Peptide Candidate to IND
Submit your development candidate and program objectives. We will assess the preclinical development requirements and outline a path to IND filing.
Confidential program discussions available under NDA.