Blog
Advancing Preclinical Bioanalytical Strategies for GLP-1 Receptor Agonists
Bioanalytical bottleneck slowing GLP‑1 receptor agonist development Despite the clinical successes of semaglutide and tirzepatide, many sponsors still encounter persistent bioanalytical challenges when translating GLP‑1 receptor agonists from discovery to clinic....
A New Playbook: 5 Ways to Improve Safety & Decision-Making With In Vitro Toxicology
In vitro toxicology is quickly becoming the most effective way to upgrade drug development and safety programs while staying compliant with evolving regulations. What used to be viewed as “nice-to-have” early screens are now widely used to deliver faster, more human-relevant insight into potential risk, while also reducing reliance on in vivo models. Regulatory bodies worldwide have also urged a shift away from animal studies, prompting drug developers to find new ways to make smarter early decisions, protect timelines, and build clearer, more persuasive safety narratives around their compounds. Here are five ways to align your drug development program with the rapidly evolving expectations of in vitro toxicology.
IND-Ready Immunotoxicity: Four Decisions to Prevent Late Surprises
Immune-modulating therapies, like bispecific T cell engagers (TCEs) and mRNA vaccines can be incredibly effective, but they can also trigger fast, hard-to-predict immune side effects that are costly if uncovered late in the development process. The question every team preparing for Investigational New Drug (IND) applications and first-in-human (FIH) decisions should be asking themselves is simple: How do we create an immunotoxicity strategy that is appropriate for IND submission and still executable on a real timeline?
2 Analytical Platforms for Peptide Preclinical Testing: LC-MS & ELISA
Peptide therapeutics are among the fastest-growing drug classes in development, but their analytical complexity can become a preclinical bottleneck. At the heart of this challenge lies a critical decision: choosing the right analytical platform.
3 Important DMPK Considerations for Successful Peptide Preclinical Testing
Peptides fill an uncommon territory in drug development. They’re too large to follow small molecule metabolic pathways but too structurally variable to behave predictably like biologics. Standard DMPK testing frameworks miss the mechanisms that actually determine peptide fate in biological systems—proteolytic degradation, membrane impermeability, and route-dependent distribution patterns that conventional assays weren’t designed to measure.
Advancing Preclinical Bioanalytical Strategies for Today’s Diverse Vaccine Platforms
As vaccine technologies diversify, so too must the strategies for evaluating their safety and efficacy in the preclinical stage. From traditional attenuated and inactivated vaccines to modern mRNA and viral vector platforms, each vaccine type poses distinct bioanalytical considerations that impact how drug developers approach pharmacokinetics, immunogenicity, and safety assessment.
Strategic Insights for Advancing PROTACs Toward IND Submission
Peptides present unique safety challenges, with distinct immunogenic potential and tissue distribution patterns that standard testing approaches often miss. What safety assessments cover these gaps?
Complete safety data packages enable confident IND submissions and help researchers avoid safety failures in later development stages
4 Essential Safety Assessments to Consider for Peptide Preclinical Testing
Peptides present unique safety challenges, with distinct immunogenic potential and tissue distribution patterns that standard testing approaches often miss. What safety assessments cover these gaps?
Complete safety data packages enable confident IND submissions and help researchers avoid safety failures in later development stages
Early-Stage Considerations for PROTAC Development: From Design to Preclinical Readiness
Since the emergence of targeted protein degraders more than 20 years ago, researchers have invested considerable time, effort, and resources specifically in developing proteolysis-targeting chimeras (PROTACs). As the first candidates approach the market, much excitement has built over the potential for PROTACs to treat conditions previously considered “undruggable.”
Early-Stage Considerations for Optimizing Respiratory Drug Development
Respiratory diseases such as asthma, chronic obstructive pulmonary disease (COPD), and idiopathic pulmonary fibrosis (IPF) present significant challenges in drug development. These conditions not only require targeted delivery to the lungs but also involve complex pharmacokinetics (PK) and variable patient responses. For drug sponsors and developers, optimizing the route of administration and designing an effective early-stage strategy are critical to improving candidate selection and reducing the risk of attrition during IND-enabling studies.
A Strategic Roadmap for Peptide Preclinical Studies: 3 Key Stages
Peptide therapeutics have proven to be a reliable pharmaceutical platform, with a growing record of FDA approvals and commercial success. Yet not every promising candidate makes it to the clinic. The difference? A strategic, three-stage preclinical approach that transforms individual studies into a cohesive regulatory roadmap.
Five Ways to Ensure hERG Assays are Scientifically Reliable
Patient safety relies on numerous early warning systems in drug development, designed to catch harmful effects long before candidates reach human trials. One of the most important tests is the hERG (human Ether-a-go-go) assay, which can predict cardiotoxic liabilities in vitro. They prevent costly late-stage failures and withdrawals and, more importantly, protect patients.