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
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
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.”
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.
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.
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.
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.
Genetic toxicology assesses the effects of xenobiotics on DNA and the genetic processes of living cells. Since the discovery of DNA’s role as the carrier of genetic information (Avery, Macleod, McCarty, 1944) and its structure (Watson and Crick, 1953), scientists have sought to gain a proper understanding of how outside agents can damage the genome. Over the decades, the practice has become increasingly important to drug development, as researchers have established the degrees of damage genotoxic agents can cause.
Setting the right starting dose is critical when designing human trials of BsAbs. Some products already in the market behave predictably at higher doses, but at lower doses become less consistent. Past clinical trials have shown that if a drug over activates T-cells, it can trigger a dangerous immune reaction called a cytokine storm. Researchers often use the Minimum Anticipated Biological Effect Level (MABEL) method to avoid this by setting very cautious first-in-human doses.
Oligonucleotide therapeutics offer a groundbreaking way to target diseases at the genetic level. Yet their development is riddled with unique, complex challenges. In this comprehensive guide, we explore the six most significant hurdles faced by oligonucleotide developers and provide actionable strategies to address them effectively.
Peptide therapeutics offer highly specific and potent treatments, but their development pathway is marked by technical challenges that can derail programs. In this comprehensive guide, we examine the nine hurdles encountered by peptide developers and provide practical strategies to overcome them.
Oligonucleotides present analytical complexities that set them apart from small molecules and biologics. Typically 13–30 nucleotides in length, these therapeutics feature highly charged backbones and dynamic structural properties, creating unique testing demands.