The European Medicines Agency (EMA) has updated its guidance on first-in-human (FIH) clinical trials. The objective is to help drug sponsors "transition from non-clinical to early clinical development and in identifying factors influencing risk for new investigational medicinal products".

The EMA updated the guideline since trial protocols have become "increasingly complex" with more multiple ascending dose clinical trials and trials that often include different parts within a single protocol.

The updated guideline includes considerations on quality aspects, non-clinical and clinical testing strategies, study design and the conduct of FIH/early clinical trials. It also includes guidance on the handling of adverse events in relation to stopping rules, and information on how to progress to the next dosing level. A new section was added entitled "Dosing selection for FIH and early clinical trials" to offer guidance on determining the starting dose for healthy volunteers and patients; criteria for dose escalation; defining the maximum exposure; moving from single to multiple dosing; and determining the route of administration.

View new guideline

At Altasciences, we are always aligned with the latest guidances for your FIH clinical trials. We place the safety and well-being of trial participants at the forefront of our drug development programs and ensure that we continuously apply the experience gained from over 200 FIH studies we have conducted.

We have built a robust feasibility process that closely considers the risks of every study we run, with particular focus on FIH studies. The process of evaluating and mitigating risks starts the day we first talk to our sponsor about the study and continues until we have dosed the last patient. Our audits by European regulators, such as MHRA, have consistently had positive results and have given us useful feedback on the safety requirements we must meet.

Altasciences has been at the forefront of bioavailability (BA) and bioequivalence (BE) testing for over 25 years. With extensive expertise working on a variety of compounds, we have an exceptional reputation for successfully conducting simple to complex BA/BE trials and have experience with regulatory agencies across the world.

We have a large pharmacokinetics (PK) database, which has supported the design and conduct of over 2 600 studies in hundreds of medications. Our PK database contains invaluable details of the design as well as the variability observed in previous studies, providing us with important data to calculate the required sample size. Our expertise covers the full range of drug administration routes, giving us a firm understanding of the specific PK requirements of each dosage form. We routinely develop and validate new bioanalytical methods for novel compounds so that we are ready when you need them. We have developed over 620 methods, all of which are reliable and reproducible, for your drug discovery and development.

Our fast recruitment and excellent retention rate will help you complete your study faster. With 600 beds at your disposal across three strategically located facilities in the U.S. and Canada, Altasciences has the capacity to conduct multiple-arm studies, or multiple studies at the same time.

Altasciences recently expanded its bioanalytical laboratory by adding space dedicated to ligand binding and cell-based assays, to continue to support and deliver quality bioanalytical solutions to our clients. The new, larger space is fully equipped to respond to the high demand of cell-based neutralization and functional assays for biologics and vaccines. We now have the additional capacity for cell lineage and functional immuno-phenotyping by flow cytometry to support both preclinical and clinical studies.

Bioanalytical Support for Your Large Molecules

Renowned for our vast experience in LC-MS/MS and Ligand Binding bioanalytical platforms, our team of dedicated scientists in both the U.S. and Canada provide a comprehensive suite of bioanalytical services, from discovery to preclinical to phase IV. They evaluate each request and provide customized workflows to allow accurate quantitation using the appropriate platforms (Mass Spectrometry and/or Ligand Binding).

Why do clients appreciate working with us? Because each bioanalytical phase of your study ― method development, validation, and sample analysis ― has a Method Development Expert and/or a Bioanalytical Principal Investigator with the appropriate scientific and regulatory expertise assigned.

Let's discuss your bioanalytical needs and how our solutions can support your preclinical and/or clinical research.

Facing bioanalytical challenges when evaluating the immunogenicity profile of protein-based therapeutic drugs

Given their complexity, it is a regulatory requirement to evaluate the immunogenicity profile of protein-based therapeutic drug products. Multiple factors can impact the bioanalytical immunogenicity assay used to characterize the immune response generated against the drug, such as the assay format used, the sensitivity of the assay, the dilution scheme, the clinical sampling strategy, or the matrix interference. For bioanalytical analysis, all these factors are crucial and need to be considered. Consequently, having the appropriate approach during method development is essential. This issue of The Altascientist illustrates some of the bioanalytical challenges that exist when assessing the clinical immunogenicity profile of oncology drug products and how Altasciences overcomes those challenges.