This year alone, 3,984 products in drug development R&D pipelines, representing six of the top 25 therapeutic agent categories, were vaccines and immunotherapeutics—a 12 percent increase from 2015 (source: Pharmaprojects). Much of this growth was driven by innovation from small and mid-sized biopharmaceutical organizations that may not have all of the information that they need to understand how current decisions impact future clinical trials.
With immunotherapeutics and vaccines in particular, employing the right immune monitoring technique—at the right time—is essential to accurately characterize the effectiveness of a therapeutic approach in clinical trials. Areas of focus for your client should be:
What Your Clients Need to Know About Vaccine and Novel Immunotherapeutics Development
Understanding a complex system. Immune cells have unique surface markers and can secrete a variety of soluble mediators, such as cytokines and chemokines, which shape the outcome of an immune response. These markers and soluble mediators can also serve as targets for drug development.
Realizing the possibility for adverse reactions. When immune cells or their soluble mediators are targeted, a potential for an adverse reaction needs to be monitored in clinical trials, even if detailed in vitro and preclinical characterization was performed on the therapeutic molecule.
Applying technologies to support immune monitoring. Your client can use several platforms to measure soluble mediators and cell-based biomarkers. From multiplex assays to ELISPOT assay analysis and flow cytometry, many choices are available. Mass spectrometry (CyTOF), the assessment of T-cell mediated anti-tumor immunity and identification of T-cell epitopes can also provide valuable information regarding safety and efficacy of your client’s treatment.
While successful immune monitoring involves a number of techniques, employing the right technique—at the right time—is essential for your client to accurately characterize the effectiveness of their therapeutic approach in clinical trials.
Read the full Whitepaper and contact ustoday to get started with our Vaccine and Novel Immunotherapeutic Laboratory Solutions team, an expert mix of lab scientists and study managers dedicated exclusively to vaccine and immunotherapeutics, who can accelerate your client’s program in this specialized area of development.
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