About this Research Topic
Vaccines were a crucial advancement in human health and a continued product area of interest, covering a wide span of diseases in the viral, bacterial, parasitic, and even fungal arena. Therapeutics, specifically antibodies, were first described in the 1900s and have since been used to target infectious, cancer, and inflammatory diseases. Today, the lives of millions of people in low-, middle- and high-income countries are benefiting from decades of basic and translational research in microbiology and immunology, and advancements continue as scientists overcome hurdles in novel vaccine and therapeutic development against infectious, cancer, and inflammatory diseases.
After the initial discovery stage, progressing the development of a vaccine or therapeutic from bench to bedside is a challenging and complex process, both scientifically and commercially. Results from currently available animal model studies have been shown to have low predictive value for efficacy in human clinical trials. Furthermore, the choice of a target population for product development is critical, manufacturing costs when scaling up are enormous, the highest standard of safety and quality is expected from the final product, and regulatory compliance varies across the world. Additionally, it is a time-intensive process, as it typically takes 10-15 years for the product to reach the market, after it goes through multiple rounds of testing. There is a high rate of attrition during development and approximately only 10% of potential vaccines or therapeutics that effectively pass preclinical development reach the market. However, new technologies and animal models, including humanized mice, may be able to help overcome some of these barriers.
We invite article contributions from authors on the pre-clinical and clinical development of vaccines and therapeutics (e.g., antibodies), particularly in the following:
- Novel animal models that mimic human immune systems more closely to test potential product efficacy
- Innovative adjuvant technology in the case of vaccines or vaccine/therapeutic delivery systems
- IND-enabling animal safety studies (GLP and non-GLP)
- Analytical development for characterization of the vaccine or therapeutics, including assay development (e.g., Potency assay, anti-drug antibody (ADA) assay, immunogenicity, and neutralization assays, Pharmacokinetic (PK) assay), Host cell protein assay)
- Phase I safety/immunogenicity clinical trials in humans
Arundhathi Venkatasubramaniam (PhD) declares to have inventorship on patents related to S. aureus vaccine and to currently own stock options and stocks of several biotechnology companies.
After the initial discovery stage, progressing the development of a vaccine or therapeutic from bench to bedside is a challenging and complex process, both scientifically and commercially. Results from currently available animal model studies have been shown to have low predictive value for efficacy in human clinical trials. Furthermore, the choice of a target population for product development is critical, manufacturing costs when scaling up are enormous, the highest standard of safety and quality is expected from the final product, and regulatory compliance varies across the world. Additionally, it is a time-intensive process, as it typically takes 10-15 years for the product to reach the market, after it goes through multiple rounds of testing. There is a high rate of attrition during development and approximately only 10% of potential vaccines or therapeutics that effectively pass preclinical development reach the market. However, new technologies and animal models, including humanized mice, may be able to help overcome some of these barriers.
We invite article contributions from authors on the pre-clinical and clinical development of vaccines and therapeutics (e.g., antibodies), particularly in the following:
- Novel animal models that mimic human immune systems more closely to test potential product efficacy
- Innovative adjuvant technology in the case of vaccines or vaccine/therapeutic delivery systems
- IND-enabling animal safety studies (GLP and non-GLP)
- Analytical development for characterization of the vaccine or therapeutics, including assay development (e.g., Potency assay, anti-drug antibody (ADA) assay, immunogenicity, and neutralization assays, Pharmacokinetic (PK) assay), Host cell protein assay)
- Phase I safety/immunogenicity clinical trials in humans
Arundhathi Venkatasubramaniam (PhD) declares to have inventorship on patents related to S. aureus vaccine and to currently own stock options and stocks of several biotechnology companies.
Keywords: animal models, clinical development, safety, potency
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