Biotherapeutics and Immunogenicity Implications in Drug Development


In contrast to new chemical entities, biotherapeutic drugs are potentially immunogenic, and, in rare cases, treatment with such products can lead to severe and devastating illnesses in humans. Therefore, the importance in understanding how immunogenicity affects drug exposure, efficacy, and toxicity at all stages of the drug development process can not be overstated.

There are more than 200 biotechnology products currently on the market with 400-plus additional therapies in clinical trials targeting diseases such as cancer, Alzheimer’s, rheumatoid arthritis, multiple sclerosis, and HIV/AIDS. In 2014, it’s predicted that 50% of the top 100 drug sales will be biologics, an increase of 28% from 2008. Continue reading

Why Some Sponsors are Considering Dedicated Resource Agreements

Many sponsor-CRO relationships are based upon one or more transactional agreements that are each focused on a specific project. Projects are offered by the sponsor and are generally bid upon by a number of different CROs. Once a project is awarded to a particular CRO, then that organization becomes responsible for the logistics, such as setting up the facility, making technology decisions, assigning staff, organizing the work flow, and ensuring compliance with appropriate regulatory guidelines. When the project is completed, the relationship between the sponsor and CRO ends, at least until the cycle of offering, bidding, and awarding has been repeated with a different project.

While this type of arrangement works very well for some sponsors, particularly those with small, well-defined projects, other sponsors find the transactional agreement presents challenges.

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