Immune responses to protein and peptide drugs can alter or reduce their efficacy and may
be associated with adverse effects. While anti-drug antibodies (ADA) are a standard clinical …

ABSTRACT A major impediment to successful use of therapeutic protein drugs is their ability
to induce anti-drug antibodies (ADA) that can alter treatment efficacy and safety in a …

Peptide drugs play an important part in medicine owing to their many therapeutic
applications. Of the 80 peptide drugs approved for use in humans, at least five are now off …

The promise of viral vector‐based gene therapy (GT) as a transformative paradigm for
treating severely debilitating and life‐threatening diseases is slowly coming to fruition with …

In silico immunogenicity risk assessment has been an important step in the development
path for many biologic therapeutics, including monoclonal antibodies. Even if the source of a …

Application of contemporary molecular biology techniques to clinical samples in oncology
resulted in the accumulation of unprecedented experimental data. These “omics” data are …

The transition from intravenous (iv) to subcutaneous (sc) administration of biologics is a
critical strategy in drug development aimed at improving patient convenience, compliance …

Optimal use and distribution of coronavirus disease 2019 (COVID‐19) vaccines involves
adjustments of dosing. Due to the rapidly evolving pandemic, such adjustments often need …

The past two decades have seen diversification of drug development pipelines and
approvals from traditional small molecule therapies to alternative modalities including …

Introduction: Safety and tolerability is a critical area where improvements are needed to
decrease the attrition rates during development of new drug candidates. Modeling …