About this Research Topic
This collection encourages contributions from scientists who are engaged in pharmaceutical industry and commercial projects to provide their insights and forecasts on the ways in which Experimental Pharmacology and Drug Discovery are utilized and explored in the industrial sector. Authors are also encouraged to identify the challenges that need to be overcome before pharmaceuticals and related products become economically viable. Varieties of challenges that arise during regulatory filling are also addressed during the product development phase. By addressing these challenges, this collection aims to foster a candid and comprehensive discussion about the practical aspects of Experimental Pharmacology and Drug Discovery in the commercial sector.
Gene therapy and mRNA-based therapeutics represent significant innovation in the pharmaceutical area, and new developments are expected in the field for treatment of a wide range of diseases based on recent preclinical and clinical studies. These novel approaches involve the administration of nucleic acids that modulate the expression of certain proteins in order to correct underlying genetic disorders or to induce cell-mediated immunity (e.g., mRNA vaccines). These approaches have shown great potential in preventing or treating various pathologies, such as cancer, genetic disorders, and infectious diseases. However, effective and safe delivery of nucleotide-based drugs represent a key challenge for their effective application, and efficient delivery systems are needed. Fusion proteins and antibody-based therapeutic proteins (monoclonal antibodies and Fc-fusion proteins) now represent another important strategy in clinical practice for the treatment of cancer, inflammatory, immune, and infectious diseases, with a more targeted therapeutic effect than small-molecules. The development of these therapeutic biologics has greatly evolved in the last decade, and this evolution shows no sign of slowing down.
Moreover, in recent decades, the progress of knowledge in the field of cell biology and biotechnology has allowed the development of innovative therapeutic protocols based on the use of cell therapy products (e.g., stem cells, CAR-T therapy) defined as preparations in which the biological action is performed by cells. It involves the transplantation of autologous or heterologous live human cells that have undergone ex vivo manipulation and in vitro propagation. These cells are manipulated in the laboratory in order to make them suitable for the treatment of a specific pathology or for the regeneration of a specific tissue. These preparations hold immense potential for revolutionizing medical treatments and warrant in-depth exploration and understanding.
This Research Topic aims to collect original research and review articles from pharmaceutical industry professionals on, but not limited to, the development, discovery, commercialization and industrialization of innovative biotechnology-based therapeutics, such as nucleotide-based drugs (e.g. gene therapy, mRNA vaccines), peptide and protein-based drugs (e.g. fusion proteins, antibody-based therapeutic proteins), and cell therapy (e.g. CAR-T therapy). Additionally, those synthetic and semi-synthetic drugs originate from bacterial, plant, or animal cells that are undergoing preclinical and clinical stages of testing as well as regulatory filing.
Keywords: Commercialization, Industrialization, Nucleotide-based drugs, Peptide-based, Protein-based, Cell therapy
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