Highway to Success—Developing Advanced Polymer Therapeutics

Abstract

Polymer therapeutics are advancing as an important class of drugs. Polymers have already demonstrated their value in extending the half-life of proteins. They show great potential as delivery systems for improving the therapeutic index of drugs, via biophysical targeting and more recently with more precision targeting. They are also important for intracellular delivery of nucleic acid based drugs. The same frameworks that have been successfully applied to improve the small molecule drug development can be adopted. This approach together with improved pathophysiological disease knowledge and critical developability considerations, imperative given the size and complexity of polymer therapeutics, provides a structured framework that should improve their clinical translation and exploit their functionality and potential. Progress in understanding the right target, gaining the right tissue and cell exposure, ensuring the right safety, selecting the right patient population is discussed. The right commercial considerations are outlined and the need for a multi-disciplinary approach is emphasized. Crucial developability factors together with scientific and technical advancements to enable pharmaceutical development of a quality robust product are addressed. It is argued that by applying this structured approach to their design and development, polymer therapeutics will continue to grow and develop as important next generation medicines.