The Role of Form and Formulation Development in Transforming a New Era of Molecules into Therapeutics

To produce drugs for new and challenging biological targets, drug development has expanded to include a variety of chemical entities (i.e. modalities) that span a wide molecular weight spectrum, from traditional small molecules to biologically-based large molecules and even cells. This diversity has created new challenges for formulation scientists who are now required to design and manufacture robust formulations for multiple modalities. The 2019 Gordon Research Conference on Preclinical Form and Formulation for Drug Discovery will present cutting edge research on the development, characterization and manufacture of formulations that span multiple modalities. The conference will highlight: (i) advances in characterization tools that enable molecular understanding of formulations, (ii) new methods to enable intracellular cellular delivery of large molecules and cell and gene-based therapies, (iii) novel manufacturing techniques, and (iv) modeling and simulation approaches that aid in formulation design. Insights into new contributions of colloidal sciences and crystallization of molecules to formulation development will also be highlighted in two new sessions.

The conference will bring together academic and industry leaders from both the small molecule and biologics areas to address challenges at the interface between drug discovery and preclinical/clinical development. Experts will share methodologies that enable the deep mechanistic insights into how different delivery systems work. Additionally, discussions will focus on ways that science and technology could transform the current state in this area and identify further knowledge gaps in scientific understanding and technological capabilities that can be explored and discussed at future conferences.