Four Program Themes
Significant progress has recently been made in the design and characterization of smarter functional materials to meet current drug delivery challenges. More powerful analytical tools have also led to better understanding of how process impacts material properties and how material properties in turn impact product performance.
This theme will focus on recent advances in:
- novel materials and their applications: e.g. ionic liquids, nano and meso materials etc.,
- state of the art analytical methodology to characterize novel materials, raw materials, API, in-process intermediates and finished products, and
- material sparing, miniaturized, and automated approaches for form, formulation, and process selection.
New Delivery Modalities
The focus of this theme will be on new delivery modalities emerging in peptides, proteins, and conjugates:
- molecular design to enable development,
- new and novel delivery approaches,
- analytical and bioanalytical characterization, and
- CMC challenges manufacturing and regulatory.
Accelerated Drug Development
Strategic content will include risk-based and phase-appropriate development, quality attributes, attrition reduction, and navigation of expedited regulatory pathways (e.g., breakthrough therapy designation) for all therapeutic modalities. Technical content will include:
- In Silico Modeling
- (Bio) Analytical Methods
- CMC Challenges
- PK/PD Approaches
- Clinical Study Design
- Global Outsourcing Strategies
This theme is focused around patient-centric approaches to optimize outcomes that entail contributions from pharmacometrics, genomics/epigenomics, companion diagnostics, novel clinical study designs, quality matrix and regulatory guidance and challenges.