Pharma Research and Development

Statement of the Problem: In universities, pharmaceutical scientists are encouraged to dream of building marvelous creations, such as self-propelled drug delivery systems, self-assembling nanoscale devices and stimulus-responsive drug targeting mechanisms. While immense efforts are spent on accomplishing these transformative feats in chemistry, engineering and biomedicine research labs, the resulting advances are often not practical to translate into the clinical arena.

Methodology & Theoretical Orientation: In order to realign academic, drug formulation research with the more practical considerations inherent to drug product development, many challenges that precede clinical translation must be taken into account and dealt with, at the earliest, inception phase of formulation design. In this regard, my research group has grounded itself in reality, by carefully studying the nanoscale transport and distribution properties of existing drugs, prior to launching itself into a new, formulation design project.

Conclusion & Significance: By pioneering the formulation and development of biomimetic drug complexes, we have been able to balance fundamental discovery-driven research and technological innovation, with the more mundane necessities and regulatory requirements underlying successful clinical translation (from scale-up to manufacturing; and, from sterilization to commercialization).