Director, Formulation and Stabilization Sciences, Vaccine Production Program National Institutes of Health (NIH) Gaithersburg, Maryland
Development of vaccines for first-in-human clinical studies can present unusual challenges. These challenges are compounded when development occurs in the context of emerging infectious diseases, which frequently necessitate rapidly accelerated timelines to get the vaccine into human trials and, hopefully, make it available to the general public. This presentation will focus on the role of pre-formulation data on rapid formulation development of recombinant protein vaccine candidates. The relative importance of different data sets, and the pros and cons of leveraging data from similar molecular entities will be discussed.
Define the challenges that may arise during rapid vaccine formulation development.
Understand the options available and relative utility of various biophysical characterization methods in pre-formulation study design.
Gain awareness of the potential benefits and pitfalls of leveraging data from formulation development of similar molecular entities.