Formulation Strategies for Early Clinical Phase Studies


Formulation strategies for orally administered small molecules can vary widely for early phase clinical studies and are not always optimal for the program. Sponsors should consider a wide range of formulation options as they develop program strategies, weighing level of effort versus clinical needs for the short and long term. This webinar will discuss formulation strategies and their appropriateness depending on drug properties, dosing requirements, and corporate strategy.


Key Learning Objectives:

  • To understand various formulation approaches and the situations in which each is best utilized

  • To balance formulation level of effort vs clinical needs (or wants)

  • To identify common issues, traps, and unforced errors in formulation development


Who Should Attend:

  • Executives in charge of development of new small-molecules

  • Formulation and analytical scientists

  • Professionals overseeing the design of clinical studies




Rob Tuohy

Rob Tuohy oversees all research and development activities at Pace Philadelphia including formulation development, analytical services, and clinical supplies manufacture. He offers extensive knowledge relative to the design and development of various dosage forms.

Rob has participated in the development of over 100 pharmaceutical compounds spanning a variety of oral and topical dosage forms. Particular areas of expertise include coating applications, controlled release, bioavailability enhancement, semi-solid formulations, and fixed dose combination products.

Rob holds a Master of Science degree in Pharmaceutical Sciences from Temple University and a Bachelor of Science degree in Chemical Engineering from Virginia Polytechnic Institute and State University.