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Goals and Objectives

Unfavorable physiochemical and pharmacokinetic properties of therapeutic peptides, proteins, and nucleic acids represent unique challenges for the development of safe and efficacious medications intended for human use. Inherent instability, combined with the macromolecular nature of this class of biotherapeutics, most often translates into preparation of lyophilized parenteral formulations. Since parenteral administration bypasses important protective barriers of the body, manufacturers have to comply with highest FDA standards associated with parenteral drug delivery systems. This limits the use of formulation excipients and significantly increases the cost of goods. Furthermore, patients do not prefer parenteral dosage forms as they are invasive and less suitable for self administration. Over the past decade, novel scientific concepts have been explored to develop nonparenteral formulations for biotherapeutics that produce acceptable therapeutic efficacy. The primary objective of the workshop is to highlight promising approaches that have emerged from these efforts (e.g., oral, nasal, and pulmonary delivery systems) and successfully entered clinical development.

The goals set forth by the organizing committee include:

  • uniting fundamental understanding of critical physicochemical properties of biotherapeutics with successful design of nonparenteral drug delivery systems, 
  • outlining emerging formulation strategies with functional excipients that enable targeted delivery and augment bioavailability, 
  • summarizing clinical results of industrial case studies and critically discuss advantages and limitations of nonparenteral formulation approaches, 
  • finding out how to design and conduct appropriate quality assurance programs, and
  • sharing best practice on how to implement safe production of novel, nonparenteral formulations.

Leading academic, government, and industrial scientists will outline the current status of nonparenteral formulation approaches for clinical development of biotherapeutics, including the role of novel excipients in rational design of formulation programs. Attendees will learn to identify critical development challenges on the path to commercialization and gain an understanding of limitations associated with conventional quality assurance methodologies.

Who should attend?

Pharmaceutical scientists from industry and academia, including graduate students, with a primary interest in clinical development of nonparenteral drug delivery systems for biotherapeutics. The program is designed to benefit scientists, who are already working in formulation development of biologics. In addition, it is expected that the topics of this workshop will provide new directions for scientists currently engaged in small molecule development to expand into the growing world of biotherapeutics using appropriately tailored, nonparenteral drug delivery systems.