AAPS BAY AREA DISCUSSION GROUP

AAPS-BADG is jointly hosting a workshop with PBSS-San Francisco on
September 27, 2018;  8:45 – 5:00 pm

Workshop Agenda

Crowne Plaza, 1221 Chess Drive, Foster City, CA 94404

Small Molecule Formulation Development: Strategies for Challenging APIs

Event Registration

Speakers:

Tom Chiang (Genentech), Vahid Zia (Gilead), Andrew Phimister (Seaview Pharma Solutions), Rajiv Nayar (HTD Biosystems), Ravi Mahalingam (ReechPharma), Dennis Leung (Genentech)

About the Topic

The pharmaceutical industry is focusing on more challenging biological targets to address unmet medical needs. These new targets are increasingly more difficult to drug due to their lipophilicity and complex mode of actions. Medicinal chemists are therefore creating new molecular entities that often have low solubility, permeability, or both low solubility and permeability. Th requires scientists to challenge the current formulation development paradigm. Identifying innovative strategies for drug development helps to shift the industry from empirical to more mechanistic approaches. The benefit is the ability to have flexible formulation strategies that can adjust to meet pre-clinical and clinical demands, while also meeting the requirements of a dynamic regulatory environment. This workshop will survey current formulation practices and how they are changing to address challenging APIs. The evolving science includes knowing new technologies and how to take advantage of them. Furthermore, discussions will focus on the mechanistic understanding of formulations which help to ensure successful drug products that meet quality-by-design (QbD) regulatory requirements.

This workshop will cover the following topics:

Overview of formulation development — pre-clinical to market image formulation
Biopharmaceutic concepts
New analytical tools and strategies for formulation development
Material sparing approaches to reduce cost and time while increasing formulation understanding
Particle engineering to address poor API PK properties

 
BADG Sustaining Sponsors: