Formulation and Delivery
Joshua Katz, PhD
Senior R&D Manager
International Flavors and Fragrances Inc.
Wilmington, Delaware
Mary Krause, PhD
Associate Scientific Director
BMS
New Brunswick, New Jersey
Joshua Katz, PhD
Senior R&D Manager
International Flavors and Fragrances Inc.
Wilmington, Delaware
Andrea Hawe, PhD (she/her/hers)
Chief Scientific Officer
Coriolis Pharma
Martinsried, Bayern, Germany
Can Araman, PhD
Senior Manager, Laboratory Head Protein Formulations R&D
MilliporeSigma
Darmstadt, Hessen, Germany
Novel excipients for biopharma is an area of on-going need and interest for the community. Novel modalities and formulation platforms raise new challenges that compendial excipients cannot always solve. Excipient innovation is required to address many of these challenges, but adaptation of new excipients has been slow due to regulatory and risk assessments. This Hot Topic session will bring together leading scientists from academia, excipient manufacturers, and pharmaceutical producers to discuss the state of excipient innovation, the industry needs, and the barriers to entry. Specific topics that will be discussed include an overview of recent novel excipients that have been introduced, the FDA's Novel Excipients program and its implications for excipient development, key gaps in the formulator's toolbox, and risk/benefit analyses for deciding if/when to introduce novel excipients.