Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
Stephen Buckley, PhD (he/him/his)
Vice President
Novo Nordisk A/S
Maaloev, Denmark
Rikhav Gala, PhD, M.Sc.
Sr. Principal Scientist and Group Lead
Pfizer INC
Lowell, Massachusetts
Oral delivery is the preferred route of administration for patients living with serious chronic diseases but remains challenging to achieve for peptide, protein and nucleic acid-based therapeutics owing to the significant physiological obstacles which must be overcome. Permeation enhancers are the most mature delivery technology for enabling oral absorption and they are employed to good effect in marketed drug products and novel peptides under clinical investigation, albeit with modest single digit bioavailability. Inspired by nature, a number of novel delivery approaches have been explored and validated pre-clinically and suggest the possibility of achieving double-digit bioavailability and expanding the breadth of modalities to include mAbs and nucleic acids, which can be delivered orally. This presentation will describe a number of case studies, which exemplify delivery technologies inspired by mother nature and in doing so, point towards encouraging future possibilities for achieving broader availability of oral-based biologics and thereby, affording greater convenience to patients with serious chronic diseases and helping achieve better outcomes.