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Oral administration of small molecules has become increasingly difficult due to a majority of new candidates demonstrating poor aqueous solubility. The bioavailability hurdle is made more challenging with the accelerated timelines, limited drug substance availability and financial restrictions associated with many of today’s drug programs. This presentation discusses a proven model-based technology selection methodology for poorly soluble molecules and an integrated formulation approach to minimize first-in-human timelines. The role of API development and supply, solid state characterization and rational bioavailability-technology selection will be presented.
Key Learning Objectives:
David Lyon, Ph.D.
Sr. Fellow, Research, Lonza Pharma & Biotech—Bend
David Lyon received his B.S. in Chemistry from Western Washington University and Ph.D. in Inorganic Chemistry from the University of Oregon. Following a Post-Doctoral stint at the California Institute of Technology, David joined Bend Research as a Research Chemist. During his tenure at Bend Research he held positions of increasing responsibility culminating in the role of Senior Vice President, Research prior to the company’s acquisition by Capsugel and, subsequently, Lonza. He currently serves as a Sr. Fellow, Research advising internal and external collaborations in bioavailability enhancement technologies, modified release and bioprocessing. David has been involved in numerous technology innovation efforts during his career including the development of amorphous dispersions, modified release formulations, engineered particles for inhalation, nanotechnology and formulation and processing of biotherapeutics.
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