Macromolecules, such as allergens, vaccines, and peptides are an important part of clinical treatments and an increasing number of novel macromolecular drugs are under development. However, due to low permeability, many macromolecule drugs are administered via invasive injectable formats. Invasive delivery comes with several limitations, including poor patient adherence, patient inconvenience, higher overall healthcare costs, leading to poor health outcomes. Given this, there is a need for a non-invasive delivery system for macromolecules. This means that conversion of a product from an invasive to an oral dose form presents great rewards for biotech companies.
This webinar provides an overview of strategies, challenges, and technologies for the oral delivery of macromolecules including an integrated solution designed to rapidly screen biomolecule’s potential for non-invasive delivery route and assess the formulation strategies in parallel. Experts will provide insights on assessment of oral developability of macromolecules, formulation challenges in oral delivery of macromolecules, and strategies to overcome these challenges. A case study describing the development, manufacture, and commercial launch of an orally delivered macromolecule drug will be presented.
Professor Scott Lokey,
Director, UCSC Chemical Screening Center
Scott Lokey received his Ph.D. at the University of Texas of Austin in organic chemistry, where his research centered on the synthesis of molecules that fold into protein-like shapes in water and bind to specific DNA sequences. He did post- doctoral research at Genentech, where he worked on the synthesis of bioactive cycle peptides, and then at Harvard Medical School on the synthesis of molecules designed to disrupt cellular processes related to motility.
He joined the faculty at UCSC in 2002 in the Department of Chemistry and Biochemistry, where his research group focuses on the relationship between molecular structure and drug-like properties, especially cell permeability. Professor Lokey is also the Director, UCSC Screening Center, a high-throughput screening facility dedicated to early stage lead discovery, especially against infectious agents and neglected disease targets.
Vincent Plassat,
Lead Scientist, PD
Dr. Plassat is a pharmacist, and received his Ph.D. from the University of Paris Sud, France, in Pharmaceutical Technologies. He is a scientific expert in formulation development with over 8 years of experience in solving bioavailability and drug delivery challenges for new chemical entities using advanced drug delivery technologies and innovative formulation approaches.
Dr. Plassat joined Catalent in 2013 as a formulation scientist, drawing upon his experience in lipid-based softgel development for the oral delivery of macromolecules. He now is leading novel technology platforms for new drug development at Catalent Pharma Solutions (OptiGel® Bio and OptiGel® Lock).
Ralph Gosden,
Head of Product Development, R&D
Ralph Gosden, Head of Product Development at Catalent’s Swindon, UK site oversees Catalent’s Zydis® Fast Dissolve Tablet development capabilities. In a career spanning over 20 years, Ralph has worked in all the major disciplines in pharmaceutical R&D from feasibility through scale up and validation.
He has extensive experience understanding formulation and process development for oral dose forms and has been featured in multiple articles regarding the development of orally disintegrating tablets. A certified Kaizen leader, Ralph has a proven track record in leading cross functional teams to solve problems and reduce waste.
Ralph received his masters in industrial pharmacy from the University of Manchester and his bachelors of science in environmental science from Wye College, University of London.
- Learn how different oral delivery technologies overcome biologic barriers for macromolecules
- Understand how parallel screening can expedite the oral development for macromolecules
- Understand what molecule characteristics make a molecule a good fit for oral delivery route
- Formulation Scientist
- Head of Development
- Head of Pharmaceutical Technology
- Director - Formulation
- Director - CMC
- VP - Pharmaceutical R&D
- Director - Formulation Development
- Head of Product Development
