Of all new chemical entities (NCE) in development, 70% are poorly soluble, and 20% have both solubility AND permeability challenges. As a results, more than 40% NCEs development consistently fail. Selecting the best formulation and drug delivery strategies, to overcome bioavailability challenges at early phase of drug development, is critical to a successful and fast development pathway.
This 60-minute webinar will provide an overview of various formulation approaches and drug delivery technologies for compounds with bioavailability challenges. Examples will be shown to demonstrate how companies achieve the optimized and expedited drug development process by applying those technologies.
Stephen Tindal,
Director, Formulation and Site R&D Lead
Stephen holds a bachelors degree in Chemistry and Analytical Science from Loughborough University, UK. He has worked in softgel R&D for 27 years and has broad expertise in the technology. Stephen specializes in root cause investigation, technology innovation, gelatin innovation, customer liason and supporting business development. Stephen is part of Catalent's R&D Team at the Company Headquarters in Somerset, New Jersey.
Ronald Vladyka,
Director, Formulation R&D ADT
Ron Vladyka has over 20 years of experience in pharmaceutical development. His development experience, over his career, has included development of novel delivery systems for parental, inhalation, and oral administration. Ron has been part of the formulation development team at Catalent for over six years. His responsibilities include development and transfer of technologies and oral delivery systems that aid in solubilizing poorly soluble drugs compounds. His other research interests include compaction and multi-particulate modified release systems. He also holds several U.S. Patents in the area of improvement of bioavailability.
- Learn about how proven and innovative softgel technologies address API and processing challenges, therefore advance more products to development pipeline
- Understand how other advanced oral drug delivery technologies (e.g, Hot Melt Extrusion) enable extended or modified release profiles, and further optimize drug therapies
- A brief introduction to a formulation predicative tool FormProRx™
- Formulation Scientist
- Head of Development
- Head of Pharmaceutical Technology
- Director of Formulation
- Director CMC
- VP Pharmaceutical R&D
- Director Formulation Development
- Head of Product Development
- R&D Scientist
- Drug Development Scientist
- Formulation Pharmacist
