Accelerating To The Clinic: Building Oral Dosage Forms For Speed Today And Success Tomorrow

Getting an oral solid dosage form into the clinic quickly requires more than speed. It demands a development strategy that balances rapid execution with the flexibility to adapt as new data emerge. By integrating biopharmaceutics, formulation and process development, analytical sciences, manufacturing, and quality within a structured framework, teams can make smarter decisions earlier and avoid costly rework later.

This session explores how biopharmaceutics modeling and fit-for-purpose in vitro testing can reveal clinically relevant product-performance sensitivities, guide formulation selection, and reduce development risk before clinical studies begin. Real-world examples demonstrate how risk-based development approaches, scalable unit operations, and science-driven scale-up strategies support efficient translation to GMP manufacturing.

Attendees will also gain insight into how early technical understanding can streamline clinical manufacturing, analytical development, and quality activities, helping accelerate the path to Phase I while building a stronger foundation for long-term program success.

Speakers:

David Vodak, PhD. | Chief Science Officer, Bend Bioscience

David has worked in the pharmaceutical field for over 20 years in Research and Development of drug delivery technologies. He has over 40 scientific and industry publications as well as over 20 patent and patent applications related to drug delivery via various modalities. Dr. Vodak is currently the Chief Scientific Officer of Bend Bioscience.

After a post-doctoral research fellowship at the Scripps Research Institute in San Diego CA, working on self-assembling cyclic peptides, David joined Bend Research in Oregon where he worked on Spray-Dried Dispersion technology and bioavailability enhancement as well as other various particle engineering technologies, including nasal/pulmonary and non-invasive delivery of biologics. During his tenure with the organization, which eventually became part of Lonza, David led R&D in North America for the Dosage Form Solutions division before taking the position of Global Head of R&D for Small Molecules.

Devon Dubose, PE | Head of Manufacturing Science and Operations, Bend Bioscience

Devon DuBose, PE, is Head of Manufacturing Science and Operations at Bend Bioscience’s Bend, Oregon site, where he leads manufacturing operations supporting the advancement of pharmaceutical programs from development through GMP clinical production. A professional engineer with extensive experience in pharmaceutical manufacturing and process scale-up, Devon brings a practical, science-driven perspective to translating development processes into robust manufacturing solutions for clinical programs.