Dave Edgren Email & Phone Number

Palo Alto, Ca, Us

• Designed and developed osmotic dilators for remodeling biological tissues• Identified and formulated semipermeable elastomeric membrane systems and osmotic engines to dilate biological ducts• Designed and fabricated prototype devices for use in dilating nasal ostia• Demonstrated successful functionality in animal models and in humans• Devices based on the prototype design are now commercially available in the EU

Hayward, California, Us

• Performed root cause analysis on batches of a commercial tiny time pill product• Identified sources of variability in dissolution performance attributed to the spray coated, rate controlling membrane • Sources of variability included raw material of membrane composition, coating solvent composition, and processing conditions• Improved reproducibility of the membrane permeability and dissolution performance

• Developed direct compression formulations of SR tablets for oral administration • Formulated and characterized powder blends (flow, compression curves, propensity for punch sticking) and tablets (tensile strength, content uniformity, dissolution patterns)• Monitored manufacture at CMO of Phase 2b supplies through 40 kg scale• Inventor on patent application for these dosage forms and processes to manufacture them

o Generated concepts to potentially enhance drug delivery and evaluated the feasibility of these concepts. The concepts included the areas of• increasing extent of drug absorption in the gastrointestinal tract• designing biodegradable implants and depots for delivery of drug to the posterior of the eye• developing hydrogels for use as electrodes in electrotransport systems to deliver drugs across skin and ocular tissueso Presented concepts to upper management

o Developed a wide variety of coatings for use on oral dosage forms including• acetone-based, aqueous-based, and ethanol-based membrane formulations• membranes with permeability values that respond to changes in osmotic pressure to produce different delivery patterns• high flux and low flux membranes for fast and slow drug delivery• stable and cosmetically elegant color coating films for tablets with surfaces that commercial color coating companies were unable to successfully spray coat with their off-the-shelf formulationso Developed erodible matrix tablets for oral delivery including• hydrogel matrix systems with printed insoluble bands to control drug delivery rate patterns (RingCap)• layered erodible hydrogel matrix systems for delivering immediate and slow release fractions that were tested in a large-scale clinical studyo Developed an enabling technology using surfactant hydrogels to increase drug solubility in situ for use in tableted osmotic delivery systems (S-Core)o Evaluated formation of nanoparticles using focused acoustic energyo Developed osmotic delivery system for localized delivery of drug within the oral cavity that was tested in human studies

• Developed osmotic systems with internal buffering systems to control drug solubility and delivery• Developed rate control membranes for osmotic oral dosage forms with permeability values that respond to changes in pH