American Drug Delivery & Formulation Summit 2026

Head, CDMO North America

Nearly 20 years (17 to be exact!) of experience in life sciences and CDMO as well as healthcare packaging supporting both operational and commercial transformations in highly regulated environments. Lead multiple site transformations, embedding lean methodologies and employing a better every 30 days approach for internal and external stakeholders. Customer focused and solutions oriented leader with a passion for developing future leaders in Publicly traded and Private Equity organizations.Most recently served as VP, Operations at Amcor Healthcare Division leading seven (7) sites and spent 15 years prior with Catalent across small and large molecule supply of critical medications. Holds a Master of Science (MSc) in Bioengineering from the University of Nottingham.

Product Development Director & Site R&D Head

Hibreniguss (Hibre) Terefe, PhD, is Director of Product Development and Site Head of R&D at Ardena Somerset. He leads integrated preformulation, formulation R&D, and analytical R&D teams supporting drug product development programs from early-stage enabling technologies through Phase III and commercial launch. Hibre brings more than 20 years of pharmaceutical industry experience in oral drug delivery systems and drug product development. His expertise includes hot melt extrusion, solubility enhancement, amorphous solid dispersions, modified release technologies, pediatric formulations, and abuse deterrent platforms. Throughout his career, he has combined scientific expertise with strategic and organizational leadership to support efficient and milestone-driven development programs. He is also recognized as an industry thought leader in oral drug product development and CMC strategy, with more than 15 publications across industry and scientific journals, contributions to the Handbook of Pharmaceutical Granulation Technology, and involvement as co-inventor on 10 patents and patent applications related to drug delivery technologies. Hibre obtained his pharmacy degree and earned his PhD in Pharmaceutical Chemistry, with an emphasis in Analytical Chemistry, from Westfälische Wilhelms-Universität Münster, Germany. He also served as a Fulbright Visiting Scholar at the University of California, Berkeley.

Associate Director of Formulation Development

Stephen Csernica is Associate Director of Formulation Development at Ardena. He brings extensive experience in solid oral formulation development, with expertise spanning solubility enhancement and complex extended-release technologies. Throughout his career, Stephen has developed expertise across end-to-end pharmaceutical development, CMC compliance, and formulation development activities supporting complex drug product programs. He also has experience leading high-functioning teams within pharmaceutical development environments. Stephen obtained his PhD in Chemical Engineering from Lehigh University in 2013.