Isaac Ghebre-Sellassie, Ph.D. – Founder and President
Isaac is an entrepreneur with extensive executive and management experience. He is Founder of two start-up pharmaceutical product development companies. He is highly experienced in strategy development and implementation as well as in product enhancement and life cycle planning, and has a demonstrated ability to integrate individuals with diverse educational backgrounds and disciplines into cohesive and highly productive teams.
Isaac is creative, problem solver and forward thinker. He was the first scientist who applied hot melt extrusion (HME) for enhancing the solubility of a poorly soluble drug substance in 1991 when he converted a spray drying process to HME (Patent granted in 1997). The technology was subsequently transferred to production, and the product (RezulinR) was approved by the FDA in 1997. In addition, Isaac designed and developed the first continuous twin screw extrusion-based wet granulation, radio-frequency drying process (patent granted in 2000), and a liquid-assisted continuous twin screw extrusion solubility enhancement technology (Patent granted in 2009). His in-depth knowledge in twin screw extrusion technology coupled with his expertise in formulation science has led him to design a breakthrough abuse deterrent formulation technology platform that resists all forms of dosage form tampering with the potential to reduce or eliminate all forms of drug abuse (Patent granted in 2017). He is also a leading expert in multiparticulate drug delivery and film-coating technology, and has been involved in the development of over 20 drug products.
Isaac has published extensively on aqueous film coatings, extrusion technology, pelletization processes and fluid bed technology; authored or co-authored 14 book chapters, was granted 23 patents and edited or co-edited three books – Pharmaceutical Pelletization Technology (1989), Multiparticulate Drug Delivery (1991) and Pharmaceutical Extrusion Technology (2003).
Hibre Terefe, Ph.D. - Vice President, Research & Development
Hibre has over 15 years of academic and industrial research and development experience, particularly in the area of drug delivery and technology. He has extensive experience in twin screw extrusion technologies, including hot melt extrusion and liquid assisted extrusion as applied to solubility enhancement, modified release and tamper resistance products. His expertise in the area has helped him to contribute significantly in the development of abuse deterrent formulations for which he is a co-inventor. Hibre has applied innovative drug delivery systems to support discovery preclinical studies.