Isaac Ghebre-Sellassie, Ph.D. – Founder and President: Isaac has over 35 years of extensive executive and management experience including as Senior Director of the Department of Technology Development at Warner-Lambert/Pfizer, whose main responsibilities was the design and development of novel formulations that optimize drug delivery, development of non-conventional manufacturing technologies that improve quality and increase manufacturing efficiency as well as evaluation of established and emerging drug delivery systems.
Isaac was the first scientist in the industry to apply a hot melt extrusion (HME) process to enhance the solubility of a poorly soluble drug substance in 1991 when he converted a spray drying process to an HME process. The technology was subsequently scaled up and used to manufacture the first HME-based product (Rezulin®) approved by the FDA in 1997 (Patent granted 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). His in-depth knowledge in twin screw extrusion technology coupled with his expertise in formulation science has led to the design and development of many breakthrough drug delivery technologies, including a multibarrier abuse deterrent formulation technology platform that resists all forms of dosage form tampering with the potential to reduce or eliminate 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 significant experience in strategy development and implementation, product enhancement of new and marketed products and life cycle planning.
Isaac has published extensively on aqueous film coatings, pelletization processes and fluid bed technology. He has 23 patents, authored or co-authored 14 book chapters, edited two books - Pharmaceutical Pelletization Technology (1989) and Multiparticulate Drug Delivery (1991) and co-edited one more book - Pharmaceutical Extrusion Technology first edition (2003), second edition (2018).
Hibre Terefe, Ph.D. - Vice President, Research & Development: Hibre has over 20 years of academic and industrial research and development experience, particularly in the area of drug delivery. He has extensive experience in twin screw extrusion technologies, including melt extrusion as applied to solubility enhancement, modified release and taste-masking applications. In addition, his expertise in the area has helped him to contribute significantly during the development of abuse deterrent formulations (Patent granted in 2017), and a liquid-assisted extrusion process for solubility enhancement (Patent granted in 2009) for which he is a co-inventor in both instances. Hibre has successfully been applying his experience and expertise in twin screw technology to support preclinical research and clinical product development.