Hibreniguss (Hibre) Terefe
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.
James Ngai
James Ngai is Director of Business Development at Ardena. He brings more than 18 years of experience across the biotech and pharmaceutical industries, combining scientific expertise with commercial leadership in support of drug development programs.
With a background in analytical chemistry, James has built extensive experience in commercial growth and strategic client partnerships. Based in the San Francisco Bay Area and supporting the Pacific Northwest region, he works closely with clients to navigate CMC development and support the advancement of therapeutic programs.
James is recognized for his ability to bridge scientific understanding with strategic business opportunities across pharmaceutical development and manufacturing programs.
Moniek van der Eem
Moniek van der Eem is Director Analytical Sciences at Ardena. She is an experienced analytical chemist with more than 20 years of experience in the pharmaceutical industry, specializing in CMC development and analytical strategies supporting drug development programs.
Throughout her career, Moniek has led analytical and quality strategies across complex pharmaceutical projects, supporting the advancement of development programs from early stages into the clinic. She has extensive experience delivering robust analytical data packages and supporting regulatory readiness across development activities.
Moniek is recognized for her expertise in analytical sciences and her focus on supporting efficient and compliant pharmaceutical development programs.
Paul van Tilborg
Paul van Tilborg is a senior scientific and operational leader with over 25 years of experience in analytical sciences, CMC development, and CRO operations. As Director CRO Services at Ardena in Oss, he is responsible for building and scaling bioanalytical capabilities and leading solid-state research activities, while contributing at an executive level to API analytical sciences.
Paul has a strong track record in developing organisations, facilities, and teams with a clear focus on operational efficiency, customer value, and financial performance. At Ardena, he transformed the analytical sciences function from a small start-up operation into a fully established department supporting multiple development programmes, combining technical capability build-up with scalable, financially robust operations. He consistently drives growth by aligning scientific excellence with client needs, ensuring reliable delivery, transparency, and long-term partnerships. His approach emphasises fit-for-purpose solutions, efficient execution, and creating measurable value for customers and the organisation.
Earlier in his career at MSD (Organon/Schering-Plough), he led analytical development teams and contributed to CMC strategies, regulatory submissions, and the delivery of complex drug development programmes.
He holds a PhD in Chemistry from Utrecht University and contributes to postgraduate education through teaching in applied NMR spectroscopy.
