Elliott Pauli is a high-achieving, motivated senior program manager with upwards of 20 years of excellent performance in pharmaceutical research and development. He has expertise in chemistry, manufacturing, and controls (CMC) and a thorough working knowledge in nonclinical, clinical, and regulatory from pre-IND through commercialization. He created product development strategies and managed project activities with multinational development teams, CMOs, and CROs using strong communication skills.
Mr. Pauli is currently developing novel regimens for the treatment of tuberculosis, which including compounds such as pretomanid, bedaquiline, sutezolid, and others. Since joining RTI in 2006, he has been responsible for directing scientific teams from pre-IND to Phase IIb and has managed CMC teams/consultants and external CMOs on combination therapies from pre-IND through NDA/MAA.
Mr. Pauli has multiple professional accomplishments. As a program manager, he prepares fast-tracked development timelines and project finances and writers clinical study publications. Mr. Pauli contributes to drug discovery by managing the HEOS database and leading optimization and screening efforts to IND candidate selections. He is an expert in CMC, planning and managing CMOs on drug substances and route optimization. Additionally, he specializes in fixed-dose combination development, QbD experiments, clinical supply acquisition (primary and secondary packaging/labeling), and drug substance and product release plus stability testing.
Mr. Pauli holds a field epidemiology certification from the University of North Carolina at Chapel Hill and a project management professional certification from the Project Management Institute.