Reginald Jacques, Ph.D. Email & Phone Number

As an accomplished Senior Director with over 15 years of extensive experience in Drug Product Development and Manufacturing within the pharmaceutical industry, I have demonstrated expertise in formulating and executing CMC strategies across all development stages, from candidate selection to commercial launch and supply. I possess a profound understanding of sponsor needs and CDMO/vendor perspectives, which drives successful relationship building, vendor collaboration, and the delivery of complex planning across internal and external contributors. AREAS OF EXPERTISE:Vendor OversightContract NegotiationRegulatory CompliancecGMPDrug Product DevelopmentFormulation OptimizationCMC Strategy DevelopmentGlobal Partnership BuildingHigh Shear wet granulationFluid Bed Granulation Roller CompactionFilm CoatingTablet Compression (Monolayer, Bilayer)EncapsulationSpray DryingWurster CoatingProduct Chemical and Physical characterization techniques CAREER HIGHLIGHTS:Strategic CMC Development Leadership:I led end-to-end CMC strategy and development activities at Ikena Oncology, including technical assessment and execution using external partners. I successfully managed global regulatory submissions and ensured alignment with project timelines and corporate goals. I defined and drove a stage-appropriate strategy that balanced effective investment with delivering on CMC objectives aligned with the development strategy and corporate priorities of the portfolio.Effective External Collaboration Management:I built extensive external collaborations for pharmaceutical development at Ikena Oncology, overseeing pre-formulation, formulation development, and GMP manufacturing. I provided technical expertise to ensure compliance with development and GMP activities, contributing to successful project outcomes.Leadership in Formulation and Process Development:I directed formulation and drug product development at Reata Pharmaceutical, focusing on phase-appropriate CMC strategy, streamlined tactical planning, and execution. I ensured compliance with cGMP and regulatory requirements, leading to the on-time release and supply of drug products.Innovative Drug Formulation and Technology Transfer:I designed and implemented formulation strategies for low solubility compounds at Reata Pharmaceutical, leveraging enabling formulation technology (Amorphous Spray Dried Dispersion). I led technical transfer efforts and developed process validation strategies at third-party contractors, advancing a phase 3 registration asset towards commercialization objectives.