Kevin Hu

Working on Late-Stage Process Development for AT-527, an oral anti-viral drug targeted for COVID-19. Supervising CMO manufacturing activities and ensuring API needs for clinical trials; Supervising CRO to prepare radiolabeled API for clinical studies; Preparing Regulatory filing documents.

Process chemistry lead to develop a new molecule from Phase I; Selecting CROs and CDMOs for RSMs and API development and manufacturing; Setting up CDAs and MSAs with vendors; Defining Scope of Work and requesting and negotiating RFPs and Change Orders. Working with project management to prepare budget and timeline; Supervising CROs and CMOs for developing phase-appropriate tasks and manufacturing activities; Drafting technical documents and regulatory filing documents (IB, IND); Working with other functions to move the program forward.

Worked on Late-Stage process development for Niraparib (ZEJULA); Drifted and reviewed CMC documents for Process Validation and NDA/MAA filing; Performed Technical Transfer to CMOs successfully; Performed API process validation for NDA Approval and supervised API production at CMO sites; Drafted SOW, Requested RFP, and supervised Phase III development activities at CRO site; Managing API genealogy and support supply chain to meet API needs. Managing Phase IV activities at CMO site.

Process research and development for a Gen-2 project; Process characterization studies, such as Range selection and Robustness using Design of Experiment (DoE); Impurity spiking and purging studies; Process research and scale-up of a new small molecule API from medicinal route (pre-Phase I).

Optimized medicinal route to make ready for phase I; Late-Stage activities for Process Validation; Participation of CMC writing for NDA filing; Performed Technical Transfer to CMO.

•Worked on prostate cancer research area. Evaluated and improved synthesis routes for pre-clinical small molecule drug candidates; •Develop robust process chemistry for the production of API at CMO to support preclinical and Phase 1/2 clinical studies; •Improved the overall yield of an inherited project from 20% to >50% and carried the project from Tox to Phase II successfully; •Identified and selected CMO for large scale manufacturing; Coordinated and overseen technology transfer and GMP scale-up for APIs; •Using knowledge from various disciplines to trouble-shoot synthesis hurdles and impurity profile issues in API; Worked with other functions in the CMC group to move the program forward;

•Managing all analytical activities of one API project (generic API); Method Development and Validation; •IPC and Release method development and validation; •Batch Record review for GMP production of API; •Perform various USP analyses.

•Scaled up various small molecules for preclinical studies at fast paces; •Leading contract scientist for Millenium Pharmaceuticals, Inc.; Synthesis of metabolites of anti-cancer drug Velcade® (2003); New method developed to solve synthetic problems; •FTE process scientist for a small biotech company; API synthesis; Improve yield to >90% each step; Selection of re-crystallization conditions; Pilot plant ready; •FTE process scientist for a small pharmaceutical company; large scale intermediates synthesis; Improve process and procedures; Increase output from 200g/month to 200g/week; •FTE scientist for a large pharmaceutical company; large scale multi-step intermediate and scaffold synthesis; Scaled-up a 7-step literature route to 100g-scale with elimination of costly and dangerous reagents and improved yield (3-fold); Worked for Sugen to synthesize ALK analogs.

•Process research of various beta-lactams used for Paclitaxel analog synthesis; •Improve medicinal route to pilot plant ready route; Eliminate column chromatography usage; •Structural elucidation of Paclitaxel analogs and impurities using various NMR techniques; •Total synthesis of Lonomycin and synthetic method development;