Xiao Yu Email & Phone Number

Boston, Ma, Us

Boston, Ma, Us

Cambridge, Massachusetts, Us

Cambridge, Massachusetts, Us

-Led the efforts of developing products in oral solid dosage forms (immediate release tablets, extended-release tablets and multi-particulates) and suspensions for NDA 505 (b)(2) and ANDA projects. -Developed co-crystal formulation to enhance bioavailability of poorly soluble drugs.-Designed and executed scientific experiments to support product development. -Served as a technical representative and project lead; drafted, reviewed, and approved study protocols, technical reports and batch records, executed batches at the CMO.-Drafted Pre-IND and IND documents CMC section. -Prepared and organized materials for a Type B Pre-IND meeting with FDA. Participated in the Type B meeting and received positive project feedback from FDA.-Provided all essential materials and collaborated with Simulation Plus, Inc. to establish PK models and IVIVR, reviewed reports and utilized the model to guide formulation design and development.-Drafted and reviewed four patent applications, discussed and drafted responses for examiners. -Drafted, reviewed and finalized critical documents for three NIH grant applications. -Conducted due diligence on various projects, prepared product presentations for potential investors.-Maintained good oral and written communication with external vendors and excipient suppliers.-Supervised and trained interns.

Maple Grove, Mn, Us

-Led the late-stage product development efforts of a marketed brand product (extended-release capsules).-Led the CMC activities of selecting an alternative API supplier and managed planning, preparation, execution and submission of the pivotal batches. PAS was successfully approved by the FDA.-Utilized QbD principles to establish the QTPP, perform risk assessment and identify CQAs of the drug product, identify CMAs and CPPs and support development of a proper control strategy and determine the design space of the drug product. -Led the research project to improve solubility of poorly soluble drugs by forming cocrystals and amorphous solid dispersion, performed an animal PK study and successfully demonstrated enhanced bioavailability of the poorly soluble drug.

Maple Grove, Mn, Us

• Led oral solid dosage product development projects • Successfully supported and reviewed NDA submission CMC section (NDA approved by FDA) • Worked with CMO on process development, process validation, tech transfer, new equipment evaluation, batch record review, protocol review, and troubleshooting, etc. • Led the project on selection of alternative raw material suppliers and coordinated with different departments (internally and externally) on activity planning, material ordering, specification setting up, etc. • Design of experiments (DoEs), interpreted the results using statistical tools and analysed process capability using JMP • Conducted and completed multiple tasks with different priorities to meet project timelines

College Station, Tx, Us

Project: Synthesis of New Functional PolymersProject: Fabrication & Characterization of Nanoparticles and microgels Project: Material Coating and Surface ModificationProject: Controlled Release and Colon Drug DeliveryProject: Material Cytotoxicity and Drug Targeting Test with Mammalian Cells

Gaithersburg, Maryland, Us

Project: Development and Optimization of Microcarrier based Cell Culture Process for large scale Vaccine Production •Cultivate mammalian cells in flasks, roller bottles, bioreactors •Optimize bead-to-bead transfer strategies to build a platform of scaling up cell culture process•DoE and analyze data by JMP software

Doctor Of Philosophy (Ph.D.), Chemical Engineering

Master, Medicine

Bachelor, Pharmaceutical Engineering