Yong Wu, PhD, RAC-Drugs, RAC-Devices

Managed the post-marketing regulatory and compliance activities for commercial HCT/Ps, biologics, medical devices and biologic/device combination products.

• Led company’s CMC, clinical and preclinical regulatory strategies and US/EU/China submission aspects of 3D printed drug product pipelines for the disease areas of rheumatoid arthritis, clotting disorder, ulcerative colitis and pulmonary hypertension. • Led Health Authority interactions (PIND meeting, FDA ETT meeting, EMA Innovative Task Force meeting, EMA Scientific Advice procedures, etc.), by setting objectives, preparing briefing books, coordinating and planning rehearsals and risk mitigation plans. • Articulates complex regulatory CMC issues (related to continuous manufacturing, process analytical technology (PAT), 3D printing, drug-device combination products, complex product design, novel excipients, GMP compliance issues, etc.) to project teams and external stakeholders. • Maintained expert knowledge in US/EU/China and ICH regulatory guidance/guideline. • Oversaw the regulatory affairs team with two direct reports, supervising subordinates to set annual achievement goals and personal development plans, and identifying resource needs.

Regulatory Review • Extensive CMC review experience of pre-and post-market drug submissions, such as 505(b)(1) and 505(b)(2) NDAs, ANDAs, Supplements, and IND/Pre-ANDA meeting packages. • Sound understanding in the development and manufacturing of various drug product dosage forms, such as tablets, capsules, sublingual films, semi-solids, oral/topical/parenteral/ophthalmic liquid products, topical/transdermal patches, and drug/device combination products. • Conveyed the regulatory concerns and feedbacks to sponsors in IND and Pre-ANDA Meetings, Mid-Review Cycle Meetings (MRCM), and Post-Complete Response Letter Meetings. • Comprehensively evaluated drug submissions, pertaining highly complex issues related to manufacturing process and controls, such as PLGA based microspheres, reservoir type transdermal systems, novel Process Analytical Technology (PAT) used in Continuous Manufacturing, Real Time Release Testing (RTRT) proposals, 3D printing technology, and Comparability Protocols. • Led and served as a Subject Matter Expert (SME) for onsite Pre-Approval Inspections (PAI) and 704a4 remote regulatory assessments of manufacturing facilities, with expertise in cGMP compliance, quality systems, equipment IQ/OQ/PQ and facility qualification, process validation, executed batch record review, deviation investigation, change controls, and laboratory data integrity. Research Initiatives • Evaluated and funded Broad Agency Announcement (BAA) research proposals from universities/companies. • Led to draft research proposals and acquired 2017 and 2019 FDA CORES grant funding. • Advocated to draft 2021 FDA CDER Critical Path research proposal.

Regulatory Review • Led to investigate the trend of nanotechnology evolution in medical device applications, such as Premarket Approval Application (PMA), Premarket Notifications (510(k)), Investigational Device Exemption (IDE), Pre-Submission Program (Pre-Sub), Requests for Information (513(g)) and De Novo. Research Initiatives • Led to draft research proposals and acquired 2017 and 2019 FDA CORES grant funding. • Consulted for physicochemical characterization of complex drug formulations. Leadership Initiatives • Mentored four summer interns, with one research project spotted on FDA news and FDA Twitter. • Managed the FDA Advanced Characterization Facility, which is equipped with transmission and scanning electron microscopies, atomic force microscopy, ICP-MS, dynamic light scattering, and etc. Guidance/Standard Development • Advocated to the development of five product specific guidances (PSG) on complex drug products. • Counseled for the revision of ASTM E56 and ISO TC229 guidance.

• Development of Polymer Hydrogel for Controlled Release of Hydrophilic Drug Molecules Achievement: Enhanced 50 times more drug loading capacity of polymer composites to ensure desired therapeutic quantity in the body. • Transport Phenomena Modeling of Drug Molecules in Polymer Composites and across Interface Achievement: Improved traditional hydrophilic drug release duration by 4 times and controlled drug delivery profiles over 30 days. This approach aims to maintain drug levels within the therapeutic window and to maximize therapeutic efficiency in human body. • Biomaterials Surface Modification to Inhibit Infection and Promote Bone Integration Achievement: Established industrial bone implants surface design to reduce biomaterials-associated infection by a factor of 100. • Lab Establishment, Instruments Management and Junior Researchers Supervision Achievement: Managed lab and instruments, ensured proper operation and maintained documentation.

• Advanced synthesis routes of carbon-metal oxide coaxial nanocables by pyrolysis of ferrocene in the environment of supercritical carbon dioxide. • Identified the mechanism of chemical reactions in nanoscale reactors by conducting a thermal stability study of Fe-encapsulated carbon nanotubes.

• Improved performance of MWCNT anode materials used for lithium-ion batteries, by one-step in-situ synthesis of nickel oxide-carbon nanotube composites.