Jiaying Liu

- Lead cross-functional teams in the development of intravenous (IV) infusion and subcutaneous injectable drug products across diverse biologic modalities (e.g., monoclonal antibodies (mAbs), bioconjugates, T-cell engagers, small molecules, and prodrugs) - Drive strategic planning and execution for early- and late-phase product development and lifecycle management, from formulation and process development through BLA submission and commercialization. - Oversee end-to-end development and external manufacturing activities at CDMOs, ensuring quality, timeline, and regulatory alignment. - Innovate and implement forward-thinking formulation and manufacturing solutions to address complex technical challenges, with a strong focus on long-term strategy and product robustness.

- As leads of crossfunctional working groups, develop strategies of commercial product development of biologics combination product to enable clinical trials and BLA - Develop strategies of quality-by-design and risk assessment to ensure successful development and launch of drug product - Mentor junior scientists on innovation projects or pipeline programs

• Led/participated in the formulation development effort of biologics and long-acting injectables, suspension, adult capsule/tablet and pediatric formulations for PhI-III clinical studies in a number of pipeline programs, including the Molnupiravir COVID-19 Oral Program • Led/participated in IND/CTA/NDA filling, technical memo/report documentation effort, which resulted in multiple successful regulatory submissions and approvals • Led a ~$0.7MM capital business project to establish new developmental and GMP manufacturing capabilities • Managed/collaborated with CRO/CMOs for process scale-up development and clinical manufacturing • Led innovation on in-situ gels, novel viscosity reducers, oral delivery of weak bases, peptides and film coating in-process analytical technology • Managed multiple cross-functional development teams and mentored junior scientists to facilitate talent development

• Designed and developed synthetic nanoparticle antibodies (SNAbs) that mimic the functions of antibodies, leading to one PCT patent application No.PCT/US18/25827 • Developed siRNA-delivering polymeric micro/nanoparticles for checkpoint inhibition in cancer • Investigated immunomodulation methods using various adjuvants and delivery systems in murine models, leading to one peer-reviewed publication

Connect to the biotech industry and coordinate their activities on campus

Mentored Undergraduate Exchange Student from Peking University for Laboratory Research

Worked as teaching assistant for BMED 2300 Problems in BME II (Design and Prototype)

Worked as teaching assistant for BMED 3110 Quantitative Engineering Physiology Laboratory I

Mentored Undergraduate Exchange Student from Peking University for Laboratory Research.

Independently investigated on the influence of different extracellular niche of hydrogel and dendrimer on cell behavior and worked on the development of cell encapsulation device for immuno-isolation for diabetes

Worked in Dr.Platt's lab assisting research as undergrad research assistant on Gene therapy for Sickle Cell Diseases

Working as graduate research assistant in Krish Roy Lab on nanoparticle-mediated immunomodulation for cancer and autoimmune diseases.

As undergrad Research Assistant in Laboratories for Biofunctional Material and Regenerative Technologies Lead by Dr.Ying Luo, independently researched on how 3D engineered biomaterial constructs ( hydrogel micro-arrays/dentrimer-peptide.etc) influence cell behaviors and worked on the development of hydrogel-based immuno-isolation device for treatment of diabetes, which led to both peer-reviewed publication and conference presentations. Ranked the first in class of 2013 Honored Outstanding College Graduates of Beijing of Year 2013 Honored Triple A students of Peking University 2012 Awarded Suzhou Industrial Park Scholarship 2011 Awarded Fanzheng Scholarship 2010 Worked as aMember of Red Cross Association in PKU.