- Led research plan to develop targeted lipid-based nanoparticle systems with enhancing potency and stability of encapsulated mRNA.- Collaborated with academic institutions to advance LNP research, driving innovation and scientific progress.- Built and managed a team, ensuring efficient resource allocation and budget management for successful project execution.

- Milestones: (1) Identified ionizable lipids, facilitating a deal with Merck (together with oRNATherapeutics) for collaboration in infectious disease and two additional therapeutic areas; (2)Developed LNP formulations targeting bone marrows, establishing pipelines for treating sickle celldisease and β-thalassemia.- Established and cultivated a high-performing formulation team, fostering the expertise to effectively prepare, characterize and scale up LNP formulations, pivotal for supporting in vitro and in vivo studies.- Oversaw a team to screen novel ionizable lipids for hepatic and extra-hepatic delivery and map out the strategy to optimize the identified lead formulations to improve the potency, delivery and targeting of the formulations.- Demonstrated effective cross-functional collaboration by advance the formulations to therapeutic programs, aligning with aggressive timelines and ensuing timely delivery.

- Led a team to identify and develop novel lipid nanoparticle formulations for targeted delivery of ceDNA (closed-end DNA) to hepatocytes while avoiding myeloid cells uptake.- Developed a breakthrough process to encapsulate large payload DNA into lipid nanoparticles with superior nanoparticle characteristics and favorable in vivo activities.- Optimized scale up process to manufacture LNP test articles to support various preclinical studies (rodent and non human primates) for development candidate selection and IND enabling studies.

- Lead to develop best-in-class RNA nanoparticles with endosome release property for in vivo delivery, including design, development, characterization, process development to support PKPD, efficacy and toxicology studies for IND filing.- Identify and collaborate with CMO to scale up the formulation, including technology transfer and optimization of lipid nanoparticles for toxicology study and clinical trial materials.- Responsible for development and validation of LC-MS/MS methods for RNA quantification in biological matrices to support PK and efficacy studies according to FDA/ICH guidelines.- Drive to optimize formulation to enhance bioavailability of poorly soluble drug candidates for clinical trials; initiate the strategy to formulate water insoluble API for intravenous administration.

- Led in design and execution of nanotechnologies to formulate nucleic acids and protein biologics; developed a device to encapsulate biologics with high efficiency: >95% for nucleic acids and >80% for protein achieved with simple procedures and at mild conditions.- Validated analytical methods for lipids and payloads, investigated functional assays of formulated biologics. The transient transfection efficiency and toxicity of nucleic acid formulation were superior to dominant products in market. The cellular activity of protein formulation was 5-fold of its counterparts.- Collaborated with CMO and marketing to support product launch.

- Led in pre-formulation and formulation studies of cancer stem cell inhibitors to support IND filing and clinical trials: salt selection, crystallization screening, solubility study, formulation development, dissolution test, etc.- Developed and validated HPLC methods for drug substance and drug product for IND filing; optimized analytical methods and extraction procedures from biological matrices in DMPK studies. The validated method was transferred to CRO to analyze clinical samples.- Performed PK/PD and efficacy studies in tumor xenograft models. The lead candidates are in different phases of clinical trials.- Created and implemented formulation development strategy for siRNA formulation to evaluate the formulation in vitro and in vivo