Yun Shan

Preclinical formulation development and selection (solution, suspension, ASD - amorphous solid dispersion formulations) Analytical method development for all selecting formulations Stability study and evaluation for API and various formulations Enhance bioavailability or toxicity exposure of the poor soluble compound via formulation enhancement (complex, co-solvent), particle size reduction, and solid dispersion technology, etc. Solid state characterization, PXRD, DSC/TGA, DVS, microscopy, KF etc. API salt screening, polymorph screening, and hydrate screening, Clinical formulation development for phase I and phase II clinical trials. Hands-on excipients compatibility study and analytical method development and analysis Experience in softgel, capsule and tablet formulation development Currently in UCSD extension program for Good Clinical Practice class, and Design of Clinical Trials Actively participate GMP, GxP training, conference and short course

Preformulation research to support early stage projects Preclinical formulation development Solid state characterization, PXRD, DSC, TGA, HPLC, UPLC, DVS, Particle size Polymorph screening and salt screening Solubility, stability, disolution study HPLC Method development and validation Formulation development for early phase clinical studies

Characterizations for microemulsion, encapsulation, liposome formulations via varies analytical tools Drug release method development by HPLC, LC/MS, and UV/Vis, etc. Excipient compatibility study Liposome formulation development for poorly water soluble drug (Direct mixing, Microfluidics, etc.) Stability study for lead formulations Project management for several project, coordinate, communication, and collaboration skills

Lead a team of 2-3 associates to provide critical preformulation support for drug discovery programs. Projects ranged from insomnia, obesity, diabetes, platelet, anti-inflammatory, etc. Advise discovery team on key physicochemical properties: pH- solubility, LogP, pKa, thermal analysis (TGA, DSC), PXRD, hygroscopicity and stabilities. Tablet and softgel (SGC, HGC) formulation development Excipient screening and compatibility study Dissolution study and method development for drug products Participate GMP clinical batch manufacture Hands-on experience with Xcelodose and other formulation equipment Participate IND submission on CMC sections. Work with IP Department on salt and polymorphism patent applications Extensive involvement in formulation development strategies for poorly water soluble compounds

Toxicology formulation support for early stage programs Design and execute the stable form screening and polymorphs screening; determine the relative stability of all identified polymorphs Interface with Medchem, Pharmacology group, Drug metabolism and PK group, Drug Safety Evaluation group for compound EDC nomination; Help company to reduce attrition rate by eliminating high risk compounds at early stage. Recommend suitable salt strategy to enhance bioavailability, stability or manufacturability. Enhance the bioavailability or toxicity exposure of the poor soluble compound via formulation enhancement (complex, co-solvent, particle size reduction, etc).

Polymorphism study, stable form screening, solubility screening, salt screening Solubility study to support preclinical formulation and toxicology formulation