Jing Yang, Ph.D.

Professional Experience

Feb *012-Present: Senior Scientist, Fougera Pharmaceuticals Inc., Technical Operations Department

July 2011-Jan 2012: Scientist, Fougera Pharmaceuticals Inc., Technical Operations Department

• Conduct DDI investigations for process deviations and product defects. Identify the root cause and evaluate product impact. Develop corrective and preventative actions to prevent re-occurrence.

• Investigate and resolve long-term back order issues. Provide technical/lab support for changes, e.g. raw materials, vendors, equipments, existing process redesign.

• Collaborate with multiple groups in a matrix environment including Quality, Regulatory Affairs, Clinical, Validation and Manufacturing groups.

• In-depth knowledge of FDA requirements for GMP, GLP, ANDA, IND/NDA applications, SUPAC guidelines. Write and review DDI reports, validation reports and other summary reports for filling to FDA.

Dec 2007-June 2011: Scientist, Fougera Pharmaceuticals Inc., Product and Process Development Department, R&D

• Develop drug products with focus on semi-solid dosage forms. Perform reverse engineering, solubility and compatibility studies. Design prototype formulations. Conduct stability on lab-scale batches and interpret data to develop sound conclusions. Prepare pilot-scale batches to determine a suitable process for the product.

• Select container/closure systems for the proposed drug formulations.

• Perform routine equipment calibrations and maintenance.

• Prepare, review and approve documents prepared for submission to FDA including Product Formula, Manufacturing Instructions, Filling Instructions, Product Development Report, QOS, Process Optimization Reports and Stability Protocols.

Aug 2002- Aug 2007: Research Assistant, University of New Mexico, College of Pharmacy

• Study aqueous film coating of tablets using fluorescence microscopy and XPS spectroscopy.

• Design and characterize cyclodextrin-complexation for topically delivery of UV-absorbing compounds. Examine formulation factors that influence drug delivery across skin membranes.

• Perform pre-formulation studies including pH-solubility profiling, pH, pKa, particle sizing, dissolution characteristics and polymorphism. Conduct thermal property evaluation on API or mixtures. Examine physical properties of polymer using SEM.

• Develop analytical methods for the quantitation of drugs and their metabolites in pharmaceutical preparations and biological samples (HPLC, LC/MS, GC, spectrophotometry etc.).

• Investigate acute UV-induced toxicological effects (DNA damage, cell apoptosis, epidermal lipid peroxidation and immunosuppression etc.) and chronic UV-induced skin cancer in animal models. Design and perform in vivo study and analyze results using various biological research techniques (cell culture, immunohistochemistry, H&E staining, DNA/RNA/protein extraction) and fluorescence microscopic image analysis.

Aug 1999-July 2002: Research and Teaching Assistant, Tongji Medical University, College of Pharmacy, China,

• Develop a colon-targeted delivery systems for 5-fluorouracil, and determination of pharmacokinetics and tissue distributions in mice.

Education

University of New Mexico, Albuquerque, NM

Aug 2002-Aug 2007: Doctor of Philosophy in Biomedical Sciences

Advisor: Linda A. Felton, Chair of Pharmaceutical Sciences

Dissertation: Influence of formulation factors on oxybenzone delivery across biological membrane and in vivo photoprotective effects

Tongji Medical University, Wuhan, China

Sep 1995-July 1999: Bachelor of Science in Pharmacy with Honors

Publications

• J. Yang, C.J. Wiley, D.A. Godwin and L.A. Felton, Influence of hydroxypropyl-beta-cyclodextrin on transdermal penetration and photostability of avobenzone. Eur J Pharm Biopharm. 2008 Jun; 69(2):605-12.

• L.A. Felton, K. Shah, J. Yang, H. Omidian, and J.G. Rocca, A rapid technique to evaluate the oxidative stability of a model drug, Drug Development and Industrial Pharmacy, 33 (2007), 1-7. (Drug Development and Industrial Pharmacy Outstanding Paper Award Winner for 2007).

• C.L. Kear, J. Yang, D.A. Godwin and L.A. Felton, Investigation into the mechanism by which cyclodextrins influence transdermal drug delivery, Drug Dev Ind Pharm. 2008 Jul;34(7):692-7.

• D. Barbash, J. Fulgham, J. Yang, and L.A. Felton, A novel imaging technique to investigate the influence of atomization air pressure on film-tablet interfacial thickness, Drug Development and Industrial Pharmacy, 35, 480-487, 2009

Professional Presentations

• J. Yang, C.J. Wiley, D.A. Godwin, and L.A. Felton, Poster: Use of novel sunscreens to reduce the incidence of ultraviolet-induced skin cancer in SKH-1 hairless mice. Mountain West Society of Toxicology, Park City, Utah, September, 2004.

• L.A. Felton, J. Yang, D. Barbash, and J. Fulghum, Poster: Influence of atomization air pressure used during the coating process on film-tablet interfacial thickness. AAPS Annual Meeting, Baltimore, Maryland, November, 2004.

• L. A. Felton and J. Yang, Poster: Use of confocal laser scanning microscopy to investigate drug migration into a sustained release coating. Controlled release Society Annual Meeting, Miami, FL, June, 2005.

• J. Yang, C. Kear, D.A. Godwin, and L.A. Felton, Poster: Do cyclodextrins interact with lipids in the epidermis to alter barrier function? AAPS Annual Meeting, Nashville, TN, November, 2005.

• L.A. Felton, K. Shah, J. Yang, H. Omidian, and J.G. Rocca, Poster: A rapid technique to evaluate the oxidative stability of a model drug. AAPS Annual Meeting. San Antonio, TX, October, 2006.

• J. Yang and L.A. Felton, Poster: Influence of cyclodextrin complexation on the skin distribution of a model UV absorber. AAPS Annual Meeting. San Antonio, TX, October, 2006.

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