Name: Li Chen

****D Walker Building, Harrison School of Pharmacy, Auburn University, AL, 36849

Mobile: 334-***-****; Work: 334-***-****; Email: acgfj1@r.postjobfree.com

Education

PhD, Pharmaceutical Sciences July2010-Present

Auburn University, Auburn, AL GPA:4.0/4.0

MS, Pharmaceutics September 2007-June 2010

Shanghai Institute of Pharmaceutical Industry, China GPA: 3.68/ 4.0 (Rank: 1/72)

BE, Food Science and Engineering September 2003-June 2007

Huaihai Institute of Technology, China GPA: 3.70/4.0 (Rank: 1/300)

Technical Skills Summary

Statistical Design of Experiments, Formulation Design and Development of Nanoemulsions for Topical/Transdermal Delivery, Permeation studies across skin and cornea by using Franz Diffusion Cells, Excipients interaction and stability studies according to ICH guidelines, Rheology measurements by Brookfield Rheometer, Osmolality measurements by Osmette Osmoteter, Tablet compression and bend analysis by using Carver press, Tablet dissolution studies using Hansen’s dissolution rate testing equipment, Freeze dryin g using Labconco lyophilizer, Cell cytotoxicity evaluation by MTT assay and Cell uptake studies by Flow Cytometry and Enzyme Immunoassay, Protein and DNA assays by SDS-PAGE.

HPLC analytical method development and validation according to FDA guidelines using Waters Alliance HPLC with photodiode array UV detector operated by Empower 3 software.

Pharmacokinetic and tissue distribution studies in animals (rats, mice).

Significant Accomplishments

Successfully developed an ocular nanoparticle based formulation leading to commercial launch by Newgen Biopharma Corporation.

Successfully developed two topical nanoparticle based formulations leading to commercial launch by Newgen Biopharma Corporation.

Successfully developed docetaxel microemulsion for IV injection and this work was patented by Shanghai Institute of Pharmaceutical Industry, Shanghai, China.

Winner of several awards and scholarships at Auburn University (listed in page 3). Remained outstanding graduate student at Auburn University with 4.0/4.0 GPA.

Awards

First class scholarship during undergrad. Studies (awarded 4 times): 2003-2007

First-class scholarship during postgraduate studies: 2007-2008

Outstanding graduate student during undergraduate studies: 2006-2007

Graduate School Travel Award (awarded two times): 2012-2013

Fellowship from the Don Tillery Fund (awarded three times): 2012-2013

Meritorious scholarship award from Harrison School of Pharmacy: 2010-2011

Graduate scholarship for new students, Teaching Assistantship: 2010-Present

Auburn University Research Initiative in Cancer (AURIC) Scholarship: 2014-Present

Newgen Biopharma Corp. research incentive (awarded two times) 2012-2014

Professional Experience

U.S. Pharmacopeial Convention, Rockville, MD, Intern: May-August 2013

Assisted in the development of a harmonized, global compendia viscosity standard for development of a harmonized chapter/monograph procedure(s) for excipients viscosityndetermination.

Collected and reviewed current official USP, EP, JP, BP, ChP compendia viscositynstandards, associated literature and USP historical revision files relating to official USPnviscosity chapters and USP–NF monographs that reference these chapters.

Newgen Biopharma Corporation, Titusville, NJ, Research Assistant: March 2012-Present

Development of topical nanoparticle based formulations

Formulation development of micellar nanoparticles (ocular,transdermal delivery) andncharacterization of formulations for particles size, zeta potential, viscosity, osmolality, drugnloading, etc.

Stability indicating HPLC assay method development and validation.Permeability test of nanoparticles across human skin and cornea using Franz Diffusion cells.

Preparation of standard operation procedures (SOPs) and final technical reports in accordance to GLP practices.

Preparation of product dossiers for technology transfer to a cGMP manufacturing facility.

Siga Technologies, Corvallis, OR, Research Assistant: January 2011 – December 2011

ST 246 Blend analysis and Characterization.

Study of granulation characteristics and flow properties of tablet blend.

Compression analysis of the granules using the custom designed tablet punches.

Auburn University Auburn, AL, Research Assistant: July 2010-Present

Delivery of Anthracyclines through Novel pH Sensitive Micelles

Development of a novel pH sensitive Oxidized Phospholipid-based micelle formulation via both electrostatic and hydrophobic interactions for delivery of doxorubicin and idarubicin.

Characterization of micelles based on particle size, encapsulation efficiency, stability and release profiles.

In vitro uptake and cytotoxicity evaluation for leukemia P388 and its resistant subline P388/ADR.

Co-delivery of Zoledronic Acid and Double-strand RNA from Core-Shell Nanoparticles

Development of core-shell nanoparticles with calcium-phosphate core and cationic lipid shell for simultaneous delivery of zoledronic acid and double strand RNA.

Characterization of formulations for particle size, encapsulation efficiency, drug loading efficiency, etc.

Evaluation of in vitro cytotoxicity on melanoma cell line B16BL6.

In vivo efficacy testing of formulations on melanoma mouse model.

Formulation of Genistein Nanoemulsions for Enhanced Genistein Transdermal Delivery Preparation and optimization of genistein loaded nanoemulsions through pseudo ternary phase diagram.

Characterization of formulations for particle size, drug encapsulation efficiency, etc.

Skin permeability testing of formulations across human skin and cornea using Franz Diffusion cells.

Co-delivery of Doxorubicin and Ceramide as a Nanoparticle Based System for Melanoma Treatment

Formulation of ceramide and doxorubicin loaded liposomes.

Optimization of formulations for the types of lipids and ceramides, the ratio of ingredients, encapsulation efficiency, size and drug release kinetics.

In vitro determination of cytotoxicity on melanoma cell line B16BL6 with optimized formulations.

In vivo efficacy testing of formulations on melanoma mouse model.

Graduate Teaching Assistant Auburn University, Auburn, AL: July 2010-Present

Teach and grade Contemporary Aspects of Pharmacy Practice to Pharm.D. students.

Supervise and manage Pharm.D. student lab work; Grading of Pharmacokinetics course for Pharm.D. students.

Shanghai Institute of Pharmaceutical Industry Shanghai, China: July 2008 - June2010

Improvement of Bioavailability of Forsythiasides through Emulsion Formulation Development of water-in-oil emulsions with five times higher oral bioavailability enhancement.

Evaluation for oral drug absorption in a rat model by using a validated HPLC assay.

Development of Docetaxel Microemulsions for Intravenous Injection

Formulation Development of stable docetaxel microemulsions

Optimization of formulations through different variables: pseudo-tertiary phase diagrams, agitation velocity, types and amounts of stabilizers, drug release etc.

In vivo evaluation of targeting efficiency of microemulsions toward tumor sites in comparison to the reference listed product Taxotere®.

Pharmacokinetic studies in rats and tissue distribution studies in mice using validated HPLC assay procedures.

Membership and Service to Professional Organizations

Member: American Association of Pharmaceutical Scientists: 2012-Present

Member: American Association of the Advancement of Science 2012-Present

Member: Rho Chi Honor Society 2013-Present

Member: Controlled Release Society 2014-Present

Abstract reviewer: AAPS Annual Meeting and Exposition: 2012-Present

Patents

Chen L, Lu W. A new composite of Docetaxel for intravenous injection. 201*********

Publications

1. Wang Y, Ding Y, Liu Z, Liu X, Chen L, Yan W. Bioactive lipids-based pH sensitive micelles for co-delivery of doxorubicin and ceramide to overcome multidrug resistance in leukemia. Pharm Res.2013; 30(11): 2902-16.

2. Chen L, Ding Y, Wang Y, Liu X, Babu RJ, Ravis WR, Yan W. Co-delivery of Zoledronic Acid and Double-strand RNA from Core-shell Nanoparticles. Int J Nanomedicine. 2013; 8:137-45.

3. Chen L, Tang W, Lu W. Stability and controlling strategies in particle size of nanosuspension. World Clinical Drugs. 2010; 31(4):245-249.

4. Wang Y, Chen L, Ding Y, Yan W. Oxidized phospholipid based pH sensitive micelles for delivery of anthracyclines to resistant leukemia cells in vitro. Int J Pharm. 2012; 422(1-2):409-17.

5. Wang L, Lu W, Chen T, Chen L. Study on the absorption of Forsythiasides in rats’ Gastrointestinaltract. Chinese Traditional Patent Medicine. 2010; 32(3):409-412.

6. Chen L, Ravis WR, Babu RJ. Topical Delivery of Genistein Nanoemulsion for UV Induced Skin Damage.(Manuscript in preparation for submission to Biomedical Nanotechnology)

7. Chen L, Ravis WR, Babu RJ. Co-delivery of Doxorubicin and Ceramide as a Nanoparticle Based System for the Treatment of Melanoma (In preparation for submission to Int. J. Nanomedicine)

8. Chen L, Ravis WR, Babu RJ. High performance liquid chromatography (HPLC) assay method for analysis of Genistein and Tetrahydrocumin in the nanoemulsion formulation (In preparation for submission to Biomedical Chromatography)

9. Chen L, Ravis WR, Babu RJ. Stability Indicating High performance liquid chromatography (HPLC)assay for analysis of Acyclovir and Lidocaine in a nanoemulsion formulation (In preparation for submission to Biomedical Chromatography)

Book Chapters

1. Babu RJ, Chen L, Kanikkannan N. Fatty alcohols, fatty acids and fatty acid esters, In Percutaneous Penetration Enhancers, Volume 3. Dragicevic-Curic,N. and Maibach, H.I., Eds., Springer Science,Palo Alto, CA. (In Press)

2. Babu RJ, Chen L. Pyrrolidones, In Percutaneous Penetration Enhancers, Volume 3. Dragicevic-Curic,N and Maibach, H.I., Eds., Springer Science, Palo Alto, CA. (In Press)

Conference Presentations

1. Chen L, Ravis WR, Babu RJ, Formulation of Genistein Nanoemulsions for Enhanced Cytotoxicity in Melanoma Treatment, Accepted for poster presentation in the Annual National Meeting of American Association of Pharmaceutical scientists (AAPS) to be held in San Diego, CA during November 02 -06, 2014.

2. Chen L, Ravis WR, Babu RJ, Co-delivery of Doxorubicin and Ceramide as a Nanoparticle Based System for the Treatment of Melanoma, Accepted for poster presentation in the Annual National Meeting of American Association of Pharmaceutical scientists (AAPS) to be held in San Diego, CA during November 02-06, 2014.

3. Porter, H, Chen L, Kurapati S, Mulabagal V, Babu RJ, Stability and Degradation Profiles of Betamethasone Diporpionate in Topical Nanoparticle Formulation, Accepted for poster presentation in the Annual National Meeting of American Association of Pharmaceutical scientists (AAPS) to be held in San Diego, CA during November 02-06, 2014.

4. Chen L, Babu RJ, Ravis WR. Formulation of Genistein Nanoemulsions for Enhanced Transdermal Delivery, In Vitro. Annual National Meeting of American Association of Pharmaceutical Scientists(AAPS). #T2245, 2013.

5. Chen L, Babu RJ, Ravis WR, Yan W. Co-delivery of Zoledronic Acid and Double-strand RNA from Core-shell Nanoparticles. Annual National Meeting of American Association of Pharmaceutical Scientists (AAPS). #T3195, 2012.

6. Chen L, Ravis WR, Babu RJ. Stability and Degradation Profiles of Genistein Topical Nano-emulsions.Annual National Meeting of American Association of Pharmaceutical Scientists (AAPS), #R6071,2012.

7. Chen L, Babu RJ, Ravis WR, Yan W. Co-delivery of Zoledronic Acid and Double-strand RNA from Core-shell Nanoparticles. Annual Regional Meeting of Graduate Association of Students of pharmacy (GRASP), #F5, 2012.

8. Chen L, Babu RJ, Ravis WR, Yan W. Co-delivery of Zoledronic Acid and Double-strand RNA from Core-shell Nanoparticles. Auburn University Research Week, 2013.

9. Chen L, Babu RJ, Ravis WR, Yan W. Co-delivery of Zoledronic Acid and Double-strand RNA from Core-shell Nanoparticles. Annual Regional Meeting of Graduate Association of Students of pharmacy (GRASP), #F5, 2012.

10. Chen L, Ravis WR, Babu RJ, Formulation of Genistein Nanoemulsions for Enhanced Transdermal Delivery, In Vitro, Graduate Students Council, Auburn University, 2014.

11. Chen L, Ravis WR, Babu RJ, Formulation of Genistein Nanoemulsions for Enhanced TransdermalDelivery, In Vitro, Harrison School of Pharmacy, Auburn University, 2014.

12. Duran SH, Ravis WR, Passler T, Bayne J, Lin YJ, Chen L. Pharmacokinetics of Intravenous and oral Flunxin in Alpacas, Auburn University Research Week, 2013.

References

Available up on request

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