Rashmi Sharma, Ph.D.

5407 Balsam Place, Apt. 302

Mason, OH 45040
425-791-5132 (Cell)
E-mail: rsac22ec@westpost.net

Summary: Oversee Preclinical drug development under GLP regulations for the deve
lopment of small and large molecules.
Work Experience
Senior Manager, Non-Clinical Study Management; June, 2008-June, 2010, Xanodyne
Pharmaceuticals Inc., Newport, KY.
Played pivotal role in approvals of Zipsor and Lysteda through 505(b)(2) submiss
sions; Completed 12 GLP Tox studies and Pharmacology /Toxicology sections of tw
o 505 (b)(2) applications, labels and Investigator brochure (IB) within 8 months
. Improved regulatory applications by writing and responding to regulators' inqu
iries by providing satisfactory safety data for approval.
Oversee preclinical drug development programs for small molecules.
Manage Contract Research Organizations (CROs) help design, monitor and summarize
GLP toxicology studies along with bio-analytical and analytical work.
Continued collaborations with Chemistry, Manufacturing and Control (CMC), Regula
tory and Clinical teams to maintain the progress and meet the timelines.
Actively participate in the preparation and filling of IND and NDA submissions.
Good professional contacts with MPI Research, BioReliance Corporation, ChanTest
Inc., Charles River Laboratories, Kendle International Inc. , Stratoxon LLC and
Aclairo.

Scientist / Study Director; October, 2005-June, 2007, SNBL USA Ltd., Everett, W
ashington.
Direct preclinical /non-clinical studies for development of small molecules and
monoclonal antibodies for Pharmaceutical, Biotechnology and Academic Clients for
non-GLP and GLP studies.
General toxicology, pharmacokinetic/toxicokinetic and Ophthalmology studies perf
ormed on Non-human Primates and rodent models.
Design and implement studies, GLP and standard operating procedures (SOPs), Writ
e protocols, discussions with the supporting laboratories, make necessary change
s with client consultation from time to time for effective preclinical testing.
Active on-going collaboration with IACUC, clinical pathology, pathology services
, test article laboratory, scientific services, quality assurance groups, veteri
nary and Study Co-ordinators within the company.
Active collaboration with subcontractors to conduct supportive testing for clien
ts.
Interpretation and analysis of study data
Interaction with preclinical support group for report writing.
Continued GLP training.
Toxicologist; September, 2004-August, 2005, Healthpoint Ltd. Fort Worth, Texas.
Non-clinical safety evaluation of products for IND and NDA submissions for small
molecules, managing non-clinical safety studies conducted at Contract Research
Organizations (CROs).
Providing technical expertise on protocols and summary reports.
Participated in pre- IND and IND submissions, Oversaw preclinical studies at CRO
s
Performed safety assessment on products in all stages of development including p
ost-marketing surveillance.
Scientist III; February, 2002- September, 2004, ICAgen Inc., Research Triangle P
ark, North Carolina.
Supported Early drug discovery by running tissue culture facility and helping wi
th cell-based assays for High Throughput Screening (HTS) and electrophysiology,
transient transfection, writing SOPs.
Senior Research Associate, National Research Council/ United States Environmenta
l Protection Agency; July, 1997-June, 2001, Environmental Carcinogenesis Divisi
on, National Health and Environmental Effects Research Laboratory, United States
Environmental Protection Agency, Research Triangle Park, North Carolina.
Oncology; Carcinogenicity, genotoxicity and methylation of arsenic
Worked with 45Ca and 73As isotopes, certified for the use of radiolabels by Radi
ation Safety Office, USEPA, Research Triangle Park, North Carolina.
Neurological and toxicological effects of polychlorinated biphenyls during brain
development; effect on calcium homeostasis and nitric oxide synthases.
Published 3 papers in peer-reviewed international jounals.
Renewed contract through progress report each year.
Post doctoral fellow; September, 1991- July, 1997 Department of Human Biologica
l Chemistry & Genetics, Division of Hematology-Oncology, Department of Internal
Medicine, , University of Texas Medical Branch, Galveston, Texas.
Pharmacokinetics of chemotherapeutic drugs in drug-resistant cells.
Managed tisuue culture laboratory for 6 years.
Subchronic and chronic rodent carcinogenic studies, histology.
DNA and RNA isolation, plasmid preparation, polymerase chain reaction, agarose g
el electrophoresis, northern blot analysis.
Protein purification by affinity - chromatography, Western blot analysis, gel el
ectrophoresis, characterization of glutathione-S-transferases, worked with 32P
, 3H, and 14C.
Published 10 papers in peer-reviewed international journals; reviewed NIH grants
; supervised laboratory technicians and summer students for 3 years.
Research Associate in Pharmacology & Toxicology; August, 1989- March, 1991, Uni
versity of Mississippi Medical Center, Jackson, Mississippi.
Drug metabolism using isolated lung perfusion technique, thin-layered chromatogr
aphy.
Published one paper in peer-reviewed international journal.
Education
Ph.D. Environmental Toxicology, 1989, University of Allahabad, Allahabad, India
.
-Thesis Topic : "Toxico-ecological interaction of certain insect growth inhibit
ors and juvenile hormone analogue R-20458." Published one paper in peer-reviewed
International Journal.
M.Sc. Zoology (Genetics and cell biology), 1983, University of Allahabad, Allaha
bad, India.

Immigration Status
Naturalized Citizen of United States of America since 2006.
Permanent Resident of Unites States of America- 1997 to 2006.

Scientific Memberships and Seminars Attended

Society of Toxicology (1991, 1993, 1999, 2005, 2007 to 2010); Full Member -2005
to present.
ISPO-5th International Symposium on Predictive Oncology & Therapy, Geneva, Switz
erland (2000).
Fourth International Conference on Arsenic Exposure and Health Effects, San Dieg
o, California (2000).
American Association for Cancer Research (Associate and Active memberships in 19
92, 1993, 1994, 1995 and 2000).
Indian Science Congress Association (1985 and 1986).
One of the four delegates from India to the Fifth Pugwash USA International Conf
erence, Stanford University, Palo Alto, California (1987).

Awards and Continuing Education in Toxicology

ICH Initiatives for Conducting Pharmaceutical Preclinical Safety Studies: New an
d Revised Guidelines and Challenges (2010).
Received Excellence Award for client services (2007).
Concept, Methods and Applications of Discovery and Investigative Toxicology (Soc
iety of Toxicology 2007)
Preclinical Safety Evaluation in Drug Development -By Dr. Shayne Cox Gad (2006)
GLP training -By Debbie Garwin (2006)
GMP, GLP and GCP trainings (2005)
International Conference of Harmonization (ICH) guidelines (Society of Toxicolog
y, 2005)
Immunotoxicology (Society of Toxicology, 1991)
Publications
Peng B, Sharma R, Mass MJ and Kligerman A (2002) Induction of genotoxic damage
is not correlated with the ability to methylate arsenite in vitro in the leukocy
tes of four mammalian species. Environ. Mol. Mutagen. 39: 323-332.
Rashmi Sharma and Prasada Rao S. Kodavanti (2002) In vitro effects of polychlor
inated biphenyls and hydroxy metabolites on nitric oxide synthases in rat brain
. Toxicol. Appl. Pharmacol. 178:127-136.
James T. Lin, Rashmi Sharma and Sanjay Awasthi (2001) A flow cell assay for eval
uation of whole cell drug efflux kinetics: Analysis of paclitaxel (taxol) efflux
in CCRF-CEM leukemia cells expressing mdr-1. Drug Metab. Dispos.29:103-110.
Rashmi Sharma, Ethel C. Derr-Yellin, Dennis E. House and Prasada Rao S. Kodavan
ti (2000) Age-dependent effects of Aroclor 1254 on calcium uptake by subcellular
organelles in selected brain regions of Long-Evans rats. Toxicology 156:13-25.
Rashmi Sharma , Abida K. Haque, Sanjay Awasthi, John T. Piper, Shivendra V. Sing
h and Yogesh C. Awasthi (1997) Differential carcinogenicity of benzo(a) pyrene i
n male and female CD-1 mouse lung. J. Toxicol. & Environ. Hlth. 52: 45-62.
Rashmi Sharma, Urmila P. Kodavanti, Lewis L. Smith and Harihara M. Mehendale (1
995) The uptake and metabolism of cystamine and taurine by isolated perfused rat
and rabbit lungs . Int. J. Biochem. Cell Biol. 27:655-664.
Sanjay Awasthi, Rashmi Sharma, Sharad S. Singhal, Meena Chaubey, Norbert K. Herz
og and Yogesh C. Awasthi (1994) Modulation of cisplatin cytotoxicity by sulphasa
lazine. Br. J. Cancer 70: 190-194.
Yogesh C. Awasthi, Rashmi Sharma and Sharad S. Singhal (1994) Human Glutathione
S-transferases: Minireview. Int. J. Biochem. 26:295-308.
Piotr Zimniak, Sharad S. Singhal, Sanjay K. Srivastava, Sanjay Awasthi, Rashmi S
harma, Janet B. Hayden and Yogesh C. Awasthi (1994) Estimation of Genomic Comple
xity, Heterologous Expression, and enzymatic characterization of mouse glutathi
one S-transferase mGST A4-4 (GST 5.7). J. Biol. Chem. 269: 992-1000.
Sanjay Awasthi, Sharad S. Singhal , Piotr Zimniak, Krishna K. Bajpai, Manju Saxe
na, Rashmi Sharma, Stephen A. Ziller III, Eugene P. Frenkel, Shivendra V. Singh,
Nong G. He and Yogesh C. Awasthi (1994) ATP-dependent transport of Doxorubicin
in human tissues by an ATP-dependent mechanism distinct from P-glycoprotein. J.
Clin. Invest. 93:958-965.
Sharad S. Singhal, Piotr Zimniak, Rashmi Sharma, Sanjay K. Srivastava, Sanjay Aw
asthi and Yogesh C. Awasthi (1994) A novel glutathione S-transferase isozyme sim
ilar to GST 8-8 of rat and mGST A4-4 (GST 5.7) of mouse is selectively expressed
in human tissues. Biochim. Biophys. Acta 1204 : 279-286
Rashmi Sharma, Hassan Ahmad, Sharad S. Singhal, Manju Saxena,Sanjay K. Srivasta
va and Yogesh C. Awasthi (1993) Comparative studies on the effect of butylated h
ydroxianisole on glutathione and glutathione S-transferases in the tissues of ma
le and female CD-1 mice. Comp. Biochem. Physiol. 105 C: 31-37.
Rashmi Sharma , Sharad S. Singhal, Sanjay K. Srivastava, Krishna K. Bajpai, Euge
ne P. Frankel and Sanjay Awasthi (1993) Glutathione and Glutathione-linked enzym
es in human small cell lung cancer cell lines. Cancer Lett. 75: 111-119.
Sanjay Awasthi, Faiyaz Ahmed, Rashmi Sharma and Hassan Ahmad (1992) Reversed-pha
se chromatographic method for specific determination of glutathione in cultured
malignant cells. J. Chromatogr. : Biomedical applications 584: 167-173.
R. Sharma, A.N. Chattoraj and K.K. Sharma (1989) Effect of a JHA, R-20458 on ce
rtain biochemical aspects of Dysdercus koenigii F. Ind. J. Exp. Biol., 27:580-58
1.

References will be available upon request.