Medical Project Management

IGOR SKIDAN, Ph.D.,

*** ******** ***, *********, ** 19041

E-mail: abmb1m@r.postjobfree.com; http://www.linkedin.com/in/skidan

Phone (cell): 1-617-***-****

CAREER OBJECTIVE:

Seeking a challenging research oriented position that utilizes my

experience in preclinical pharmacology

ABSTRACT:

Research scientist with over 8 year's academic/industrial experience.

Extensive "hand-on" experience in multiple areas of preclinical drug

development: in vivo cancer models, extensive experience in drug efficacy

studies, preclinical safety assessment, pharmacokinetics, animal surgery,

in vivo imaging of small animals, and drug-drug interaction. Experience

with analytical methods of analysis, particularly HPLC. Knowledge in the

techniques of drug formulation. Proven proficiency in experiment design,

data interpretation, and statistical process. Goal and team oriented, self-

motivated; creative with strong analytical, communication, and writing

skills.

RESEARCH INTERESTS:

Preclinical pharmacology; small-molecule kinase inhibitors; therapeutic

antibodies; combination chemotherapy; drug delivery systems

(nanoparticles).

PROFESSIONAL EXPERIENCE:

2009 - Present

MORPHOTEK INC/EISAI., PRECLINICAL PHARMACOLOGY, EXTON, PA, USA

Senior Scientist

Designed, performed and interpreted in vivo experiments. Established and

implemented a variety of tumor models in immunodeficient/transgenic animals

for the characterization of the efficacy of therapeutic monoclonal

antibodies (mAbs) as single agents or in combination with well-established

chemotherapeutic agents/toxins. Established primary cell cultures from

tumor specimens. Investigated and supported PK/PD studies (analyzed PK/PD

relationships). Viral vector transduction of cancer cells for

bioluminescent analysis. Optical imaging of tumors in live animals

(mice/rats) and studied PK of mAbs-dye conjugates, using the IVIS imaging

system. Generate research/technical reports, study designs, and meeting

reports. Supervised and trained research scientists and contractors. Served

as the "Involved Scientist" on the IACUC.

2008 - 2009

AMGEN INC., CANCER PHARMACOLOGY, BOSTON, MA, USA

Research Fellow (contractor)

Established and implemented a variety of xenograft tumor models in

immunodeficient mice for the characterization of the efficacy of new small-

molecule kinase inhibitors as single agents or in combination with well-

established chemotherapeutic agents. Investigated the efficacy of novel

kinas inhibitors and supported PK/PD studies. Directly involved in

protocols preparation. Additional responsibilities included operation and

maintenance of analytical equipment and microscopes, performed cell culture

experiments, analyzed data and presented it's at internal meetings.

2006 - 2008

NORTHEASTERN UNIVERSITY, CENTER FOR PHARMACEUTICAL BIOTECHNOLOGY AND

NANOMEDICINE, BOSTON, MA, USA

Postdoctoral researcher

Investigated the efficacy, safety, and PK/PD of a new class of small

molecule inhibitors of PI3K signaling (PIT-1) in a variety of

subcutaneous/metastatic human tumor xenograft and murine tumor models.

Evaluated the therapeutic efficacy of PIT-1 in in vitro and in vivo using

PIT-1 as a single agent, PIT-1-loaded into polymeric micelles as well as

PIT-1/micellar PIT-1 in combination with tumor necrosis factor-related

apoptosis-inducing ligand (TRAIL). Developed an HPLC method for the

detection and quantification of PIT-1 in biological samples (blood, tumor,

etc.). In addition, prepared and characterized Photosensitizer-loaded

micelles for photodynamic therapy (PDT). Carried out PDT, phototoxicity and

biodistribution of micellar drug in healthy animals or in a murine melanoma

model. Supervised two junior research associates and one doctoral student.

2003 - 2006

MOUNT SINAI SCHOOL OF MEDICINE, DIVISION OF HEMATOLOGY/ONCOLOGY, NEW YORK,

NY, USA

Postdoctoral researcher

Evaluated cytotoxicity and analyzed mechanisms of action of new small-

molecule kinase inhibitors on various human leukemic cell lines, human bone

marrow and human fibroblasts. Characterized the pharmacological interaction

of new small molecules with well-established chemotherapeutic agents under

a variety of experimental conditions (Median-effect analysis for evaluating

of drug interactions). Studied the efficacy of new small molecules on human

xenograft tumor models. Supervised one junior research associate.

2001 - 2003

INSTITUTE OF NEW ANTIBIOTICS, LABORATORY OF PHARMACOLOGY/ CHEMOTHERAPY,

MOSCOW, RUSSIA

Research Fellow

Performed experiments involving PK/PD and toxicological studies of

anticancer antibiotics loaded into polymeric poly-butylcyanoacrylate

nanoparticles. Designed and implemented experiments to characterize the in

vitro and in vivo activity of doxorubicin-loaded nanoparticles in a murine

glioblastoma model.

EDUCATION:

PhD, Pharmacology

2000, Institute of New Antibiotics, Russian Academy of Medical Sciences,

Moscow, RU.

Research thesis: Pharmacokinetics and efficacy of doxorubicin-loaded

poly(butylcyanoacrylate) nanoparticles in normal and tumor-bearing rodents.

MS, Epidemiology

1990-1996, Karaganda State Medical School, Karaganda, KZ.

MEMBERSHIP IN PROFESSIONAL SOCIETIES:

2003 - New York Academy of Sciences

2006 - Controlled Release Society

2006 - Society of Toxicology

2006 - Massachusetts Biotechnology Council

2009 - American Association for Laboratory Animal Science

SKILLS:

Animal work: dosing (i.v, i.p, i.m, s.c, p.o, retro-orbital sinus, mammary

fat pad, intratumoral), sampling and necropsy; preclinical safety

evaluation (MTD, acute toxicity, repeated dosing studies, dermal toxicity,

phototoxicity); evaluation of anticancer activity in syngeneic/transgenic

and human tumor xenograft models (various solid tumor models, lung and

liver metastases models); quantitative angiogenesis assays;

pharmacokinetics; whole body molecular imaging in vivo (Kodak Image

Station)/Optical imaging of tumors in live mice using the IVIS 200 imaging

system (Xenogen); complex surgical aseptic models ("primary" tumor removal,

hepatectomy, liver ischemia (rat), splenectomy, nephrectomy, kidney

ischemia (rat)); animal models of infection/noninfectious diseases

(peritonitis induced by surgical perforation of the cecum, bacterial

peritonitis, neutrophil/monocyte migration irritant-induced (peritonitis),

monoarticular arthritis Mycobacterium tuberculosis/zymosan-induced, lung

infection model, sepsis, pyelonephritis)).

Work with cell cultures: processing, manipulation, cryopreservation of

human bone marrow and various tumor cell lines; vector transduction;

establishing primary cell cultures from tumor specimens; cell staining for

morphological examinations; histological processing; human bone marrow

hematopoietic clonogenic assay; bone marrow cell harvesting (mice and

rats), cell viability/proliferation/cytotoxicity assays; cell permeability

assays (CaCo-2).

Molecular biology techniques: DNA/RNA manipulation; apoptosis assays;

caspase assays; immunohistochemistry; electrophoresis; ELISA; BCA protein

assay.

Preparation and characterization of drug delivery systems: preparation of

non-targeted and targeted (with cell penetrated peptide or cancer-specific

antibodies) PEGylated micelles and liposomes, micelle size and surface

charge measurements, determination of nanoparticle loading efficiency and

drug relies studies.

Computer skills: Microsoft Office; GraphPad Prism; Living Image 3.1; Median-

effect analysis of the CalcuSyn software; ED50plus; PK Solutions

(Pharmacokinetics Data Analysis, Version 2.0); Kinetica PK/PD analysis.

Analytical lab skills: dynamic light scattering; spectrofluorimetry;

spectrophotometry; HPLC; FACS; microscopy (fluorescent and confocal),

analytical procedures and methods validation for INDs.

SELECTED CONFERENCE PRESENTATIONS:

. Micellar form of N 2-hydroxy-5-nitrophenyl)amino]carbonothioyl}-3,5-

dimethylbenzamide (DM-PIT-1) for effective targeting to solid tumors,

NSTI Nanotech, Boston, MA, USA, June 1-5, 2008.

. Development of HPLC method for the detection and quantification of N 2-

hydroxy-5-nitrophenyl) amino] carbonothioyl} -3, 5-dimethylbenzamide in

biological samples, NU Research and Scholarship Expo 2008, Boston, MA,

USA, March 26, 2008.

. Photodynamic killing of melanoma cells in vitro and in vivo with micellar

meso-Tetraphenylporphin, 5th International Nanomedicine and Drug Delivery

Symposium, Boston, MA, November 2-3, 2007.

. Micellar Form of novel poorly soluble proapoptotic agent, Dimethyl-PIT.

34th Annual CRS meeting, Long Beach, California, USA, July 7-11, 2007.

. Toxicity of a novel small molecule ON1910Na on human bone marrow and

leukemic cells in vitro. 97th Annual AACR meeting, Washington, D.C, USA,

April 1-5, 2006.

. Chemotherapy of glioblastomas in rats using doxorubicin-loaded

nanoparticles. Proc. 4th World Meeting ADRITELF/APGI/APV, Florence,

Italy, April 8-11, 2002.

. Modification of pharmacokinetics and antitumor efficacy of doxorubicin

bound to polysorbate 80-coated polybutylcyanoacrylate nanoparticles.

CECHTUMA 2001 3rd Central European Conference on Human Tumour Markers,

Karlovy Vary, Czech Republic, February 22-25, 2001.

. Chemotherapy of brain tumors using doxorubicin bound to polysorbate 80-

coated nanoparticles. Proc. 3rd World Meeting APV/APGI, Berlin, Germany,

3-6 April, 2000.

SELECTED PUBLICATIONS:

. Skidan I, Miao B, Thekkedath R, Dholakia P, Degterev A, Torchilin V. In

vitro cytotoxicity of novel pro-apoptotic agent DM-PIT-1 in PEG-PE-based

micelles alone and in combination with TRAIL. Drug Deliv, 2009, 16(1):45-

51.

. Skidan I, Dholakia P, Torchilin V. Photodynamic Therapy of Experimental

B16 Melanoma in Mice with Tumor-Targeted 5, 10, 15, 20-Tetraphenylporphin-

Loaded PEG-PE Micelles. J. of Drug Targeting. 2008 Jul; 16(6):486-93.

. Steiniger S, Kreuter J, Khalansky A, Skidan I, Bobruskin A, Smirnova Z,

Severin S, Uhl R, Kock M, Geiger K, Gelperina S. Chemotherapy of

glioblastoma in rats using doxorubicin-loaded nanoparticles. Int. J.

Cancer. 2004 May 1; 109(5):759-67.

. Skidan I, Gelperina S, Severin S, Gulyaev A "Enhanced activity of

Rifampicin loaded into polybutyl cyanoacrylate nanoparticles in relation

to intracellular localized bacteria". Antibiot. Chemother. 2003, 48(1):23-

6.

. Gelperina S, Khalansky A, Skidan I, Smirnova Z, Bobruskin A, Severin S,

Turowski B, Zanella F, Kreuter J. Toxicological studies of doxorubicin

bound to polysorbate 80-coated poly (butylcyanoacrylate) nanoparticles in

healthy rats and rats with intracranial glioblastoma. Toxicol. Lett. 2002

Jan 25; 126(2):131-41.

. Skidan I, Bobruskin A, Guliaev A, Shalkharbaeva S, Severin S, Steinniger

S, Kreuter J, Gelperina S. Optimization of "Photosens" pharmacokinetics

by biodegradable nanospheres" Antibiot. Chemother. 2001; 46(4):6-10.

. Gulyaev A, Gelperina S, Skidan I, Antropov A, Kivman G, and Kreuter J.

Significant transport of doxorubicin into the brain with polysorbate 80-

coated nanoparticles. Pharm. Res. 1999 Oct; 16(10):1564-9.

. Miao B, Skidan I, Reibarkh M, Peterson J, Yuan J, Wagner G, Torchilin V,

Degterev A. PIT-1, a selective phosphatidylinositol-3,4,5-trisphosphate

(PIP3) antagonist, exerts antitumor activity by inhibiting PIP3-dependent

functions in both cancer and endothelial cells (manuscript submitted).

. Skidan I, Grunwald J, Thekkedath R, Degterev A, Torchilin V. Development

and validation of an HPLC method for N 2-hydroxy-5-

nitrophenyl)amino]carbonothioyl}-3, 5-dimethylbenzamide quantification in

micellar and in biological samples (manuscript submitted).

AWARDS:

. Russian scholarship for outstanding academic performance.

. Innovation Award from Russian Academy of Medical Sciences, Exchange

program in Drug Delivery Research, 2002, Moscow, Russia.

OTHER:

. Patent - RU#200*******/14, "Nanoparticle composition containing

polybutylcyanoacrylate and a Rifampicin for treatment of pulmonary

infection", Russian Federation, 07/27/2002.

. Certificate on invention - KZ # 13/98, "Device limiting the level of

needle penetration into the brain of experimental animals", Republic of

Kazakhstan, 08/24/1998.

. Participated in European cooperation programs: INTAS-94-310 and INTAS-00-

838 aimed at the investigation of drug delivery to the brain using

nanoparticles, Frankfurt, Germany.

SEMINARS/COURSES:

. MBC seminar on "Project Management", Cambridge, MA, USA, 2008.

. Biological specimen handling and aseptic technique courses (Amgen Inc.,

Boston, MA, USA, 2008).

. Hazardous chemical safety and hygiene course (Amgen Inc., Boston, MA,

USA, 2008).

. Minimizing and management of pain and distress in rodents course (Amgen

Inc., Boston, MA, USA, 2008).

. Aseptic techniques seminar (Amgen Inc., Boston, MA, USA, 2008).

. Radioisotope handling curse (Northeastern University, Boston, MA, USA,

2007).

. William Black post-graduate school, the Mount Sinai School of Medicine

course on "Chemotherapy", New York, NY, USA, 2004.

LETTERS OF RECOMMENDATION:

Available upon request.

*Ability to work in the United States - Permanent Residence ("Green Card").

Contact this candidate