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Management Clinical

Location:
Wadsworth, Illinois, 60083, United States
Posted:
May 23, 2010

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Jaseem Anwer, Ph. D

abmrzr@r.postjobfree.com

**** * ******** **

Residence:(847) ***-****

Wadsworth, IL 60083 Mobile:(847) ***-****

PROFILE:

Highly motivated Scientific Professional with extensive experience in

designing, conducting and supervising pre-clinical toxicity studies

(in-vitro and in-vivo) for drug development and regulatory filings.

Led pre-clinical studies to file IND and advanced 3 drug candidates

from pre-clinical studies to phase 1 clinical trial. Extensive hands

on experience in conducting therapeutic efficacy, pharmacokinetic and

bio-analysis of drugs. Expertise in bioanalytical method development

and analysis using LC-MS/MS techniques. Highly experienced in

developing and implementing Standard Operating Procedures (SOPs) and

working under GLP guidelines. Skilled in outsourcing, project

management and monitoring CRO activities. Expert in establishing and

managing animal facility. Well-recognized as a supportive team player.

PROPFESSIONAL EXPERIENCE:

Consultant March 2010 till

Present

Goodwin

Biotechnology Inc,

Plantation, Florida

. Developing and validating bio-analytical assays.

. Initiation, planning, execution, monitoring and control, and

closure of projects.

An Oncology Biopharmaceutical Company Neopharm Inc.

Senior Scientist, Research and Development Lake

Bluff, IL

Designed and led in-house Non- GLP and GLP studies as study director

Rodents:

Non-GLP Studies

- Toxicity screening study of LE-DT formulations with different

concentrations of cholesterol in CDF1 mice.

- Dose ranging finding and prescreening toxicity assessment of LE-DT

formulations in CDF1 mice.

- NeoPhectin formulations prescreening toxicity study in mice.

- Dose ranging finding toxicity study of nasally instilled IL13-PE38

in male CDF1 mice.

- A multiple iv dose toxicity study of buffered and non-buffered LE-

rafAON formulations in CDF1 mice

- Dose ranging finding and prescreening toxicity studies of Liposomal

rafAON Easy To Use (LE-rafAON-ETU) in CDF1 mice.

- Comparison of toxicity profiles of LEP, Taxol and Abraxane after

intravenous administration in male CDF1 mice.

- A dose ranging and multiple dose toxicity assessment of Liposomal

Encapsulated Paclitaxel (LEP-ETU) in male CDF1 mice.

- Comparison of safety profile of Liposomal Doxorubicin (LED)

formulations in CDF1 mice.

GLP Studies:

- A multiple intravenous (iv) dose toxicity of Liposomal Docetaxel

(LE-DT) and Taxotere in CDF1 mice

- Toxicokinetics study of Liposomal Encapsulated (LE-DT) and

Taxotere in CDF1 mice.

- Safety profile assessment of LE-rafAON-ETU formulations after

multiple intravenous administration in male CDF1 mice.

- Evaluation of toxicity profile of Liposomal-PNT100 (LE-PNT100)

after five days intravenous administration in CDF1 mice

- Multiple dose administration and toxicity profile evaluation of

Liposome Entraped Paclitaxel Easy to Use (LEP-ETU) in mice.

- A toxicokinetics study of LEP-ETU in mice.

- Multiple dose toxicity study of intranasal instillation of IL13-

PE38 (protein drug) in CDF1 mice.

- Toxicokinetics study of IL13-PE38 in serum and bronco alveolar

lavage (BAL) fluid after single and multiple dose treatment in

mice.

Non-Rodents:

- Designed and generated protocols for non-rodents (dog and monkey)

toxicity studies.

- Initiated, managed and coordinated all activities with CROs to

conduct pre-clinical animal studies.

. Developed a technique for intra nasal instillation of IL13-PE38 into

lungs of mice for GLP study.

. Conducted and validated in-vitro cytotoxicity studies of liposomal

docetaxel, paclitaxel, rafAON and IL13-PE38 in human cancer cell lines

for IND submission.

. Led efficacy studies in human xenograft model to screen liposomal drug

candidates for the therapeutic efficacy.

. Participated in in-house PK studies.

. Actively participated in preparing regulatory documents for IND

submissions.

. Initiated, managed and coordinated all activities with CROs to conduct

pre-clinical animal studies.

. Prepared protocols, technical reports, summaries and presented update

at senior management and board meetings.

. Supervised and trained scientists and supporting staff. Managed animal

facility for pre-clinical studies.

. Interacted with other R&D departments including Chemistry, Regulatory,

QA and Pharmaceutics and served as lead on pre-clinical projects.

. Completed certified training to run LC-MS/MS for bioanalysis and

trained others at the company. Qualified method for the quantification

of docetaxel in human plasma using LC-MS/MS.

. Presented pre-clinical studies in outside meetings.

Management Associate

1999 - 2004

Ahold

Information Service, Greenville, SC

. Led effort to obtained and organized list of doctors and tested

appropriate software to

run pharmacies.

. Maintained the drugs supply in pharmacies.

. Analyzed drug supply on basis of seasonal forecasting.

. Managed and tracked drug supply.

Research Associate Scientist

1994 - 1998

Department of

Pharmacology and Toxicology,

College of Pharmacy, Florida A&M University, Tallahassee,

FL

. Performed studies to evaluate the effects of ethanol on Beta-

endorphin in different region of rat brain.

. Established the effects of ethanol on Met-enkephalin in brain

regions.

. Supervised scientific and technical work of Ph.D. students and

helped them in writing papers.

. Guided pharmacy students on small scientific projects and writing

reports.

. Excelled research efforts collaboration with National Institute of

Toxicology Research Little Rock, Arkansas.

Research Associate Scientist

1990 - 1994

Department of Pharmacology

School of Medicine, East Carolina University, Greenville, NC

. Investigated the role of adenosine of ethanol-induced glucose

utilization.

. Established role of cyclic AMP as possible mechanism of ethanol

induced effects.

. Discovered in vivo effects of -Nicotine on Ethanol-Induced

increase in glucose utilization in the

mouse cerebellum.

. Established the role of chloride flux in ethanol induced motor in-

coordination.

. Performed the detection of HIV virus in the needles of drug users

. Wrote and submitted a startup grant on "Role of adenosine in

ethanol induced motor in-

coordination."

. Developed and implemented standard procedures and protocols to

handle the animals in animal

facility.

Research Associate Scientist

1989 - 1990

Department of Pharmacology, School of Medicine

University of North Dakota, Grand Forks, ND

. Evaluated the effects of cocaine and marijuana on glucose

metabolism

. Responsible to teach scientific techniques specially the

intravenous injections to students.

. Supervise technician and students to perform the scientific

experiments.

. Responsible to plan the experiments according to schedules.

. Responsible for proper care of rats after the surgical operations.

. Responsible to maintain the supply, records, and feeding of animals

EDUCATION:

Ph.D. Toxicology

PUBLICATIONS:

Published 14 original articles in peer reviewed journals.



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