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.