clinical scientist /regulatory officef

Mohammad Bashir, DVM

*** ********* ***. *********, ** 10594

Email: ******@***.***

914-***-**** (Home) - 914-***-**** (Cellular)

US Citizen

EDUCATION

Jan 1983 AMERICAN VETERINARY MEDICAL ASSOCIATION Schanmburg, IL

Educational Council for Foreign Veterinary Graduates (ECFVG)

May 1972 UNIVERSITY OF AGRICULTURE Lyallpur, Pakistan

DVM (Doctor of Veterinary Medicine)

May 1969 DYAL SING COLLEGE Lahore, Pakistan

Bachelor of Science, Biology

EXPERIENCE

July2007----present.. NEW YORK-PRESBYTERIAN HOSPITAL 622 W 168 ST NY,NY10032

THE UNIVERSITY HOSPITAL OF COLUMBIA AND CORNELL

Working as clinical /research scientist technologist in Virology lab of the hospital.Duties include

As molecular lab technologist ,doing smart PCR for MRSA SCREENING,KPG GENE ISOLATION

And identification,PVL GENE PCR, HIV PCR,AND GENOTYPING,HCV PCR AND GENOTYPING.

CMV DNA PCR VIRAL LOAD,HIV VIRAL LOAD ,HCV VIRAL LOAD TESTING.TISSUE CULTURE TECHNIQUE ,SHELL VIALS CMV ISOLATION.RSV,ROTA VIRUS ISOLATION.HIV

VIRAL LOAD ,STANDARD/ULTRASENSITIVE ASSAYS.

May 2007 ---july 2007 .Procter@Gamble Research @ Development L ab Stmford Ct

Worked as research Scientist in R@ D Lab for P@G Company ,developing methods for products approval ,beauty products ,hair application products, Reology ,Tint filling,intrinsic Viscosity,Laser

Scattering methods,G priming on AR 2000.

1974-May 2006 MONTEFIORE MEDICAL CENTER Bronx, NY

Lab Manager, Administrator and Clinical Virologist, Division of Pathology/Virology.

• Supervising doctor of virology lab consisting of 15 person staff, specializing in diagnostic clinical trials/tests of infectious diseases and viruses

• Formulating hospital policies and administration in support of laboratory management and clinical trials

• Teaching and training medical students, house staff physicians, pathology and infectious disease fellows in project specific training programs and training materials

• Preparing, overlooking and implantation of 3 million dollar laboratory budget for clincial trials and research programs of all divisions of virology

• Preparing clinical trial protocol summaries and clinical trial protocols

• Serving as leading CAP (College of American Pathologist) inspector for Quest Diagnostics

• Clinical trails monitoring ,coordinating with contracts research organization,with other team

• Members,contractors,consultants,and other staff members.

• Experience in clinical trails phase 1-3and 4 ,application of data,tracking,overall planning,general

• Performance of clinical study that support the clinical development plan.

• FDA/GCP/ICH guidelines expert.

• Planning programs relating to FDA/JCAHO/CAP inspection

• Overlooking New York City and State Department of Health regulatory and legislative affairs.

• Technical services experience dealing with CDC for influenza virus

• Lead marketing advice representative and technical information person for future laboratory test clients

CLINCIAL TRIAL PARTICIPATION

May 2002 Clinical Trial of Lamivudine (GlaxoSmithKline) in Children with Chronic Hepatitis B

• Children with chronic hepatitis B were randomly assigned in 2:1 ratio to receive either oral (3 mg per kg of body weight; maximum 100 mg) or placebo once daily for 52 weeks

• Primary end point was virologic response (designed by the absence of serum hepatitis B e antigen and serum HBV DNA) at week 52 of treatment

April 1999 Clinical Trial of Oral Ribavirin (Roche) in Combination with Interferon for Hepatitis C Therapy

• Clinical efficacy has been demonstrated for the treatment of infection caused by hepatitis C

June 1997 Clinical Trial of Acyclovir (GlaxoSmithKline) for the Treatment of Herpes Simple and Varicellazoster

• Acyclovir is the only one available for intravenous administration

• Study of primary genital herpes infection a 5 day course of intravenous acyclovir resulted in complete healing of lesions in a average of 9 days, as compared with 21 days for placebo

DRUG SAFETY EXPERIENCE____________________________________________________________________

• Assisting in all applicable Drug Safety Operations- OTC team members in the maintenance, processing and the integrity of case files.

• Performing daily responsibilities in accordance to all applicable SOPs, conventions and company policies

• Processing, databasing and assessment of all initial follow-up medical reports in the Global Safety Database ARGUS

• Reviewing and medically evaluating relevant drug safety data while alerting Medical Safety Experts (MSE) of potential serious cases trends

• Performance of medical coding of Adverse Events with the MedDRA dictionary

• Experience in product coding with the WHO dictionary

• Continuously updating case records as applicable

• Generating communication to call center regarding follow-up needs

• Maintaining both paper and electronic documents according to all applicable SOPs/departmental conventions

• Supporting in the review of QA (Annual Product Review Reports and Lack of Efficacy Reports) and US Periodic Safety reports

• Participating in literature searches for medical inquires

• Expert in reconciliation of cases (CRS and ARGUS, shared products Pharma)

• Contributing in the development of SOPs, Working Procedures and Drug Safety conventions

• Assisting in the creation of drug safety relevant product information

• Referring all medical drug safety inquiries to the appropriate medical team members

• Processing cases with high quality in a productive and orderly manner

• Participating in special projects as needed

PUBLICATIONS

Jan 1998 Are there Any Risk Factors for Hepatitis B Infection in Inner City Adolescents Pre Vaccination Screening. Journal of Adolescent Health. Jan, 1998.

SPECIALIZATION

1974-Present TESTS

• Research and Development Assay

• Flowcytometery

• HPLC system

• Chromatography

• Molecular clinical PCR from Roche

• bDNA from Bayer Diagnostics

• NASBA from Murix Corp

• Hepatitis A, B, C testing from Abbott Lab

• MMR and VZ testing by Trinity/Wamploe Lab

• Western Blot testing from BioRad for HIV

• EIA/IFA testing

• Tissue Culture technique

• Pathology slides reading

1974-Present INSTRUMENTS

• PCR 9600 Analyzer

• Tachman 48 and 96

• Cobas Amplicor

• bDNA from Bayor System 340, 440

• Abbott Asxm

• Commander PPC

• Autoblot from BioRad

• Tigris from Genprobe

AWARDS

2005 Lab Safety and Hazardous Communications Award

2005 Certificate of Training for Transportation of Dangerous Goods

2001 Loyal and Devoted Service Award (25 Years) from MMC

1997 Directors Award from Montefiore Medical Center

1996 Roche PCR Diagnostic Testing Award

1995 Lab Supervisor Award from Montefiore Medical Center

PROFESSIONAL MEMBERSHIP

1996 American Society of Clinical Pathology, Clinical Scientist

1993 American Veterinary Medical Association

1987 Who’s Who in Veterinary Medicine, 1st Edition

1985 New York State Veterinary Medical Society

1983 New York Academy of Science

2006 NEW YORK STATE DOH TECHNOLOGIST LICENSE.

REFERENCES

• Furnished upon request.

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