Expert Details
Clinical Development, Safety Reviews, Pharmacovigilance, Pharmacoeconomics
ID: 731580
Pennsylvania, USA
• Design and implementation of Phase I-IV clinical studies
• Employer to many large pharmaceutical companies
• Employer to Biotechnology companies and CROs
• Medical safety reviews and Pharmacovigilance
• Design of animal models for preclinical development
• FDA meetings
• Employer for two EMEA pediatric vaccine submissions
• DSMB
• Technology assessments and Due Diligence evaluations
• Pharmacoeconomic assessments and HEOR projects
• Extensive medical writing including sections of IND, NDA, BLA applications
• Medical reviewer, clinical trials
• Manuscript, abstract and medical/clinical presentations
• Investigator’s meetings
• Extensive interactions with sales and marketing
• Creation of medical/clinical databases
• Clinical Development roles including protocol creation and implementation
• Medical Affairs roles
• Expert witness for Medical Malpractice Litigation
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 1983 | Degree: MD | Subject: Medical Degree | Institution: New York Medical College |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 2003 to Present | Employer: Undisclosed | Title: Many positions | Department: |
Responsibilities:Available upon request. |
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| Years | Employer | Title | Department |
| Years: 1993 to 1999 | Employer: Merck | Title: Various positions | Department: |
Responsibilities:Available upon request. |
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| Years | Employer | Title | Department |
| Years: 1999 to 2000 | Employer: BMS | Title: Director, Professional Services | Department: |
Responsibilities:Available upon request. |
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| Years | Employer | Title | Department |
| Years: 2003 to 2011 | Employer: Thomas Jefferson University Hospital | Title: Director Clinical Research, Division of Infectious Diseses | Department: |
Responsibilities:Available upon request. |
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| Years | Employer | Title | Department |
| Years: 2011 to 2013 | Employer: Mid-Atlantic BioTherapeutics, Inc. | Title: CEO | Department: |
Responsibilities:Available upon request. |
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Fields of Expertise
AIDS, anti-infective agent, antibiotic, antibiotic resistance, antifungal agent, aspergillosis, bacterial disease, bacterial pneumonia, blood borne disease, candidiasis, clinical database development, clinical medicine, clinical research, clinical study, clinical trial, disease, disease control, drug development, drug therapy, expert witness, gram-negative bacterial infection, immunization, infection, infectious disease, infectious disease treatment, medical diagnosis, medical errors, medical malpractice evaluation, nosocomial infection, outcomes research, pharmaceutical analysis, pharmaceutical drug, pharmaceutical industry, pharmaceutical research and development, pharmacoeconomics, pharmacovigilance, preclinical research, vaccination, vaccine, vaccine development