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Clinical Development, Regulatory Development
Following more than 25 years in the pharmaceutical industry (Big Pharma, Contract Research Organizations, Small Pharma), Expert has accumulated experience from several hundred clinical studies, primarily in Phase I/Phase II ("First-in-Human", "proof-of-concept") across most therapeutic areas (Metabolic, Infectious, Oncology, Urology,…
Systems and Processes in Clinical & Regulatory in Pharmaceutical, Healthcare and Health Insurance
Accounting ethics | Expert is a CPA, member of AICPA and NYSSCPA. Expert has global experience with pharmaceuticals, focused on corporate integrity agreements and Physician Payment Sunshine Act, interacting with finance, audit, clinical and regulatory teams, physicians and non-physician investigators,…
Personality-Based Organizational Effectiveness & Development
Expert is a Licensed Clinical Psychologist with a wide range of professional experience in private practice, healthcare, forensic, academic and corporate settings. He is a specialist in psychological assessment and the science of personality, and is a skilled teacher of…
Advanced Practice Nursing Hospital and Community Based, Epic Systems Certified
Advanced Registered Nurse Practitioner with experience in Internal Medicine and Community/ Public Health currently pursuing a PhD in Nursing with a special interest in Epidemiology and Public Health Policy. Epic Systems electronic medical record system certified with multi hospital go…
Biotechnology & Pharmaceuticals: Drug Development, Due Diligence, Strategy, Finance, Market Analysis
With an MD-PhD, clinical training, ten years of experience analyzing and investing in companies developing drugs, ex[erience as a CEO of both private and public biotechnology companies, Expert has seen the drug and biotechnology industries from many angles. As an…
Medical Device Regulatory Affairs, Quality Assurance, FDA 820 EU ISO 13485 510(k) & Medical Software
Lead and developed regulatory plan and strategy for Molecular Diagnostic System. Blood Analyzer, Gene Profiling Reagents, Blood Analyzer etc. Assembled with team regulatory submission and obtained 510(k) clearance, EU CE Mark, Health Canada, China SFDA, Mexico, Australia, South Korea, and…
Obstetrics, Gynecology, Urogynecology, Female Incontinence, GYN Surgery, Laparoscopy
Expert has been in the practice of Obstetrics and Gynecology for over 23 years. He has practiced in all types of settings including tertiary care/teaching hospitals, community based private practice, and very rural, undeserved areas. During his career, Expert has…
Visual Development, Amblyopia (‘lazy eye’), Children’s Vision, Vision in Sport
Graduated as an Optometrist. As well as clinical training, he received training in research and research methods, completing his PhD. Since then he has combined his clinical and research interests. He continues to practice in the area of biocular vision…
Infectious Diseases, Infection Control, Healthcare-Associated Infections, HIV/AIDS, Med-Peds
Expert S. Expert, FACP, FAAP, FIDSA, AAHIVS is Clinical Professor of Medicine and Pediatrics at the Employer and Hofstra North Shore-LIJ School of Medicine in New York and former Global Medical Director and Senior Vice President for Pall Corporation. After…
Pharmaceutical Formulation, Drug Delivery, CMC, NDA, and Formulation Patents
Expert has developed multiple immediate release and modified release oral formulations at ALZA Corporation and at Transcept Pharmaceuticals. Many of these formulations have been commercialized including Invega (OROS paliperidone) and Exalgo (OROS hydromorphone). Recently, Expert was instrumental in developing a…