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Neuroscience, Auto-Immune Drug Development, and the CDMO Sector
Expert in Neurology at the clinical stage and rare disease specialist with deep domain knowledge and financial acumen. He is an entrepreneurial builder of brand intelligence, growing contract manufacturing consultancy to high profile industry recognition and B2B sale at full…
Medical Device Quality Assurance and Regulatory Compliance
Expert is a 34-year food, cosmetic, drug, biologic, clinical, medical device, and combination product non-technical quality assurance and regulatory compliance veteran with over 21 years of FDA/ governmental experience as an analyst and level II certified international medical device investigator…
Pharmacovigilance
Pharmacovigilance professional with 18 years’ experience developing and reengineering PV departments in small to medium sized pharmaceutical/biotechnology companies. Operational expertise includes the evaluation, development and implementation of PV processes and infrastructure, vendor management, SOP development and revision, CAPA management, compliance…
Clinical Research, Clinical Trials, Drug Development, Drug Safety, Patient Consenting Process
Experienced clinical research professional with a demonstrated global leadership in the pharmaceutical and medical device industry. Global organization and oversight of clinical research, QA and regulatory strategies. Leadership in new business development (medical device and medical software development quality management,…
Environmental and Spatial Statistics, Especially Site Assessment and Remediation
Expert is a statistician with many years of experience in environmental statistics, especially related to site characterization and remediation. He has developed numerous environmental sampling designs for field projects and experimental designs for studies and has analyzed and reported the…
BioStatistics, Pharmaceutical Devices, Biotechnology, and FDA and EMA Submissions
Expert holds a Ph.D in Statistics and has 25 years' applicable industry experience. He currently serves as a biostatistical expert witness in high-stakes pharmaceutical and medical device litigations. He has expertise in pre- and non-clinical, Phases I-IV in biostatistics, data…
Clinical Development, Safety Reviews, Pharmacovigilance, Pharmacoeconomics
• Employer for preparation for an FDA Advisory Committee regarding review of an NDA. • Design and implementation of Phase I-IV clinical studies • Employer to many large pharmaceutical companies • Employer to Biotechnology companies and CROs • Medical safety…
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…
Clinical Epidemiology, Public Health Medicine, Drug Safety, Clinical Trials
Expert is Director of Pharmacoepidemiology in a Public Health Consultancy providing advice and expertise to the public, regulators and medical professionals on the evaluation and safety monitoring of drugs in the European Community. He has: conducted state-of-the-art pharmacoepidemiological studies including…
Immunological Methods, Study Design, Data Interpretation, PDX, Immuno-Oncology
Expert has conducted the evaluation, physical, and laboratory diagnosis of how aging effects the role of T lymphocytes, specifically CD8 T cells. In those studies, he has examined young versus older individual as well as the reasoning behind a decreased…