Clinical and regulatory physician has both an M.D. and Ph.D. and is board certified in Neurology and Clinical Neurophysiology . He has over 20 years of combined clinical, regulatory, and pharmaceutical company experience. In addition to his experience as a medical reviewer at the FDA in the Division of Neuropsychopharmacological Drug Products, he has over seven years' experience as the Vice-President of Clinical Research. During that time his team had four NDAs approved. He also served as the Medical Director. His duties included the managing the Pharmacovigilance program for over 100 drug products, assisting with business development, and working with the Marketing departments. For the last three years, he has been actively working as a consultant to pharmaceutical companies, investment groups, and academic institutes. He has served on mock advisory panels, assisted companies with clinical hold issues, performed due diligence on products and companies, prepared INDs, Protocols, Clinical study reports, integrated summaries of safety and efficacy.

The expert is an MD with an MPH in Epidemiology . Three years as Medical Officer in the Division of Metabolism and Endocrine Drug Products. Risk Assessment. Preventative Medicine. One year as Medical Epidemiologist and four years as Branch Chief, Division of Epidemiology and Surveillance, Office of Epidemiology and Statistics. Advisor to WHO. Member of the Working Group on Fertility Regulatory Methods, Special Programs Research, Development, and Research Training in Human Reproduction.

The expert is an MD board certified in Internal Medicine and held positions with the FDA for 8 years and now consults in the domains of drugs, biologics and devices .
Medical review officer, Division of Blood Applications, Office of Blood Research and Review, Center for Biologic Evaluation and Research (CBER) working with clinical trial design and xenograft transplantation. Acting Director, Office of Surveillance and Biometrics, Center for Devices and Radiological Health (CDRH), responsible for monitoring safety and effectiveness of all medical devices marketed in the US. Medical Review Officer, Division of Antiviral Drug Products, Center for Drug Evaluation and Research (CDER) reviewer for initial clinical trials of new drugs developed to treat HIV, Herpes, Vericella - Zoster and other human viral pathogens. Deputy Director, Office of AIDS and Special Health Concerns, Office of the Commissioner, US FDA National and international representative for FDA policies on regulation of HIV-related products for diagnosis and treatment. Staff Epidemiologist, Office of Epidemiology and Biostatistics, CDER monitored post market safety and effectiveness of market drugs, Consultant to CBER for drugs and biologic evaluation and research on epidemiologic issues and problems.

MD with Board Certifications in Internal Medicine and Infectious Diseases. MPH Biostatistics/ Epidemiology Track.
6 years at the FDA as Medical Officer/Team Leader Division of Clinical Trial Design and Analysis, Immunology and Infectious Diseases Branch. Reviewed all phases of clinical trial evaluations of biological agents for the treatment of autoimmune and inflammatory diseases and the treatment of infectious diseases, e.g., sepsis, HIV/AIDS, inflammatory bowel disease and rheumatoid arthritis. Provides assistance in the clinical development strategy for biopharmaceutical therapeutics Indications for these therapeutics include inflammatory disease, cancer, and diseases responsive to immunomodulation, e.g., rheumatoid arthritis, inflammatory bowel disease, sepsis, psoriasis. Other indications include infectious diseases, neurology, dermatology, angiogenesis, and ophthalmology. Types of products include monoclonal antibodies, proteins, antisense, and cell and gene therapies. Served as clinical monitor for clinical trials at a CRO.

Expert is an MD board certified in Internal Medicine and Rheumatology, at the FDA for 8 years in the Center for Biologics and Research (CBER). Deputy Director, Division of Vaccines and Related Product Applications, Medical Officer, Division of Vaccines and Related Product Applications, Medical Officer, Hematologic Products Branch Division of Biological IND's. Expert in biologic agents with emphasis in the development of drugs and therapeutic proteins for the treatment of autoimmune and inflammatory diseases such as rheumatoid arthritis and multiple sclerosis, clinical trials in systemic sclerosis, coronary artery disease, sepsis, solid tumors, and hematological malignancies, monoclonal antibodies, cytokine inhibitors, systemic lupus erythematosus, and acute/ chronic pain syndromes. Has organized and participated on medical advisory panels in the U.S. and Europe, designing clinical trials, analyzing clinical data, participating on safety monitoring committees, and submitting marketing applications to regulatory authorities in the U.S., Europe and Japan.
In positions with big PHARMA firms served as Medical Director.

This expert is a DVM with clinical, regulatory and pharmaceutical company experience . At the FDA (in the Center for Veterinary Medicine -CVM) for over 14 years. Supervisory Medical Officer for more than three years in the Office of New Animal Drug Evaluation/Division of Theraoeutic Drugs for Non-Food Animals including the review of labeling within the division. Three years as a Master Reviewer. Reviewed companion animal drug products including a broad range of classes, equine and small animal. Reviewed protocols, safety and effectiveness studies, and labeling for cattle antimicrobial drugs. Performed milk safety work; served on the Teat Dip Committee Mastitis Council. Over four years at the Office of Surveilance and Compliance. Reviewed annual drug experience reports, labeling, supplemental applications, and promotional material. Expertise in adverse drug experience reporting. Two years as a consultant to the pharmaceutical industry. While in industry, the expert was Product Development Manager managing clinical aspects from Phase I to Phase III including protocols for the US and EU. Responsible for negotiations with EMEA, and the FDA. Prepared Safety and Efficacy Technical sections of new submissions for Veterinary Medical Products/New Animal Drugs; provided clinical and trend analysis for pharmacovigilance reports to relevant regulatory authorities.

The expert has a DVM and a PhD in Comparative (Human and Animal) Pharmacology and Toxicology and served as the Director, Division of Toxicology at the Center for Veterinary Medicine at the FDA for five years . This position involved assistance to pharmaceutical and food industries in new drug develop and food safety. Board certified in Toxicology; Founding Member. Foreign languages French (fluently), Greek (fluently), English (fluently), Italian and Spanish (technical literature). Provides expert technical advice to the Center for Veterinary Medicine (CVM), the Center for Drug Evaluation and research (CDER), the Center for Food Safety and Applied Nutrition (CFSAN), and the Center for Biologic Evaluation and Research (CBER) and other Agencies (USDA, EPA). Expert held positions in the pharmaceutical industry and the California Department of Agriculture.