Find an Expert
Medical Device Technology, Clinical Research & Business Development
Expert has decades experience in Multi-modality medical imaging: digital x-ray, ultrasound, IVUS, MRI, intra-operative MRI, multi-slice and cone beam computed tomography, hybrid PET/CT and SPECT/CT, optical coherence tomography (OCT), endo-confocal microscopy and fluoroscopy imaging. Furthermore, he has experience in Image-guided…
Clinical Development
Expert is a Clinical Development executive with over 18 years of expertise and experience in the pharmaceutical industry. Proven track record of successfully managing large budgets with multiple programs and taking drugs from Phase I to Health Authorities’ approvals. Expertise…
Medical Device Regulatory Submissions
She has extensive experience writing and compiling 510(k)s and PMAs for product clearance or approval with a well-established track record of success. Some of the device types she has experience include Surgical Instrumentation, Cardiac Ablation Systems and Catheters; Surgical, Ophthalmic…
Biostatistics, Epidemiology, Methodology, Mental Health, Police Procedures, Drug Safety, Malpractice
As a Professor of Statistics, Epidemiology, Public Health and Psychiatry for the last 30 years he has taught, applied and consulted on all of these methods. First trained as public health physician, he did his graduate work (MS and PhD)…
Drug Delivery, Formulation Development of NCE\’s, Pre-formulation, Stability, and Clinical Manufacturing
She has been involved in contract manufacturing of pharmaceuticals for the drugs and devices. Contract manufacturing for drugs have included identification, evaluation, screening and selection of CRO's and CMO's in the area of sterile solution and oral solids. For the…
Immunology, Vaccinology, Infectious Diseases, Recombinant Proteins
Expert has been involved in numerous animal studies examining various aspects of infectious disease agents. Expert has worked with animal models of infection with the following diverse pathogens: Schistosoma mansoni, Candida albicans, Borrelia burgdorferi, and S. aureus. In addition, he…
Pharmaceutical Imaging, Biological, Physical and Analytical Research, Pharma Commercial Viability
He served as the CEO, President of two public companies, one private company and also as the Chairman of the Board of a Not-for-Profit. His experiences include: managing research, clinical studies, finance, managing personnel, legal issues, patent issues, restructuring companies,…
Hand Injuries, Hand Tool Design, Ergonomic Issues, Work Related Injuries in Dental/Medical
Expert is a certified associate ergonomist. Expert is founder and owner of a nationally based ergonomic consulting firm. Expert's background in ergonomics has allowed her to utilize her skills in preventing work related accidents and in assisting with the development…
Medical Devices, Electronic Systems, Acoustics and Hearing, Intellectual Property
Because of his long-term interest in sound and hearing, Expert has been involved with many aspects of acoustic measurement. He has developed proprietary technology for sound level measurement and noise dose determination and has utilized his skills in acoustic measurement…
Orphan Drugs: FDA/EU/Canada; FDA Approval; Drug Development: CMC, QA, QC, Manufacturing
12 product approvals from FDA including 6 new chemical entities, a 510k device, and three major pharmaceutical efficacy indication supplemental approvals. All received 5-10 years of regulatory exclusivity (Hatch-Waxman, Orphan Drug). These products are generating over $100 million dollars in…