Find an Expert
Pharma/Biotech Development, Life-Cycle Management, 505(b)(2), Chemical Development, CRO Services
Expert is a Pharmaceutical development leader with ~25 years drug development and manufacturing experience with large Pharma, large Biotech, and a highly successful small start-up. Managed large groups (from three different countries), teams and budgets. Played critical roles in several…
Psychopharmacology, Drug Development, Medical Devices
Expert's training in psychiatry has focused on biological psychiatry (the biological basis of psychopathology) and on psychopharmacology. He currently directs the Developmental Biopsychiatry Research Program and the Laboratory of Developmental Psychopharmacology at McLean Hospital/Harvard Medical School. He has a broad…
Molecular Pathology and Novel Solutions to Thrombosis, Cancer, Sepsis, Immunopathology.
Expert has pioneered the identification of the proteins of the Coagulation cascade responsible for Thrombosis, Hemostasis, Disseminated Intravascular Coagulation, Sepsis, Inflammation and the roles in neoplastic cell invasion and metastasis. He was the first to successfully identify and isolate Factor…
Biostatistics Phase I, II trials, Translational research; Design, Analysis, Presentation
MD and MS in biostatistics with more than ten years of relevant professional, supervision and management experience • Experience in providing support to biomedical researchers regarding statistical aspects of study design • Expert in statistical techniques used in analysis of…
Behavioral Science, Memory, Psychopharmacology, Statistics, Research Design, Sensation & Perception
He has conducted several research studies on nicotine and nicotine withdrawal, as well as the mnemonic effects of benzodiazepines. He has conducted studies examining the anesthetic drug midazolam and it's effects on human memory. He has extensive training and experience…
Nanotechnology, Biomaterials, Sol-gel Sciences, Optics, Biotechnology, Glass, Ceramics, Spectroscopy
Expert is a specialist of sol-gel chemistry. He developed a new non-aqueous method for sol-gel glass coating to obtain transparent films for integrated optics and photonics using polysiloxane materials. The aim was to obtain low-softening temperature glasses to permit facile…
Nanobiotechnology, Drug Delivery Platforms, Medical Devices, Targeted Therapeutics, Diagnostics
Expert has extensive experience establishing R&D operations in early stage biotechnology companies. He applied his knowledge in nano(bio)technology to develop innovative solutions to drug delivery and drug targeting challenges. His efforts to enhance the use of biomaterials in a variety…
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…
Drug & Device Clinical Development, Regulatory Approval, Adverse Reactions, Expert Witness
Clinical Pharmacology is the scientific discipline that brings science to the process of drug development, particularly at the key stage where a molecule of interest becomes a drug candidate. From this point, through the rest of Development, the science of…
Healthcare, Medical Device, Diagnostics, Pharmaceuticals coding, reimbursement
Expert, MD FACP AGAF FASGE FACG is a physician whose focus is strategy for coverage, reimbursement, quality improvement, bundled payments and accountable care. Executive clinician with over 30 years of experience providing strategic leadership and medical oversight to data-driven health…