Experienced in Target Validation and Lead Discovery Through Nomination of Compounds for Preclinical Development and due diligence evaluation for in-licensing opportunities.Drug Discovery: Target discovery and validation, assay development, High-Throughput Screening (HTS), hit-to-lead and lead optimization.In vivo pharmacology: Disease modeling, neurodegeneration and neuroscience, efficacy testing, biomarker discovery.Preliminary Pharmacokinetics (PK) and Pharmacodynamics (PD).Project management.Laboratory design and streamlining laboratory operations.Business: Strategic planning and decision matrix evaluation, scientific due diligence, I...

Expert and professor on environmental toxicity, teratology, developmental biology, human embryology and reproductives physiology.Environmental toxicity and developmental toxicology (teratology).Toxicology, teratology (reproductive toxicology), reproductive physiology, environmental medicine, and endocrinology.Taught courses on teratology, developmental toxicology, both general and environmental toxicology, developmental biology, human embryology, reproductive physiology, endocrinology, general physiology, and technical methods.Current research interests include investigation of mechanisms and development of assays for developmental toxici...

DABT Toxicologist and Scientist with Applied Industrial Experience Specific to IND and NDA Submissions to the FDA and Global Equivalents.DABT Toxicologist and Scientist, Department Head with over 12 years applied industrial experience, supporting and directing interdisciplinary teams to both IND and NDA submissions to the FDA and global equivalents.Management, budgetary and scientific skills include discovery, investigative, and regulatory drug safety assessment with an excellent foundation in toxicology, pharmacology, physiology, biochemistry and DMPK.Therapeutic areas supported are anti-infectives, cancer, immune regulation, diabetes, CN...

Expert and Consultant for Pulmonary Toxicity and Related Lung DiseasePulmonary fibrosis and pulmonary pathology.Lung diseases such as asthma and bronchitis.Environmental lung disease.Metal toxicity, vanadium toxicity.Carbon nanotube pulmonary toxicity.Occupational lung disease.Air pollution particles and associated lung disease.Research InterestsCellular and molecular mechanisms of pulmonary fibrosis and chronic airway remodeling in asthma and bronchitis.Disruption of intracellular signaling pathways by air pollution particulate matter and metal-induced oxidative stress, particularly vanadium pentoxide.Pulmonary responses to manufactured c...

Consultant for drug development for cardiovascular therapeutics and heart failure; experienced as an expert witness.Drug development, specializing in cardiovascular therapeutics.Expert witness and the evaluation of cardiovascular drugs.Drug safety.Medical writing: Protocols, study reports, manuscripts, FDA submission (NDA) briefing documents and investigation of new drugs (IND).Product support-promotional review and medical information.Evaluation of previously monitored clinical studies.Principal Investigator in the following areas:Vasodilator and inotropic drugs.Vasodilator therapy for acute myocardial infarction.Nitrates and hydralazin...

Neurobiologist Consultant: Central Nervous System, Spinal Cord Injury, Hemostasis, Thrombosis and Autoimmune DiseasesEight (8) years of experience in biotherapeutic drug discovery and development with a focus on neurobiology, hemostasis, thrombosis and autoimmune diseases.Drug discovery research for hemophilia and in critical bleeding indications.Development of therapeutics for spinal cord injury, multiple sclerosis and other central nervous system disorders.Experienced with molecular and cellular pharmacology, cell-based assays with central nervous system (CNS) and immune cell types, immunohistochemistry and thrombosis pathology, animal m...

Pharmaceutical Chemistry Consultant for Drug Discovery, ADME, and Drug Toxicity and Drug SafetyPharmaceutical drug discovery process and implementation.Drug discovery and medicinal chemistry.Preclinical pharmacology, ADME (absorption, distribution, metabolism, and excretion of drugs) and pharmaceutical toxicology and safety.Pharmaceutical drugs for anti-infectives, anti-virals, oncology and immunology.Pharmaceutical drugs for cardiovascular and metabolic disease.Pharmaceutical drugs for diabetes, obesity, aging and frailty.Due diligence assessments, including intellectual property.

Synthetic and Medicinal Chemistry Consultant Specializing in the Integration of All Aspects of Drug Discovery; Chemistry, Biology, Patent Protection, Pre-Clinical Development; IND Filing, Support of Phase I & II Clinical TrialsSynthetic and medicinal chemistry.The integration of all aspects of drug discovery, from early-stage research in chemistry and biology, through patent protection, pre-clinical development, CMC, IND-filing and support of Phase I and II clinical trials.Indication areas of experience: Inflammation, cancer, neurological and neurodegenerative diseases, age-related macular degeneration, and diabetic retinopathy.18 years o...

Expertise in designing, planning and executing in vitro and in vivo molecular, cell biological, biochemical, immunological and toxicological research studies in compliance with funding agencies' GLP.Demonstrated leadership and versatility in directing multi-disciplinary research teams to investigate the molecular mechanisms, identifying pathways and bio-markers involved in developmental and reproductive biology and neurodegenerative diseases using genomic and proteomic approaches.Practical and demonstrated experience in one or more of the following areas: Neurobiology, toxicology, molecular biology, genomics, proteomics, transgenic technol...

Regulatory Expert in the Fields of Food and Feed Additive Safety Assessment, GRAS Notifications, Food Additive Petitions, Quality, Hazard Analysis and Good Manufacturing PracticeRegulatory support in the fields of food and feed additive safety assessment, GRAS notifications, food additive petitions, quality, hazard analysis and good manufacturing practice.GRAS Notifications for CFSAN and CVM, and FSMA compliance.Broad knowledge of the fermentation-derived enzyme, food ingredient, food and feed additive, and dairy culture fields.Additive, ingredient or product safety assessment, preparation and submission of GRAS notifications or additive p...