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...

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...

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...

Molecular biology consultant expert in pharmacology, oncology, endocrinology with expert witness and interpreter of scientific literature experience.Pharmacology: Mechanisms of drug action and side-effects.Oncology: Specializing in breast cancer, endocrine regulated cancers and lung cancer.Endocrinology: Hormone replacement therapy with estrogens and progestins.Steroid receptors, steroid hormones and mechanisms of action.Dose-response curves: Tamoxifen, raloxifene, fulvestrant, SERMs, letrozole, anastrozole, exemestane and aromatase inhibitors.Molecular biology, biochemistry, biophysics.Recombinant DNA technology, PCR, mutagenesis, cl...

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...

Over 30 Years of Experience in Pharmaceutical Research and Development. Expert Support in Clinical Pharmacology, Toxicology, Drug Development, Regulatory Affairs and Clinical Research at Major Pharmaceutical CompaniesOver 30 years' experience in pharmaceutical research and development.Clinical pharmacology, toxicology, drug development, regulatory affairs and clinical research at major pharmaceutical companies.Led the research teams that discovered and developed misoprostol (Cytotec®), a worldwide anti-ulcer drugWorldwide clinical research at major pharmaceutical companies.Educator: Pharmacology and toxicology to medical, dental and p...

Innate and Adaptive Immunity, Inflammation, In Vitro and In vivo models. Biochemistry, Protein Modification, Signal Transduction, Gene RegulationBiochemistry, protein chemistry, and protein modification.Immunology, toll receptors, vaccines and vaccine adjuvants.In vitro and in vivo models of disease.Forecasting and determining future needs in pharmaceutical and biomedical industries.Research for development of 3M TLR agonists, created new opportunities as vaccine adjuvants and cancer therapies.In vitro and in vivo immune response and oncology models to demonstrate efficacy.Widely acknowledged for innovation and creativity to identify pharm...

Occupational and Industrial Toxicology Expert: Program Development, R&D and Product Safety Working in the Biotechnology, Medical Device and Pharmaceutical IndustriesOccupational and industrial toxicology, development programs (both preclinical and clinical) and study design.Conduct and reporting, in evaluating clinical and product safety data, in training and managing staff; in dealing with a wide range of U.S. and foreign regulatory bodies.Addressing commercial concerns, and contract research organizations in labeling and other FDA compliance issues for drugs, devices and dietary supplements.Identifying, developing and implementing new...

International Immunology and Virology Ph.D. Specializing in Genetics, Molecular Hematology, DNA and Dementia DisordersRare genetic diseases.Gene therapy.Stem cell.Molecular biology diagnostics.Immunology and virology diagnostics, development and basic research.Genetic analysis in human biological samples, (amniotic fluid, chorionic villus blood, bone marrow, buccal swab and DNA samples).Molecular hematology, blood, bone marrow, buccal swab and DNA samples and genetic analysis.Investigation of genetic causes of dementia disorders.Genetic plant analysis, plant material, seed, food, and feed.Educator and examiner within pharmacology, pharmacy...

Drug Therapeutic Discovery Medicinal Chemist Consultant: Pain, Inflammation, Cardiometabolic, Oncology and AntimicrobialsHit generation, lead identification, and lead optimization. Strategies, implementation plans and problem solving.Drug Discovery - "Concept to Clinic" - Road map and expectations. Goal setting, testing schemes, progression path tracking.Intellectual Property - Assessment, strategies and management. Due diligence on prior art, patentability. Expert witnessDrug discovery across therapeutic areas - Pain, inflammation, cardiovascular, metabolic, oncology and antimicrobial therapeutics.PK/PD (Pharmacokinetic and Pharmacodynam...