Consultant in Drug Discovery and Development; Preclinical and Clinical Drug Metabolism and Pharmacokinetics, Toxicokinetics, and Clinical Pharmacology; Preparation and Submission of IND's/ERC's and NDA's/MAA's.Over 35 years of experience in the discovery and development of novel drugs in multiple therapeutic areas (anti-bacterial, anti-inflammatory, anti-viral, cardiovascular, central nervous system, oncology, ophthalmic, pulmonary, and renal).Strong managerial and leadership skills with scientific expertise in the areas of drug discovery and development, preclinical and clinical drug metabolism, pharmacokinetics, and clinical pharmacology...

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...

Developing and validating standards for pharmaceuticals and biopharmaceuticals. Technical and regulatory aspects of pharmaceutical and biopharmaceutical development and manufacturing including analytical and bioanalytical characterization as well as stability testing and formulation development. Audit and FDA experience.Developing and validating standard and state of the art analytical methods to characterize pharmaceuticals and biopharmaceuticals.Expert in liquid and gas chromatography, capillary electrophoresis, spectrophotometry and mass spectrometry (single and triple quad and MALDI and ion - trap).Developing and validation of biologi...

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...

Pharmaceutical Statistics Data Analysis and Clinical Trial DesignPharmaceutical bio-statistician.Pharmacokinetics and data analysis for clinical trials.CNS: Schizophrenia, bipolar disorder, Alzheimer's disease, migraine and over-active bladder.CV: Hyperlipidemia, diabetes (novel PPAR y & %u0105, atrial fibrillation, anti-platelet agent.Oncology: VEGFR EGFR inhibitors, lung and thyroid cancer, non-small cell lung cancer, chronic lymphocytic leukemia (CLL), acute myeloid leukemia (AML), advanced solid tumors.Immunology: Malignant melanoma (DNA immunotherapy, hepatitis B and C (PEG-Inetrferon), H5N1 vaccine, RNAactive-derived vaccine (for p...

FDA Regulatory Statistician Experienced in all phases of Clinical Trial Design, Analysis, and BiostatisticsBiostatistics: Regulation of drugs, drug devices and biologics.Clinical and preclinical study design and data analysis, methodological research in statistics, and computer program validation.Expert regulatory statistician (FDA designation).Areas of application include clinical trial design and analysis, interim analyses, multiple imputation, pharmacokinetics, bioavailability and bioequivalence, chemistry and manufacturing controls, stability studies (including bracketing and matrixing), animal safety studies, and carcinogenicity stud...

Medical Chemist Specializing in Synthetic, Chemistry, Medicinal Chemistry and Due Diligence Evaluation of Preclinical Packaging. Drug Licensing for Clinical Development, Pre-IND, (Pre-Investigational New Drug Application), With an Emphasis on Early Clinical Trials, Prior to Out licensing CompoundsMedical Chemist specializing in synthetic, chemistry, medicinal chemistry and due diligence evaluation of preclinical packaging.Drug licensing for clinical development, pre-IND, (Pre-Investigational New Drug Application), with an emphasis on early clinical trials, prior to out licensing compounds.Identification of clinical candidates for potential...

Medicinal and Organic Chemistry Consultant Specializing in Drug Discovery and Development, Patents and Project Management of Chemistry Outsourcing ProgramsMedicinal chemistry consulting and discovery.Drug research and development (pre-clinical and clinical).Patent interference consulting and IP management strategy.Managing medicinal and organic chemistry outsourcing projects.Licensing negotiations; due diligence.Chemical safety training.Neuroscience drug discovery.Cardiovascular drug discovery.Anti-infective drug research.Syntheses of complex, diverse targets through novel methodologies.Structure-based design using enzyme-inhibitor crystal...

Commercial Pharmaceutical Strategy: New Product Launches, Profit and Loss Management, sales and Marketing. National and International Pharmaceutical LicensingCommercial leadership in the global life sciences industries, with extensive experience guiding both large and small life-science companies.Life science commercial strategy development.Product development (commercial): Clinical study design, labeling development, and KOL networks.Product launch in various disease states and platforms including diagnostics, vaccines and nutriceuticals.Market access strategy development: expert recommendation, Key Opinion Leader (KOL) in support, pr...

Pharmacokinetics Consultant Specializing in Drug Metabolism, Drug Discovery and Early Drug Development.ADME, (Absorption, Distribution, Metabolism, and Excretion) and PK (Pharmacokinetics) in drug discovery.Early drug development.In vivo and in vitro enzyme induction.Cytochrome P450 enzyme inhibition and potential for drug-drug interaction.In vitro and in vivo metabolism and metabolite profiling.Preclinical studies to evaluate ADME, toxicokinetics, and PK profile of drug candidates.Due diligence to evaluate DMPK profile of drug candidates for potential purchasing or in-licensing opportunities.Interaction with CROs for contracting and monit...