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...

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...

Ph.D. Consultant with expertise in Characterization and Quantitation of Proteins and Small Molecules. Subject Matter Expert (SME), Oversight (in-house-external) CRO support, and GLP/GMP.Analytical and bioanalytical methods for characterization and quantitation of drug therapeutics and pharmaceutical product development.Monitor analytical and bioanalytical activities at CROs in support of non-clinical and clinical trials.Characterization of small molecule, biologics (peptides, proteins, and antibodies), antibody drugs conjugates (ADCs), PEGylated proteins, and oligonucleotides.Drug Metabolism and Pharmacokinetics (DMP) parameters, basic no...

PhD Biostatistician with expertise in Regulatory (FAD and EMA activity), Data - Safety Monitoring in the Pharmaceutical and Medical Device Industries. Scientific Advisory Participant.Biotechnology FDA and EMA submission in the pharmaceutical and medical device industries.Biostatical litigation specific to pharmaceutical and medical devices.Pre- and Nonclinical, Phases I - IV in biostatistics, data management, statistical programming, and etechnology across various therapeutic areas.Analysis of over 420 clinical studies, with over 30 in Integrated Summary of Safety and Integrated Summary of Efficacy (ISS/ISE).Build effective innovative an...

Expert in Identification and Optimization of Pharmaceuticals, Drug Discovery, Profile Development (Central Nervous System-Non CNS Drugs), Therapeutic Drugs, Pharmacophore ModelingScientific research and management records for the pharmaceutical industry:Inventor of a preferred method in the industry for LogP calculation3D-QSAR methodPharmacophore modelingA quantitative definition of drug like moleculesPotent anticancer compounds.Provide computational chemistry and chem- and bio- informatics problem solving for drug discovery.Computer aided drug discovery: Developed and led computational chemistry, cheminformatic laboratories in industrial...