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...

Veterinary Pharmacology and Pharmacokinetics, Bibliographic Assistance, Tissue Residues and Product RegistrationPharmacokinetics in domestic animals.Tissue residues of veterinary drugs.Milk residues of veterinary drugs.Pharmaco-toxicological monographs for veterinary drugs.Registration and development of veterinary pharmaceuticals.Expert-Pharmaceutical RegistrationTechnical support for the development and registration of more than 200 pharmaceutical products for veterinary use in Argentina and Latin America.Independent Consultant...

Ph.D. with expertise in Drug Metabolism and Pharmacokinetics, Pharmacodynamics, and Toxicokinetics. Investigational New Drug approval experience in USA and ChinaDMPK (Drug Metabolism and Pharmacokinetics), PD (Pharmacodynamics), TK (Toxicokinetics), Toxicology, and Safety fields.Oversight of outsourced GLP studies and in-house non-GLP studies for candidate drugs in oncology, inflammation, anti-virus, and hypertension fields.IND (Investigational New Drug) approval both in U.S.A. and China, as well as 15 years of experience in small molecular novel drug discovery and development, and 20 years of experience in drug metabolizing genes/enzymes...

Medicinal Chemist Specializing in the Design and Synthesis of Antibacterials and other Antiinfectives. Drug Development and Project Management from idea to Clinical Trials.Antibacterial chemotherapy including beta-lactams, quinolones, DNA - gyrase and top IV inhibitors, peptide antibacterials, pleuromutilins, glycopeptides, oxazolidinones, 2-component signaling, natural products, single enzyme targets such as the Fab and Mur proteins, GlmU, LpxC, and mechanism based small molecule inhibitors projects.Antiviral chemotherapy: HIV and Herpes antivirals, HIV protease, HIV integrase, HIV-NCp7 (nucleocapsid protein).All aspects of medicinal che...

Large Molecule Bioanalytical Consultant with PK, PD, and ADA experience. Over 20 Years Experience Developing and Validating Bioanalytical Methods to Support Drug Development Programs.  Experience in Summary  Accomplished bioanalytical scientist with extensive and diverse experiences in biotechnology and pharmaceutical industries.  Strong reputation for planning and organizing, analytical problem solving, multi-tasking. and coordinating team efforts.  Creative, collaboration and highly goal-driven scientist.  Expert in Ligand Binding Assays including immunogenicity. Successfully implemented complex acid...

Senior pharmaceutical R&D professional focused on analytical methods, methods validation, validation of computer systems and quality assurance and quality systems. Experience with parenterals, liquids, solids and semi-solids.Analytical Techniques: GC, HPLC, GC/LC/MS, FTIR, UV-Vis.Stability-indicating method development, validation and transfer.Analytical equipment validation: IQ, OQ, PQ.Part 11 compliance and GAP analysis.Validation master plan development.Stability protocol development.CTD dossier preparation.Cleaning validation strategy.LIMS and Laboratory Data Acquisition Computer systems.Coumadin, Percodan, Naloxone, Numorphan and N...

Medicinal chemist and Pharmaceutical Technology Consultant with Expertise in Drug Research, Drug Formulation, Drug Analysis, Drug Synthesis and Purification, In-Vitro, In-Vivo (Efficacy and Pharmacokinetics) and Dosing RoutsDiscovery and development of novel human therapeutics for: Anti-infective, anti-inflammatory and neurodegenerative diseases.Development of antibacterial clinical candidates, and the discovery of five preclinical candidates for Multiple Sclerosis, Arthritis and Spinal Muscular Atrophy.Drug research and development from synthesis/purification, in-vitro, in-vivo (efficacy and pharmacokinetics) testing, dosing routs, formul...

Consultant for Pharmaceutical Marketing Research and Drug Program ManagementSenior consultant with 15 years of research experience in academic and industrial settings with a Ph.D. in Immunology.Marketing research of competitive assessment of pharmaceutical market segments and geographical regions.Pharmaceutical and biotechnology drug development, drug company portfolio analysis, strengths, weaknesses and opportunity assessment.Pharmaceutical and biotechnology drug and intellectual property valuation.Clinical trials, FDA filings, product lifecycle management and project management.Experience in collaborating with customers, at different le...