Expert in applied statistics, biostatistics and mathematics - designs analyses for clinical trials, pharmaceutical exposure and efficacy, Medicare/Medicaid effectiveness and learning methodologiesClinical trials protocols, statistical analysis plan and clinical study reports.Bayesian inferential and decision analysis.Integrated Analyses of Efficacy and Safety.Due diligence.Pharmaceutical adaptive designs: blinded and un-blinded sample size adjustment, group sequential designs.Clinical trials sample size determination.Mixed models repeated measures models.Pharmaceutical product exposure modeling.Statistical programming in SAS (MACROs, IML,...

Medical Doctor with Expertise in all Phases of the Drug Development Process, Including Medical, Legal and Policy Issues Related to Pharmaceuticals, Devices, and Dietary SupplementsAll phases of the drug development process, including medical, legal and policy issues related to pharmaceuticals, devices, and dietary supplements.Therapeutic areas included asthma, epilepsy, cancer, cardiovascular disease, infectious disease, sleep, depression, and prostate cancer.Drug development initiatives, protocol development, data analysis, review and revision submission materials and manuscripts, safety data review, medical monitoring, and medical review...

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...

Medical Doctor focused on cures for short term memory lossCentral cholinergic mechanisms (nucleocortical and septohippocampal pathways) related to the learning process and short-term memory in normal and aged brains.Experimental models and tests of acetylcholine as a neurotransmitter in learning and memory loss.Screening of compounds (such as pyroglutamic acid, oxiracetam, aniracetam and pramiracetam) with the potential of use in humans for Alzheimer's disease and other age-associated memory impairments.Expertise in European pharmaceutical research and development and common technical documents.Managing and monitoring Phase 1 and 2 clinica...

Design and Synthesize Drug Candidates for Discovery and Development: Chiral, Polycyclic, 3-8 Step Synthesis for Cancer, CNS, Pain, Diabetes, Microbial Infection, AIDS). Design and Synthesize Diagnostic Reagents and In Vivo Imaging Agents - Macrocycles, Antigens, Polycyclic Heterocycles.Synthetic and discovery organic chemistry for the pharmaceutical industries with applications in CNS, cancer, and pain.Preclinical development chemistry for pharmaceutical scale-up, metabolites, impurities, and deuterated drug candidates.Synthetic organic chemistry for in-vitro and in vivo diagnostics, including antigens and biotin conjugates with varied r...

Pharmaceutical Drug Development Expert: Scale-up, Technology Transfer, Process Optimization, Troubleshooting, Clinical Supplies, FDA and ICH Quality and ComplianceManaging pharmaceutical operations, process and analytical methods development.New pharmaceutical product formulation development, scale-up, process start-up, optimization and troubleshooting.FDA-recognized expert in formulation development and technology transfer.Pharmaceutical licensing, Regulatory Affairs (CMC), quality systems and staff management.

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...