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...

Drug Quality and Compliance Expert in Analytical Chemistry, Drug Stability, Out of Specification Investigation, Manufacturing Change Control and cGMPSummaryPharmaceutical quality and compliance, analytical method development and validation.Interpretation of changing regulations.Thirteen years of pharmaceutical industry experience operating within both GLP (Good Laboratory Practices) and GMP (Good Manufacturing Practices) environments that included eight years of pharmaceutical research and development, hands on technical and research experience, in analytical method development, validation, and application and five years of technical and...

Medicinal Chemistry Consultant, Experienced Expert Witness, and Patent Agent Specializing in Drug Discovery, Drug Design, Intellectual Property Rights, Patent Application and ProsecutionTechnical ExpertiseMedicinal chemistryDrug discovery and developmentHit to lead optimizationStructure based drug designFragment based drug designMolecular modelingBiological TargetsVoltage gates ion channelsLigand gated ion channelsG protein-coupled receptorsKinasesTyrosine phosphatasesMetalloproteasesDisease StatesCardiovascular diseaseOncologyChronic pain and inflammationNeurodegenerative diseaseOsteoporosisArthritisIntellectual Property ExpertiseRegister...

Small Molecule Drug Development and Manufacturing Expert with Extensive Biotechnology ExperienceSummaryDrug development from proof-of-concept to commercialization in early to mid stage biotech and large pharmaceutical companies.Extensive background in biotechnology and small molecule development, manufacturing, quality, analytical, regulatory, outsourcing, project management and business development. ServicesMarketed products: Biotech Products: Remicade (infliximab), Simponi (golimumab), Retavase (reteplase), Eprex (epoetin), ReoPro. Small Molecule: Patanol, Azopt and Volfenol%uFFFF.Development drugs: Large molecules: AntiIL5, AntiTNF,...

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...

Ph.D. Chemical and Biochemical Engineer Specializing in Cell Culture and Sterile Drug Product Process Development, Technology Transfer, Scale-up, and Manufacture.Fermentation and cell culture development, scale-up, and manufacture.Sterile drug product development, technology transfer, and manufacture.Current good manufacturing practices (cGMP).Metabolic modeling.Educator for undergraduate Bioengineering program and workshop facilitation.Undisclosed Company, Owner, 2011 - PresentPr...

Biopharmaceutical Marketing Executive - Broad Commercialization Expertise in Marketing Strategy, Commercial Assessment, New Product Development and Launch PlanningBiopharmaceutical marketing executive with broad commercialization expertise including strategy development and execution for new product launches, label changes, and market events across lifecycle stages and customer segments.Primary care and specialty categories, including cardiovascular/atherosclerosis, osteoporosis, metabolic, antiemetics, oncology, and biosimilars.Marketing strategy, commercial, market, and competitor assessment, launch excellence, new product development an...

Global Pharmaceutical Creation and Implementation of Systems to Increase Efficiency, Sustain Regulatory Compliance, Interpretation of Regulatory Requirements: Quality Systems, cGMP, Good Laboratory Practices, IND/NDA/ ANDA/ DMF and CAPAGlobal market place creation and support; implementing systems, increase efficiency and sustain regulatory compliance in the pharmaceutical industries.In-depth knowledge and interpretation of regulatory requirements as applied to quality systems, cGMP, Good Laboratory Practices, laboratory equipment expertise.Vendor assurance programs, stability programs, validation (equipment, process, and analytical), manu...

PhD with expertise in Pharmaceutical Assessments, Investigations, 3rd party certifier, and Regulatory; FDA EMA, MHRAOver 33 years' experience in quality, microbiology and regulatory affairs.Pharmaceutical assessments, prioritization, establishment of realistic timelines for the implementation of consent decree commitments and 3rd party certifier of deviations-investigations.Ensure the robustness of quality systems - change control, product complaint handling, revision of SOPs, and control of 3rd parties.Quality assessment of sterile injectable, small molecules and biological as well as other dosage forms.Solid and liquid oral dosage forms...

Analytical Chemistry Consultant Specializing in Drug Stability and cGMP, FDA, and ICH Quality and ComplianceManage pharmaceutical commercial internal-external stability programs providing, guidance for laboratory investigations, input for laboratory information management systems, support sample management programs, and support data review. Provide support to Operational Excellence Projects.Ensuring stability studies are conducted to support regulatory commitments.Communicating trending stability data from the QC laboratory and contract laboratories.Drug stability program management for development and commercial products.Statistical anal...