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Strategic CMC development and planning of ophthalmic, respiratory, and nasal products. Formulation development of ophthalmic, respiratory, nasal, and dermatological productsStrategic CMC development and planning of ophthalmic, respiratory, and nasal products.Formulation development of ophthalmic, respiratory, nasal, and dermatological products.Manufacturing process development, technology transfer, and scale-up of ophthalmic, respiratory, and nasal products.Extractables and leachables testing planning and execution for ophthalmic, respiratory, and nasal products.CMC regulatory writer: Pharmaceutical development and stability reports; CMC...
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...
Ph.D Pharmaceutical Regulatory and Laboratory Compliance, Quality Assurance and Controls (cGMP, FDA, ICH, EMA, ISO) ConsultantPharmaceutical and biotechnology product development, management of cGMP compliance quality systems, quality control, quality assurance, (in unique dosage forms, and sterile-nonsterile processing methods).Laboratory quality systems for both pharmaceutical development and quality control testing.Complete laboratory outfitting including qualification and method implementation.Test method development, transfer and validation.Analytical measurement and techniques.Auditing systems and processes.Analysis of APIs, raw mate...