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Immuno-Oncology
Core Competencies: - Cancer-biomarker and drug discovery - Biomarkers and biosimilars - Immunotherapy - Tumor microenvironment - Orthotopic animal models of disease - Knowledge about the cancer drug market - Analytical, strategic, and critical thinking - Highly adaptive and team…
Human Resources Industry
Expert in Corporate Librarianship, Career Development, and Federal Human Resource Management. Expert served in the Army Reserves for six years as a Human Resource Specialist. She is a service-connected disabled veteran that has navigated the Veterans Health Administration (VHA) for…
Biotechnology, Pharmaceuticals,
Expert in Biopharmaceutical molecule development and licensure. Experience with top Biotech companies (BMS, sanofi, MedImmune, AZ, Adello, etc.). Designed successful Analytical strategy for 100s of IND and many BLA submissions in multiple countries. Expert in the following areas: Scientific writing…
Pharmaceutical Development
Expert is a former FDA Review Chemist, with > 39 years of career experience in pharmaceutical R&D, Quality Operations and Regulatory Affairs. For 25+ years as a consultant in his own pharmaceutical development advisory firm, Expert has furnished clients with…
Pharmaceutical Marketing
Working both in an agency environment and for a number of leading pharmaceutical organisations Expert has managed the challenge of gaining patients access to innovative therapies. Although the industry has been slow to recognize the issues and move away from…
Protein aggregation, characterization, purification
Expert leads a team of exceptionally talented downstream scientists to develop scalable downstream processes for viral vectors for use in Gene, Cell and Oncolytic therapies and for Vaccine production and for therapeutics proteins and antibodies. Keywords: Process development, DSP, Downstream…
Pharmaceutical Sciences (Small Molecules and Peptide Delivery), Novel Drug Delivery (Micelles, Liposomes, and Insitu Forming Gel), and Conventional Dosage Forms (Solid, Semisolid, and Liquid)
Expert is an experienced pharmacist with a demonstrated history of working in the pharmaceuticals industry. A skilled researcher, she is knowledgeable of R&D development in Pharmaceutics (small molecules), cosmetics and OTC (herbal products). Expert is experienced in industry and academic…
Biotechnology, Pharmaceuticals, Diagnostics, Market Research, and Writing
Expert possesses two decades' experience in consulting, market research, and medical writing experience in biotechnology. She possesses laboratory research experience in biotechnology as well. Expert has amassed two decades of consulting, market research, and medical writing experience in biopharmaceuticals and…
IVD Assays and Diagnostic Tests Development
Expert's areas of expertise include the following: IVD (in vitro diagnostics) clinical laboratory regulation molecular diagnostics blood assay diagnostic instrumentation assay development CLIA-88 (Clinical Laboratory Improvement Amendments of 1988) clinical laboratory regulation quantitative risk analysis (risk assessment) laboratory management GLP…
Pharmaceuticals, Drug Delivery, OTC, and Rx products
Expert actively consults in nearly all routes of drug delivery, including oral, transdermal, topical, inhalation, injection/infusion, nasal, buccal and others. He holds a Ph.D in Polymer Science and Engineering, as well as an MS on the same topic. He holds…