Natalie Cohen, Ph.D., MBA, has over 10 years of hands-on industry experience encompassing many aspects of biologics development. Her expertise covers the technical, quality and regulatory requirements for the physiochemical and functional analysis of biopharmaceutical products, both new biologics and biosimilars. She has extensive experience in evaluation of analytical methods and method validation for products ranging from pre-clinical to clinical and commercial phases. Her specialties include biotechnology product characterization, comparability, release and stability testing, necessary for product development and commercialization. She is an expert in methods for characterization and potency, pharmacokinetics, immunogenicity and neutralizing antibody assays for biologics. She has conducted bioanalytical test method development, qualification and validation, and test method tech transfers. She audited bioanalytical laboratories for bioassay performance, quality and compliance, and performed due diligence of biotechnology projects and companies.
As the head of Global Biological Development Department in Teva Pharmaceuticals Innovative R&D, Natalie managed both biological development and biological quality control laboratories, developing and validating assays for API and for Drug product, as well as pre-clinical and clinical studies, and leading sample analysis. She led development and QC activities in Teva sites in Israel and Europe, as well as development and validation by outsourcing, utilizing multiple specialized CROs. She implemented innovative technologies in line with up-to-date regulatory expectations. The department provided support for regulatory submissions and communication with the agencies. The expertise of the department ranged from peptides, polypeptides, recombinant proteins, monoclonal therapeutic antibodies, and enzymes, to anti-sense and nanomedicine complex synthetic molecules.
Natalie holds a Ph.D. in Biology from Bar-Ilan University, Israel, followed by post-doctoral positions in Mount Sinai School of Medicine, NY, NY.
Since the beginning of 2011, Natalie has been consulting various companies. She is working with R&D, GLP and cGMP laboratories from startup organizations to pharmaceutical companies. She is performing due diligence of biotechnological projects and startup companies. She teaches biologic drug development for the M.Sc. program in Ort Braude College of Biotechnology, as well as courses on Bioassay Method Development and Immunogenicity.
Associated with the following groups:
Immunogenicity for Biotherapeutics