Biological Assay – Talk Bio

Sandoz Launches Tyruko (Natalizumab-Sztn), First Tysabri Biosimilar, in US After JCV Assay Delays

3 weeks ago talkbio0Tagged Approved, Biological Assay, Biosimilars, JC Virus, JCV, Leukoencephalopathy, Progressive Multifocal, Multiple Sclerosis, Polpharma Biologics, Progressive, sandoz, Tyruko, Tysabri, United States Food and Drug Administration

Sandoz; Tyruko; Tysabri biosimilar; natalizumab-sztn; multiple sclerosis (MS); biosimilar launch; JCV assay; progressive multifocal leukoencephalopathy (PML); FDA approval; Polpharma Biologics

Future-proofing gene therapy assays: Validation strategies for long-term success

9 months ago talkbio0Tagged Biological Assay, Develop, Long-term, Validation

Long-term, Validation, Biological Assay, Develop

Director/Vice President of Translational Research: Leading the Bridge from Discovery to Clinical Development

2 years ago talkbio0Tagged approvals, Biological Assay, Biological Markers, Biomarker Strategy, Clinical Development, Clinical Trial Design, Cross-Functional Collaboration, development aspects, Discover, Drug Molecule Development, End Point, Leadership, PK/ PD/, Preclinical Development, regulatory, Target, Team Building, Translational Research, Biomedical, Translational Science Leadership

Translational Research, Biomarker Discovery, Preclinical Development, Early Clinical Development, Drug Molecule Development, Translational Science Leadership, Biomarker Development, Target Engagement Strategies, Assay Development (PK/ PD/ Immunogenicity), Clinical Trial Design, Endpoint and Biomarker Strategy, Team Building and Leadership, Cross-Functional Collaboration, Regulatory Approvals