Senior Advisor
BioData Solutions LLC
Pacific Grove, California
Joleen T. White, PhD is a Senior Consultant with BioData Solutions LLC, specializing in bioanalysis strategy development and implementation. Her expertise includes immunogenicity risk assessments, integrated summaries of immunogenicity, and authoring nonclinical and clinical reports for regulatory submissions such as IND and BLA.
She has held pivotal roles at the Bill & Melinda Gates Medical Research Institute, EMD Serono, Biogen, Bristol-Myers Squibb, and BioMarin Pharmaceutical Inc., where she led departments and managed cross-departmental initiatives. Her work in drug modalities spans antibodies, enzymes, conjugated factors, nucleic acids, and peptides. Dr. White is proficient in strategic planning, including bioanalytical and biomarker strategy development, operational risk assessments, and data analysis, including statistical analysis plans within clinical trials.
Dr. White holds a B.S. in Chemistry from Harvey Mudd College and a Ph.D. in Biochemistry from The Scripps Research Institute.
She is active in the international bioanalytical and immunogenicity community, chairing and moderating conferences, representing employers in AAPS and the International IQ Consortium, and volunteering with PhUSE and CDISC for bioanalytical data initiatives. Dr. White's contributions have significantly advanced bioanalytical methodologies and improved patient outcomes.
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Assessing Risk for the IVDR Application
Monday, November 10, 2025
3:15 PM - 3:30 PM CT