Crystal Sung
CDx & IVD Strategic Operations Leader | Bridging Drug Development & Precision Medicine | Clinical Laboratory Director — CLIA, CAP, NY State, ISO 15189 | American Board Certified Medical Laboratory Immunologist (DABMLI)
- Role
- VP, Companion Diagnostics at Precision For Medicine
- Location
- Frederick, MD, US
- LinkedIn followers
- 500 followers
About Crystal Sung
Board-certified medical laboratory immunologist with over 25 years of scientific and operational leadership in biomarker-driven personalized medicine. Recognized expert in immunogenicity, biomarker qualification, and Companion Diagnostics (CDx) development across neurological disorders, oncology, autoimmune, and rare genetic diseases. Skilled in advancing drug development from proof-of-concept through regulatory approval and post marketing activities with expertise spanning small molecules, biologics, advanced modalities (ADC, bispecifics, ASO, siRNA), and gene/cell therapies. Proven leader in clinical laboratory operations, strategic planning and regulatory compliance(GCP, GCLP, CAP/CLIA, ISO13485/15189, NY). Published author with 20+ peer-reviewed papers, 50+ abstracts, and multiple industry white papers.
Experience
VP, Companion Diagnostics
May 2022 — Present
Lead IVD/CDx operations and product device development. Support development of global commercialization capabilities and manage LCM activities.Bridge Translational Sciences and Clinical Diagnostics to drive strategically aligned program/product development. Provide operational and scientific strategies for laboratory developed tests. Work closely with clinical and regulatory departments for IDE/IVDR/PMA submission.Direct ISO15189/13485, CLIA, CAP and New York State accredited Diagnostic Immunology Lab to provide speciality laboratory services.
Education
National Taiwan University
Bachelor of Science - BS, Clinical Laboratory Science/Medical Technology
Northwestern University - The Feinberg School of Medicine
Children's Memorial Hospital Research Institute Postdoctoral Research Fellow
The Ohio State University
Graduate School of Allied Health-Biomedical Computing
American College of Microbiology
Accredited Postgraduate Residency Program in Medical Laboratory Immunology
The Ohio State University College of Medicine
Doctor of Philosophy (Ph.D.), Pathology
Skills
- Flow Cytometry
- Clinical Development
- Pharmacokinetics
- Translational Medicine
- Clinical Research
- Immunoassays
- Translational Research
- Biotechnology
- Infectious Diseases
- Neuropathology
- Pharmaceutical Industry
- Validation
- Biomarkers
- Regulatory Submissions
- Chromatography
- Immunology
- Assay Development
- Molecular Biology
- Clinical Trials
- Lims
- Drug Development
- Gcp
- Biopharmaceuticals
- Clia
- Sample Management
- Pharmacovigilance
- Oncology
- Therapeutic Areas
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