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Dr. Abdel Halim

CHIEF SCIENTIFIC OFFICER, EXECUTIVE VICE PRESIDENT,
BIOPHARMA AND DIAGNOSTIC SERVICES

Executive and internationally recognized key opinion leader with 25+ years of experience in biomarker and precision medicine for drug and diagnostic developments.


•    One of only four lab professionals in the US who are triple-board certified in Molecular Diagnostics, Clinical Chemistry, and Toxicology and licensed as CLIA clinical lab director in NY, NJ, FL, and TN in several specialties 

•   Accredited by FDA as a third-party reviewer of IVD 510k submissions in Pathology, Hematology, Immunology, Clinical Chemistry, Microbiology and Toxicology 

•  Abdel holds a Pharm D, two master's degrees, and a Ph.D. in Cancer Molecular Biology, two fellowships in Cancer Diagnostics and Molecular Pathology

•  Expert in drug and device regulations and guidelines in the US, EU, and other countries

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Achievements

  • Led the biomarkers and precision medicine aspects in 150+ PI-PIII clinical trials in 50 development programs in oncology, immune-oncology and other therapeutic areas
  • Led 12 end-to-end registrable CDx programs as LDT or universal IVD; from rationale to regulatory submissions, with full oversight and management of CRO labs and IVD partners
  • Enabled LDT CTA-based patient selection in 30+ PI-PII trials
  • Qualified, deployed and oversaw partnerships with 30+ reference CRO labs in different specialties 
  • Led development and validation of several hundred assays on different technologies/platforms including NGS, FFPE and liquid biopsies Sanger, PCR, gene microarray, IHC, ISH, flow cytometry, LC/MS, CTC, and single/multiplex immunoassays - with effective tools for mitigating biological, pre-analytical, and analytical variables
  • Expert in PK for small and large molecules, ADA assays, and PK/PD data analysis and interpretation 
  • Proficient in transformational improvement of quality and harmonization of clinical trial biomarker results at multiple CRO laboratories and diagnostic companies including the world’s largest organizations.

Affiliations: Boards & Committees

  • Accredited by FDA as a third-party reviewer of 510K submissions including in all classes of IVD
  • One of only four lab professionals in the US who are triple-board certified in Molecular Diagnostics, Clinical Chemistry and Toxicology, and licensed as CLIA clinical lab director in NY, NJ, FL and TN in several specialties 
 
  • Served on 20+ CLSI committees to create clinical and laboratory guidelines; authored 12 of those guidelines
  • Served as KOL on 25+ governmental and public expert panels and advisory boards in US, Canada & EU  

Publications

  • 70+ peer-reviewed articles, 3 book chapters and delivered 110 presentations;
  • interviewed by top clinical and diagnostic news;