Our Team

Wasela Diagnostics

Partner

Senior regulatory affairs and diagnostic development expert with PhD and 20+ years of experience in IVD/CDx
development and regulatory strategy. Proven track record in drug-diagnostic co-development and strategy development for Cell & Gene Therapy (CGT) and precision medicine programs, managing multiple IVD partnerships, and ensuring successful regulatory outcomes in the US FDA and knowledgeable in global IVD/CDx regulations (EU, Japan, China). Deep expertise in biomarker testing technologies (NGS, PCR, flow cytometry, immuno-assays) and strong leadership in cross-functional teams. Extensive experience in regulatory submissions (510(k), PMA, DeNovo, IDE, Breakthrough designation, pre-submission) and regulatory authority interactions. 

Skilled in developing integrated diagnostic strategies for IVD/CDx in different therapeutic areas including oncology 
and CGT.