Qinhua Cindy Ru
Managing Director @Crc Oncology
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WORK HISTORY
Managing Director @Crc Oncology
San Diego, CA, US
CRC Oncology has distinguished itself as a leader in the field of regulatory submission and clinical development consultation since its inception in 2018. CRC Oncology has established a track record that stands as a testament to our proficiency and commitment as presented on our company website
EDUCATION
Tsinghua University
Doctor of Philosophy (PhD), Chemistry, Bioanalytical Chemistry
SKILLS
ABOUT QINHUA CINDY RU
Reflecting on my journey over the past two decades, I\'ve been fortunate enough to contribute to the fields of Regulatory Affairs, Oncology Clinical Development, Product Launches, and Business Development, serving in key roles at globally recognized pharmaceutical firms including Merck, Novartis, Pfizer, and Exelixis.As part of a larger team, I\'ve had the opportunity to contribute to the VORINOSTAT MAA submission and served as the Global Clinical Trial Head for BURPARLISIB (BKM120) for six years, witnessing its progression from Phase I through to Phase I\'ve also been part of the collective effort that drove the pivotal phase 3 METEOR trial, supporting the market approval of CABOZANTINIB in advanced renal cell carcinoma (aRCC), and have worked collaboratively on the development of INOTUZUMAB OZOGAMICIN (Besponsa®) and GEMTUZUMAB OZOGAMICIN (Mylotarg®).In the dynamic emerging market, I\'ve learned a great deal from my experience as the Chief Scientific Officer for two HKEX-listed pharmaceutical and biotech companies, Sihuan and Carsgen.In 2018, I founded CRC Oncology in San Diego. Under our collective leadership, we\'ve successfully submitted a series of US Investigational New Drug (IND) applications with innovative Chemistry, Manufacturing, and Controls (CMC) packages, particularly in the advanced fields of Chimeric Antigen Receptor T-cells (CAR-T), Induced Pluripotent Stem Cells (iPSC), and Antibody-Drug Conjugates (ADC). Together, we\'ve navigated through numerous PDUFA meetings with the US FDA at various critical stages, and secured multiple FDA designations, including Orphan Drug Designations, Fast Track Designations, and Regenerative Medicine Advanced Therapy (RMAT) Designations.Looking back, I feel humbled by the experiences and opportunities I\'ve had to contribute to the pharmaceutical industry. My journey so far is a testament to the power of teamwork and dedication, and I look forward to what the future holds.
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