Marquis Who's Who Honors Qinhua Cindy Ru, PhD, for Excellence in Global Pharmaceutical Drug Development, Product Launches, and Regulatory Affairs, with an Oncology Focus
Press Release December 23, 2025
Qinhua Cindy Ru, PhD, brings more than two decades of global, oncology-focused expertise in clinical development, CMC, and regulatory affairs across small molecules, biologics (mAbs/ADCs), cell & gene therapy, and mRNA to CRC Oncology
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Dr. Ru's expertise spans more than two decades and encompasses topics ranging from proteomic profiling in breast cancer to clinical studies on novel oncology therapeutics.

VISTA, CA, December 23, 2025 /24-7PressRelease/ -- Qinhua Cindy Ru, PhD, has been selected for inclusion in Marquis Who's Who. As in all Marquis Who's Who biographical volumes, individuals profiled are selected on the basis of current reference value. Factors such as position, noteworthy accomplishments, visibility, and prominence in a field are all taken into account during the selection process.

Marked by significant contributions to regulatory affairs, clinical development, product launches and business advancements at several global pharmaceutical firms, Dr. Ru has established herself as a leading expert in oncology drug development. As the founder of CRC Oncology in San Diego, which she founded in 2017, she has positioned the company at the forefront of bridging global innovative assets for development and marketing approval in the United States.

Under Dr. Ru's leadership, CRC Oncology has successfully submitted numerous United States Investigational New Drug (IND) applications featuring advanced chemistry, manufacturing and controls packages. The company's work encompasses cutting-edge fields such as chimeric antigen receptor T-cells, induced pluripotent stem cells and antibody-drug conjugates, all with a focus on regulatory submissions and clinical development consultations. She and her team have navigated multiple Prescription Drug User Fee Act meetings with the United States Food and Drug Administration at critical stages, securing several key designations including orphan drug, fast track and regenerative medicine advanced therapy.

Prior to founding CRC Oncology, Dr. Ru was the executive vice president and chief scientific officer at CARsgen Therapeutics in 2017. In this leadership role, she gained valuable insights into the dynamic emerging market for cell therapies and immunotherapies while spearheading global clinical development. She also served as chief scientific officer at Sihuan Pharmaceutical Co. Ltd. from 2016 to 2017, during which she contributed to the research and development direction of a Hong Kong Stock Exchange-listed pharmaceutical company.

From 2014 to 2016, Dr. Ru held the position of senior director and asset team leader for Besponsa at Pfizer. During her tenure, she led the approval process for two drugs, including collaboration on the development of inotuzumab ozogamicin (Besponsa) and gemtuzumab ozogamicin (Mylotarg) — both of which have had a significant impact on cancer treatment. In recognition of her success in delivering database lock and scientific publication while facing strict deadlines, she was honored with the W.E. Upjohn Prizes Award from Pfizer.

As a senior director and the clinical science lead at Exelixis in San Francisco, Dr. Ru played a pivotal role in the phase three METEOR trial that supported the market approval of cabozantinib for advanced renal cell carcinoma. Her outstanding leadership during this time saw her presented with the Award for Excellent Execution in 2013.

For six years, Dr. Ru served as a global clinical trial head at Novartis, overseeing first-in-man through phase three global clinical trials for the anti-cancer medication buparlisib (BKM120). She was pivotal in advancing this compound from early-stage development to late-phase studies. Her achievements at Novartis were acknowledged with several pharmaceutical honors including four OGD PQS Awards, the OTM POC Award, the OTM Star Award, and the Novartis President Award.

Dr. Ru's earlier experience includes her role as a clinical research scientist on the ZOLINZA marketing authorization application filing team at Merck Oncology from 2006 to 2007. As filing author, study lead and protocol author, she contributed significantly to obtaining global approval for a drug from both the United States Food and Drug Administration and European Medicines Agency. Her efforts during this time saw her honored with The Award for Excellence for cancer vaccine IND filing in 2007.

From 2003 to 2006, Dr. Ru excelled as the principal scientist at The Henry M. Jackson Foundation for the Advancement of Military Medicine, where she conducted research that furthered advancements within the Clinical Breast Care Project. She began her professional journey as a postdoctoral research fellow at Los Alamos National Laboratory from 2001 to 2003 after moving from her native China to the United States.

Throughout her career, Dr. Ru has been deeply involved in uniting global standards to accelerate innovation in oncology. One of her most notable achievements was organizing a face-to-face meeting between representatives from the United States Food and Drug Administration and China's Center for Drug Evaluation at Tsinghua University School of Medicine. This gathering facilitated an exchange of regulatory perspectives on cell therapies such as chimeric antigen receptor T-cell therapy before China's first official approval of this class of drugs.

Before relocating to the United States, Dr. Ru pursued higher education and earned a Doctor of Philosophy in chemistry with a focus on bioanalytical chemistry from Tsinghua University in Beijing in 2001. This rigorous scientific training provided her with many of the analytical skills that proved essential for her later work in regulatory submissions and clinical trial management.

To augment her knowledge and qualifications, Dr. Ru was certified as a quality auditor by the American Society for Quality in 2018. Dedicated to the ideals of continuous learning, she has completed additional training programs through Corner Stone, The Hay Group and the Project Management Institute in business management, regulatory strategy development and effective people management.

Dr. Ru's expertise is reflected not only in her leadership roles but also through her extensive publication record, which spans more than two decades and encompasses topics ranging from proteomic profiling in breast cancer to clinical studies on novel oncology therapeutics. Her works have been featured in high-impact journals such as Clinical Cancer Research, the Journal of Clinical Oncology and Molecular & Cellular Proteomics, with her research works being presented at the American Society of Clinical Oncology (ASCO) Annual Meeting proceedings over multiple years.

Beyond her professional and scholarly endeavors, Dr. Ru is committed to advancing science through civic engagement and volunteerism. In recent years, she has served as a volunteer speaker at Drug Information Association (DIA) events and supported breast cancer foundations through donations and participation in awareness walks.

Reflecting on her storied journey thus far, Dr. Ru attributes her success to self-motivation — a drive that propelled her into bioscience despite concerns from her family about pursuing a challenging career in medicine — and an unwavering focus on solving problems rather than reacting emotionally to challenges. Her willingness to take risks is exemplified by her move from Novartis to Exelixis, where she proved her ability to lead major clinical trials outside of large corporate environments.

Dr. Ru's longstanding passion for science is rooted in its potential to improve lives — especially those affected by late-stage cancer — by extending survival rates even modestly for patients and their families. She encourages young professionals entering the pharmaceutical realm to start from foundational roles such as scientists or clinical researchers while maintaining their interest within the rapidly evolving industry.

Determined to further her impact in the future, Dr. Ru plans to devote more time to volunteer work with a focus on sharing knowledge with future generations and engaging with educational institutions and professional organizations. Her journey stands as an example of how dedication, teamwork, mentorship and thoughtful decision making can drive meaningful change within global health care innovation and affect people across the world for the better.

About Marquis Who's Who®:
Since 1899, when A. N. Marquis printed the First Edition of Who's Who in America®, Marquis Who's Who® has chronicled the lives of the most accomplished individuals and innovators from every significant field of endeavor, including politics, business, medicine, law, education, art, religion and entertainment. Who's Who in America® remains an essential biographical source for thousands of researchers, journalists, librarians and executive search firms around the world. The suite of Marquis® publications can be viewed at the official Marquis Who's Who® website, www.marquiswhoswho.com.

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