Yuqian’s passion in bringing cutting-edge science to patients started when she studied as a Ph.D. student. Since then, she has worked both in academic institutions and in industry focusing on bringing cell and gene therapy products to patients. Yuqian brought to Dark Horse her expertise in viral vector and cell therapy products GMP manufacturing; in-depth knowledge in process improvements/optimization and comparability justifications throughout CMC development from clinical to commercial stage for CGT products; and operational and resource planning, as well as timeline and risk management in cell and gene therapy product development.
During Yuqian’s time at DHC, she has focused particularly on regulatory writing projects across the spectrum from pre-IND to BLA, across five regulatory regions. She has provided support across various modalities and technologies, such as viral vectors, CRISPR, mRNA, and gene modified cell products. She also enjoys providing technical opinions and judgement (especially relative to client audits) and CMC support such as CDMO selection.
During her previous tenures, Yuqian had extensive experience in GMP/GCP inspection activities, supply audits, engaging with Regulatory Agencies in areas such as GMP licensure, GMP facility design, and engaging with EMA and FDA for IMPD/IND fillings, as well as for MAA/BLA filings.
Earlier in her career, Yuqian spent 7 years in a GMP manufacturing facility in King’s College London, pioneering the manufacturing of a clinical grade lentiviral/retroviral vector to supply multiple clinical trials in EU and US. She left King’s as the Head of the Production, where she recruited and trained a GMP manufacturing team with the capacity of manufacturing 20 batches of 10L viral vectors per year and managed two MHRA licensed GMP facilities, as well as a new facility being built for future expansion.
Just before joining DHC, Yuqian worked at Orchard therapeutics as the CMC lead for a late-stage stem cell gene therapy product for a rare disease; while at Orchard, she was one of the authors in MAA filing for a product treating a devastating condition called Metachromatic Leukodystrophy (MLD), which had been granted approval in 2020 by EMA (Libmeldy™).