Hao Liu
Hao Liu is Senior Director at Syneos Health®
JournalBeyond product approval: Bridging the gap between regulatory success and patient access for biosimilars
This article examines the post-authorisation barriers for biosimilars through the dimensions of affordability, availability and system readiness and gives recommendations to advance access
JournalCell therapy, gene therapy and tissue-engineered product manufacturing: Technical challenges, enablers and regulatory evolution
This article examines the barriers that constrain cell and gene therapy accessibility, discusses emerging solutions and highlights current regulatory expectations
JournalDemystifying complex generic products: Regulatory pathways and characterisation
This article explores complex generic products, providing guidance for their definition and classification.
JournalFDA comparability guidance: The impact of cell and gene therapy products
This article analyses FDA draft guidance and other guidance documents and aims to address concerns about CGT products.
JournalGene Therapy Medicinal Products: An examination of regulatory CMC requirements
This article explores the CMC requirements for GTMPs to help ensure high quality and safe products are brought to market.
JournalUnique aspects of biologic reference standards
Reference standards are pivotal in ensuring pharmaceutical quality, especially for complex biologics. This article reviews definitions and classifications of reference standards as outlined by the US Food and Drug Administration (FDA), the World Health Organization (WHO) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q6B and Q7 guidelines. It addresses types of standards based on source and use, with particular emphasis on the distinct requirements for biologics.
