Discovery Chemistry
Discovery Chemistry covers two research areas, medicinal chemistry and phytochemistry.
Medicinal chemistry focuses on chemical modifications of leads generated from phytochemistry, and/or on fast follow-on compounds against validated therapeutic targets. Modern synthetic organic chemistry, including advanced purification and spectroscopic technology, is applied to efficiently carry out structure-activity relationship studies.
Phytochemistry selectively prepares samples from natural sources, identify and characterize the active components as the leads for optimization or drug development.
Discovery Biology
Hutchison MediPharma Discovery Biology has the expertise in molecular biology, cell biology, oncology, hematology, immunology, HTS assay development, validation and screening. The discovery research is focused on pathway-specific and single/multiple target-based screening platforms against molecular targets in the pathogenesis of inflammation/autoimmune diseases and cancer.
• Assay development and validation
• Screening
• MOA (mechanism of action) studies
• Exploratory research
Discovery Pharmacology
Pharmacology covers preclinical efficacy evaluations and preliminary toxicity studies in drug discovery. We focus on inflammation, autoimmune disease and oncology therapeutic areas. We have established a series of inflammatory and autoimmune disease animal models, including Freund’s adjuvant arthritis, collagen-induced arthritis, inflammatory bowel disease, asthma, allergy, diabetes, multiple sclerosis and etc. In oncology, a full panel human xenograft tumor and mice tumor models have been established. Experimental animal facility is comprised of more than 5,000 ft2 of laboratory space equipped with world-class technology and advanced instrumentation for new drug R&D. The facility offers reliable support for the internal research and development of new drug candidates.
Drug Metabolism and Pharmacokinetics (DMPK)
Fully integrated into our drug discovery programs, DMPK plays a critical role in drug discovery and development. We provide full in vitro DMPK studies, including metabolic stability using liver microsomes or hepatocytes, CYP inhibition and/or induction, metabolic reaction phenotyping, in vitro absorption, protein binding, metabolite identification and in vivo pharmacokinetic evaluations in various animal species
Pharmaceutical Sciences
Pharmaceutical Sciences is responsible for the pharmaceutical development of drug candidates.
• Analytical method development/validation
• Drug quality studies
• Drug stability studies and product shelf life determination
• Process research and development for clinical supply manufacturing
• Formulation development
• CMC regulatory filings
Clinical and Regulatory Affairs
Clinical and Regulatory Affairs is responsible for clinical program design and operation, as well as registration of IND and NDA with China SFDA and the US FDA.
Clinical Development
• Preparation of Investigational New Drug (IND)
• Strategic planning for new drug development
• Clinical program design, study management and execution
• Compliance with the US GCP and ICH guidelines
• Liaison with medical experts worldwide
Regulatory Affairs
• Effective communications with regulatory authorities (FDA and SFDA)
• Maintenance and archiving of documents and correspondence
• Clinical program support and strategic advice from regulatory prospectives