Provide effective solutions for the entire early-stage drug development process of innovative drugs, from target identification, lead compound discovery and design, to compound synthesis, screening, property analysis, and further optimization and modification, by integrating AI-based drug discovery methods and experimental approaches.
Research Direction and Collaboration Areas
Deep learning-based molecular generation methods
Structure-based drug design and discovery
Mass spectrometry-based compound screening
Separation and pharmacological and efficacy evaluation of active ingredients in traditional Chinese medicine
Drug discovery for metabolic diseases
Drug discovery for neurodegenerative diseases
Optimization of drug synthesis routes based on continuous flow technology
Core Technological Methods
Bioaffinity mass spectrometry
Magnetic Bead-based Biomolecular Affinity Separation Technology
AI-driven Molecular Generation
Structure-based Drug Design
2. Biomarker Discovery & Validation
Introduction
This platform mainly focuses on the discovery and validation of novel biomarkers using AI omics technologies. From a systems biology perspective, it comprehensively interprets the changes in biomolecules closely related to disease and health within the organism, providing strong support for the entire process of new drug development, clinical diagnosis, and precision medicine. In addition, with regard to the translational application of biomarkers, this platform is mainly involved in the development of novel detection technologies and high-throughput screening of lead compounds, providing new insights for the clinical application of biomarkers and new drug development.
Research Direction and Collaboration Areas
Based on high-throughput life omics technologies and data-driven algorithms, we deeply explore biomarkers closely related to the occurrence and development of diseases, establish disease diagnostic models, and assess their feasibility as drug targets.
AI-driven multidimensional data integration analysis, applying biomarkers to support the entire process of drug development, and guiding patient stratification and precision medicine.
Developing more reliable, convenient, and sensitive non-invasive detection technology for “biomarkers” based on biofunctional new materials.
3. Drug Delivery & Novel Formulation Research
Introduction
Our goal is to establish an innovative, professional, and comprehensive research platform, providing the ability to further optimize the current drug delivery systems, specifically develop suitable drug delivery systems for small molecule drugs and macromolecule biopharmaceuticals, and design corresponding new drug formulations and delivery strategies, to meet different clinical needs and improve drug stability and bioavailability.
Research Direction and Collaboration Areas
The focus is on the development of new materials, new formulations, and new strategies for drug delivery, including two main directions: (micro-/nano-) drug delivery systems and novel drug formulations.
Research on (micro-/nano) Drug Delivery Systems:
Development of lipid-based drug delivery systems
Development of extracellular vesicles based drug delivery systems
Development of drug delivery systems based on proteins and polymers
Development of virus-based drug delivery systems
Research on New Drug Formulations:
High Bioavailability Oral Administration
Transdermal Administration
Nasal Administration
Targeted Drug Delivery
Long-Acting/Sustained-Release Formulation
Novel Cocrystal Drug
Core Technological Methods
1）Intelligent responsive material-mediated controlled, targeted delivery, and long-acting sustained-release technology for protein peptides.
The platform focuses on the development and optimization of continuous flow systems, carrying out innovative drug design, synthesis, analysis, optimization, and screening. It aims to establish automated continuous flow systems with an integrated combination of hardware and software (such as equipment, automated control, analytical methods, scale-up strategies, etc.), and to build various application scenario databases, assisting in the full-chain innovative drug research and development. The platform is equipped with high-end reactor systems and analytical equipments to support the design, validation, continuous optimization, and industrial exploration of various small molecule drug compounds and biopharmaceuticals (such as antibody drugs and conjugate drugs).
Research Direction and Collaboration Areas
The platform integrates advanced technologies such as drug development, continuous flow production processes, automation control, and online detection, aiming to achieve an efficient, low-cost, high-quality approach to drug production. The key research directions include:
Discovery and process development of novel drugs (including small molecule drugs and biologics)
Construction of continuous flow process equipment systems
Utilization and optimization of highly automated control systems and advanced online detection systems to achieve real-time monitoring and automatic parameter adjustment, ensuring product quality and batch-to-batch consistency.
Core Technological Methods
5. Organoid-based Druggability Evaluation
Introduction
This platform provides more clinically relevant research models for preclinical drug efficacy, drug intake, drug safety evaluation, and cell therapy, to support the drug development and regenerative medicine research needs of biopharmaceutical research institutions and enterprises. The institute has a research team engaged in the design and development of organoid technology, and has established patient-derived breast cancer organoids, pancreatic ductal adenocarcinoma organoids, and conducted preclinical studies on drug efficacy, drug intake, and drug safety. It has also established pluripotent stem cell-derived islet organoids and small intestinal organoids to explore innovative treatment options for diabetes and inflammatory bowel disease, achieving excellent therapeutic effects.
Research Direction and Collaboration Areas
The design, construction, and evaluation of drug efficacy, drug absorption, and drug safety in organoid-based biobanks derived from patients with different types of tumors.
Design and establish a biobank for patient-derived tumor organoids and pluripotent stem cell-derived functional organoids, providing technical services and collaborations based on the biobank of organoids.
On-demand design and development of Organoid-on-Chips (OoC).
Core Technological Methods
The design and development of patient-derived tumor organoids with independent property rights for the preclinical evaluation of drug efficacy, drug intake, and drug safety.
Cancer Res (2023) 83 (17): 2924-2937
Conducting research on drug resistance using patient-derived pancreatic ductal adenocarcinoma organoids.
Designing and optimizing a 3D culture-based system for the directed differentiation of pluripotent stem cells towards functional islet-like organoids, with implications for innovative diabetes therapy.
6. Pharmacometrics
Introduction
This platform can be utilized for pharmacokinetic (PK) and pharmacodynamic (PD) modeling, building comprehensive databases, and conducting model analysis. Researchers can simulate and forecast the behavior of drugs in vivo through this platform, optimize clinical dosages, support clinical trial design, and provide decision support to help expedite the drug development process.
Research Direction and Collaboration Areas
Preclinical study design both in vitro and in vivo, pharmacokinetic (PK) and pharmacokinetic-pharmacodynamic (PK-PD) data analysis.
Clinical pharmacological consultation involving clinical trial design and PK analysis at various stages of clinical development (non-compartmental and model-based analysis).
Population pharmacokinetic (POPPK) analysis, mechanism-based PK-PD and disease model development for exposure-response (E-R) analysis of safety and efficacy endpoints.
Support the selection of initial dose and RP2D dose, as well as the design and preparation of clinical protocols.
AI-assisted model building and regulatory data organization.
Core Technological Methods
Concentration-Time Curve
The relationship between dose and drug response.
Regulatory, Clinical Pharmacology, Quality, and Clinical Operation
7. Innovative Drug Lifecycle Regulation & Management
Introduction
This platform aims to assist researchers in understanding regulatory requirements, optimizing research and development management, mastering research and development logic, extending drug life cycles, and promoting and advancing scientific regulation through in-depth exploration of the entire process of innovative drug research and development, technology transfer, large-scale production, market use, and post-market research.
Research Direction and Collaboration Areas
AI-assisted research on regulatory science
Interpretation of domestic and international regulations for the registration of innovative drugs
Analysis of technical requirements for innovative drug registration
Evaluation of domestic and overseas innovative drug registration strategies
Decision-making considerations at critical stages during innovative drug development process
Innovative drug CMC R&D strategies at different clinical phases
Management of communication between sponsors and Regulatory Agency
Risk-based post-market change management
Training on the R&D strategies and lifecycle management of Innovative drugs
1. Drug Design, Screening & Discovery
Introduction
Provide effective solutions for the entire early-stage drug development process of innovative drugs, from target identification, lead compound discovery and design, to compound synthesis, screening, property analysis, and further optimization and modification, by integrating AI-based drug discovery methods and experimental approaches.
Research Direction and Collaboration Areas
Core Technological Methods
Bioaffinity mass spectrometry
Magnetic Bead-based Biomolecular Affinity Separation Technology
AI-driven Molecular Generation
Structure-based Drug Design
2. Biomarker Discovery & Validation
Introduction
This platform mainly focuses on the discovery and validation of novel biomarkers using AI omics technologies. From a systems biology perspective, it comprehensively interprets the changes in biomolecules closely related to disease and health within the organism, providing strong support for the entire process of new drug development, clinical diagnosis, and precision medicine. In addition, with regard to the translational application of biomarkers, this platform is mainly involved in the development of novel detection technologies and high-throughput screening of lead compounds, providing new insights for the clinical application of biomarkers and new drug development.
Research Direction and Collaboration Areas
3. Drug Delivery & Novel Formulation Research
Introduction
Our goal is to establish an innovative, professional, and comprehensive research platform, providing the ability to further optimize the current drug delivery systems, specifically develop suitable drug delivery systems for small molecule drugs and macromolecule biopharmaceuticals, and design corresponding new drug formulations and delivery strategies, to meet different clinical needs and improve drug stability and bioavailability.
Research Direction and Collaboration Areas
The focus is on the development of new materials, new formulations, and new strategies for drug delivery, including two main directions: (micro-/nano-) drug delivery systems and novel drug formulations.
Research on (micro-/nano) Drug Delivery Systems:
Research on New Drug Formulations:
Core Technological Methods
1）Intelligent responsive material-mediated controlled, targeted delivery, and long-acting sustained-release technology for protein peptides.
2）Virus & exosome-mediated gene therapy technology
4. Intelligent Pharmaceutical Manufacturing
Introduction
The platform focuses on the development and optimization of continuous flow systems, carrying out innovative drug design, synthesis, analysis, optimization, and screening. It aims to establish automated continuous flow systems with an integrated combination of hardware and software (such as equipment, automated control, analytical methods, scale-up strategies, etc.), and to build various application scenario databases, assisting in the full-chain innovative drug research and development. The platform is equipped with high-end reactor systems and analytical equipments to support the design, validation, continuous optimization, and industrial exploration of various small molecule drug compounds and biopharmaceuticals (such as antibody drugs and conjugate drugs).
Research Direction and Collaboration Areas
The platform integrates advanced technologies such as drug development, continuous flow production processes, automation control, and online detection, aiming to achieve an efficient, low-cost, high-quality approach to drug production. The key research directions include:
Core Technological Methods
5. Organoid-based Druggability Evaluation
Introduction
This platform provides more clinically relevant research models for preclinical drug efficacy, drug intake, drug safety evaluation, and cell therapy, to support the drug development and regenerative medicine research needs of biopharmaceutical research institutions and enterprises. The institute has a research team engaged in the design and development of organoid technology, and has established patient-derived breast cancer organoids, pancreatic ductal adenocarcinoma organoids, and conducted preclinical studies on drug efficacy, drug intake, and drug safety. It has also established pluripotent stem cell-derived islet organoids and small intestinal organoids to explore innovative treatment options for diabetes and inflammatory bowel disease, achieving excellent therapeutic effects.
Research Direction and Collaboration Areas
Core Technological Methods
The design and development of patient-derived tumor organoids with independent property rights for the preclinical evaluation of drug efficacy, drug intake, and drug safety.
Cancer Res (2023) 83 (17): 2924-2937
Conducting research on drug resistance using patient-derived pancreatic ductal adenocarcinoma organoids.
Designing and optimizing a 3D culture-based system for the directed differentiation of pluripotent stem cells towards functional islet-like organoids, with implications for innovative diabetes therapy.
6. Pharmacometrics
Introduction
This platform can be utilized for pharmacokinetic (PK) and pharmacodynamic (PD) modeling, building comprehensive databases, and conducting model analysis. Researchers can simulate and forecast the behavior of drugs in vivo through this platform, optimize clinical dosages, support clinical trial design, and provide decision support to help expedite the drug development process.
Research Direction and Collaboration Areas
Core Technological Methods
Concentration-Time Curve
The relationship between dose and drug response.
Regulatory, Clinical Pharmacology, Quality, and Clinical Operation
7. Innovative Drug Lifecycle Regulation & Management
Introduction
This platform aims to assist researchers in understanding regulatory requirements, optimizing research and development management, mastering research and development logic, extending drug life cycles, and promoting and advancing scientific regulation through in-depth exploration of the entire process of innovative drug research and development, technology transfer, large-scale production, market use, and post-market research.
Research Direction and Collaboration Areas