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Drug Discovery Support Services and SolutionsOur Services
RDN's streamlined analytical chemistry platform offers the opportunity to obtain the ADME profile and physicochemical property of compounds even at the very early stage of lead finding and optimization, which provides valuable information for selecting promising compounds for the next stages. RDN also offers modern formulation technologies adapted for the practice of early stage research, for which combination with our expertise of bioanalysis enables clients to obtain the preliminary evidence of in vivo efficacy using prototype compounds, of which physicochemical properties are not fully optimized.
- Early ADME Profiling
- Our early ADME profiling service, based on proprietary automated high throughput assay technologies and accumulated data, aids in the section of promising compounds for the next stages. At the late stage of the discovery research, the D/P system,* the in vitro simulator of gastrointestinal absorption, enables predictions of the pharmacokinetics profiles of different formulations and helps clients select candidate compounds for development. * D/P system was originally developed by Prof. Yamashita at Setsunan University and licensed to RDN. RDN is continuously optimizing the system in terms of throughput and predictability.
- Physicochemical Property Analysis and Preliminary Formulation
- For the effective selection of candidate compounds for development, we offer high throughput physicochemical property analysis services. The risk assessments of compounds executed at the early stage of research guide the strategy of compound optimization and minimize project failures. We provide solutions to solubilize hardly-soluble compounds using various formulations and/or DDS, so that in-vivo pharmacokinetics can be evaluated using prototype compounds. The consulting services on the issues caused by the physicochemical properties will also be available.
- Through the expertise of various isolation technologies and mass spectrometry, we offer in vivo quantitative analysis of drug candidate compounds (small molecules /biologics) for pharmacokinetics and their related small molecules as pharmacodynamics biomarkers, where we not only apply the analytical methods given by clients, but also develop novel methods for specific target molecules, if necessary.
Utilizing broad organic synthesis technologies and facilities, including high-throughput, low-volume parallel synthesis and medium- and high-volume synthesis, RDN provides various compounds required for different stages of drug discovery research as described below. Our experienced chemists offer optimized synthesis methods in terms of cost, time and scalability.
Synthetic Chemistry Expertise
- Synthetic Chemistry Expertise
- We provide a wide variety of bioactive substances and intermediates for exploratory research in small, medium and large quantities in response to client requests. The products are delivered with the standard instrumental analytical data supporting their structures and quality.
- Compound Library Construction and HTS Hits Profiling
- The construction of DS's original Pharma Space Library (PSL) is ongoing, utilizing technologies and accumulated know how. The technology of parallel synthesis, which has been developed through compound library design and synthesis, is effectively applied to HTS hit expansion for effective creation of lead compounds.
- Design/Synthesis of Tool Compounds for Chemical Biology
- Collaborating closely with related functions, the expertise of synthetic chemistry is applied to provide tool compounds that are used to identify target macromolecules for the compounds acquired from phenotype screenings.
Hit to Lead
RDN offers a comprehensive platform for validated hits acquisition, consisting of library management, HTS campaign and, hit validation, which are supplemented with the support of protein production and structure biology functions.
Hit to Lead
- Compound Library Management
- For the execution of the high-throughput screening (HTS) campaign, compound libraries, including DS's proprietary PSL (Pharma Space Library) are maintained in the automated storage and ready to dispatch on request. The cherry picking process based on the computerized retrieval system allows for the flexible handing of library compounds.
- Hit Identification
- RDN is successful in operating HTS campaigns using high density plates with 1536 and 3456 wells, which reduces both the time and cost for acquiring hits. To improve the success rate of the HTS campaigns further, our efforts are now focusing on the optimization of assay methods in terms of sensitivity, specificity, speed and cost.
- Hit Validation
- Hit compounds acquired in a HTS campaign must be confirmed by another method not used for the HTS campaign, including detection of direct interaction by physical methods. It is very critical, we believe, for hit validation to design hit validation strategy combining assay methods with different readouts and different detection principles.
- Structure Based Hits Evaluation and Structure Guided Lead Optimization
- To detect the direct interaction of hits or other bioactive molecules with the intended drug targets, X-ray, NMR and SPR are applied depending on the extent to which the details of structural information is required. The modes of interaction between bioactive compounds (drug candidates) and drug targets derived from experimental X-ray analysis or in silico molecular modeling are interpreted by our experts and shared with clients to efficiently create and optimize lead compounds from hit compounds.
In vivo Pharmacological Evaluation
RDN offers in vivo pharmacological screening in various therapeutic areas for in-depth evaluation to guide lead optimization and select clinical candidates.
In vivo Pharmacological Evaluation
- Pharmacological Testing in Various Therapeutic Areas
We provide high-quality in vivo pharmacological screening in cancer, cardiovascular and metabolic disease areas, among others, for optimization of lead compounds.
- Construction of a novel in-vivo assay system and custom pharmacological testing
- Our value-added solution services include the construction of a new pharmacological assessment system with improved pathological similarity to human disease, and custom pharmacological testing with the composite protocol, in which the in-vivo pharmacological assay is combined with any other test items like in vitro bioassays, pharmacokinetics, pathological assessment, and others.
Recombinant Protein Supply
RDN is constructing a streamlined recombinant protein production platform using the expression systems of bacteria, insect cells and eukaryotic cells, where each process element is parallelized to absorb the negative impacts on timeline and cost, which may be inevitable due to the heterogeneous nature of proteins.
Recombinant Protein Supply
- Production and purification of proteins for HTS, in vitro biological assays and structure biological analysis
- Besides offering a protein production service to clients, our protein production platform contributes to improved productivity of other functions by managing the internal supply of proteins required for different purposes.
Natural Product Chemistry
Utilizing our world-class collection of microbial resources, RDN offers unique opportunities to identify bioactive compounds difficult to find from chemical libraries, and to design the novel synthetic route using microbial conversion.
Natural Product Chemistry
- Microbial Resources, Extract Libraries and Bioactive Substance Searches
- We supply high-quality, highly diverse extract libraries taken from a range of microbial resources collected using proprietary separation sources, processing methods and separation technologies. Based on various screenings using this highly unique extract library, we carefully scrutinize the potential of active constituents and isolate bioactive compounds with required profiles using our expertise in purification and structural analysis.
- Microbial Conversion
- Utilizing isolated genes responsible for a biosynthesis or conventional microbial conversion, we provide alternate routes for creating intractable compounds by chemical synthesis, which helps accelerate drug discovery processes.
Translational Research SolutionsOur Services
Translational Research Solutions
We are conducting translational research as part of the global biomarker/companion diagnostics (BM/CDx) function of the Daiichi Sankyo Group. By integrated analysis of pre-clinical and clinical samples using cutting-edge technologies, we provide the information needed for drug development, such as a drug's mechanism of action (determining how a drug works); efficacy or target-engagement biomarker development (finding ways to detect a drug's efficacy); predictive biomarker discovery (determining which patient groups a drug works in); indication selection (working out which indications are appropriate for a drug); and combination selection (finding out which drugs are suitable in combination).
Translational Research Solutions
- Comprehensive analyses of DNA, RNA, and epigenomes by using next-generation sequencing (NGS), microarray, and other technologies are used for such tasks as biomarker discovery, research into mechanisms of action, and new target discovery.
- Comprehensive analyses of proteins by using mass spectrometry, chemical biology, and other cutting-edge technologies are used for such tasks as research into mechanisms of action, new target discovery, and biomarker discovery.
- Analyses of "Omics" data and analytical platform development by using machine learning (including artificial intelligence) are used for such tasks as biomarker discovery, research into mechanisms of action, and new target discovery.
- Gene analysis
- Microfluidic PCR technology, digital barcode technology, and in situ hybridization are used to analyze gene expression and mutations.
- Protein analysis
- Western blot and flow cytometry are used to analyze biomarkers. Multiplex technologies for cytokine measurement, blood biochemistry, and kinase panel profiling are used to evaluate the efficacy and mechanism of action of candidate drugs.
- Molecular pathology
- Technologies for pathological specimen preparation, laser microdissection, immunohistochemical staining, FISH, and electron microscopy are used for pathological evaluation, biomarker analysis, and target cancer identification.
- Cell line panels
- Cancer cell-line panels with various Omics data are used for biomarker discovery, mechanism of action analysis, target cancer identification, and establishment of drug-resistant cell lines.
Clinical Development Services and SolutionsOur Services
RDN provides efficient, high-quality clinical development, including post-manufacturing/marketing clinical trials in various therapeutic areas*, where the rights, welfare and safety of participants must be ensured as well as the quality and reliability of the data obtained. We are currently working to expand our services beyond monitoring, which will include data management, statistical analysis, and medical writing, so that we can offer comprehensive services as a package.ﾂ
*Currently we have experience in clinical trials for the therapeutic areas of cardiovascular, infectious diseases, cancer, dementia, rheumatism, and vaccines.
- Screening and Selection of Candidate Medical Institutions/Principal Investigators for Clinical Trials
- We select relevant medical institutions and principal investigators based on the precise understanding of the objective , cohort size, and other details described in the clinical development plan, and various guidelines applied to the trial (including facility selection policies).
- Requesting and Contracting Medical Institutions for Clinical Trials
- In the negotiation process with medical institutions and principal investigators, we explain the details of the clinical trial plan (protocol) sufficiently enough to answer their questions and obtain their consent. After the contract is concluded, we successively explain various cautions and reminders to investigational agent administrators at medical institutions with regards to the transfer of investigational agents, and their storage and handling methods.
- Monitors, who have the expertise and knowledge of various therapeutic areas and strong ethical commitments, conduct monitoring of clinical trials in accordance with the Pharmaceutical Affairs Act, GCP, clinical trial protocol and standard operating procedures (SOPs), so that trials are executed smoothly. Moreover, we are also working to innovate the monitoring process using information andcommunications technology (ICT).
- Clinical Trial Quality Maintenance and Improvement (Quality Management)
- Quality management staff with the expertise of regulatory requirements and experience with the practices of clinical trials conduct inspections, assessments, and feedback on whether the clinical trial is being carried out in accordance with the Pharmaceutical Affairs Act, GCP, clinical trial protocol, SOPs, whether documents and records are complete, and whether there have been any legal violations, to ensure the quality and reliability of the trial. Nonetheless, we are not satisfied with just keeping the appropriate quality of documents and records, but make continuous efforts to improve their quality through the analysis of identified issues.
- Creation of Seamless Development Processes (Clinical Development Platform)
- Constructing seamless development process (clinical development platform) is a Key Success Factor in managing the development of pharmaceutical products effectively. We are working to build a comprehensive development service package, including data management, biostatistics and document preparation for approval applications.
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