Capabilities
Integrated Drug Discovery & Development
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Integrated Drug Development Platform
We have built an integrated drug development platform connecting discovery and research, manufacturing and CMC, clinical trials and development, and our clinical network and real-world data.
Linking the specialist functions within the group with universities and research institutions in Japan and abroad, we carry research findings into the next stage of development, and turn observations from the clinic into new research hypotheses.
Contents
01
The integrated platform
03
Manufacturing and CMC
02
Discovery and research
04
Clinical development and clinical network
Contents
01
The integrated platform
02
Discovery and research
03
Manufacturing and CMC
04
Clinical development and clinical network
Integrated Structure
In drug development it matters that the findings from each stage — discovery research, manufacturing and CMC, non-clinical work, clinical development — are assessed continuously. Advalife Science Group links these specialist functions so that the evidence behind each decision carries through to the next stage.
Working from a complex-systems approach to drug discovery, we form research hypotheses from clinical observation and carry them through scientific validation, intellectual property, joint research, licensing and clinical development.
Discovery research
Non-clinical
Manufacturing and CMC
Clinical trials and development
Clinical network and real-world data
Intellectual Property
Partnering & Licensing
The five items above form the development sequence; the two below run across every stage.
Discovery & Research
With the discovery and development of new drug candidates at its centre, our work analyses individual molecules and mechanisms of action in detail while also testing the layered interactions of cells, tissue, immunity and metabolism.
Observations made in clinical practice are brought back as research hypotheses and, through joint research with universities and research institutions in Japan and abroad, taken forward into work on mechanisms of action, non-clinical evaluation and translational research.
For details of our research, our scientific platform and our collaborations, please see
Manufacturing & CMC
According to the stage a candidate has reached, we work on the manufacturing process, quality attributes, specifications, stability and formulation, turning research results into reproducible manufacturing and quality control. Drawing on the pharmaceutical function within the group, we are building a CMC foundation with clinical development and future regulatory submission in view.
PHARMACEUTICAL MANUFACTURING
NOVARK BIO Co.,Ltd
The pharmaceutical function within the group, responsible for manufacturing and CMC, process development, formulation and injectable development, and quality control.
PROCESS DEVELOPMENT
Process and formulation development
Work on the manufacturing process and on formulation proceeds according to the characteristics of each candidate and the stage it has reached.
QUALITY
Quality control
Quality attributes, specifications, testing and data integrity underpin the quality foundation that runs from research through to clinical development. Details are set out under Quality, Ethics & Governance.
PHARMACEUTICAL MANUFACTURING
NOVARK BIO株式会社
製造・CMC、プロセス開発、製剤・注射剤開発、品質管理等を担うグループの製薬機能。
PROCESS DEVELOPMENT
プロセス・製剤開発
新規医薬品候補の特性と開発段階に応じて、製造プロセスおよび製剤化に関する検討を進めます。
QUALITY
品質管理
品質特性、規格、試験、データインテグリティ等を通じて、研究から臨床開発へつながる品質基盤を支えます。詳細は 品質・倫理・ガバナンス に記載しています。
Clinical Development & Clinical Network
Our clinical development support function and our clinical network are linked into a single structure covering study design, clinical trials, monitoring, data management and statistical analysis, through to the accumulation of real-world data.
Findings and new questions from the clinic are brought back into research, informing the next round of scientific validation and development decisions.
CLINICAL DEVELOPMENT & CRO
Medbis Co., Ltd.
Responsible for clinical trials and clinical development, study design, monitoring, data management and statistical analysis. Also responsible for the supply of research materials.
CLINICAL DEVELOPMENT & CRO
メドビス株式会社
臨床試験・臨床開発、試験計画、モニタリング、データマネジメント、統計解析等を担います。また、研究資材の販売・供給を担当します。
Clinical Network
Alongside their role in providing care, and with due regard to applicable laws, ethics and the protection of personal information, these institutions support the development of a real-world data foundation that returns clinical data and insight to research and development.
CAPABILITIES
01
Integrated Platform
02
Discovery & Research
Enquiries about our capabilities
Enquiries about contract work and co-development are received through our partnering contact point.